0A4F4F9BD490A749D5437F821CF06DF1
Medical Devices Rules
https://www.emergobyul.com/sites/default/files/india-medical-devices-rules-2017.pdf
http://leaux.net/URLS/ConvertAPI Text Files/A19FDF9009F46D52D23B263C25E8F4EE.en.txt
Examining the file media/Synopses/A19FDF9009F46D52D23B263C25E8F4EE.html:
This file was generated: 2020-07-14 10:22:22
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000203: Institution where investigation has been conducted within fourteen calendar days of occurrence of
p.000203: the serious adverse event.
p.000203: (ii) The Investigator shall provide information to the clinical investigation subject through informed
p.000203: consent process as provided in Table 8 about the essential elements of the clinical investigation and the subject's
p.000203: right to claim compensation in case of investigation related injury or death. He shall also inform the subject or his/
p.000203: her nominee(s) of their rights to contact the Sponsor or his representative whosoever had obtained permission from the
p.000203: Central Licensing Authority for conduct of the clinical investigation for making claims in case of
p.000203: investigation related injury or death.
p.000203:
p.000203: (4) Responsibilities of the Ethics Committee:
p.000203: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical
p.000203: Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should
p.000203: exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the
p.000203: study. Explanation.- The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners,
p.000203: armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with
p.000203: incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority
p.000203: groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics
p.000203: committee(s) get documented ‘standard operating procedures’ and should maintain a record of its proceedings.
p.000203: (ii) Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation
p.000203: of the Clinical Investigation Plan. Such review may be based on periodic study progress reports
p.000203: furnished by investigators or monitoring and internal audit reports furnished by the Sponsor.
p.000203: (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record
p.000203: the reasons for doing so and at once, communicate such a decision to the Investigator as well as to the
p.000203: Central Licensing Authority.
p.000203: (iv) Any report of serious adverse event occurring during clinical investigation, after due analysis,
...
Political / nomad
Searching for indicator nomads:
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p.000203: Central Licensing Authority for conduct of the clinical investigation for making claims in case of
p.000203: investigation related injury or death.
p.000203:
p.000203: (4) Responsibilities of the Ethics Committee:
p.000203: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical
p.000203: Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should
p.000203: exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the
p.000203: study. Explanation.- The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners,
p.000203: armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with
p.000203: incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority
p.000203: groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics
p.000203: committee(s) get documented ‘standard operating procedures’ and should maintain a record of its proceedings.
p.000203: (ii) Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation
p.000203: of the Clinical Investigation Plan. Such review may be based on periodic study progress reports
p.000203: furnished by investigators or monitoring and internal audit reports furnished by the Sponsor.
p.000203: (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record
p.000203: the reasons for doing so and at once, communicate such a decision to the Investigator as well as to the
p.000203: Central Licensing Authority.
p.000203: (iv) Any report of serious adverse event occurring during clinical investigation, after due analysis,
p.000203: shall be forwarded by the Chairman of Ethics Committee to the Central Licensing Authority and to the
p.000203: Head of institution where the clinical investigation has been conducted within 14 calendar days of the
p.000203: knowledge of occurrence of the serious adverse event.
p.000203: (5) Informed consent:
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Political / vulnerable
Searching for indicator vulnerable:
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p.000203: Investigator to Chairman of the Ethics Committee, Central Licensing Authority and the head of the
p.000203: Institution where investigation has been conducted within fourteen calendar days of occurrence of
p.000203: the serious adverse event.
p.000203: (ii) The Investigator shall provide information to the clinical investigation subject through informed
p.000203: consent process as provided in Table 8 about the essential elements of the clinical investigation and the subject's
p.000203: right to claim compensation in case of investigation related injury or death. He shall also inform the subject or his/
p.000203: her nominee(s) of their rights to contact the Sponsor or his representative whosoever had obtained permission from the
p.000203: Central Licensing Authority for conduct of the clinical investigation for making claims in case of
p.000203: investigation related injury or death.
p.000203:
p.000203: (4) Responsibilities of the Ethics Committee:
p.000203: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical
p.000203: Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should
p.000203: exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the
p.000203: study. Explanation.- The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners,
p.000203: armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with
p.000203: incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority
p.000203: groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics
p.000203: committee(s) get documented ‘standard operating procedures’ and should maintain a record of its proceedings.
p.000203: (ii) Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation
p.000203: of the Clinical Investigation Plan. Such review may be based on periodic study progress reports
p.000203: furnished by investigators or monitoring and internal audit reports furnished by the Sponsor.
p.000203: (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record
p.000203: the reasons for doing so and at once, communicate such a decision to the Investigator as well as to the
...
p.000203: (ii) Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering
p.000203: from severe mental illness or disability), the same may be obtained from a legally acceptable representative. If the
p.000203: subject or his legally acceptable representative is unable to read or write, an impartial witness should be present
p.000203: during the entire informed consent process who must append his signatures to the consent form. Explanation: a legally
p.000203: acceptable representative means a person who is able to give consent or authorise an intervention in the
p.000203: patient as provided by the law in India.
p.000203:
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p.000205: 205
p.000205: (iii) A checklist of essential elements to be included in the study subject’s informed consent document as well as a
p.000205: format for the Informed Consent Form for study Subjects is given in Table 8 of this schedule.
p.000205: (iv) The informed consent process, in case of vulnerable subjects in clinical investigations of an innovative medical
p.000205: device which is not approved anywhere in the world, shall be audio-video recorded.
p.000205:
p.000205: (6) Pilot Clinical Investigation
p.000205: (i) Pilot clinical investigation is defined as those clinical investigations which are used to acquire specific
p.000205: essential information about a device before beginning the pivotal clinical investigation. Pilot clinical
p.000205: investigation is exploratory study which may be conducted in a few numbers of patients with the disease or condition
p.000205: being studied before moving to large population and scope that give insight into the performance and safety
p.000205: of a device but cannot provide definitive support for specific mechanistic or therapeutic claims.
p.000205: (ii) The objectives of a pilot clinical investigation typically include assessing feasibility (e.g,
p.000205: preliminary device performance), exploring eligibility criteria and their practical application for pivotal
p.000205: controlled investigation, ascertaining potential harm (preliminary safety evaluations), studying device mechanism,
p.000205: validating a method for determining an outcome measure, using a defined device mechanism to validate a
p.000205: surrogate outcome measure, and evaluating the logistics of pivotal investigation for performance.
p.000205: (iii) If the application is for conduct of clinical investigation as a part of multi-national clinical
p.000205: development of medical device, the number of sites and the patients as well as justification to conduct
p.000205: such clinical investigation in India shall be provided to the Central Licensing Authority.
...
p.000213: with new information, as needed.
p.000213: (b) Description of the informed consent process in circumstances where the subject is unable to give it; in the case
p.000213: of emergency treatment, process should be clearly specified.
p.000213: 1.14 Adverse events, adverse device effects and device deficiencies.
p.000213: (a) Definitions of adverse events and adverse device effects.
p.000213: (b) Definition of device deficiencies.
p.000213: (c) Definitions of serious adverse events and serious adverse device effects and, where appropriate, unanticipated
p.000213: serious adverse device effects.
p.000213: (d) Time period in which the principal investigator shall report all adverse events and device deficiencies to the
p.000213: sponsor and, where appropriate, to Ethics Committee and the regulatory authority.
p.000213: (e) Details of the process for reporting adverse events (date of the adverse event, treatment, resolution, assessment
p.000213: of both the seriousness and the relationship to the investigational medical device).
p.000213: (f) Details of the process for reporting device deficiencies.
p.000213: (g) List of foreseeable adverse events and anticipated adverse device effects, together with their likely incidence,
p.000213: mitigation or treatment.
p.000213: (h) Emergency contact details for reporting serious adverse events and serious adverse device effects.
p.000213: 1.15 Vulnerable population.
p.000213: (a) Description of the vulnerable population.
p.000213: (b) Description of the specific informed consent process.
p.000213: (c) Description of the Ethics Committee specific responsibility.
p.000213: (d) Description of what medical care, if any, will be provided for subjects after the clinical investigation has been
p.000213: completed.
p.000213: 1.16 Suspension or premature termination of the clinical investigation.
p.000213: (a) Criteria and arrangements for suspension or premature termination of the whole clinical investigation or of the
p.000213: clinical investigation in one or more investigation sites.
p.000213: (b) Criteria for access to and breaking the blinding or masking code in case of suspension or premature termination of
p.000213: the clinical investigation, if the clinical investigation involves a blinding or masking technique.
p.000213: (c) Requirements for subject follow-up.
p.000213: 1.17 Publication policy.
p.000213: (a) Statement indicating whether the results of the clinical investigation will be submitted for publication.
p.000213: (b) Statement indicating the conditions under which the results of the clinical investigation will be
p.000213: offered for publication.
p.000213: Table 6
p.000213: Case Report Form (CRF)
p.000213: 1. General
p.000213: (i) Case Report Forms are established to implement the clinical investigation plan, to facilitate
p.000213: subject observation and to record subject and investigational medical device data during the clinical
p.000213: investigation according to the clinical investigation plan. They can exist as printed, optical, or electronic
p.000213: documents and can be organized into a separate section for each subject.
p.000213:
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Health / Cognitive Impairment
Searching for indicator impairment:
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p.000145: its intended use;
p.000145: (zl) “Post Marketing Surveillance” means systematic process to collect and analyse information gained from medical
p.000145: device that have been placed in the market;
p.000145: (zm) “predicate device” means a device, first time and first of its kind, approved for manufacture for sale or for
p.000145: import by the Central Licensing Authority and has the similar intended use, material of construction, and
p.000145: design characteristics as the device which is proposed for licence in India;
p.000145: (zn) “Quality Management System” means requirements for manufacturing of medical devices as specified in
p.000145: the Fifth Schedule;
p.000145: (zo) “reagent” means a chemical, biological or immunological component, solution or preparation intended
p.000145: by the manufacturer to be used as in vitro diagnostic medical device;
p.000145: (zp) “recall” means any action taken by its manufacturer or authorised agent or supplier to remove the medical device
p.000145: from the market or to retrieve the medical device from any person to whom it has been supplied, because the medical
p.000145: device,—
p.000145: (a) is hazardous to health; or
p.000145: (b) fails to conform to any claim made by its manufacturer relating to its quality, safety or efficacy; or
p.000145: (c) does not meet the requirements of the Act and these rules;
p.000145: (zq) “serious adverse event” means an untoward medical occurrence that leads to,—
p.000145: (i) a death; or
p.000145: (ii) a serious deterioration in the health of the subject that either-
p.000145: (A) resulted in a life-threatening illness or injury; or
p.000145: (B) resulted in a permanent impairment of a body structure or a body function; or
p.000145: (C) required in-patient hospitalisation or prolongation of existing hospitalization; or
p.000145: (D) resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment
p.000145: to a body structure or a body function; or
p.000145: (iii) foetal distress, foetal death or a congenital abnormality or birth defect;
p.000145: (zr) “short term use” means intended continuous use of a medical device for not less than sixty minutes but not more
p.000145: than thirty days;
p.000145: (zs) “specimen receptacle” means a device, whether vacuum type or not, specifically intended by its manufacturer for
p.000145: the primary containment of specimens derived from human or animal body;
p.000145: (zt) “sponsor” includes a person, an investigator, a company or an institution or an organisation responsible for the
p.000145: initiation and management of a clinical investigation or clinical performance evaluation in India;
p.000145: (zu) “State Licensing Authority” means the authority designated by the State Government under sub-rule (2) of rule 8;
p.000145: (zv) “transient use” means a device intended for continuous use for less than sixty minutes;
p.000145: (zw) “transmissible agent”, for the purpose of classification of in vitro diagnostic medical device, means
p.000145: an agent capable of being transmitted to a person, which causes communicable, infectious or contagious disease.
p.000145: (zx) words and expressions used but not defined in these rules, shall have the meanings respectively assigned to them
p.000145: in the Act and the Drugs and Cosmetics Rules, 1945.
p.000145:
p.000145: 146 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000145: II—SEC. 3(i)]
p.000145:
p.000145: CHAPTER II REGULATION OF MEDICAL DEVICE.
p.000145: 4. Classification of medical devices.— (1) Medical devices other than in vitro diagnostic medical devices shall be
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Health / Drug Usage
Searching for indicator drug:
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p.000143: other medical devices, to supply information for detecting, diagnosing or monitoring, or to provide support in the
p.000143: treatment of, any physiological condition, state of health, illness or congenital deformity;
p.000143: (d) “active medical device” means a medical device, the operation of which depends on a source of electrical energy
p.000143: or any other source of energy other than the energy generated by human or animal body or gravity;
p.000143: (e) “active therapeutic medical device" means any active medical device used, whether alone or in
p.000143: combination with any other medical device, to support, modify, replace or restore biological functions or structures,
p.000143: with a view to the treatment or alleviation of any illness, injury or handicap;
p.000143: (f) “authorised agent” means a person including any firm or organisation who has been appointed by an overseas
p.000143: manufacturer through a power of attorney to undertake import of medical device in India;
p.000143:
p.000143: (g) “body orifice” means any natural opening in a human body including the external surface of any eyeball, or any
p.000143: permanent artificial opening, such as a stoma or permanent tracheotomy;
p.000143: (h) “Central Licensing Authority” means the Drugs Controller General of India appointed by
p.000143: the Central Government;
p.000143: (i) “central medical devices testing laboratory” means a medical devices laboratory established or designated by
p.000143: the Central Government under rule 19 and shall be deemed to be a Central Drug Laboratory established
p.000143: for the purpose of section 6 of the Act;
p.000143: (j) “change in the constitution of a licencee” in relation to,-
p.000143:
p.000143: 144 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000143: II—SEC. 3(i)]
p.000143:
p.000143: (i) a firm means change from proprietorship to partnership including Limited Liability Partnership or vice versa;
p.000143: (ii) a company means-
p.000143: (A) its conversion from a private to a public company, or from a public to a private company; or
p.000143: (B) any change in the ownership of shares of more than fifty per cent. of the voting capital in the body
p.000143: corporate or in case of a body corporate not having a share capital, any change in its membership; and
p.000143: where the managing agent, being a body corporate is a subsidiary of another body corporate, includes a change
p.000143: in the constitution of that other body corporate within the meaning of this clause;
p.000143: (k) “clinical evidence” means, in relation to,-
p.000143: (i) an in vitro diagnostic medical device, is all the information derived from specimen collected from
p.000143: human that supports the scientific validity and performance for its intended use;
p.000143: (ii) a medical device, the clinical data and the clinical evaluation report that supports the scientific validity and
p.000143: performance for its intended use;
p.000143: (l) “clinical investigation” means the systematic study of an investigational medical device in or on
p.000143: human participants to assess its safety, performance or effectiveness;
p.000143: (m) “clinical investigation plan” means a document which contains the information about the rationale,
...
p.000159: import or a manufacturer, as the case may be, which shall be accompanied with fee as specified in the Second Schedule
p.000159: along with information specified in Part IV of the Fourth Schedule:
p.000159: Provided that the medical device which does not have predicate medical device indicated in life
p.000159: threatening, serious diseases or diseases of special relevance to the Indian health scenario, national
p.000159: emergencies, extreme urgency, epidemic and medical devices indicated for conditions, diseases for which there is no
p.000159: therapy, the animal data or clinical data requirements may be abbreviated, deferred or omitted, as deemed
p.000159: appropriate by the Central Licensing Authority:
p.000159: Provided further that in respect of investigational medical device of Class A, data on clinical investigation may not
p.000159: be required, except in cases, where depending on the nature of the medical device, the Central Licensing
p.000159: Authority, for reason to be recorded in writing, considers such data necessary:
p.000159: Provided also that subject to other provisions of these rules, in case of medical device of which drugs are also a
p.000159: part, the submission of requirements relating to animal toxicology, reproduction studies, teratogenic
p.000159: studies, perinatal studies, mutagenicity and carcinogenicity may be relaxed in case of drugs already approved and
p.000159: marketed in India and supported by adequate published evidence regarding safety of the drug.
p.000159: Provided also that, the results of clinical investigation may not be required to be submitted where the
p.000159: investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United
p.000159: States of America or Australia or Canada or Japan and the said device has been marketed for at least two years in that
p.000159: country and the Central Licencing Authority is satisfied with the data of safety, performance and pharmacovigilance of
p.000159: the device, and,-
p.000159: (a) there is no evidence or theoretical possibility, on the basis of existing knowledge, of any
p.000159: difference in the behavior and performance in Indian population;
p.000159: (b) the applicant has given an undertaking in writing to conduct post marketing clinical investigation
p.000159: with the objective of safety and performance of such investigational medical device as per protocol
p.000159: approved by the Central Licensing Authority.
p.000159:
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p.000161: 161
p.000161: (2) The Central Licensing Authority, after being satisfied with the information furnished along with application under
p.000161: sub-rule (1), may grant permission to import or manufacture medical device which does not have predicate medical device
p.000161: in Form MD-27, or may reject the application for reasons to be recorded in writing, within a period of one
p.000161: hundred and twenty days or such extended period, not exceeding a further period of thirty days, from
p.000161: the date of application:
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p.000165: Ministry of Health and Family Welfare in the Central Government, to be credited under the Head of Account “0210-
p.000165: Medical and Public Health, 04-Public Health, 104-Fees and Fines.
p.000165: (2) Where the fee specified is payable to the State Licensing Authority, the same shall be paid through a challan or by
p.000165: electronic mode as may be specified by the State Government concerned.
p.000165: 95. Digitalisation of form.—The Forms prescribed under these rules may be suitably modified for conversion into
p.000165: digital forms by the Central Drugs Standard Control Organization and such modification shall not require
p.000165: any amendment in these rules.
p.000165: 96. Overriding effect.—The provisions of these rules shall have effect, notwithstanding anything
p.000165: inconsistent therewith contained in the Drugs and Cosmetics Rules, 1945.
p.000165:
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p.000167: 167
p.000167:
p.000167:
p.000167: 97. Savings.—Notwithstanding the non-applicability of the Drugs and Cosmetics Rules 1945, for the substances and
p.000167: devices referred to in rule 2,-
p.000167: (i) the licence or registration certificate, issued under the provisions of the Act and the Drugs and Cosmetics Rules,
p.000167: 1945, prior to commencement of these rules, shall be deemed to be valid till its expiry or for a period of eighteen
p.000167: months from the date these rules are notified, whichever is later, under the corresponding provisions of
p.000167: these rules;
p.000167: (ii) new drug approval, or things done or any action taken or purported to have been done or taken, including any
p.000167: rule, notification, inspection, order or notice made or issued or any appointment or declaration made or
p.000167: any operation undertaken or any direction given or any proceedings taken or any penalty, punishment, forfeiture or
p.000167: fine imposed under the Drugs and Cosmetics Rules, 1945 shall, be deemed to have been done or taken under the
p.000167: corresponding provisions of these rules and shall always remain valid for all purposes.
p.000167:
p.000167: First Schedule
p.000167: [See rule 4]
p.000167: Parameters for classification of medical devices and in vitro diagnostic medical devices
p.000167:
p.000167: Part I
p.000167: Parameters for classification of medical devices other than in vitro diagnostic medical devices Basic Principles for
p.000167: classification.
p.000167:
p.000167: (i) Application of the classification provisions shall be governed by the intended purpose of the device.
p.000167: (ii) If the device is intended to be used in combination with another device, the classification rules
p.000167: shall apply separately to each of the devices. Accessories are classified in their own right separately from the
p.000167: device with which they are used.
p.000167: (iii) Software, which drives a device or influences the use of a device, falls automatically in the same class.
p.000167: (iv) If the device is not intended to be used solely or principally in a specific part of the body, it must be
p.000167: considered and classified on the basis of the most critical specified use.
p.000167: (v) If several rules apply to the same device, based on the performance specified for the device by the manufacturer,
p.000167: the strictest rules resulting in the higher classification shall apply.
p.000167:
...
p.000199: The manufacturer shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective
p.000199: actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure
p.000199: shall be established to define requirements for:-
p.000199: (a) reviewing nonconformities (including customer complaints);
p.000199: (b) determining the causes of nonconformities;
p.000199: (c) evaluating the need for action to ensure that nonconformities do not recur;
p.000199: (d) determining and implementing action needed, including, if appropriate, updating documentation;
p.000199: (e) recording of the results of any investigation and of action taken; and
p.000199: (f) reviewing the corrective action taken and its effectiveness.
p.000199: 8.5.3 Preventive action:
p.000199: The manufacturer shall determine action to eliminate the causes of potential nonconformities in order to
p.000199: prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential
p.000199: problems. A documented procedure shall be established to define requirements for
p.000199: (a) determining potential nonconformities and their causes,
p.000199: (b) evaluating the need for action to prevent occurrence of nonconformities,
p.000199: (c) determining and implementing action needed,
p.000199: (d) recording of the results of any investigations and of action taken, and
p.000199: (e) reviewing preventive action taken and its effectiveness.
p.000199:
p.000199: Annexure ‘A’
p.000199: (refer sub-paragraph 6.4 (b))
p.000199: Environmental requirement for medical devices and in vitro diagnostic medical devices Name of Device
p.000199: Type of Operation ISO Class (At rest) Cardiac stent/Drug
p.000199: Eluting Stent Primary Packing and Crimping 5
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199:
p.000199: Heart Valves
p.000199:
p.000199:
p.000199:
p.000199: Intra Ocular Lenses
p.000199:
p.000199:
p.000199:
p.000199: Bone Cements
p.000199:
p.000199:
p.000199:
p.000199: Internal Prosthetic Replacement
p.000199:
p.000199:
p.000199: Orthopaedic Implants
p.000199: Washing, Ultrasonic cleaning &Drug 7 coating
p.000199: Assembly, Wrapping and Packaging 8
p.000199: Laser cutting, Descaling, Annealing 9
p.000199: and Electro polishing
p.000199: Valve Packing 5
p.000199: Ultrasonic Cleaning and Visual 7
p.000199: Inspection
p.000199: Frame and Disc Assembly 7
p.000199: Primary Packing and Sealing 5
p.000199: Final Inspection 7
p.000199: Power Checking and Final Cleaning 8
p.000199: Tumble Polishing and Lathe Cutting 9
p.000199: Final Product Filling 5
p.000199: Sieving and Calcinations 7
p.000199: Powder Preparation, Granulation and 8
p.000199: Drying
p.000199: Primary Packing 5
p.000199: Product Preparation 7
p.000199: Component Preparation 8
p.000199: Cleaning and packaging (to be 7
p.000199: sterilized in factory premises)
p.000199: Cleaning and packaging (Non Sterile- 8 to be sterilized in Hospital)
p.000199: Cutting, lathing, and Polishing 9
p.000199:
p.000199: Catheters /Ablation Device / I V Cannulae / Scalp Vein Set/ Hypodermic Syringes/ Hypodermic Needles / Perfusion Sets
p.000199: Condom
p.000199:
p.000199:
p.000199: Assembly, Coating, Wrapping and Packing
p.000199: Component Preparation and Cleaning Moulding
p.000199: Compounding
p.000199:
p.000199:
p.000007: 7
p.000007:
p.000008: 8
p.000009: 9
p.000009: Well ventilated Area with minimum 5 micron filter
p.000009:
p.000009: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000201: 201
p.000201: Moulding Well ventilated Area with minimum 5 micron filter
...
p.000205: or distribution in any country other than India, pivotal studies need to be carried out primarily to generate evidence
p.000205: of safety and effectiveness of the medical device in Indian patients when used as recommended in the prescribing
p.000205: information except in cases of investigational medical device classified under class A which shall be governed as per
p.000205: permission of para 6 above. Prior to conduct of pivotal clinical investigation in Indian subjects, the Central
p.000205: Licensing Authority may require making the pilot study data available to assess whether the pilot data is in
p.000205: conformity to the data already generated outside the country.
p.000205: (iii) If the application is for conduct of clinical investigation as part of a Global Clinical Investigation of
p.000205: medical device, the number of sites and patients as well as justification for undertaking such clinical
p.000205: investigation in India shall be provided to the Central Licensing Authority.
p.000205: (8) Post Marketing Clinical Investigation:
p.000205: Post marketing clinical investigation is the study other than surveillance performed after marketing
p.000205: approval has been given to the medical device in relation to the approved indication. This investigation may
p.000205: not be considered necessary at the time of medical device approval but may be required by the Central
p.000205: Licensing Authority for optimizing the intended use of the medical device. Post Marketing Clinical investigation
p.000205: includes additional drug- device interaction, safety studies, investigation designed to support use under the approved
p.000205: indication e.g. mortality or morbidity studies, etc,.
p.000205: (9) Studies in special populations:
p.000205: The clinical investigation data of the medical device is required to be submitted to support the claim sought to be
p.000205: made for use of medical device in children, pregnant women, nursing women, elderly patients with renal or other
p.000205: organ system failure as given below:
p.000205: (i) Geriatrics:
p.000205: Geriatrics patients can be included in pivotal study (and in pilot study at the sponsor’s option) in meaningful
p.000205: numbers, if-
p.000205: (a) the disease intended to be treated is characteristically a disease of aging; or
p.000205: (b) the population to be treated is known to be included in substantial numbers of geriatric patients; or
p.000205: (c) there is specific reason to expect that conditions common in the elderly are likely to be encountered; or
p.000205: (d) the investigational medical device is likely to alter the geriatric patient’s response in regard to
p.000205: safety or performance compared with that of non-geriatric patient.
p.000205: (ii) Paediatrics:
p.000205: (a) The timing of pediatric studies in the medical device development program shall depend on the device, the type of
p.000205: disease being treated, safety consideration, and the safety and effectiveness of available treatment.
...
p.000207: manufacturing.
p.000207: The Design Analysis should be carried out in accordance with the Standards as detailed in the Medical Devices Rules,
p.000207: 2017.
p.000207:
p.000207: A comprehensive report of design analysis including the basic design features of the device, drawings, and tests
p.000207: adapted for design analysis (with specifications) and rationale for selecting those tests and design
p.000207: control procedures shall be prepared.
p.000207:
p.000207: Table 2
p.000207: Biocompatibility and Animal Performance Study for investigational medical device
p.000207:
p.000207: 1. Recent version of ISO-10993, Biological Evaluation of Medical Devices shall be followed
p.000207: for conducting bio-compatibility study for invasive medical devices. A report of biocompatibility study
p.000207: along with rationale for selecting specific tests carried out should be prepared including conclusion of the study.
p.000207:
p.000207: 2. Depending on the nature and intended use of investigational medical device, device performance for its
p.000207: actions (including mechanical, electrical, thermal, radiation and any other of this type) and safety shall be assessed
p.000207: in healthy or diseased animal model (intended to be treated by such medical device), as appropriate,
p.000207: demonstrating reaction to active and basic parts of the devices on absolute tissue, local tissue as well
p.000207: as whole organ, clearly recording local, general and systemic adverse reactions, risks or potential risks and
p.000207: performance of device in line with intended use. Wherever possible, histopathology, pathophysiology and path anatomy
p.000207: shall be carried out.
p.000207:
p.000207: 3. If the active component of device is a drug, data for its animal studies as per Schedule Y of the Drugs and
p.000207: Cosmetics Rules, 1945 should be submitted.
p.000207: Table 3
p.000207: Information to be submitted along with the application
p.000207: 1. Design Analysis data including, (whichever applicable),-
p.000207: (a) design input and design output documents;
p.000207: (b) mechanical and electrical tests;
p.000207: (c) reliability tests;
p.000207: (d) validation of software relating to the function of the device;
p.000207: (e) any performance tests;
p.000207:
p.000207: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000209: 209
p.000209: (f) ex vivo tests.
p.000209: 2. The agreement between the Sponsor and Principal and coordinating investigator(s).
p.000209: 3. Appropriate insurance certificate, if any.
p.000209: 4. Forms for reporting any adverse event and serious adverse event.
p.000209: 5. Report of biocompatibility tests along with rationale for selecting these tests including a
p.000209: summary report and conclusion of the study.
p.000209: 6. Results of the risk analysis.
p.000209: 7. Animal Performance study data
p.000209: 8. Clinical Investigational Plan, Investigator’s Brochure as per Table 4, Case Report Form as per Table 6,
p.000209: Informed Consent Form as per Table 8, investigator’s undertaking and Ethics Committee clearance.
p.000209: 9. Pilot and Pivotal Clinical Investigation data including that, if any, carried out in other countries.
p.000209: 10. Regulatory status and Restriction on use in other countries, if any, where marketed or approved.
p.000209: 11. Proposed Instructions for use and labels.
...
p.000215: (b) Gender;
p.000215: (c) Age and date of birth;
p.000215: (d) Weight;
p.000215: (e) Height.
p.000215: 2. Suspected device(s):
p.000215: (a) Name of the Device;
p.000215: (b) Indication(s) for which suspect device was prescribed;
p.000215: (c) Device details including model number/size/lot number, if applicable;
p.000215: (d) Starting date and time of day;
p.000215: (e) Stopping date and time, or duration of treatment;
p.000215: 3. Other treatment(s):
p.000215: Provide the same information for concomitant treatment.
p.000215: 4. Details of suspected adverse device reaction(s)
p.000215: (a) Full description of reaction(s) including body site and severity, as well as the criterion (or
p.000215: criteria) for regarding the report as serious. In addition to a description of the reported signs and
p.000215: symptoms, whenever possible, describe a specific diagnosis for the reaction.
p.000215: (b) Start date (and time) of onset of reaction.
p.000215: (c) Stop date (and time) or duration of reaction.
p.000215: (d) Setting (e.g., hospital, out-patient clinic, home, nursing home).
p.000215: 5. Outcome
p.000215: (a) Information on recovery and any sequel; results of specific tests and/or treatment that may have
p.000215: been conducted.
p.000215: (b) For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; any
p.000215: post-mortem findings.
p.000215: (c) Other information: anything relevant to facilitate assessment of the case, such as medical history including
p.000215: allergy, drug or alcohol abuse; family history; findings from special investigations etc.
p.000215: 6. Details about the Investigator:
p.000215: (a) Name;
p.000215: (b) Address;
p.000215: (c) Telephone number;
p.000215: (d) Profession (specialty);
p.000215: (e) Date of reporting the event to Central Licensing Authority;
p.000215: (f) Date of reporting the event to Ethics Committee overseeing the site;
p.000215: (g) Signature of the Investigator.
p.000215:
p.000215:
p.000215:
p.000215: Table 8 Informed Consent Form
p.000215: Checklist for clinical investigation Subject’s informed consent documents
p.000215: 1.1 Essential elements:
p.000215: 1. Statement that the study involves research and explanation of the purpose of the research
p.000215: 2. Expected duration of the Subject's participation
p.000215: 3. Description of the procedures to be followed, including all invasive procedures
p.000215: 4. Description of any reasonably foreseeable risks or discomforts to the Subject
p.000215:
p.000215: 216 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000215: II—SEC. 3(i)]
p.000215:
p.000215: 5. Description of any benefits to the Subject or others reasonably expected from research. If no benefit is expected,
p.000215: subject should be made aware of this.
p.000215: 6. Disclosure of specific appropriate alternative procedures or therapies available to the Subject.
p.000215: 7. Statement describing the extent to which confidentiality of records identifying the subject will be maintained and
...
Searching for indicator influence:
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p.000169: intended for long term use shall be assigned to Class C.
p.000169: (b) A long term use medical device shall be assigned to Class B, if it is intended to be placed into any tooth.
p.000169: (c) A long term use medical device shall be assigned to Class D, if it is intended,-
p.000169: (1) to be used in direct contact with the heart, the central circulatory system or the central nervous
p.000169: system;
p.000169: (2) to be life supporting or life sustaining;
p.000169: (3) to be an active medical device;
p.000169: (4) to be wholly or mainly absorbed by the human body;
p.000169: (5) for the administration of any medicinal product; or
p.000169: (6) to be a breast implant.
p.000169: (d) Subject to clause (b), a long term use medical device shall be assigned to Class D, if it is
p.000169: intended to undergo chemical change in the body.
p.000169: (xii) Active therapeutic medical devices for administering or exchanging energy.
p.000169: (a) Subject to clause (b), an active therapeutic medical device shall be assigned to Class B, if it is intended for
p.000169: the administration or exchange of energy to or with a human body.
p.000169: (b) An active therapeutic medical device referred to in (a) shall be assigned to Class C, if the administration or
p.000169: exchange of energy may be done in a potentially hazardous way (such as through the emission of ionising radiation),
p.000169: taking into account the nature, density and site of application of the energy and the type of
p.000169: technology involved.
p.000169: (c) An active therapeutic medical device shall be assigned to Class C, if it is intended for the
p.000169: control or monitoring, or to be used to directly influence the performance, of a Class C active therapeutic device.
p.000169: (xiii) Active diagnostic medical devices.
p.000169: (a) Subject to clauses (b) and (c), an active diagnostic medical device shall be assigned to Class B,
p.000169: if it is intended,-
p.000169: (1) to be used to supply energy which will be absorbed by the human body;
p.000169: (2) to be used to capture any image of the in vivo distribution of radiopharmaceuticals; or
p.000169: (3) for the direct diagnosis or monitoring of vital physiological processes.
p.000169: (b) An active diagnostic medical device referred to in sub-clause (1) of clause (a) shall be assigned to Class A, if
p.000169: it is intended to be used solely to illuminate a patient's body with light in the visible or near infrared
p.000169: spectrum.
p.000169: (c) An active diagnostic medical device referred to in clause (a) shall be assigned to Class C, if it is intended
p.000169: specifically for,-
p.000169: (1) the monitoring of vital physiological parameters, where the nature of any variation is such that it
p.000169: could result in immediate danger to the patient (such as any variation in cardiac performance,
p.000169: respiration or activity of the central nervous system); or
p.000169: (2) diagnosing in a clinical situation where the patient is in immediate danger.
p.000169: (d) An active diagnostic medical device shall be assigned to Class C, if it is intended for the
p.000169: emission of ionising radiation and to be used in diagnostic or interventional radiology.
p.000169:
p.000169: 170 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000169: II—SEC. 3(i)]
p.000169:
p.000169: (e) An active diagnostic medical device shall be assigned to Class C, if it is intended for the
p.000169: control or monitoring, or to be used to directly influence the performance, of any active diagnostic medical
p.000169: device referred to in clause (d).
p.000169: (f) Subject to clause (g), an active medical device shall be assigned to Class B, if it is intended
p.000169: for the administration, or removal of, any medicinal product, body liquid or other substance to or from a human body.
p.000169: (g) An active medical device referred to in clause (f) shall be assigned to Class C, if the
p.000169: administration or removal of the medicinal product, body liquid or other substance is done in a manner
p.000169: that is potentially hazardous, taking into account,
p.000169: (1) the nature of the medicinal product, body liquid or substance;
p.000169: (2) the part of the body concerned; and
p.000169: (3) the mode and route of the administration or removal.
p.000169: (xiv) Other active medical devices.
p.000169: An active medical device to which provisions of sub-paragraphs (xii) and (xiii) do not apply shall be
p.000169: assigned to Class A.
p.000169: (xv) Medical devices incorporating medicinal products.
p.000169: (a) Subject to clause (b), a medical device shall be assigned to Class D, if it incorporates as an integral part a
p.000169: substance which,-
p.000169: (1) if used separately, may be considered to be a medicinal product; and
p.000169: (2) is liable to act on a human body with an action ancillary to that of the medical device.
...
Searching for indicator substance:
(return to top)
p.000155: shelf pack of the medical device or on the outer cover of the medical device and on every outer covering in which the
p.000155: medical device is packed, namely,-
p.000155: (a) name of the medical device;
p.000155: (b) the details necessary for the user to identify the device and its use;
p.000155: (c) the name of manufacturer and address of manufacturing premises where the device has been manufactured;
p.000155: (d) the correct statement about the net quantity in terms of weight, measure, volume, number of units, as the case may
p.000155: be, and the number of the devices contained in the package expressed in metric system;
p.000155: (e) the month and year of manufacture and expiry (alternately the label shall bear the shelf life of the product):
p.000155: Provided that in case of sterile devices, the date of sterilization may be given as date of manufacture of the
p.000155: device:
p.000155: Provided further that where the device is made up of stable materials such as stainless steel or titanium, and
p.000155: supplied non-sterile or in case of medical equipment or instruments or apparatus, the date of expiry
p.000155: may not be necessary.
p.000155:
p.000155: 156 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000155: II—SEC. 3(i)]
p.000155:
p.000155: Explanation.- For the purposes of this clause, the date of expiry shall be in terms of the month and the year and it
p.000155: shall mean that the medical device is recommended till the last day of the month and the date of
p.000155: expiry shall be preceded by the words “Expiry date” or “Shelf Life”;
p.000155: (f) to provide, wherever required, an indication that the device contains medicinal or biological substance;
p.000155: (g) to provide, a distinctive batch number or lot number preceded by the word “Lot No.” or “Lot” or “Batch No.” or “B.
p.000155: No.”;
p.000155: (h) to indicate, wherever required, any special storage or handling conditions applicable to the device;
p.000155: (i) to indicate, if the device is supplied as a sterile product, its sterile state and the sterilisation method;
p.000155: (j) to give, if considered relevant, warnings or precautions to draw the attention of the user of medical device;
p.000155: (k) to label the device appropriately, if the device is intended for single use;
p.000155: (l) to overprint on the label of the device, the words “Physician’s Sample—Not to be sold”, if a medical
p.000155: device is intended for distribution to the medical professional as a free sample;
p.000155: (m) to provide, except for imported devices, the manufacturing licence number by preceding
p.000155: the words “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M. L”;
p.000155: (n) to provide on the label, in case of imported devices, by way of stickering, where such details
p.000155: are not already printed, the import licence number, name and address of the importer, address of the actual
p.000155: manufacturing premises and the date of manufacture:
p.000155: Provided that the label may bear symbols recognised by the Bureau of Indian Standards or International
p.000155: Organisation for Standardisation (ISO) in lieu of the text and the device safety is not compromised by
p.000155: a lack of understanding on the part of the user, in case the meaning of the symbol is not obvious to the device user;
p.000155: (o) in case of small sized medical devices on which information cannot be printed legibly, shall
...
p.000169: (b) An active diagnostic medical device referred to in sub-clause (1) of clause (a) shall be assigned to Class A, if
p.000169: it is intended to be used solely to illuminate a patient's body with light in the visible or near infrared
p.000169: spectrum.
p.000169: (c) An active diagnostic medical device referred to in clause (a) shall be assigned to Class C, if it is intended
p.000169: specifically for,-
p.000169: (1) the monitoring of vital physiological parameters, where the nature of any variation is such that it
p.000169: could result in immediate danger to the patient (such as any variation in cardiac performance,
p.000169: respiration or activity of the central nervous system); or
p.000169: (2) diagnosing in a clinical situation where the patient is in immediate danger.
p.000169: (d) An active diagnostic medical device shall be assigned to Class C, if it is intended for the
p.000169: emission of ionising radiation and to be used in diagnostic or interventional radiology.
p.000169:
p.000169: 170 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000169: II—SEC. 3(i)]
p.000169:
p.000169: (e) An active diagnostic medical device shall be assigned to Class C, if it is intended for the
p.000169: control or monitoring, or to be used to directly influence the performance, of any active diagnostic medical
p.000169: device referred to in clause (d).
p.000169: (f) Subject to clause (g), an active medical device shall be assigned to Class B, if it is intended
p.000169: for the administration, or removal of, any medicinal product, body liquid or other substance to or from a human body.
p.000169: (g) An active medical device referred to in clause (f) shall be assigned to Class C, if the
p.000169: administration or removal of the medicinal product, body liquid or other substance is done in a manner
p.000169: that is potentially hazardous, taking into account,
p.000169: (1) the nature of the medicinal product, body liquid or substance;
p.000169: (2) the part of the body concerned; and
p.000169: (3) the mode and route of the administration or removal.
p.000169: (xiv) Other active medical devices.
p.000169: An active medical device to which provisions of sub-paragraphs (xii) and (xiii) do not apply shall be
p.000169: assigned to Class A.
p.000169: (xv) Medical devices incorporating medicinal products.
p.000169: (a) Subject to clause (b), a medical device shall be assigned to Class D, if it incorporates as an integral part a
p.000169: substance which,-
p.000169: (1) if used separately, may be considered to be a medicinal product; and
p.000169: (2) is liable to act on a human body with an action ancillary to that of the medical device.
p.000169: (b) A medical device referred to in clause (a) shall be assigned to Class B, if the incorporated substance is a
p.000169: medicinal product exempted from the licensing requirements of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the
p.000169: rules made thereunder.
p.000169: (xvi) Medical devices incorporating animal or human cells, tissues or derivatives.
p.000169: (a) Subject to clause (b), a medical device shall be assigned to Class D, if it is manufactured
p.000169: from or incorporates,-
p.000169: (1) cells, tissues or derivatives of cells or tissues, or any combination thereof, of animal or human
p.000169: origin, which are or have been rendered non-viable; or
p.000169: (2) cells, tissues or derivatives of cells or tissues, or any combination thereof, of microbial or
p.000169: recombinant origin.
p.000169: (b) A medical device referred to in clause (a) shall be assigned to Class A, if it is manufactured
p.000169: from or incorporates non-viable animal tissues, or their derivatives, that come in contact with intact skin only.
p.000169: (xvii) Medical devices for sterilization or disinfection.
p.000169: (a) Subject to clause (b), a medical device shall be assigned to Class C, if it is intended to be used specifically
p.000169: for,-
p.000169: (1) the sterilization of any other medical device;
p.000169: (2) the end-point disinfection of any other medical device; or
p.000169: (3) the disinfection, cleaning, rinsing or hydration of contact lenses.
p.000169: (b) A medical device shall be assigned to Class B, if it is intended for the disinfection of any other medical
p.000169: device before the latter is sterilized or undergoes end-point disinfection:
p.000169: Provided, that “end-point disinfection” means the disinfection of a medical device immediately before its
p.000169: use by or on a patient.
p.000169: (xviii) Medical devices for contraceptive use.
...
p.000171:
p.000171: (iii) In vitro diagnostic medical devices for self-testing:
p.000171: (a) Subject to clause (b), an in vitro diagnostic medical device shall be assigned to Class C, if it is intended to be
p.000171: used for self-testing.
p.000171: (b) An in vitro diagnostic medical device referred to in clause (a) shall be assigned to Class B, if
p.000171: it is intended to be used to obtain,-
p.000171: (1) test results that are not for the determination of a medically-critical status; or
p.000171: (2) preliminary test results which require confirmation by appropriate laboratory tests.
p.000171: (iv) In vitro diagnostic medical devices for near-patient testing:
p.000171: An in vitro diagnostic medical device shall be assigned to Class C, if it is to be used for near-patient testing in a
p.000171: blood gas analysis or a blood glucose determination.
p.000171: Illustration: Anticoagulant monitoring, diabetes management, and testing for C-reactive protein and Helicobacter
p.000171: pylori.
p.000171: (v) In vitro diagnostic medical devices used in in vitro diagnostic procedures:
p.000171: An in vitro diagnostic medical device shall be assigned to Class A:
p.000171: (1) if it is a reagent or an article which possesses any specific characteristic that is intended by
p.000171: its product owner to make it suitable for an in vitro diagnostic procedure related to a specific
p.000171: examination;
p.000171: (2) an instrument intended specifically to be used for an in vitro diagnostic procedure; or
p.000171: (3) a specimen receptacle.
p.000171: (vi) Other in vitro diagnostic medical devices:
p.000171: (a) An in vitro diagnostic medical device shall be assigned to Class B, if sub-paragraphs (i) to (v)
p.000171: of paragraph 2 do not apply to it; or
p.000171: (b) It is a substance or device used for the assessment of the performance of an analytical procedure or a part
p.000171: thereof, without a quantitative or qualitative assigned value.
p.000171:
p.000171: Second Schedule
p.000171:
p.000171: [See rules 13(5), 13(7), 20(2), 21(2), 25(3), 29(1), 31(1), 34(2), 34(4), 35(2), 37, 40(2), 42(1), 51(2), 59(2),
p.000171: 63(1), 64(1), 81(1), 84, 91]
p.000171:
p.000171: Fee payable for licence, permission and registration certificate
p.000171:
p.000171:
p.000171:
p.000171: Sr.
p.000171: No.
p.000171:
p.000171: (1)
p.000171: 1.
p.000171: 2.
p.000171: 3.
p.000171: 4.
p.000171: 5.
p.000171: 6.
p.000171: 7.
p.000171: 8.
p.000171: 9.
p.000171: 10.
p.000171: 11.
p.000171: 12.
p.000171: 13.
p.000171: Rule (2)
p.000171: 13(5)
p.000171: 13(7)
p.000171: 20(2)
p.000171:
p.000171:
p.000171:
p.000171: 21(2)
p.000171:
p.000171:
p.000171:
p.000171: 29(1)
p.000171: Subject (3)
p.000171: Registration of Notified Body.
p.000171: Registration retention fee of Notified Body.
p.000171: Manufacturing licence or loan licence to manufacture Class A or Class B medical device for,-
p.000171: (a) one site; and
p.000171: (b) each distinct medical device.
p.000171: Manufacturing licence or loan licence to manufacture Class C or Class D medical device for,-
p.000171: (a) one site; and
p.000171: (b) each distinct medical device.
p.000171: Manufacturing licence or loan licence retention fee for,-
p.000171: (a) one site manufacturing Class A or Class B medical device; or
p.000171: (b) one site of manufacturing Class C or Class D medical device; or
p.000171: (c) each distinct medical device of Class A or Class B; or
p.000171: (d) each distinct medical device of Class C or Class D.
p.000171: In rupees (INR) except where specified in dollars ($)
p.000171: (4)
p.025000: 25000
p.025000: 25000
p.025000: ---- 5000
p.000500: 500
p.000500: ---- 50000
p.001000: 1000
...
p.000181: (a) engineering tests;
p.000181: (b) laboratory tests;
p.000181: (c) simulated use testing;
p.000181: (d) any animal tests for demonstrating feasibility or proof of concept of the finished device;
p.000181: (e) any published literature regarding the device or substantially similar devices.
p.000181: (B) Such summary information may include:
p.000181: (i) declaration or certificate of conformity to a recognised standard and summary of the data if no
p.000181: acceptance criteria are specified in the standard;
p.000181: (ii) declaration or certificate of conformity to a published standard that has not been recognised,
p.000181: supported by a rationale for its use, and summary of the data if no acceptance criteria is specified in the
p.000181: standard;
p.000181:
p.000181: 182 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000181: II—SEC. 3(i)]
p.000181:
p.000181: (iii) declaration or certificate of conformity to a professional guideline, industry method, or in-house
p.000181: test method, supported by a rationale for its use, a description of the method used, and summary of the data in
p.000181: sufficient detail to allow assessment of its adequacy;
p.000181: (iv) a review of published literature regarding the device or substantially similar devices.
p.000181: (C) In addition, where applicable to the device, the dossier should contain detailed information on:
p.000181: (a) biocompatibility studies data as per prescribed standards;
p.000181: (b) medicinal substances incorporated into the device, including compatibility of the device with the
p.000181: medicinal substance;
p.000181: (c) biological safety of devices incorporating animal or human cells, tissues or their derivatives;
p.000181: (d) sterilisation;
p.000181: (e) software verification and validation;
p.000181: (f) animal studies that provide direct evidence of safety and performance of the device, especially
p.000181: when no clinical investigation of the device was conducted;
p.000181: (g) clinical evidence.
p.000181: (D) Detailed information will describe test design, complete test or study protocols, methods of data analysis, in
p.000181: addition to data summaries and test conclusions. Where no new testing has been undertaken, the dossier
p.000181: should incorporate a rationale for that decision, e.g. biocompatibility testing on the identical materials was
p.000181: conducted when these were incorporated in a previous, legally marketed version of the device.
p.000181: The rationale may be incorporated into the Essential Principle checklist.
p.000181: 7.2 Biocompatibility:
p.000181: (i) The dossier should contain a list of all materials in direct or indirect contact with the patient or user.
p.000181: (ii) Where biocompatibility testing has been undertaken (as per prescribed standards) to characterize
p.000181: the physical, chemical, toxicological and biological response of a material, detailed information
p.000181: should be included on the tests conducted, standards applied, test protocols, the analysis of data and
p.000181: the summary of results. At a minimum, tests should be conducted on samples from the finished,
p.000181: sterilized (when supplied sterile) device.
p.000181: (iii) Depending on nature and intended use of the investigational medical device, device performance for its actions
p.000181: (including mechanical, electrical, thermal, radiation and any other of this type) and safety should be assessed in
p.000181: healthy or diseased animal model (intended to be treated by such medical device), as
p.000181: appropriate, demonstrating reaction to active and basic parts of the devices on absolute tissue, local tissue as well
p.000181: as whole organ, clearly recording local, general and systemic adverse reactions, risks or potential risks and
p.000181: performance of device in line with intended use. Wherever possible, histopathology, pathophysiology and
p.000181: path anatomy should be carried out.
p.000181: (iv) ISO-10993, Biological Evaluation of Medical Devices, should be followed for conducting bio-compatibility
p.000181: study for invasive medical devices should be carried out. A report of biocompatibility study along with rationale for
p.000181: selecting specific tests carried out should be prepared including conclusion of the study.
p.000181: 7.3 Medicinal substances:
p.000181: Where the medical device incorporates a medicinal substance, the dossier should provide detailed
p.000181: information concerning that medicinal substance, its identity and source, the intended reason for its presence, and its
p.000181: safety and performance in the intended application.
p.000181: 7.4 Biological safety:
p.000181: (i) The dossier should contain a list of all materials of animal or human origin used in the
p.000181: device. For these materials, detailed information should be provided concerning the selection of
p.000181: sources or donors; the harvesting, processing, preservation, testing and handling of tissues, cells
p.000181: and substances of such origin should also be provided. Process validation results should be included to
p.000181: substantiate that manufacturing procedures are in place to minimize biological risks, in particular, with regard to
p.000181: viruses and other transmissible agents. Transmissible Spongiform Encephalopathies (TSE) or Bovine Spongiform
p.000181: Encephalopathy (BSE) Certificates should also be submitted.
p.000181: (ii) The system for record-keeping to allow traceability from sources to the finished device should be
p.000181: fully described.
p.000181: 7.5 Sterilization:
p.000181: (i) Where the device is supplied sterile, the dossier should contain the detailed information of the initial
p.000181: sterilization validation including sterilizer qualification, bioburden testing, pyrogen testing, testing for
p.000181: sterilant residues (if applicable) and packaging validation as per prescribed standards. Typically, the detailed
p.000181: validation information should include the method used, sterility assurance level attained, standards applied,
p.000181: the sterilization protocol developed in accordance with prescribed standards, and a summary of results.
p.000181:
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p.000187: with a summary of the data and conclusions.
p.000187: 10. Analytical sensitivity:
p.000187: This section should include information about the study design and results. It should provide a description of
p.000187: specimen type and preparation including matrix, analyte (measurand) levels, and how levels were established. The number
p.000187: of replicates tested at each concentration should also be provided as well as a description of the calculation
p.000187: used to determine assay sensitivity. For example:
p.000187: (a) Number of standard deviations above the mean value of the sample without analyte (measurand),
p.000187: commonly referred to as limit of blank (LoB).
p.000187: (b) Lowest concentration distinguishable from zero, based on measurements of samples containing analyte
p.000187: (measurand), commonly referred to as limit of detection (LoD).
p.000187: (c) Lowest concentration at which precision and/or trueness are within specified criteria, commonly referred to as
p.000187: limit of quantitation (LoQ).
p.000187: For Class C and D in vitro diagnostic medical devices, detailed information would be provided.
p.000187: 11. Analytical specificity:
p.000187: (i) This section should describe interference and cross reactivity studies to determine the analytical
p.000187: specificity, defined as the ability of a measurement procedure to detect or measure only the analyte
p.000187: (measurand) to be detected, in the presence of other substances/agents in the sample.
p.000187: (ii) Provide information on the evaluation of potentially interfering and cross reacting substances/agents
p.000187: on the assay. Information should be provided on the substance/agent type and concentration tested,
p.000187: sample type, analyte (measurand) test concentration, and results.
p.000187: (iii) Interferents and cross reacting substances/agents, which vary greatly depending on the assay type and design,
p.000187: could derive from exogenous or endogenous sources such as:
p.000187: (a) substances used for patient treatment (e.g. therapeutic drugs, anticoagulants, etc.);
p.000187: (b) substances ingested by the patient (e.g. over the counter medications, alcohol, vitamins, foods, etc.);
p.000187: (c) substances added during sample preparation (e.g. preservatives, stabilizers);
p.000187: (d) substances encountered in specific specimens types (e.g. hemoglobin, lipids, bilirubin, proteins);
p.000187: (e) analytes of similar structure (e.g. precursors, metabolites) or medical conditions unrelated to the
p.000187: test condition including specimens negative for the assay but positive for a condition that may mimic the
p.000187: test condition (e.g. for a hepatitis A assay: test specimens negative for hepatitis A virus, but positive for hepatitis
p.000187: B virus).
p.000187: Explanation,- Interference studies involve adding the potential interferent to the sample and determining
p.000187: any bias of the test parameter relative to the control sample to which no interferent has been added.
p.000187: 12. Metrological traceability of calibrator and control material values:
p.000187: Where applicable, summarize the information about metrological traceability of values assigned to calibrators and
p.000187: trueness control materials. Include, for example, methods and acceptance criteria for the metrological
p.000187:
p.000187: 188 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000187: II—SEC. 3(i)]
p.000187:
...
p.000189: 3.2 Active medical device.- Medical device relying for its functioning on a source of electrical energy or any
p.000189: source of power other than that directly generated by the human or animal body or gravity.
p.000189: 3.3 Advisory notice.- Notice issued by the manufacturer, subsequent to delivery of the medical device
p.000189: and in vitro diagnostic medical devices, to provide supplementary information or to advise what action should be
p.000189: taken in or both in:-
p.000189: (a) the use of a medical device and in vitro diagnostic medical devices;
p.000189: (b) the modification of a medical device and in vitro diagnostic medical devices;
p.000189: (c) the return of the medical device and in vitro diagnostic medical devices to the organization that supplied it; or
p.000189: (d) the destruction of a medical device and in vitro diagnostic medical devices.
p.000189: 3.4 Customer complaint.-Written, electronic or oral communication that alleges deficiencies related to
p.000189: the identity, quality, durability, reliability, safety, effectiveness or performance of a medical device
p.000189: and in vitro diagnostic medical devices that has been placed on the market.
p.000189: 3.5 Implantable medical device. - Medical device intended:-
p.000189: (a) to be totally or partially introduced into the human or animal body or a natural orifice; or
p.000189: (b) to replace an epithelial surface or the surface of the eye;
p.000189:
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p.000191: by surgical intervention, and which is intended to remain after the procedure for at least thirty days, and which can
p.000191: only be removed by medical or surgical intervention.
p.000191: 3.6 Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly
p.000191: which is intended to be included as part of the finished, packaged, and labeled device.
p.000191: 3.7 Design input means the physical and performance requirements of a device that are used as a
p.000191: basis for device design.
p.000191: 3.8 Design output means the results of a design effort at each design phase and at the end of the total design
p.000191: effort. The finished design output is the basis for the device master record. The total finished design
p.000191: output consists of the device, its packaging and labeling, and the device master record.
p.000191: 3.9 Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of
p.000191: the design requirements, to evaluate the capability of the design to meet these requirements, and to
p.000191: identify problems.
p.000191: 3.10 Finished device means any device or accessory to any device that is suitable for use or capable
p.000191: of functioning, whether or not it is packaged, labeled or sterilized.
p.000191: 3.11 Management with executive responsibility means those senior employees of a manufacturer who have the authority
p.000191: to establish or make changes to the manufacturer's quality policy and quality system.
p.000191: 3.12 Medical device including substances used for in vitro diagnosis referred to in rule 3 of these rules.
p.000191: 3.13 Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed
p.000191: at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of
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p.000197: manufacturer are identified and distinguished from conforming product.
p.000197: 7.5.3.2 Traceability.-
p.000197: 7.5.3.2.1 General:
p.000197: The manufacturer shall establish documented procedures for traceability. Such procedures shall define the
p.000197: extent of product traceability and the records required.
p.000197: Where traceability is a requirement, the manufacturer shall control and record the unique identification of the
p.000197: product.
p.000197: NOTE.-Configuration management is a means by which identification and traceability can be maintained.
p.000197: 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices:
p.000197: In defining the records required for traceability, the manufacturer shall include records of all components, materials
p.000197: and work environment conditions, if these could cause the medical device not to satisfy its specified requirements.
p.000197:
p.000197: 198 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000197: II—SEC. 3(i)]
p.000197:
p.000197: The manufacturer shall require that its agents or distributors maintain records of the distribution of active
p.000197: implantable medical devices and implantable medical devices to allow traceability and that such records are available
p.000197: for inspection. Records of the name and address of the shipping package consignee shall be maintained.
p.000197: 7.5.3.3 Status identification:
p.000197: The manufacturer shall identify the product status with respect to monitoring and measurement
p.000197: requirements. The identification of product status shall be maintained throughout production, storage, implant, usage
p.000197: and installation of the product to ensure that only product that has passed the required inspections and tests (or
p.000197: released under an authorized concession) is despatched, used or installed.
p.000197: 7.5.4 Customer property:
p.000197: The manufacturer shall exercise care with customer property while it is under the manufacturer’s control or being used
p.000197: by the manufacturer. The manufacturer shall identify, verify, protect and safeguard customer property provided for use
p.000197: or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for
p.000197: use, this shall be reported to the customer and records maintained.
p.000197: NOTE.-Customer property can include intellectual property or confidential health information.
p.000197: 7.5.5 Preservation of product:
p.000197: The manufacturer shall establish documented procedures or documented work instructions for preserving the conformity of
p.000197: product during internal processing and delivery to the intended destination. This preservation
p.000197: shall include identification, handling, packaging, storage and protection. Preservation shall also apply to
p.000197: the constituent parts of a product.
p.000197: The manufacturer shall establish documented procedures or documented work instructions for the control of product with
...
p.000217: justification to the satisfaction of the Central Licensing Authority. I also agree to report the serious
p.000217: adverse events, after due analysis, to the Central Licensing Authority, Chairman of the Ethics
p.000217: Committee and head of the institution where the investigation has been conducted within fourteen days of the occurrence
p.000217: of serious adverse events.
p.000217: (xi) I will maintain confidentiality of the identification of all participating clinical investigation patients
p.000217: and assure security and confidentiality of clinical investigation data.
p.000217: (xii) I agree to comply with all other requirements, guidelines and statutory obligations as
p.000217: applicable to clinical Investigators participating in clinical Investigations
p.000217:
p.000217:
p.000217: Date:
p.000217: Signature of Investigator
p.000217:
p.000217: Table 10
p.000217: Clinical Investigation Report
p.000217:
p.000217: 1. General
p.000217: This table specifies the contents of the clinical investigation report that describes the design, execution,
p.000217: statistical analysis and results of a clinical investigation.
p.000217:
p.000217: 2. Cover page
p.000217: The page shall be contain the following information:-
p.000217: (a) title of the clinical investigation;
p.000217: (b) identification of the investigational medical devices, including names, models, etc. as relevant for
p.000217: complete identification;
p.000217: (c) if not clear from the title, a single sentence describing the design, comparison, period, usage method, and
p.000217: subject population;
p.000217: (d) name and contact details of sponsor or sponsor's representative;
p.000217: (e) CIP identification/protocol code;
p.000217: (f) name and department of coordinating investigator and names of other relevant parties,
p.000217: e.g. experts, biostatistician, laboratory personnel;
p.000217: (g) statement indicating whether the clinical investigation was performed in accordance with declaration
p.000217: of Helsinki, Good Clinical Practice guidelines and applicable regulations;
p.000217: (h) Brief description of investigation design;
p.000217:
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p.000219: 219
p.000219: (i) Start and end date of patient accrual and names of the sponsor and the participating institutes;
p.000219: (j) author(s) of report.
p.000219: 3. Table of contents
p.000219: The table of contents may include the following information:
p.000219: (a) the page number or locating information of each section, including summary tables, figures, and graphs;
p.000219: (b) a list of appendices and their location.
p.000219: 4. Summary
p.000219: The summary may contain the following items:
p.000219: (a) the title of the clinical investigation;
p.000219: (b) an introduction;
p.000219: (c) the purpose of the clinical investigation;
p.000219: (d) description of the clinical investigation population;
p.000219: (e) the clinical investigation method used;
p.000219: (f) the results of the clinical investigation;
p.000219: (g) the conclusion;
p.000219: (h) the date of the clinical investigation initiation;
p.000219: (i) the completion date of the clinical investigation or, if the clinical investigation is discontinued, the date of
p.000219: premature termination.
p.000219: 5. Introduction
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Health / Mentally Disabled
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p.000153: and quantity of medical device.
p.000153: (5) A licence in Form MD-17 shall, unless cancelled earlier, be in force for a period of three years from the date of
p.000153: its issue.
p.000153: (6) The medical devices including in vitro diagnostic medical device referred to in sub-rule (2) that are not used, may
p.000153: be permitted to be exported or destroyed under intimation to the Central Licensing Authority.
p.000153: (7) Where any licencee under sub-rule (1) contravenes any provision of these rules, the Central Licensing Authority,
p.000153: shall, issue a show cause notice to such licencee asking, as to why an order should not be made to cancel the licence.
p.000153: (8) The Central Licensing Authority shall after giving an opportunity to the licencee to explain, in writing,
p.000153: licencee’s defence, pass an order for cancellation or otherwise and record the reasons therefor in the said order.
p.000153: (9) A licencee, whose licence has been cancelled under sub-rule (8), may appeal to the Central Government within forty
p.000153: five days from the date of such order.
p.000153:
p.000153: 42. Import of investigational medical device by Government hospital or statutory medical institution for
p.000153: treatment of patient.— (1) Small quantity of investigational medical device, the import of which is not allowed, but
p.000153: approved in the country of origin, may be allowed to be imported by the Central Licensing Authority for treatment of a
p.000153: patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring
p.000153: therapy for unmet medical need, on an application made by a Medical Officer through the medical superintendent of a
p.000153: Government hospital or a statutory medical institution in Form MD-18 and such application shall be accompanied by
p.000153: documents required and the fee as specified in the Second Schedule.
p.000153:
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p.000155: 155
p.000155: (2) On receipt of an application under sub-rule (1), the Central Licensing Authority shall, on being satisfied about
p.000155: the information and the documents enclosed with the application, grant import licence for treatment of patient in
p.000155: Form MD-19.
p.000155: (3) The medical device for which the licence is granted under sub-rule (2), shall, be used exclusively for the purpose
p.000155: of treatment of the patient referred to in sub-rule (1).
p.000155: (4) The holder of licence shall maintain record of the name of the manufacturer, quantity imported and used, date of
p.000155: import, name and address of the patient and diagnosis.
p.000155: (5) The holder of the licence shall allow the medical device officer authorised by the Central Licensing Authority in
p.000155: this behalf to enter, with or without prior notice, the premises where the medical devices are stocked and to inspect
p.000155: the premises and relevant records and investigate the manner in which the medical device is being used and to take, if
p.000155: required, samples thereof.
p.000155: (6) The quantity considered necessary shall be determined by the Central Licensing Authority after taking
p.000155: into account the recommendation of the hospital concerned for treatment of patient suffering from a life
p.000155: threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical
p.000155: need.
p.000155: (7) Where the Central Licensing Authority is satisfied, it may, in exceptional and special circumstances, allow import
p.000155: of larger quantity of medical devices for use by the patient.
p.000155: (8) The consignment of medical device shall be accompanied by an invoice or a statement showing the name
p.000155: and quantity of medical device.
p.000155:
p.000155: 43. Import of medical device for personal use.—(1) Small quantity of medical device, the import of
p.000155: which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to
p.000155: the following conditions, namely,-
p.000155: (i) the medical device shall form part of a personal baggage of a passenger and be intended for the exclusive use of
p.000155: such passenger;
p.000155: (ii) the medical device shall be declared as personal baggage of the passenger to the customs authorities, if they so
p.000155: direct;
p.000155: (iii) the quantity of any single medical device so imported shall not exceed the quantity specified by the registered
p.000155: medical practitioner;
p.000155: (iv) the medical device has been prescribed by a registered medical practitioner; and
p.000155: (v) the medical device so imported shall be accompanied with an invoice or a statement showing the
p.000155: name and quantity of medical device.
p.000155: (2) Small quantity of medical device, the import of which is otherwise prohibited under section 10 of the Act, and
p.000155: which is not forming a part of bona fide personal baggage, may be imported for personal use, on an application made by
...
p.000171: medical device reagent.
p.000171: (g) If several rules apply to the same device, based on the performance specified for the device by
p.000171: the manufacturer, the stringent rules resulting in the higher classification shall apply.
p.000171: 2. The parameters for classification of in vitro diagnostic medical devices as follows:-
p.000171: (i) In vitro diagnostic medical devices for detecting transmissible agents, etc.:
p.000171: (a) An in vitro diagnostic medical device shall be assigned to Class D, if it is intended to be used for detecting
p.000171: the presence of, or exposure to, a transmissible agent that,-
p.000171: (1) is in any blood, blood component, blood derivative, cell, tissue or organ, in order to assess the
p.000171: suitability of the blood, blood component, blood derivative, cell, tissue or organ, as the case may be, for transfusion
p.000171: or transplantation; or
p.000171: (2) causes a life-threatening disease with a high risk of propagation.
p.000171: (b) An in vitro diagnostic medical device shall be assigned to Class C, if it is intended for use in,-
p.000171: (1) detecting the presence of, or exposure to, a sexually transmitted agent;
p.000171: (2) detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation
p.000171: (for example, Cryptococcus neoformans or Neisseria meningitidis);
p.000171: (3) detecting the presence of an infectious agent, where there is a significant risk that an erroneous
p.000171: result will cause death or severe disability to the individual or foetus being tested (for example, a diagnostic
p.000171: assay for Chlamydia pneumoniae, Cytomegalovirus or Methicillin-resistant Staphylococcus aureus);
p.000171: (4) pre-natal screening of women in order to determine their immune status towards transmissible agents
p.000171: such as immune status tests for Rubella or Toxoplasmosis;
p.000171: (5) determining infective disease status or immune status, where there is a risk that an erroneous result will lead to
p.000171: a patient management decision resulting in an imminent life-threatening situation for the patient being tested (for
p.000171: example, Cytomegalovirus, Enterovirus or Herpes simplex virus in transplant patients);
p.000171: (6) screening for disease stages, for the selection of patients for selective therapy and management, or in the
p.000171: diagnosis of cancer;
p.000171: (7) human genetic testing, such as the testing for cystic fibrosis or Huntington's disease;
p.000171: (8) monitoring levels of medicinal products, substances or biological components, where there is a risk
p.000171: that an erroneous result will lead to a patient management decision resulting in an immediate life-threatening
p.000171: situation for the patient being tested (for example, cardiac markers, cyclosporin or prothrombin time testing);
p.000171: (9) management of patients suffering from a life-threatening infectious disease such as viral load of Human
p.000171: immunodeficiency virus or Hepatitis C virus, or genotyping and sub-typing Hepatitis C virus or Human
p.000171: immunodeficiency virus);or
...
p.000203: (i) In all investigations, a freely given, informed, written consent is required to be obtained from
p.000203: each study subject. The investigator shall provide information about the study verbally and
p.000203: through the patient information sheet, in a language that is non-technical and is understandable by the study
p.000203: subject. The Subject’s consent must be obtained in writing using an ‘Informed Consent Form’. The patient information
p.000203: sheet as well as the Informed Consent Form shall be approved by the Ethics Committee and furnished to
p.000203: the Central Licensing Authority. Any change in the informed consent documents should be approved by the
p.000203: Ethics Committee and submitted to the Central Licensing Authority before such changes are implemented.
p.000203: (ii) Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering
p.000203: from severe mental illness or disability), the same may be obtained from a legally acceptable representative. If the
p.000203: subject or his legally acceptable representative is unable to read or write, an impartial witness should be present
p.000203: during the entire informed consent process who must append his signatures to the consent form. Explanation: a legally
p.000203: acceptable representative means a person who is able to give consent or authorise an intervention in the
p.000203: patient as provided by the law in India.
p.000203:
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p.000205: 205
p.000205: (iii) A checklist of essential elements to be included in the study subject’s informed consent document as well as a
p.000205: format for the Informed Consent Form for study Subjects is given in Table 8 of this schedule.
p.000205: (iv) The informed consent process, in case of vulnerable subjects in clinical investigations of an innovative medical
p.000205: device which is not approved anywhere in the world, shall be audio-video recorded.
p.000205:
p.000205: (6) Pilot Clinical Investigation
p.000205: (i) Pilot clinical investigation is defined as those clinical investigations which are used to acquire specific
p.000205: essential information about a device before beginning the pivotal clinical investigation. Pilot clinical
p.000205: investigation is exploratory study which may be conducted in a few numbers of patients with the disease or condition
...
Health / Mentally Incapacitated
Searching for indicator incapable:
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p.000203: Central Licensing Authority for conduct of the clinical investigation for making claims in case of
p.000203: investigation related injury or death.
p.000203:
p.000203: (4) Responsibilities of the Ethics Committee:
p.000203: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical
p.000203: Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should
p.000203: exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the
p.000203: study. Explanation.- The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners,
p.000203: armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with
p.000203: incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority
p.000203: groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics
p.000203: committee(s) get documented ‘standard operating procedures’ and should maintain a record of its proceedings.
p.000203: (ii) Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation
p.000203: of the Clinical Investigation Plan. Such review may be based on periodic study progress reports
p.000203: furnished by investigators or monitoring and internal audit reports furnished by the Sponsor.
p.000203: (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record
p.000203: the reasons for doing so and at once, communicate such a decision to the Investigator as well as to the
p.000203: Central Licensing Authority.
p.000203: (iv) Any report of serious adverse event occurring during clinical investigation, after due analysis,
p.000203: shall be forwarded by the Chairman of Ethics Committee to the Central Licensing Authority and to the
p.000203: Head of institution where the clinical investigation has been conducted within 14 calendar days of the
p.000203: knowledge of occurrence of the serious adverse event.
p.000203: (5) Informed consent:
p.000203: (i) In all investigations, a freely given, informed, written consent is required to be obtained from
...
Health / Motherhood/Family
Searching for indicator family:
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p.000143: MINISTRY OF HEALTH AND FAMILY WELFARE
p.000143: (Department of Health and Family Welfare) NOTIFICATION
p.000143: New Delhi, the 31st January, 2017
p.000143: G.S.R. 78(E).—WHEREAS the draft of the Medical Devices Rules, 2016 was published, as required under sub-section (1) of
p.000143: Section 12 and Sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of
p.000143: India, Extraordinary, Part II, section 3, sub-section (i), vide notification number G.S.R. 983(E), dated the 17th
p.000143: October, 2016, by the Central Government, after consultation with the Drugs Technical Advisory Board,
p.000143: inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of
p.000143: a period of thirty days from the date on which copies of the said Gazette containing the said notification were made
p.000143: available to the public;
p.000143: AND WHEREAS, copies of the Gazette containing the said notification were made available to the public on the 17th
p.000143: October, 2016;
p.000143: AND WHEREAS, all objections and suggestions received in response to the said draft notification have been
p.000143: duly considered by the Central Government;
p.000143: NOW, THEREFORE, in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940
p.000143: (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby
p.000143: makes the following rules, namely,-
p.000143:
p.000143:
p.000143:
p.000143: CHAPTER I PRELIMINARY
p.000143:
p.000143: 1. Short title and commencement.—(1) These rules may be called the Medical Devices Rules, 2017.
p.000143: (2) These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018.
p.000143:
p.000143: 2. Application.— These rules shall be applicable in respect of,-
...
p.000143: investigation;
p.000143: (n) “clinical performance evaluation” means the systematic performance study of a new in vitro diagnostic medical
p.000143: device on a specimen collected from human participants to assess its performance;
p.000143: (o) “clinical research organisation” means any entity to whom a sponsor may transfer or delegate one or more of its
p.000143: functions and duties regarding conduct of clinical investigation or clinical performance evaluation;
p.000143: (p) “conformity assessment” means the systematic examination of evidence generated and procedures undertaken, by the
p.000143: manufacturer to determine that a medical device is safe and performs as intended by the manufacturer and therefore
p.000143: conforms to the essential principles of safety and performance for medical devices;
p.000143: (q) “controlling officer” means the officer designated under rule 10;
p.000143: (r) “custom made medical device” means a medical device made specifically in accordance with a
p.000143: written prescription of a registered medical practitioner, specialised in the relevant area, under his responsibility
p.000143: for the sole use of a particular patient, but does not include a mass production of such device;
p.000143: (s) “Ethics Committee” means the committee referred to in rule 50;
p.000143: (t) “Form” means forms specified in Appendix to these rules;
p.000143: (u) “Good Clinical Practices Guidelines” means Good Clinical Practices Guidelines issued by Central
p.000143: Drugs Standards Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare,
p.000143: Government of India;
p.000143: (v) “intended use” means the use for which the medical device is intended according to the data supplied
p.000143: by the manufacturer on the labelling or in the document containing instructions for use of such device
p.000143: or in promotional material relating to such device, which is as per approval obtained from the Central
p.000143: Licensing Authority;
p.000143: (w) “invasive device” means a device which, in whole or part, penetrates inside the body, either
p.000143: through a body orifice or through the surface of the body;
p.000143: (x) “investigational medical device” in relation to a medical device, other than in vitro diagnostic medical
p.000143: device, means a medical device specified in clause (zb),-
p.000143: (i) which does not have its predicate device as defined in clause (zm); or
p.000143: (ii) which is licenced under sub-rule (4) or sub-rule (6) of rule 20, sub-rule (1) of rule 25, or sub-rule (1) of
p.000143: rule 36 and claims for new intended use or new population or new material or major design change;
p.000143: and is being assessed for safety or performance or effectiveness in a clinical investigation.
p.000143: (y) “licence” means a licence granted by the State Licensing Authority or the Central Licensing Authority in Form
p.000143: MD-5, Form MD-6, Form MD-9, Form MD-10, Form MD-15, Form MD-17 or Form MD-19 as the case may be;
p.000143: (z) “loan licence” means a licence issued for manufacturing a medical device by the State Licensing Authority or
...
p.000145: (iv) high risk- Class D.
p.000145: (2) In vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the
p.000145: First Schedule, in the following classes, namely:—
p.000145: (i) low risk - Class A;
p.000145: (ii) low moderate risk- Class B;
p.000145: (iii) moderate high risk- Class C;
p.000145: (iv) high risk- Class D.
p.000145: (3) The Central Licencing Authority shall, classify medical devices referred to in rule 2, based on the intended use
p.000145: of the device and other parameters specified in the First Schedule.
p.000145: (4) Based on the classification referred to in sub-rule (3), class wise list of medical devices shall be published on
p.000145: the website of the Central Drugs Standard Control Organisation:
p.000145: Provided that the Central Licencing Authority may, from time to time, make additions or deletions in such list of
p.000145: medical devices or modify the class of any medical device.
p.000145:
p.000145: 5. Medical device grouping.— Any person who intends to apply for grant of licence in respect of medical devices for,-
p.000145: (i) import;
p.000145: (ii) manufacture for sale or for distribution; and
p.000145: (iii) sale, stock, exhibit or offer for sale,
p.000145: may group all or any medical device in accordance with the guidelines to be issued from time to time by the Ministry
p.000145: of Health and Family Welfare in the Central Government, by taking into consideration the technological changes or
p.000145: development in the field of medical devices and in vitro diagnostic medical devices.
p.000145:
p.000145: 6. Essential principles for manufacturing medical devices.—Medical device manufacturer shall follow the
p.000145: essential principles of safety and performance of medical devices as may be specified in the guidelines issued by the
p.000145: Ministry of Health and Family Welfare in the Central Government, from time to time keeping in view the
p.000145: contemporary scientific and technological knowledge and development:
p.000145: Provided that the guidelines to be so specified shall be in conformity with the provisions of the Act and these rules.
p.000145:
p.000145: 7. Product standards for medical device.— (1) The medical device shall conform to the standards laid down by the
p.000145: Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as
p.000145: may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.
p.000145: (2) Where no relevant Standard of any medical device has been laid down under sub-rule (1), such
p.000145: device shall conform to the standard laid down by the International Organisation for Standardisation (ISO)
p.000145: or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards.
p.000145: (3) In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the
p.000145: device shall conform to the validated manufacturer’s standards.
p.000145:
p.000145: CHAPTER III AUTHORITIES, OFFICERS AND BODIES.
p.000145: 8. Licensing Authorities.— (1) The Central Licensing Authority shall be the competent authority for enforcement of
p.000145: these rules in matters relating to,-
p.000145: (i) import of all Classes of medical devices;
p.000145: (ii) manufacture of Class C and Class D medical devices;
p.000145: (iii) clinical investigation and approval of investigational medical devices;
p.000145: (iv) clinical performance evaluation and approval of new in vitro diagnostic medical devices and;
p.000145: (v) co-ordination with the State Licensing Authorities.
p.000145: (2) The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and
p.000145: shall be the competent authority for enforcement of these rules in matters relating to,-
p.000145: (i) manufacture for sale or distribution of Class A or Class B medical devices;
p.000145: (ii) sale, stock, exhibit or offer for sale or distribution of medical devices of all classes.
...
p.000147: been appointed as the Government Analyst and the Inspector, respectively.
p.000147:
p.000147: 19. Central medical device testing laboratory.— (1) The Central Government may, by notification, establish
p.000147: Central medical devices testing laboratory for the purpose of,—
p.000147: (a) testing and evaluation of medical devices; or
p.000147: (b) functioning as an appellate laboratory; or
p.000147: (c) to carry out any other function as may be specifically assigned to it.
p.000147: (2) Without prejudice to sub-rule (1), the Central Government may also designate any laboratory having facility for
p.000147: carrying out test and evaluation of medical devices as central medical devices testing laboratory for
p.000147: the purposes specified in sub-rule (1):
p.000147: Provided that no medical devices testing laboratory, shall be so designated unless it has been duly accredited by the
p.000147: National Accreditation Body for Testing and Calibration Laboratories.
p.000147:
p.000147: CHAPTER IV
p.000147: MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION
p.000147:
p.000147: 20. Application for manufacture for sale or for distribution of Class A or Class B medical device.— (1)
p.000147: Any person who intends to manufacture a Class A or Class B medical device including in vitro diagnostic medical device
p.000147: shall make an application for grant of licence or loan licence to manufacture for sale or for distribution to the State
p.000147: Licensing Authority.
p.000147: (2) The application under sub-rule (1) shall be made through an identified online portal of the Ministry of Health and
p.000147:
p.000147: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000149: 149
p.000149: Family Welfare in the Central Government in Form MD-3 for licence or in Form MD-4 for loan licence accompanied with a
p.000149: fee, as specified in the Second Schedule along with respective documents as specified in Part II of the Fourth
p.000149: Schedule.
p.000149: (3) The application made under sub-rule (1), shall, amongst others, be accompanied with an undertaking to the effect
p.000149: that the requirements of Quality Management System as specified in the Fifth Schedule have been complied with.
p.000149: (4) The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the requirements of
p.000149: these rules have been complied with, grant a licence to manufacture Class A medical devices in Form MD-5 or loan
p.000149: licence in Form MD-6, as the case may be, or if not satisfied, reject the application for reasons to
p.000149: be recorded in writing, within forty five days from the date, the application is made under sub-rule (1).
p.000149: Provided that,—
p.000149: (i) no audit of the manufacturing site shall be necessary prior to grant of licence or loan licence to manufacture for
p.000149: sale or for distribution of Class A medical device; and
p.000149: (ii) the required audit of such manufacturing site by the registered Notified Body in the manner as specified in the
p.000149: Third Schedule shall be carried out within one hundred and twenty days from the date on which the licence was granted
p.000149: by the State Licencing Authority.
p.000149: (5) Manufacturing site of the applicant, in respect of Class B device, shall conform to the requirements of
p.000149: Quality Management System as specified under the Fifth Schedule and applicable standards as specified under these rules
...
p.000149: direction and supervision, the testing activity of a medical device shall be undertaken.
p.000149:
p.000149: 23. Inspection for grant of licence or loan licence for Class C or Class D medical device.— (1) Before grant of
p.000149: licence to manufacture for sale or for distribution in respect of Class C or D medical device, the manufacturing site
p.000149: shall be inspected within a period of sixty days from the date of application by a team comprising not less than two
p.000149: Medical Device Officers which may include any officer senior to the Medical Device Officer with or
p.000149: without an expert, or a Notified Body referred to in sub-rule (4) of rule 13:
p.000149: Provided that no inspection of a medical device manufacturing site for grant of loan licence to
p.000149: manufacture such medical device shall be required to be carried out if the manufacturing site is already licenced to
p.000149: manufacture such medical device for sale or for distribution.
p.000149: (2) The composition of the inspection team referred to in sub-rule (1) shall be determined by the controlling officer
p.000149: and no inspection shall be carried out without prior approval of the controlling officer.
p.000149:
p.000149: 24. Inspection report.— After completion of inspection as referred to in rule 23, the inspection team shall forward
p.000149: a descriptive report containing findings on each aspect of inspection along with the recommendations to the Central
p.000149: Licensing Authority, through online portal of the Ministry of Health and Family Welfare in the Central Government and
p.000149: forward a copy of the same to the applicant.
p.000149:
p.000149: 25. Grant of licence or loan licence to manufacture for sale or for distribution.— (1) If the Central Licensing
p.000149: Authority, after receipt of the report as referred to in rule 24, and such further enquiry, if any, as may be
p.000149: considered necessary, is satisfied that the requirements of these rules have been complied, that Authority shall grant
p.000149: a licence in Form MD-9, or loan licence in Form MD-10 or may reject the application for reasons to be recorded in
p.000149: writing, within a period of forty five days from the date the inspection report has been received.
p.000149: (2) If the application for grant of licence or loan licence to manufacture for sale or for distribution is rejected
p.000149: under sub-rule (1), the aggrieved person may file an appeal before the Central Government within forty five days from
p.000149: the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to
p.000149: the appellant, be disposed of within a period of sixty days.
p.000149: (3) In case, a licencee or loan licencee intends to manufacture additional medical devices
p.000149: in the licensed manufacturing site, the manufacturer shall make an application for grant of permission to
p.000149: manufacture such medical devices to the Central Licensing Authority or State Licensing Authority, as the case may
p.000149: be, along with the fee as specified in the Second Schedule and the documents as referred to in rule 20 or rule 21, as
...
p.000151: where the medical device are manufactured and to satisfy himself that only clinical investigations, test, evaluation,
p.000151: examination, demonstration or training is being conducted on such device;
p.000151: (c) the licencee shall maintain a record of the quantity of medical device manufactured, tested and stocked and
p.000151: its disposition.
p.000151:
p.000151: 33. Cancellation of test licence to manufacture for test, evaluation, clinical investigations, etc.,— (1)
p.000151: Where any licencee under rule 31 contravenes any provision of these rules, the Central Licensing Authority,
p.000151: shall, issue a show cause notice to such licencee asking, as to why an order should not be made to cancel the licence.
p.000151: (2) The Central Licensing Authority shall, after giving an opportunity to the licencee to explain in writing licencee’s
p.000151: defence, pass an order for cancellation or otherwise and record the reasons therefor in the said order.
p.000151: (3) A licencee, whose licence has been cancelled, may appeal to the Central Government within forty five days from the
p.000151: date of the order.
p.000151:
p.000151: CHAPTER V
p.000151: IMPORT OF MEDICAL DEVICES
p.000151:
p.000151: 34. Application for grant of import licence.— (1) An authorised agent having licence to manufacture for sale or
p.000151: distribution or wholesale licence for sale or distribution under these rules, shall make an application
p.000151: for grant of import licence for medical device to the Central Licensing Authority through an identified
p.000151: online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a
p.000151: licence.
p.000151: (2) The application under sub-rule (1) shall be accompanied with the fee as specified in the Second Schedule along with
p.000151: respective documents as specified in the Fourth Schedule:
p.000151: Provided that any change in the documents submitted at the time of application and prior to grant of
p.000151: licence shall be informed, in writing, to the Central Licensing Authority.
p.000151: (3) Where the Central Licensing Authority, has reason to believe that the quality of the medical device
p.000151: is compromised, and decides to subject it to evaluation, test or examination, the authorised agent shall pay a fee for
p.000151: such evaluation, test or examination, to the testing laboratory as specified by the Central Licensing Authority.
p.000151: (4) Any subsequent application for,-
p.000151: (i) grant of licence for additional manufacturing site for the same medical device by the same authorised agent
p.000151:
p.000151: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000153: 153
p.000153: shall be accompanied with a fee and documents as referred in sub-rule (2);
p.000153: (ii) licence for additional medical device manufactured at the same manufacturing site shall be made by the same
p.000153: authorised agent accompanied with fee as specified in the Second Schedule and respective documents as
p.000153: specified in the Fourth Schedule.
p.000153:
p.000153: 35. Inspection of overseas manufacturing site.— (1) On receipt of an application under sub-rule (1) of rule 34, the
...
p.000165: after giving an opportunity to the applicant of being heard, shall be summarily rejected.
p.000165: 93. Debarment of applicant.—(1) Whoever himself or, any other person on his behalf, or applicant is found to be guilty
p.000165: of submitting misleading, or fake, or fabricated documents, may, after giving him an opportunity to show cause as to
p.000165: why such an order should not be made, in writing, stating the reasons thereof, be debarred by the
p.000165: Central Licensing Authority or the State Licensing Authority, as the case may be, for such period as it may deem
p.000165: proper.
p.000165: (2) Where an applicant is aggrieved by an order made by the Central Licensing Authority or the State
p.000165: Licensing Authority, as the case may be, under sub-rule (1), such applicant may, within thirty days of the receipt of
p.000165: the order, make an appeal to the Central Government or the State Government, as the case may be, and that Government
p.000165: may, after such enquiry as it considers necessary, and after affording an opportunity of being heard, make such order
p.000165: as it may deem proper.
p.000165: 94. Mode of payment of fee.—(1) The fees prescribed under these rules, in case of application made to the Central
p.000165: Licensing Authority, shall be paid through challan or by electronic mode, in the Bank of Baroda, Kasturba Gandhi
p.000165: Marg, New Delhi-110001 or any other branch of Bank of Baroda, or any other bank, notified by the
p.000165: Ministry of Health and Family Welfare in the Central Government, to be credited under the Head of Account “0210-
p.000165: Medical and Public Health, 04-Public Health, 104-Fees and Fines.
p.000165: (2) Where the fee specified is payable to the State Licensing Authority, the same shall be paid through a challan or by
p.000165: electronic mode as may be specified by the State Government concerned.
p.000165: 95. Digitalisation of form.—The Forms prescribed under these rules may be suitably modified for conversion into
p.000165: digital forms by the Central Drugs Standard Control Organization and such modification shall not require
p.000165: any amendment in these rules.
p.000165: 96. Overriding effect.—The provisions of these rules shall have effect, notwithstanding anything
p.000165: inconsistent therewith contained in the Drugs and Cosmetics Rules, 1945.
p.000165:
p.000165: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000167: 167
p.000167:
p.000167:
p.000167: 97. Savings.—Notwithstanding the non-applicability of the Drugs and Cosmetics Rules 1945, for the substances and
p.000167: devices referred to in rule 2,-
p.000167: (i) the licence or registration certificate, issued under the provisions of the Act and the Drugs and Cosmetics Rules,
p.000167: 1945, prior to commencement of these rules, shall be deemed to be valid till its expiry or for a period of eighteen
p.000167: months from the date these rules are notified, whichever is later, under the corresponding provisions of
p.000167: these rules;
p.000167: (ii) new drug approval, or things done or any action taken or purported to have been done or taken, including any
...
p.000215: (d) Weight;
p.000215: (e) Height.
p.000215: 2. Suspected device(s):
p.000215: (a) Name of the Device;
p.000215: (b) Indication(s) for which suspect device was prescribed;
p.000215: (c) Device details including model number/size/lot number, if applicable;
p.000215: (d) Starting date and time of day;
p.000215: (e) Stopping date and time, or duration of treatment;
p.000215: 3. Other treatment(s):
p.000215: Provide the same information for concomitant treatment.
p.000215: 4. Details of suspected adverse device reaction(s)
p.000215: (a) Full description of reaction(s) including body site and severity, as well as the criterion (or
p.000215: criteria) for regarding the report as serious. In addition to a description of the reported signs and
p.000215: symptoms, whenever possible, describe a specific diagnosis for the reaction.
p.000215: (b) Start date (and time) of onset of reaction.
p.000215: (c) Stop date (and time) or duration of reaction.
p.000215: (d) Setting (e.g., hospital, out-patient clinic, home, nursing home).
p.000215: 5. Outcome
p.000215: (a) Information on recovery and any sequel; results of specific tests and/or treatment that may have
p.000215: been conducted.
p.000215: (b) For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; any
p.000215: post-mortem findings.
p.000215: (c) Other information: anything relevant to facilitate assessment of the case, such as medical history including
p.000215: allergy, drug or alcohol abuse; family history; findings from special investigations etc.
p.000215: 6. Details about the Investigator:
p.000215: (a) Name;
p.000215: (b) Address;
p.000215: (c) Telephone number;
p.000215: (d) Profession (specialty);
p.000215: (e) Date of reporting the event to Central Licensing Authority;
p.000215: (f) Date of reporting the event to Ethics Committee overseeing the site;
p.000215: (g) Signature of the Investigator.
p.000215:
p.000215:
p.000215:
p.000215: Table 8 Informed Consent Form
p.000215: Checklist for clinical investigation Subject’s informed consent documents
p.000215: 1.1 Essential elements:
p.000215: 1. Statement that the study involves research and explanation of the purpose of the research
p.000215: 2. Expected duration of the Subject's participation
p.000215: 3. Description of the procedures to be followed, including all invasive procedures
p.000215: 4. Description of any reasonably foreseeable risks or discomforts to the Subject
p.000215:
p.000215: 216 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000215: II—SEC. 3(i)]
p.000215:
p.000215: 5. Description of any benefits to the Subject or others reasonably expected from research. If no benefit is expected,
p.000215: subject should be made aware of this.
p.000215: 6. Disclosure of specific appropriate alternative procedures or therapies available to the Subject.
p.000215: 7. Statement describing the extent to which confidentiality of records identifying the subject will be maintained and
p.000215: who will have access to Subject’s medical records
...
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p.000143: makes the following rules, namely,-
p.000143:
p.000143:
p.000143:
p.000143: CHAPTER I PRELIMINARY
p.000143:
p.000143: 1. Short title and commencement.—(1) These rules may be called the Medical Devices Rules, 2017.
p.000143: (2) These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018.
p.000143:
p.000143: 2. Application.— These rules shall be applicable in respect of,-
p.000143: (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical
p.000143: sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause
p.000143: (i);
p.000143: (ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and
p.000143: insecticides notified under sub-clause (ii); and
p.000143: (iii) devices notified from time to time under sub-clause (iv),
p.000143: of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940);
p.000143:
p.000143: 3. Definitions.— In these rules, unless the context otherwise requires,-
p.000143: (a) “academic clinical study” means a clinical study conducted for academic purpose on a medical device for the
p.000143: approved or a new intended use, new material of construction, new improved design or new population;
p.000143: (b) “Act” means the Drugs and Cosmetics Act, 1940 (23 of 1940);
p.000143: (c) "active diagnostic medical device" means any active medical device used, whether alone or in combination with
p.000143: other medical devices, to supply information for detecting, diagnosing or monitoring, or to provide support in the
p.000143: treatment of, any physiological condition, state of health, illness or congenital deformity;
p.000143: (d) “active medical device” means a medical device, the operation of which depends on a source of electrical energy
p.000143: or any other source of energy other than the energy generated by human or animal body or gravity;
p.000143: (e) “active therapeutic medical device" means any active medical device used, whether alone or in
p.000143: combination with any other medical device, to support, modify, replace or restore biological functions or structures,
p.000143: with a view to the treatment or alleviation of any illness, injury or handicap;
p.000143: (f) “authorised agent” means a person including any firm or organisation who has been appointed by an overseas
p.000143: manufacturer through a power of attorney to undertake import of medical device in India;
p.000143:
p.000143: (g) “body orifice” means any natural opening in a human body including the external surface of any eyeball, or any
p.000143: permanent artificial opening, such as a stoma or permanent tracheotomy;
p.000143: (h) “Central Licensing Authority” means the Drugs Controller General of India appointed by
p.000143: the Central Government;
p.000143: (i) “central medical devices testing laboratory” means a medical devices laboratory established or designated by
p.000143: the Central Government under rule 19 and shall be deemed to be a Central Drug Laboratory established
p.000143: for the purpose of section 6 of the Act;
p.000143: (j) “change in the constitution of a licencee” in relation to,-
p.000143:
p.000143: 144 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000143: II—SEC. 3(i)]
p.000143:
p.000143: (i) a firm means change from proprietorship to partnership including Limited Liability Partnership or vice versa;
p.000143: (ii) a company means-
p.000143: (A) its conversion from a private to a public company, or from a public to a private company; or
p.000143: (B) any change in the ownership of shares of more than fifty per cent. of the voting capital in the body
p.000143: corporate or in case of a body corporate not having a share capital, any change in its membership; and
...
p.000145: which data is assessed and analysed to establish or verify performance of the in vitro diagnostic medical device for
p.000145: its intended use;
p.000145: (zl) “Post Marketing Surveillance” means systematic process to collect and analyse information gained from medical
p.000145: device that have been placed in the market;
p.000145: (zm) “predicate device” means a device, first time and first of its kind, approved for manufacture for sale or for
p.000145: import by the Central Licensing Authority and has the similar intended use, material of construction, and
p.000145: design characteristics as the device which is proposed for licence in India;
p.000145: (zn) “Quality Management System” means requirements for manufacturing of medical devices as specified in
p.000145: the Fifth Schedule;
p.000145: (zo) “reagent” means a chemical, biological or immunological component, solution or preparation intended
p.000145: by the manufacturer to be used as in vitro diagnostic medical device;
p.000145: (zp) “recall” means any action taken by its manufacturer or authorised agent or supplier to remove the medical device
p.000145: from the market or to retrieve the medical device from any person to whom it has been supplied, because the medical
p.000145: device,—
p.000145: (a) is hazardous to health; or
p.000145: (b) fails to conform to any claim made by its manufacturer relating to its quality, safety or efficacy; or
p.000145: (c) does not meet the requirements of the Act and these rules;
p.000145: (zq) “serious adverse event” means an untoward medical occurrence that leads to,—
p.000145: (i) a death; or
p.000145: (ii) a serious deterioration in the health of the subject that either-
p.000145: (A) resulted in a life-threatening illness or injury; or
p.000145: (B) resulted in a permanent impairment of a body structure or a body function; or
p.000145: (C) required in-patient hospitalisation or prolongation of existing hospitalization; or
p.000145: (D) resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment
p.000145: to a body structure or a body function; or
p.000145: (iii) foetal distress, foetal death or a congenital abnormality or birth defect;
p.000145: (zr) “short term use” means intended continuous use of a medical device for not less than sixty minutes but not more
p.000145: than thirty days;
p.000145: (zs) “specimen receptacle” means a device, whether vacuum type or not, specifically intended by its manufacturer for
p.000145: the primary containment of specimens derived from human or animal body;
p.000145: (zt) “sponsor” includes a person, an investigator, a company or an institution or an organisation responsible for the
p.000145: initiation and management of a clinical investigation or clinical performance evaluation in India;
p.000145: (zu) “State Licensing Authority” means the authority designated by the State Government under sub-rule (2) of rule 8;
p.000145: (zv) “transient use” means a device intended for continuous use for less than sixty minutes;
p.000145: (zw) “transmissible agent”, for the purpose of classification of in vitro diagnostic medical device, means
p.000145: an agent capable of being transmitted to a person, which causes communicable, infectious or contagious disease.
p.000145: (zx) words and expressions used but not defined in these rules, shall have the meanings respectively assigned to them
p.000145: in the Act and the Drugs and Cosmetics Rules, 1945.
p.000145:
p.000145: 146 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000145: II—SEC. 3(i)]
p.000145:
p.000145: CHAPTER II REGULATION OF MEDICAL DEVICE.
...
p.000203: (5) Informed consent:
p.000203: (i) In all investigations, a freely given, informed, written consent is required to be obtained from
p.000203: each study subject. The investigator shall provide information about the study verbally and
p.000203: through the patient information sheet, in a language that is non-technical and is understandable by the study
p.000203: subject. The Subject’s consent must be obtained in writing using an ‘Informed Consent Form’. The patient information
p.000203: sheet as well as the Informed Consent Form shall be approved by the Ethics Committee and furnished to
p.000203: the Central Licensing Authority. Any change in the informed consent documents should be approved by the
p.000203: Ethics Committee and submitted to the Central Licensing Authority before such changes are implemented.
p.000203: (ii) Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering
p.000203: from severe mental illness or disability), the same may be obtained from a legally acceptable representative. If the
p.000203: subject or his legally acceptable representative is unable to read or write, an impartial witness should be present
p.000203: during the entire informed consent process who must append his signatures to the consent form. Explanation: a legally
p.000203: acceptable representative means a person who is able to give consent or authorise an intervention in the
p.000203: patient as provided by the law in India.
p.000203:
p.000203: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000205: 205
p.000205: (iii) A checklist of essential elements to be included in the study subject’s informed consent document as well as a
p.000205: format for the Informed Consent Form for study Subjects is given in Table 8 of this schedule.
p.000205: (iv) The informed consent process, in case of vulnerable subjects in clinical investigations of an innovative medical
p.000205: device which is not approved anywhere in the world, shall be audio-video recorded.
p.000205:
p.000205: (6) Pilot Clinical Investigation
p.000205: (i) Pilot clinical investigation is defined as those clinical investigations which are used to acquire specific
p.000205: essential information about a device before beginning the pivotal clinical investigation. Pilot clinical
...
p.000213: (2) Clinical investigation plan version and date (if required).
p.000213: (3) Version number of Case Report Forms.
p.000213: (4) Name of clinical investigation or reference number (if applicable).
p.000213: 2.3 Header or footer or Case Report Form identifier
p.000213: (a) Name of the clinical investigation or reference number.
p.000213: (b) Version number of Case Report Forms.
p.000213: (c) Investigation site/principal investigator identification number.
p.000213: (d) Subject identification number and additional identification such as date of birth or initials, if allowed by
p.000213: national regulations.
p.000213: (e) Case Report Form number or date of visit or visit number.
p.000213: (f) Page/screen number of CRF and total number of pages/screens (e.g. “page x of xx”).
p.000213: 2.4 Types of Case Report Forms
p.000213: The following is a suggested list of CRFs that may be developed to support a clinical investigation.
p.000213: This is not an exhaustive list and is intended to be used as a guideline.
p.000213: (a) Screening.
p.000213: (b) Documentation of subject's informed consent.
p.000213: (c) Inclusion/exclusion.
p.000213: (d) Baseline visit:
p.000213: (1) demographics;
p.000213: (2) medical diagnosis;
p.000213: (3) relevant previous medications or procedures;
p.000213: (4) date of enrolment;
p.000213: (5) other characteristics.
p.000213: (e) Intervention(s) or treatment(s).
p.000213: (f) Follow-up visit(s).
p.000213: (g) Clinical investigation procedure(s).
p.000213: (h) Adverse event(s).
p.000213: (i) Device deficiencies.
p.000213: (j) Concomitant illness(es)/medication(s).
p.000213: (k) Unscheduled visit(s).
p.000213: (l) Subject diary.
p.000213: (m) Subject withdrawal or lost to follow-up.
p.000213: (n) Form signifying the end of the clinical investigation, signed by the principal investigator or his/her
p.000213: authorised designee.
p.000213: (o) CIP deviation(s).
p.000213:
p.000213: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000215: 215
p.000215: 3. Procedural issues
p.000215: A system shall be established to enable cross-referencing of CRFs and CIP versions.
p.000215: Supplemental CRFs may be developed for collecting additional data at individual investigation sites in
p.000215: multicenter investigations.
p.000215:
p.000215: Table 7
p.000215: Data elements for reporting serious adverse events occurring in a clinical investigation
p.000215: 1. Patient details:
p.000215: (a) Initials and other relevant identifier (hospital/Out Patient Department’s record number etc.);
p.000215: (b) Gender;
p.000215: (c) Age and date of birth;
p.000215: (d) Weight;
p.000215: (e) Height.
p.000215: 2. Suspected device(s):
p.000215: (a) Name of the Device;
p.000215: (b) Indication(s) for which suspect device was prescribed;
p.000215: (c) Device details including model number/size/lot number, if applicable;
p.000215: (d) Starting date and time of day;
p.000215: (e) Stopping date and time, or duration of treatment;
p.000215: 3. Other treatment(s):
p.000215: Provide the same information for concomitant treatment.
p.000215: 4. Details of suspected adverse device reaction(s)
p.000215: (a) Full description of reaction(s) including body site and severity, as well as the criterion (or
...
Searching for indicator physically:
(return to top)
p.000161: from a purchaser for test or evaluation of a medical device or portion of medical device under section 26 of the Act
p.000161: shall be made in Form MD-33 and the report of such test or evaluation of the medical device which is
p.000161: prepared on such application shall be supplied to the applicant in Form MD-32.
p.000161:
p.000161: 70. Duties of Medical Device Officer.—Subject to the instructions of the Central Licensing Authority or
p.000161: State Licensing Authority, as the case may be, it shall be the duty of Medical Device Officer to,—
p.000161: (i) Inspect, not less than once in a year, all manufacturing sites licenced by the Central Licensing Authority or
p.000161: State Licensing Authority, as the case may be, within the area assigned to him;
p.000161: (ii) conform that the conditions of licence are being observed;
p.000161: (iii) take samples of medical device manufactured or imported for sale, or stocked or exhibited for sale in respect
p.000161: of which the Medical Device Officer has reason to suspect contravention of the provisions of the Act or these rules and
p.000161: send them for test or evaluation:
p.000161: Provided that in case of large sized medical device, wherein the opinion of the Medical Device Officer drawing
p.000161: samples of such a device may not be physically practical, such large sized medical device shall be
p.000161: inspected at the place where these are kept by the Medical Device Officer with or without expert and evaluated or
p.000161: tested by the Medical Device Testing Officer, for any suspect contravention, after approval of the
p.000161: Central Licensing Authority or the State Licensing Authority, as the case may be;
p.000161: (iv) maintain a record of all inspections undertaken, drawing of samples, seizure of stocks and action
p.000161: taken by Medical Device Officer in exercise and performance of duties and to furnish copies of such record to the
p.000161: Central Licensing Authority or the State Licensing Authority, as the case may be;
p.000161: (v) make such enquiries and inspections as may be necessary to detect the manufacture or sale of medical device in
p.000161: contravention of any provision of the Act and these rules;
p.000161: (vi) investigate any complaint made in writing relating to medical device to the Medical Device Officer or any other
p.000161: senior officer in accordance with the direction of the controlling officer;
p.000161: (vii) institute prosecution in relation to contravention of the provisions of the Act and these rules;
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.000163: by the applicant before grant of registration, namely,-
p.000163: (i) the premises where the test or evaluation shall be carried out shall be well lighted and properly ventilated
p.000163: except where the nature of tests of any medical device warrants otherwise, and wherever necessary, the premises shall
p.000163: be air conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the
p.000163: performance of special tests such as sterility tests, microbiological tests, etc;
p.000163: (ii) the applicant shall provide adequate space having regard to the nature and number of samples of medical devices
p.000163: proposed to be tested and evaluated:
p.000163: Provided that the approving authority shall determine from time to time whether the space provided
p.000163: continues to be adequate;
p.000163: (iii) if it is intended to carry out tests requiring the use of animals, the applicant shall provide for an animal
p.000163: house and comply with the following requirements:-
p.000163: (a) the animal house shall be adequate in area, well lighted and properly ventilated and the animals undergoing tests
p.000163: shall be kept in air conditioned area;
p.000163: (b) the animals shall be suitably housed in hygienic surroundings and necessary provisions made for
p.000163: removal of excreta and foul smell;
p.000163: (c) the applicant shall provide for suitable arrangements for preparation of animal feed;
p.000163: (d) the applicant shall provide for suitable arrangements for quarantining of all animals immediately on their arrival
p.000163: in the institution;
p.000163: (e) the animals shall be periodically examined for their physical fitness;
p.000163: (f) the applicant shall provide for isolation of sick animals as well as animals under test;
p.000163: (g) the applicant shall ensure compliance with the requirements of the Prevention of Cruelty to Animals Act, 1960 (59
p.000163: of 1960);
p.000163: (h) the applicant shall make proper arrangements for disposal of the carcasses of animals in a manner as not to cause
p.000163: hazard to public health.
p.000163:
p.000163: 83. Registration of medical device testing laboratory.—(1) Before grant of registration to any medical
p.000163: device testing laboratory by the Central Licensing Authority, the premises shall be inspected by the Medical Device
p.000163: Officer appointed by the Central Government with or without an expert in the concerned field for adequacy and
p.000163: suitability.
p.000163: (2) The Medical Device Officer, after completion of the inspection, shall forward a detailed descriptive report giving
p.000163: findings on each aspect of inspection along with recommendations to the Central Licensing Authority with a copy to the
p.000163: applicant.
p.000163: (3) If on receipt of the application and the report referred to in sub-rule (2), the Central Licensing
p.000163: Authority, is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules, the
p.000163: Central Licencing Authority may grant registration in Form MD-40 or if not satisfied, may, reject the
p.000163: application, for reasons to be recorded in writing, within a period of forty five days from the date of
...
Health / Pregnant
Searching for indicator pregnant:
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p.000205: Licensing Authority may require making the pilot study data available to assess whether the pilot data is in
p.000205: conformity to the data already generated outside the country.
p.000205: (iii) If the application is for conduct of clinical investigation as part of a Global Clinical Investigation of
p.000205: medical device, the number of sites and patients as well as justification for undertaking such clinical
p.000205: investigation in India shall be provided to the Central Licensing Authority.
p.000205: (8) Post Marketing Clinical Investigation:
p.000205: Post marketing clinical investigation is the study other than surveillance performed after marketing
p.000205: approval has been given to the medical device in relation to the approved indication. This investigation may
p.000205: not be considered necessary at the time of medical device approval but may be required by the Central
p.000205: Licensing Authority for optimizing the intended use of the medical device. Post Marketing Clinical investigation
p.000205: includes additional drug- device interaction, safety studies, investigation designed to support use under the approved
p.000205: indication e.g. mortality or morbidity studies, etc,.
p.000205: (9) Studies in special populations:
p.000205: The clinical investigation data of the medical device is required to be submitted to support the claim sought to be
p.000205: made for use of medical device in children, pregnant women, nursing women, elderly patients with renal or other
p.000205: organ system failure as given below:
p.000205: (i) Geriatrics:
p.000205: Geriatrics patients can be included in pivotal study (and in pilot study at the sponsor’s option) in meaningful
p.000205: numbers, if-
p.000205: (a) the disease intended to be treated is characteristically a disease of aging; or
p.000205: (b) the population to be treated is known to be included in substantial numbers of geriatric patients; or
p.000205: (c) there is specific reason to expect that conditions common in the elderly are likely to be encountered; or
p.000205: (d) the investigational medical device is likely to alter the geriatric patient’s response in regard to
p.000205: safety or performance compared with that of non-geriatric patient.
p.000205: (ii) Paediatrics:
p.000205: (a) The timing of pediatric studies in the medical device development program shall depend on the device, the type of
p.000205: disease being treated, safety consideration, and the safety and effectiveness of available treatment.
p.000205: (b) The medical device expected to be used in children; the performance and safety shall be made in
p.000205: the appropriate age group. When clinical investigation is required to be conducted in children, it is
p.000205: usually
p.000205:
p.000205: 206 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000205: II—SEC. 3(i)]
p.000205:
...
p.000205: informed consent shall be obtained from the parent or legal guardian. However, all paediatric participants shall be
p.000205: informed to the fullest extent possible about the study in a language and in terms that they are able to understand.
p.000205: Where appropriate, paediatric participants should additionally assent to enroll in the study. Mature minors and
p.000205: adolescents should personally sign and date a separately designed written consent form. Although a participant’s wish
p.000205: to withdraw from a study shall be respected, there may be circumstances in therapeutic studies for serious or
p.000205: life-threatening diseases in which, in the opinion of the investigator and parent or legal guardian, the welfare
p.000205: of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this
p.000205: situation, continued parental or legal guardian consent will be sufficient to allow participation in the study.
p.000205: (g) For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall
p.000205: include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.
p.000205: (iii) Pregnant or nursing women:
p.000205: (a) Pregnant or nursing women shall be included in clinical investigation only when the medical device
p.000205: is intended for use by pregnant or nursing women or fetuses or nursing infants and where the data generated from women
p.000205: who are not pregnant or nursing, would not be suitable.
p.000205: (b) For medical device intended for use during pregnancy, follow-up data pertaining to a period appropriate for that
p.000205: medical device on the pregnancy, foetus and child will be required.
p.000205: 3. Post Marketing Surveillance:
p.000205: (i) Subsequent to approval of an Investigational medical device, it shall be closely monitored for
p.000205: their clinical safety once they are marketed. The applicants shall furnish Periodic Safety Update Reports (PSURs) in
p.000205: order to,-
p.000205: (a) report all the relevant new information from appropriate sources;
p.000205: (b) relate these data to patient exposure;
p.000205: (c) summarise the market authorisation status in different countries and any significant variations related to
p.000205: safety; and
p.000205: (d) indicate whether changes will be made to product information in order to optimize the use of the product.
p.000205:
p.000205: (ii) One medical device should be covered in one PSUR. Within the single PSUR separate presentation of data for
p.000205: different indications or separate population need to be given.
p.000205: (iii) All relevant clinical and non-clinical safety data will cover only the period of the report (interval data).
p.000205: The PSURs shall be submitted every six months for the first two years after marketing approval of the
p.000205: medical device. For subsequent two years, the PSURs need to be submitted annually. The Central Licensing Authority may
p.000205: extend the total duration for submission of PSURs if it is considered necessary in the interest of public health. PSURs
...
p.000215: 11. The anticipated prorated payment, if any, to the Subject for participating in the clinical investigation
p.000215: 12. Subject's responsibilities on participation in the clinical investigation
p.000215: 13. Statement that participation is voluntary, that the Subject can withdraw from the clinical investigation at any
p.000215: time and that refusal to participate will not involve any penalty or loss of benefits to which the Subject is otherwise
p.000215: entitled
p.000215: 14. Statement that there is a possibility of failure of investigational medical device to provide intended
p.000215: therapeutic effect.
p.000215: 15. Any other pertinent information.
p.000215:
p.000215: 1.2 Additional elements, which may be required
p.000215: (a) Statement of foreseeable circumstances under which the Subject's participation may be terminated by the
p.000215: Investigator without the Subject's consent.
p.000215: (b) Additional costs to the Subject that may result from participation in the clinical investigation.
p.000215: (c) The consequences of a Subject’s decision to withdraw from the investigation and procedures for orderly termination
p.000215: of participation by Subject.
p.000215: (d) Statement that the Subject or Subject's representative will be notified in a timely manner if significant
p.000215: new findings are developed during the course of the investigation which may affect the Subject's
p.000215: willingness to continue participation will be provided.
p.000215: (e). A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or
p.000215: fetus, if the Subject is or may become pregnant), which are currently unforeseeable
p.000215: (f) Approximate number of Subjects enrolled in the clinical investigation
p.000215: 2. Format of informed consent form for Subjects participating in a clinical investigation - Informed Consent form to
p.000215: participate in a clinical investigation
p.000215: Clinical investigation Title: Clinical investigation Number:
p.000215: Subject’s Initials: Subject’s Name:
p.000215: _
p.000215: Date of Birth / Age: _ Gender:
p.000215: _ Address of the Subject: _
p.000215: Qualification: _
p.000215: Occupation: Student/Self-employed/Service/Housewife/Others (Please tick as appropriate) Annual income of the subject:
p.000215: _
p.000215: Name and address of the nominee(s) and his relation to the subject (for the purpose of
p.000215: compensation in case of clinical investigation related death).
p.000215:
p.000215:
p.000215:
p.000215: (i) I confirm that I have read and understood the information sheet dated _ for the above clinical investigation
p.000215: and have had the opportunity to ask questions.
p.000215: (ii) I understand that my participation in the clinical investigation is voluntary and that I am free to withdraw at
p.000215: any time, without giving any reason, without my medical care or legal rights being affected.
p.000215: Place initial box (Subject) [ ]
p.000215:
p.000215: [ ]
...
Health / Unconscious People
Searching for indicator unconscious:
(return to top)
p.000203: Head of institution where the clinical investigation has been conducted within 14 calendar days of the
p.000203: knowledge of occurrence of the serious adverse event.
p.000203: (5) Informed consent:
p.000203: (i) In all investigations, a freely given, informed, written consent is required to be obtained from
p.000203: each study subject. The investigator shall provide information about the study verbally and
p.000203: through the patient information sheet, in a language that is non-technical and is understandable by the study
p.000203: subject. The Subject’s consent must be obtained in writing using an ‘Informed Consent Form’. The patient information
p.000203: sheet as well as the Informed Consent Form shall be approved by the Ethics Committee and furnished to
p.000203: the Central Licensing Authority. Any change in the informed consent documents should be approved by the
p.000203: Ethics Committee and submitted to the Central Licensing Authority before such changes are implemented.
p.000203: (ii) Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering
p.000203: from severe mental illness or disability), the same may be obtained from a legally acceptable representative. If the
p.000203: subject or his legally acceptable representative is unable to read or write, an impartial witness should be present
p.000203: during the entire informed consent process who must append his signatures to the consent form. Explanation: a legally
p.000203: acceptable representative means a person who is able to give consent or authorise an intervention in the
p.000203: patient as provided by the law in India.
p.000203:
p.000203: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000205: 205
p.000205: (iii) A checklist of essential elements to be included in the study subject’s informed consent document as well as a
p.000205: format for the Informed Consent Form for study Subjects is given in Table 8 of this schedule.
p.000205: (iv) The informed consent process, in case of vulnerable subjects in clinical investigations of an innovative medical
p.000205: device which is not approved anywhere in the world, shall be audio-video recorded.
p.000205:
p.000205: (6) Pilot Clinical Investigation
p.000205: (i) Pilot clinical investigation is defined as those clinical investigations which are used to acquire specific
...
Health / injured
Searching for indicator injured:
(return to top)
p.000157: required to initiate clinical investigation;
p.000157: (ix) the Central Licensing Authority may impose or exempt any condition while granting permission in
p.000157: respect of specific clinical investigations, if considered necessary, regarding the objective, design,
p.000157: subject population, subject eligibility, assessment, conduct and treatment of clinical investigation.
p.000157:
p.000157: 54. Suspension, cancellation, etc. of permission.—(1) If any person to whom permission has been granted under rule
p.000157: 52 fails to comply with any of the conditions of permission or any of the provisions of the Act or these rules, the
p.000157: Central Licensing Authority may,—
p.000157: (a) issue warning letter giving details of deficiency found; or
p.000157: (b) debar the investigator or sponsor including their employees, subsidiaries and branches, their agents,
p.000157: contractors and sub-contractors to conduct any clinical investigation for such period as it thinks fit; or
p.000157: (c) suspend the permission for such period as it thinks fit or cancel either wholly or partly the permission.
p.000157: (2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days of the
p.000157: receipt of such order before the Central Government, which may, after such enquiry and after giving an opportunity of
p.000157: being heard to the appellant, dispose of the appeal within a period of sixty days.
p.000157:
p.000157: 55. Medical management and compensation related to clinical investigation.—(1) Where any participant is
p.000157: injured on account of participation in clinical investigation, the sponsor permitted under rule 52 shall
p.000157: provide medical management to that participant.
p.000157: (2) Where an injury is caused to the participant in a clinical investigation of any investigational medical device and
p.000157: such injury is attributable to the use of investigational medical device, the sponsor permitted under
p.000157: rule 52 shall provide to that participant, medical management and such compensation in the manner as
p.000157: specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945.
p.000157: (3) Where death of a participant is related to clinical investigation and is attributable to the use of an
p.000157: investigational medical device, the sponsor, permitted under rule 52 shall provide to the legal heir of
p.000157: that participant, such compensation, in such manner as specified under rule 122DAB of the Drugs and Cosmetics Rules,
p.000157: 1945.
p.000157:
p.000157: 56. Powers of search and seizure, etc.—The Medical Devices Officer may enter any premises related to
p.000157: clinical investigation or clinical performance evaluation, with or without an expert, with prior approval
p.000157: of the Central Licensing Authority, with or without prior notice, to inspect the facilities, search and seize,
p.000157: record, data, documents, books, and medical devices including investigational medical devices or new in vitro
p.000157: diagnostic medical device.
p.000157:
p.000157: 57. Maintenance of record.—Every person, sponsor, clinical research organisation, any other organisation or
p.000157: investigator conducting a clinical investigation or his agent holding a permission under this Chapter shall
...
p.000159: requirements of these rules for conduct of clinical performance evaluation;
p.000159: (vi) the clinical performance evaluation shall be initiated within a period of one year from the date
p.000159: of grant of permission, failing which prior permission from the Central Licensing Authority shall be
p.000159: required to initiate such clinical performance evaluation;
p.000159: (vii) the Central Licensing Authority may impose or exempt any condition while granting permission in respect of
p.000159: specific clinical performance evaluation, if considered necessary, regarding the objective, design, subject population,
p.000159: subject eligibility, assessment, conduct and treatment of clinical performance evaluation.
p.000159:
p.000159: 61. Suspension or cancellation of permission.—(1) If any person to whom permission has been granted under sub- rule
p.000159: (5) of rule 59 fails to comply with any of the conditions of permission, the Central Licensing Authority may,
p.000159: suspend the permission for such period as it thinks fit or cancel either wholly or partly.
p.000159: (2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days before
p.000159: the Central Government, which may, after such enquiry and after giving an opportunity of being heard to
p.000159: the appellant, dispose of the appeal within a period of sixty days.
p.000159:
p.000159: 62. Medical management.—Where any participant is injured on account of his participation in the clinical
p.000159: performance evaluation, the sponsor permitted under sub-rule (5) of rule 59 shall provide medical management to that
p.000159: participant.
p.000159:
p.000159:
p.000159: CHAPTER VIII
p.000159: IMPORT OR MANUFACTURE MEDICAL DEVICE WHICH DOES NOT HAVE PREDICATE DEVICE
p.000159:
p.000159: 63. Permission to import or manufacture medical device which does not have its predicate device.—(1) Save as otherwise
p.000159: provided in these rules, for import or manufacture of medical device which does not have predicate medical device, an
p.000159: application for grant of permission for such medical device after completion of its clinical investigation under
p.000159: Chapter VII shall be made to the Central Licensing Authority in Form MD-26 either by an authorised agent in case of
p.000159: import or a manufacturer, as the case may be, which shall be accompanied with fee as specified in the Second Schedule
p.000159: along with information specified in Part IV of the Fourth Schedule:
p.000159: Provided that the medical device which does not have predicate medical device indicated in life
p.000159: threatening, serious diseases or diseases of special relevance to the Indian health scenario, national
p.000159: emergencies, extreme urgency, epidemic and medical devices indicated for conditions, diseases for which there is no
p.000159: therapy, the animal data or clinical data requirements may be abbreviated, deferred or omitted, as deemed
p.000159: appropriate by the Central Licensing Authority:
p.000159: Provided further that in respect of investigational medical device of Class A, data on clinical investigation may not
...
p.000167: any operation undertaken or any direction given or any proceedings taken or any penalty, punishment, forfeiture or
p.000167: fine imposed under the Drugs and Cosmetics Rules, 1945 shall, be deemed to have been done or taken under the
p.000167: corresponding provisions of these rules and shall always remain valid for all purposes.
p.000167:
p.000167: First Schedule
p.000167: [See rule 4]
p.000167: Parameters for classification of medical devices and in vitro diagnostic medical devices
p.000167:
p.000167: Part I
p.000167: Parameters for classification of medical devices other than in vitro diagnostic medical devices Basic Principles for
p.000167: classification.
p.000167:
p.000167: (i) Application of the classification provisions shall be governed by the intended purpose of the device.
p.000167: (ii) If the device is intended to be used in combination with another device, the classification rules
p.000167: shall apply separately to each of the devices. Accessories are classified in their own right separately from the
p.000167: device with which they are used.
p.000167: (iii) Software, which drives a device or influences the use of a device, falls automatically in the same class.
p.000167: (iv) If the device is not intended to be used solely or principally in a specific part of the body, it must be
p.000167: considered and classified on the basis of the most critical specified use.
p.000167: (v) If several rules apply to the same device, based on the performance specified for the device by the manufacturer,
p.000167: the strictest rules resulting in the higher classification shall apply.
p.000167:
p.000167: 1. Parameters for classification of medical devices.
p.000167: (i) Non-invasive medical devices which come into contact with injured skin.
p.000167: (a) A non-invasive medical device which comes into contact with injured skin shall be assigned to Class A, if it is
p.000167: intended to be used as a mechanical barrier, for compression or for absorption of exudates only, for wounds which have
p.000167: not breached the dermis and can heal by primary intention;
p.000167: (b) Subject to clause (c), a non-invasive medical device which comes into contact with injured skin shall be assigned
p.000167: to Class B, if it is intended to be used principally with wounds which have breached the dermis, or is principally
p.000167: intended for the management of the microenvironment of a wound;
p.000167: (c) a non-invasive medical device which comes into contact with injured skin shall be assigned to Class C, if it is
p.000167: intended to be used principally with wounds which have breached the dermis and cannot heal by primary
p.000167: intention.
p.000167: (ii) Non-invasive medical devices for channeling or storing substances.
p.000167: (a) Subject to clauses (b) and (c), a non-invasive medical device shall be assigned to Class A, if it is intended for
p.000167: channeling or storing body liquids or tissues or liquids or gases for the purpose of eventual infusion, administration
p.000167: or introduction into a human body;
p.000167: (b) A non-invasive medical device referred to in clause (a) shall be assigned to Class B, if it is intended to be
p.000167: connected to an active medical device which is in Class B, C or D or for channeling blood or storing or channeling
p.000167: other body liquids or storing organs, parts of organs or body tissues:
p.000167: Provided, that the circumstances when a non-invasive medical device is connected to an active medical
p.000167: device include circumstances where the safety and performance of the active medical device is influenced by
p.000167: the non-invasive medical device, or vice versa; or
p.000167: (c) A non-invasive medical device referred to in clause (a) shall be assigned to Class C, if it is a blood bag that
p.000167: does not incorporate a medicinal product.
p.000167:
p.000167: 168 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000167: II—SEC. 3(i)]
p.000167:
p.000167: (iii) Non-invasive medical devices for modifying compositions of substances.
p.000167: (a) Subject to clause (b), a non-invasive medical device shall be assigned to Class C, if it is
p.000167: intended for modifying the biological or the chemical composition of blood or other body liquids or other
...
Health / patients in emergency situations
Searching for indicator emergencies:
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p.000159: (2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days before
p.000159: the Central Government, which may, after such enquiry and after giving an opportunity of being heard to
p.000159: the appellant, dispose of the appeal within a period of sixty days.
p.000159:
p.000159: 62. Medical management.—Where any participant is injured on account of his participation in the clinical
p.000159: performance evaluation, the sponsor permitted under sub-rule (5) of rule 59 shall provide medical management to that
p.000159: participant.
p.000159:
p.000159:
p.000159: CHAPTER VIII
p.000159: IMPORT OR MANUFACTURE MEDICAL DEVICE WHICH DOES NOT HAVE PREDICATE DEVICE
p.000159:
p.000159: 63. Permission to import or manufacture medical device which does not have its predicate device.—(1) Save as otherwise
p.000159: provided in these rules, for import or manufacture of medical device which does not have predicate medical device, an
p.000159: application for grant of permission for such medical device after completion of its clinical investigation under
p.000159: Chapter VII shall be made to the Central Licensing Authority in Form MD-26 either by an authorised agent in case of
p.000159: import or a manufacturer, as the case may be, which shall be accompanied with fee as specified in the Second Schedule
p.000159: along with information specified in Part IV of the Fourth Schedule:
p.000159: Provided that the medical device which does not have predicate medical device indicated in life
p.000159: threatening, serious diseases or diseases of special relevance to the Indian health scenario, national
p.000159: emergencies, extreme urgency, epidemic and medical devices indicated for conditions, diseases for which there is no
p.000159: therapy, the animal data or clinical data requirements may be abbreviated, deferred or omitted, as deemed
p.000159: appropriate by the Central Licensing Authority:
p.000159: Provided further that in respect of investigational medical device of Class A, data on clinical investigation may not
p.000159: be required, except in cases, where depending on the nature of the medical device, the Central Licensing
p.000159: Authority, for reason to be recorded in writing, considers such data necessary:
p.000159: Provided also that subject to other provisions of these rules, in case of medical device of which drugs are also a
p.000159: part, the submission of requirements relating to animal toxicology, reproduction studies, teratogenic
p.000159: studies, perinatal studies, mutagenicity and carcinogenicity may be relaxed in case of drugs already approved and
p.000159: marketed in India and supported by adequate published evidence regarding safety of the drug.
p.000159: Provided also that, the results of clinical investigation may not be required to be submitted where the
p.000159: investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United
p.000159: States of America or Australia or Canada or Japan and the said device has been marketed for at least two years in that
p.000159: country and the Central Licencing Authority is satisfied with the data of safety, performance and pharmacovigilance of
p.000159: the device, and,-
...
p.000161: Provided further that if the applicant has not furnished the required information sought by the Central
p.000161: Licensing Authority within ninety days from the date of intimation and the said Authority is satisfied
p.000161: that the information sought was possible to be furnished within the said period, it may reject the application for
p.000161: reasons to be recorded in writing.
p.000161: (3) If the applicant does not receive permission or if the application is rejected within the specified period as
p.000161: referred to in sub-rule (2), the applicant may appeal to the Central Government and that Government may, after such
p.000161: enquiry, as it considers necessary, pass such orders in relation thereto as it thinks fit within a period of sixty days
p.000161: from the date of appeal.
p.000161:
p.000161: 64. Permission to import or manufacture new in vitro diagnostic medical device.—(1) An application for grant of
p.000161: permission to import or manufacture a new in vitro diagnostic medical device may be made to the Central Licensing
p.000161: Authority in Form MD-28 either by an authorised agent in case of import or a manufacturer himself, as the case may be,
p.000161: and shall be accompanied with fee as specified in the Second Schedule along with information specified in Part IV of
p.000161: the Fourth Schedule:
p.000161: Provided that the new in vitro diagnostic medical device used for diagnosis of life threatening, serious
p.000161: diseases or diseases of special relevance to the Indian health scenario, national emergencies, extreme
p.000161: urgency, epidemic and diagnostic medical devices used for diagnosis of conditions, diseases for which there is no
p.000161: diagnostic medical device available in the country, the clinical data requirements may be abbreviated,
p.000161: deferred or omitted, as deemed appropriate by the Central Licensing Authority:
p.000161: Provided further that for new in vitro diagnostic medical device classified under Class A, data on clinical performance
p.000161: evaluation may not be necessary, except in cases, where the Central Licensing Authority, for reasons to be recorded in
p.000161: writing, considers it necessary depending on the nature of the medical device.
p.000161: (2) The Central Licensing Authority, may, after being satisfied with the information furnished along with application
p.000161: under sub-rule (1), grant permission to import or manufacture new in vitro diagnostic medical device in Form MD-29 or
p.000161: may reject the application, for reasons to be recorded in writing, within a period of ninety days or such extended
p.000161: period, not exceeding a further period of thirty days, from the date of application:
p.000161: Provided that the Central Licensing Authority shall, where the information is inadequate with regard to the
p.000161: requirements as referred to in sub-rule (1), intimate the applicant in writing within the said period, for reasons to
p.000161: be recorded in writing, the conditions which shall be satisfied before considering permission:
p.000161: Provided further that if the applicant has not furnished the required information sought by the Central
...
Social / Access to Social Goods
Searching for indicator access:
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p.000191: (a) documented statements of a quality policy and quality objectives;
p.000191: (b) a quality manual;
p.000191: (c) documented procedures required by this schedule;
p.000191:
p.000191: 192 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000191: II—SEC. 3(i)]
p.000191:
p.000191: (d) documents needed by the manufacturer to ensure the effective planning, operation and control of its processes;
p.000191: (e) records required by this Schedule, and
p.000191: where this Schedule specifies that a requirement, procedure, activity or special arrangement be “documented”, it shall,
p.000191: in addition, be implemented and maintained.
p.000191: For each type of medical device or in vitro diagnostic medical devices, the manufacturer shall establish and maintain a
p.000191: file either containing or identifying documents defining product specifications and quality
p.000191: management system requirements. These documents shall define the complete manufacturing process and, if applicable,
p.000191: installation.
p.000191: The manufacture shall prepare documentation for device or in vitro diagnostic medical devices in a form of
p.000191: a Device Master File containing specific information as referred to in Fourth Schedule.
p.000191: Data may be recorded by electronic data processing systems or other reliable means, but documents and record relating
p.000191: to the system in use shall also be available in a hard copy to facilitate checking of the accuracy of the records.
p.000191: Wherever documentation is handled by electronic data processing methods, authorized persons shall enter or
p.000191: modify data in the computer. There shall be record of changes and deletions. Access shall be restricted by ‘passwords’
p.000191: or other means and the result of entry of critical data shall be independently checked. Batch records electronically
p.000191: stored shall be protected by a suitable back-up. During the period of retention, all relevant data shall be readily
p.000191: available.
p.000191: 4.2.2 Quality manual.-
p.000191: The manufacturer shall establish and maintain a quality manual that includes:-
p.000191: (a) the scope of the quality management system, including details of and justification for any
p.000191: exclusion or non- application or both;
p.000191: (b) the documented procedures established for the quality management system, or reference to them; and
p.000191: (c) a description of the interaction between the processes of the quality management system.
p.000191: The quality manual shall outline the structure of the documentation used in the quality management system.
p.000191: The manufacturer shall prepare documentation in a form of a Plant Master File containing specific information about the
p.000191: facilities, personnel and other details as prescribed in Fourth.
p.000191: 4.2.3 Control of documents.-
p.000191: Documents required by the quality management system shall be controlled. Records are a special type of document and
p.000191: shall be controlled according to the requirements given in the control of records. Documents shall be approved, signed
p.000191: and dated by the appropriate and the authorised person.
p.000191: A documented procedure shall be established to define the controls needed.-
p.000191: (a) to review and approve documents for adequacy prior to issue;
p.000191: (b) to review and update as necessary and re-approve documents;
p.000191: (c) to ensure that changes and the current revision status of documents are identified;
p.000191: (d) to ensure that relevant versions of applicable documents are available at points of use;
p.000191: (e) to ensure that documents remain legible and readily identifiable;
p.000191: (f) to ensure that documents of external origin are identified and their distribution controlled; and
p.000191: (g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them
p.000191: if they are retained for any purpose.
p.000191: Changes to document shall be reviewed and approved. Change records shall be maintained which will
p.000191: include a description of the change, identification of the affected documents, the signature of the
p.000191: approving individual, the approval date, and when the change becomes effective.
p.000191: The manufacturer shall ensure that changes to documents are reviewed and approved either by the original
p.000191: approving functionary or another designated functionary which has access to pertinent background information upon which
p.000191: to base its decisions.
p.000191: The manufacturer shall define the period for which at least one copy of obsolete controlled documents shall be
p.000191: retained. This period shall ensure that documents to which medical devices or in vitro diagnostic medical
p.000191: devices have been manufactured and tested are retained for at least one year after the date of expiry
p.000191: of the medical device or in vitro diagnostic medical devices as defined by the manufacturer.
p.000191: 4.2.4 Control of records.-
p.000191: Records shall be established and maintained to provide evidence of conformity to the requirements and of the effective
p.000191: operation of the quality management system. Records shall remain legible, readily identifiable and
p.000191: retrievable. A documented procedure shall be established to define the controls needed for the
p.000191: identification, storage, protection, retrieval, retention time and disposition of records.
p.000191: The manufacturer shall retain the records for a period of time at least one year after the date of expiry of the
p.000191: medical device or in vitro diagnostic medical devices as defined by the manufacturer, but not less than two years from
p.000191: the date of product release by the manufacturer.
p.000191: 5 Management responsibility.-
p.000191: 5.1 Management commitment:
p.000191: Top management of the manufacturer shall provide evidence of its commitment to the development and implementation of
p.000191: the quality management system and maintaining its effectiveness by:-
p.000191: (a) communicating to the employees the importance of meeting customer as well as statutory and
p.000191: regulatory requirements;
...
p.000009: granted to repeat pilot study or to conduct Pivotal Clinical Investigation. Pivotal Clinical Investigation is required
p.000009: to be conducted in India before permission to market the medical device in India except investigational
p.000009: medical device classified under class A, in exceptional cases, the Central Licensing Authority, may, for
p.000009: reasons to be recorded in writing, if consider it necessary, mandate conduct of clinical investigation, depending on
p.000009: the nature of the medical device.
p.000009: (4) The number of study subjects and sites to be involved in the conduct of clinical investigation shall depend on
p.000009: the nature and objective of the clinical investigation.
p.000009: 2. CLINICAL INVESTIGATION:
p.000009: (1) Approval for clinical investigation
p.000009: (i) Clinical investigation on an investigational medical device shall be initiated only after approval
p.000009: has been obtained from the Ethics Committee(s), registered under rule 122DD of Drugs and Cosmetics Rules, 1945, and
p.000009:
p.000009: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000203: 203
p.000203: permission granted by Central Licensing Authority. The investigation shall be initiated at the respective sites
p.000203: only after obtaining such approval from the Ethics Committee for that site.
p.000203: (ii) All investigators should possess appropriate qualification, training and experience and should have
p.000203: access to such investigational and treatment facilities as are relevant to the proposed clinical investigation. A
p.000203: qualified physician (or dentist, when appropriate), who is an investigator or a
p.000203: sub-investigator for the investigation, shall be responsible for all investigation related decisions
p.000203: concerning medical or dental issues. Laboratories used for generating data for clinical investigation should
p.000203: be compliant with Good Laboratory Practices or should have accreditation certificate issued by National
p.000203: Accreditation Board for Testing and Calibration Laboratories. In all cases, information about laboratory or
p.000203: facility to be used for the investigation, if other than those at the investigation site, should be furnished
p.000203: to the Central Licensing Authority prior to initiation of investigation at such site.
p.000203: (iii) Clinical investigational plan amendments, if it becomes necessary, to so amend it, before initiation or during
p.000203: the course of a clinical investigation, shall be notified to the Central Licensing Authority in writing
p.000203: along with approval of the Ethics Committee, if available, which has granted the approval for the study.
p.000203: No deviations from or changes to clinical investigational plan shall be implemented without prior written
p.000203: approval of the Ethics Committee and the Central Licensing Authority except when it is necessary to eliminate
...
p.000211: 1.6.3 Subjects
p.000211: (a) Inclusion criteria for subject selection.
p.000211: (b) Exclusion criteria for subject selection.
p.000211: (c) Criteria and procedures for subject withdrawal or discontinuation.
p.000211: (d) Point of enrolment.
p.000211: (e) Total expected duration of the clinical investigation.
p.000211: (f) Expected duration of each subject's participation.
p.000211:
p.000211: 212 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000211: II—SEC. 3(i)]
p.000211:
p.000211: (g) Number of subjects required to be included in clinical investigation.
p.000211: (h) Estimated time needed to select this number (i.e. enrolment period).
p.000211:
p.000211: 1.6.4 Procedures
p.000211: (a) Description of all the clinical investigation related procedures that subjects undergo
p.000211: during clinical investigation.
p.000211: (b) Description of those activities performed by sponsor representatives (excluding monitoring).
p.000211: (c) Any known or foreseeable factors that may compromise the outcome of clinical investigation or interpretation of
p.000211: results. The follow-up period during clinical investigation shall permit demonstration of performance over
p.000211: a period of time sufficient to represent a realistic test of the performance of the investigational medical device and
p.000211: allow any risks associated with adverse device effects over that period to be identified and assessed.
p.000211:
p.000211: The Clinical investigation plan shall specifically address what medical care, if any, will be provided to the subjects
p.000211: after the clinical investigation has been completed.
p.000211:
p.000211: 1.6.5 Monitoring plan
p.000211: General outline of the monitoring plan to be followed, including access to source data and the extent of source data
p.000211: verification planned.
p.000211:
p.000211: 1.7 Statistical considerations
p.000211: With reference to 1.5 and 1.6, the description of and justification for:-
p.000211: (a) statistical design, method and analytical procedures;
p.000211: (b) sample size;
p.000211: (c) the level of significance and the power of the clinical investigation;
p.000211: (d) expected drop-out rates;
p.000211: (e) pass or fail criteria to be applied to the results of the clinical investigation;
p.000211: (f) the provision for an interim analysis, where applicable;
p.000211: (g) criteria for the termination of the clinical investigation on statistical grounds;
p.000211: (h) procedures for reporting any deviation from the original statistical plan;
p.000211: (i) the specification of subgroups for analysis;
p.000211: (j) procedures that take into account all the data;
p.000211: (k) the treatment of missing, unused or spurious data, including drop-outs and withdrawals;
p.000211: (l) the exclusion of particular information from the testing of the hypothesis, if relevant; and
p.000211: (m) in multicenter clinical investigations, the minimum and maximum number of subjects to be included for each center.
p.000211: Special reasoning and sample size(s) may apply for the early clinical investigation(s), e.g. feasibility
p.000211: clinical investigation(s).
p.000211:
p.000211: 1.8 Data management
p.000211: (a) Procedures used for data review, database cleaning, and issuing and resolving data queries.
p.000211: (b) Procedures for verification, validation and securing of electronic clinical data systems, if applicable.
p.000211: (c) Procedures for data retention.
p.000211: (d) Specified retention period.
p.000211: (e) Other aspects of clinical quality assurance, as appropriate.
p.000211:
p.000211: 1.9 Amendments to the Clinical investigation plan
...
p.000213: (d) Time period in which the principal investigator shall report all adverse events and device deficiencies to the
p.000213: sponsor and, where appropriate, to Ethics Committee and the regulatory authority.
p.000213: (e) Details of the process for reporting adverse events (date of the adverse event, treatment, resolution, assessment
p.000213: of both the seriousness and the relationship to the investigational medical device).
p.000213: (f) Details of the process for reporting device deficiencies.
p.000213: (g) List of foreseeable adverse events and anticipated adverse device effects, together with their likely incidence,
p.000213: mitigation or treatment.
p.000213: (h) Emergency contact details for reporting serious adverse events and serious adverse device effects.
p.000213: 1.15 Vulnerable population.
p.000213: (a) Description of the vulnerable population.
p.000213: (b) Description of the specific informed consent process.
p.000213: (c) Description of the Ethics Committee specific responsibility.
p.000213: (d) Description of what medical care, if any, will be provided for subjects after the clinical investigation has been
p.000213: completed.
p.000213: 1.16 Suspension or premature termination of the clinical investigation.
p.000213: (a) Criteria and arrangements for suspension or premature termination of the whole clinical investigation or of the
p.000213: clinical investigation in one or more investigation sites.
p.000213: (b) Criteria for access to and breaking the blinding or masking code in case of suspension or premature termination of
p.000213: the clinical investigation, if the clinical investigation involves a blinding or masking technique.
p.000213: (c) Requirements for subject follow-up.
p.000213: 1.17 Publication policy.
p.000213: (a) Statement indicating whether the results of the clinical investigation will be submitted for publication.
p.000213: (b) Statement indicating the conditions under which the results of the clinical investigation will be
p.000213: offered for publication.
p.000213: Table 6
p.000213: Case Report Form (CRF)
p.000213: 1. General
p.000213: (i) Case Report Forms are established to implement the clinical investigation plan, to facilitate
p.000213: subject observation and to record subject and investigational medical device data during the clinical
p.000213: investigation according to the clinical investigation plan. They can exist as printed, optical, or electronic
p.000213: documents and can be organized into a separate section for each subject.
p.000213:
p.000213: 214 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000213: II—SEC. 3(i)]
p.000213:
p.000213: (ii) The Case Report Forms should reflect the clinical investigation plan and take account of the nature
p.000213: of the investigational medical device.
p.000213: 2. Content and format
p.000213: 2.1 Overall considerations
p.000213: (i) The Case Report Forms can be organized such that they reflect all the data from a single procedure or a
p.000213: single visit or other grouping that makes clinical or chronological sense.
...
p.000215: 6. Details about the Investigator:
p.000215: (a) Name;
p.000215: (b) Address;
p.000215: (c) Telephone number;
p.000215: (d) Profession (specialty);
p.000215: (e) Date of reporting the event to Central Licensing Authority;
p.000215: (f) Date of reporting the event to Ethics Committee overseeing the site;
p.000215: (g) Signature of the Investigator.
p.000215:
p.000215:
p.000215:
p.000215: Table 8 Informed Consent Form
p.000215: Checklist for clinical investigation Subject’s informed consent documents
p.000215: 1.1 Essential elements:
p.000215: 1. Statement that the study involves research and explanation of the purpose of the research
p.000215: 2. Expected duration of the Subject's participation
p.000215: 3. Description of the procedures to be followed, including all invasive procedures
p.000215: 4. Description of any reasonably foreseeable risks or discomforts to the Subject
p.000215:
p.000215: 216 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000215: II—SEC. 3(i)]
p.000215:
p.000215: 5. Description of any benefits to the Subject or others reasonably expected from research. If no benefit is expected,
p.000215: subject should be made aware of this.
p.000215: 6. Disclosure of specific appropriate alternative procedures or therapies available to the Subject.
p.000215: 7. Statement describing the extent to which confidentiality of records identifying the subject will be maintained and
p.000215: who will have access to Subject’s medical records
p.000215: 8. Clinical investigation treatment schedule(s) and the probability for random assignment to each treatment (for
p.000215: randomised clinical investigation)
p.000215: 9. Statement describing the financial compensation and medical management as under:
p.000215: (a) In case of an injury occurring to the subject during the clinical investigation, free medical management shall be
p.000215: given as long as required or till such time it is established that the injury is not related to the clinical
p.000215: investigation, whichever is earlier.
p.000215: (b) In the event of an investigation related injury or death, the Sponsor or his representative, whoever has obtained
p.000215: permission from the Central Licensing Authority for conduct of the clinical investigation, shall provide financial
p.000215: compensation for the injury or death.
p.000215: 10. An explanation about whom to contact for clinical investigation related queries, rights of Subjects and in the
p.000215: event of any injury
p.000215: 11. The anticipated prorated payment, if any, to the Subject for participating in the clinical investigation
p.000215: 12. Subject's responsibilities on participation in the clinical investigation
p.000215: 13. Statement that participation is voluntary, that the Subject can withdraw from the clinical investigation at any
p.000215: time and that refusal to participate will not involve any penalty or loss of benefits to which the Subject is otherwise
p.000215: entitled
p.000215: 14. Statement that there is a possibility of failure of investigational medical device to provide intended
p.000215: therapeutic effect.
p.000215: 15. Any other pertinent information.
p.000215:
p.000215: 1.2 Additional elements, which may be required
...
p.000215: _ Address of the Subject: _
p.000215: Qualification: _
p.000215: Occupation: Student/Self-employed/Service/Housewife/Others (Please tick as appropriate) Annual income of the subject:
p.000215: _
p.000215: Name and address of the nominee(s) and his relation to the subject (for the purpose of
p.000215: compensation in case of clinical investigation related death).
p.000215:
p.000215:
p.000215:
p.000215: (i) I confirm that I have read and understood the information sheet dated _ for the above clinical investigation
p.000215: and have had the opportunity to ask questions.
p.000215: (ii) I understand that my participation in the clinical investigation is voluntary and that I am free to withdraw at
p.000215: any time, without giving any reason, without my medical care or legal rights being affected.
p.000215: Place initial box (Subject) [ ]
p.000215:
p.000215: [ ]
p.000215: (iii) I understand that the Sponsor of the clinical investigation, others working on the [ ]
p.000215:
p.000215: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000217: 217
p.000217: Sponsor’s behalf, the Ethics Committee and the regulatory authorities will not need my permission to look
p.000217: at my health records both in respect of the current clinical investigation and any further research that may be
p.000217: conducted in relation to it, even if I withdraw from the clinical investigation. I agree to this access.
p.000217: However, I understand that my identity will not be revealed in any information released to third parties or published.
p.000217: (iv) I agree not to restrict the use of any data or results that arise from this clinical
p.000217: [ ] investigation provided such a use is only for scientific purpose(s).
p.000217: (v) I agree to take part in the above clinical investigation.
p.000217: [ ]
p.000217:
p.000217: (vi) I understand that in case of an injury occurring during the clinical investigation, free medical management shall
p.000217: be given as long as required.
p.000217: (vii) I understand that in the event of an investigation related injury or death, financial compensation for such
p.000217: injury or death shall be provided in accordance with the provisions of the Medical Device Rules, 2017.
p.000217:
p.000217: Signature (or Thumb impression) of the Subject/Legally Acceptable Representative:_
p.000217:
p.000217: Date: _/_ /_
p.000217: Signatory’s Name: _
p.000217:
p.000217: Signature of the Investigator: _
p.000217: Contact Details (Telephone Number/ mobile) on which subject may contact: Date:
p.000217: _/_ /_
p.000217:
p.000217: Clinical investigation Investigator’s Name:
p.000217:
p.000217:
p.000217: Signature of the Witness Date:_ / / _
p.000217: Name of the Witness: _
p.000217: Address and contact details of the Witness:
p.000217: _
p.000217:
p.000217: (Copy of the Patient Information Sheet and duly filled Informed Consent Form shall be handed over to the subject or
p.000217: his/her attendant).
p.000217:
p.000217: Table 9 Undertaking by the Investigator
...
Social / Age
Searching for indicator age:
(return to top)
p.000175:
p.000175: (a) act as the official representative for obtaining import licence in India.
p.000175: (b) submit all necessary documents, as defined in the Fourth Schedule, for the import licence of medical device.
p.000175: (3) I shall comply with all the conditions imposed on the import licence and with provisions of the Medical
p.000175: Devices Rules, 2017.
p.000175: (4) I declare that M/s is carrying on the manufacture of the listed medical device at the
p.000175: manufacturing site
p.000175: specified above.
p.000175: (5) I shall allow the Central Licensing Authority or any person authorized by it in that behalf to enter and
p.000175: inspect or audit the manufacturing premise and to examine the process, procedure and documents in respect
p.000175: of any manufacturing site or to take sample of listed medical device for which the application for import licence has
p.000175: been made.
p.000175: (6) In case of any violation of Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices Rules, 2017,
p.000175: the authorised agent shall continue to be responsible even after withdraw of this Power of Attorney for
p.000175: the devices imported in India.
p.000175: (7) I do hereby state and declare that all the photocopies or scanned copies in the application are true copies
p.000175: of the original documents.
p.000175: (8) I do hereby state and declare that all the documents submitted by the undersigned are true and correct.
p.000175:
p.000175:
p.000175:
p.000175: Place:
p.000175: Date:
p.000175: Signature of the manufacturer
p.000175: (Name and Designation) Seal/Stamp
p.000175:
p.000175: Undertaking from the authorised agent
p.000175:
p.000175: I ……………....…, age……….., working as ……………………… at M/s ……………………… (Full address/ telephone no., e-mail)
p.000175: agrees to act upon the Power of Attorney as the authorized agent on behalf of M/s
p.000175: ………………………………… (Full address/ telephone no., e-mail) having manufacturing site at
p.000175: ………………….……. (Full address, telephone no., e-mail).
p.000175:
p.000175: Place:
p.000175: Date: Signature of the authorised
p.000175: agent
p.000175: (Name and Designation) Seal/Stamp
p.000175:
p.000175: Part II
p.000175: (i) Documents to be submitted with the application for grant of Import Licence or licence to manufacture for sale or
p.000175: for distribution of a Class A medical device,-
p.000175:
p.000175: (a) The applicant shall submit documents as specified in the Table below.-
p.000175:
p.000175:
p.000175: S.N.
p.000175:
p.000175: 1.
p.000175:
p.000175:
p.000175: 2.
p.000175:
p.000175: 3.
p.000175: For medical devices other than in vitro
p.000175: diagnostic medical device
p.000175: device description, intended use of the device, specification including variants and accessories;
p.000175: material of construction;
p.000175:
p.000175: working principle and use of a novel technology (if any);
p.000175: For in vitro diagnostic medical device
p.000175:
p.000175: device description, intended use of the device, specification including variants and accessories;
p.000175: a summary of analytical technology, relevant analytes and test procedure;
p.000175: working principle and use of a novel technology (if any);
p.000175:
p.000175: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000177: 177
p.000177:
p.000177:
...
p.000009: 2. in the manufacturing process, equipment, or testing which shall not affect quality of the device;
p.000009: 3. packaging specifications excluding primary packaging material.
p.000009:
p.000009: Seventh Schedule
p.000009: [See rules 51(1), 51(2), 53(ii), 53(v), 59(3)]
p.000009:
p.000009: Requirements for permission to import or manufacture investigational medical device for conducting clinical
p.000009: investigation
p.000009:
p.000009: 1. Application for permission.-
p.000009: (1) an application in Form MD-22 shall be made to the Central Licensing Authority along with following data in
p.000009: accordance with tables, namely:-
p.000009: (i) Design analysis data as per Table 1.
p.000009: (ii) Biocompatibility and Animal Performance Study as per Table 2.
p.000009: (iii) Information specified in Table 3 shall be submitted along with Investigator’s Brochure as
p.000009: prescribed in Table 4, Clinical Investigational Plan as prescribed in Table 5, Case Report Form as prescribed in Table
p.000009: 6, Serious adverse event reported, if any, as prescribed in Table 7, Informed Consent Form as prescribed in Table 8,
p.000009: investigator’s undertaking as prescribed in Table 9, of this schedule and Ethics Committee approval, if available, as
p.000009: prescribed in Appendix VIII of Schedule Y of the Drugs and Cosmetics Rules, 1945.
p.000009: (iv) Regulatory status in other countries, including information in respect of restrictions imposed, if
p.000009: any, on use of investigational medical device in other countries, prescription based device, exclusion of
p.000009: certain age groups, warning about adverse device effect. Likewise, if the investigational
p.000009: medical device has been withdrawn in any country by the manufacturer or by regulatory authority, such
p.000009: information shall also be furnished along with reasons and its relevance, if any. This information must continue
p.000009: to be submitted by the sponsor to the Central Licensing Authority during the entire duration of marketing of
p.000009: the said medical device in the Country;
p.000009: (v) Proposed Instruction for use or direction for use and labels shall be submitted as part of the
p.000009: application. The drafts of label shall comply with provisions of labeling rules specified in Medical Devices Rules,
p.000009: 2017:
p.000009: Provided that after submission and approval by the Central Licensing Authority, no change in the
p.000009: Instructions for Use shall be effected without such changes having been approved by the Central Licensing Authority;
p.000009: (vi) Report of clinical investigation should be in consonance with the format as prescribed in Table 10, such reports
p.000009: shall be certified by Principal Investigator.
p.000009: (2) For investigational medical device developed in India, clinical investigation is required to be carried out in
p.000009: India right from Pilot clinical investigation or first in human study and data generated should be
p.000009: submitted.
p.000009: (3) For investigational medical devices developed and studied in country other than India, Pilot
...
p.000205: (9) Studies in special populations:
p.000205: The clinical investigation data of the medical device is required to be submitted to support the claim sought to be
p.000205: made for use of medical device in children, pregnant women, nursing women, elderly patients with renal or other
p.000205: organ system failure as given below:
p.000205: (i) Geriatrics:
p.000205: Geriatrics patients can be included in pivotal study (and in pilot study at the sponsor’s option) in meaningful
p.000205: numbers, if-
p.000205: (a) the disease intended to be treated is characteristically a disease of aging; or
p.000205: (b) the population to be treated is known to be included in substantial numbers of geriatric patients; or
p.000205: (c) there is specific reason to expect that conditions common in the elderly are likely to be encountered; or
p.000205: (d) the investigational medical device is likely to alter the geriatric patient’s response in regard to
p.000205: safety or performance compared with that of non-geriatric patient.
p.000205: (ii) Paediatrics:
p.000205: (a) The timing of pediatric studies in the medical device development program shall depend on the device, the type of
p.000205: disease being treated, safety consideration, and the safety and effectiveness of available treatment.
p.000205: (b) The medical device expected to be used in children; the performance and safety shall be made in
p.000205: the appropriate age group. When clinical investigation is required to be conducted in children, it is
p.000205: usually
p.000205:
p.000205: 206 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000205: II—SEC. 3(i)]
p.000205:
p.000205: appropriate to begin with older children before extending the investigation to younger children and then infants.
p.000205: (c) If the medical device is predominantly or exclusively used in paediatric patients, clinical investigation data
p.000205: should be generated in paediatric population except for initial safety and performance data, which will
p.000205: usually be obtained in adults unless such initial safety studies in adults would yield little useful information or
p.000205: expose them to inappropriate risk.
p.000205: (d) If the medical device is intended to treat serious or life-threatening diseases, occurring in both adults and
p.000205: paediatric patients, for which there are currently no or limited therapeutic options, paediatric
p.000205: population may be included in the clinical investigation early, following assessment of initial safety
p.000205: data and reasonable evidence of potential benefit. In circumstances where this is not possible, lack of data has to be
p.000205: justified.
p.000205: (e) If the medical device has a potential for use in paediatric patient, paediatric studies may be
p.000205: conducted. These studies may be initiated at various stages of clinical development or after
...
p.000213: (c) Inclusion/exclusion.
p.000213: (d) Baseline visit:
p.000213: (1) demographics;
p.000213: (2) medical diagnosis;
p.000213: (3) relevant previous medications or procedures;
p.000213: (4) date of enrolment;
p.000213: (5) other characteristics.
p.000213: (e) Intervention(s) or treatment(s).
p.000213: (f) Follow-up visit(s).
p.000213: (g) Clinical investigation procedure(s).
p.000213: (h) Adverse event(s).
p.000213: (i) Device deficiencies.
p.000213: (j) Concomitant illness(es)/medication(s).
p.000213: (k) Unscheduled visit(s).
p.000213: (l) Subject diary.
p.000213: (m) Subject withdrawal or lost to follow-up.
p.000213: (n) Form signifying the end of the clinical investigation, signed by the principal investigator or his/her
p.000213: authorised designee.
p.000213: (o) CIP deviation(s).
p.000213:
p.000213: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000215: 215
p.000215: 3. Procedural issues
p.000215: A system shall be established to enable cross-referencing of CRFs and CIP versions.
p.000215: Supplemental CRFs may be developed for collecting additional data at individual investigation sites in
p.000215: multicenter investigations.
p.000215:
p.000215: Table 7
p.000215: Data elements for reporting serious adverse events occurring in a clinical investigation
p.000215: 1. Patient details:
p.000215: (a) Initials and other relevant identifier (hospital/Out Patient Department’s record number etc.);
p.000215: (b) Gender;
p.000215: (c) Age and date of birth;
p.000215: (d) Weight;
p.000215: (e) Height.
p.000215: 2. Suspected device(s):
p.000215: (a) Name of the Device;
p.000215: (b) Indication(s) for which suspect device was prescribed;
p.000215: (c) Device details including model number/size/lot number, if applicable;
p.000215: (d) Starting date and time of day;
p.000215: (e) Stopping date and time, or duration of treatment;
p.000215: 3. Other treatment(s):
p.000215: Provide the same information for concomitant treatment.
p.000215: 4. Details of suspected adverse device reaction(s)
p.000215: (a) Full description of reaction(s) including body site and severity, as well as the criterion (or
p.000215: criteria) for regarding the report as serious. In addition to a description of the reported signs and
p.000215: symptoms, whenever possible, describe a specific diagnosis for the reaction.
p.000215: (b) Start date (and time) of onset of reaction.
p.000215: (c) Stop date (and time) or duration of reaction.
p.000215: (d) Setting (e.g., hospital, out-patient clinic, home, nursing home).
p.000215: 5. Outcome
p.000215: (a) Information on recovery and any sequel; results of specific tests and/or treatment that may have
p.000215: been conducted.
p.000215: (b) For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; any
p.000215: post-mortem findings.
p.000215: (c) Other information: anything relevant to facilitate assessment of the case, such as medical history including
p.000215: allergy, drug or alcohol abuse; family history; findings from special investigations etc.
...
p.000215:
p.000215: 1.2 Additional elements, which may be required
p.000215: (a) Statement of foreseeable circumstances under which the Subject's participation may be terminated by the
p.000215: Investigator without the Subject's consent.
p.000215: (b) Additional costs to the Subject that may result from participation in the clinical investigation.
p.000215: (c) The consequences of a Subject’s decision to withdraw from the investigation and procedures for orderly termination
p.000215: of participation by Subject.
p.000215: (d) Statement that the Subject or Subject's representative will be notified in a timely manner if significant
p.000215: new findings are developed during the course of the investigation which may affect the Subject's
p.000215: willingness to continue participation will be provided.
p.000215: (e). A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or
p.000215: fetus, if the Subject is or may become pregnant), which are currently unforeseeable
p.000215: (f) Approximate number of Subjects enrolled in the clinical investigation
p.000215: 2. Format of informed consent form for Subjects participating in a clinical investigation - Informed Consent form to
p.000215: participate in a clinical investigation
p.000215: Clinical investigation Title: Clinical investigation Number:
p.000215: Subject’s Initials: Subject’s Name:
p.000215: _
p.000215: Date of Birth / Age: _ Gender:
p.000215: _ Address of the Subject: _
p.000215: Qualification: _
p.000215: Occupation: Student/Self-employed/Service/Housewife/Others (Please tick as appropriate) Annual income of the subject:
p.000215: _
p.000215: Name and address of the nominee(s) and his relation to the subject (for the purpose of
p.000215: compensation in case of clinical investigation related death).
p.000215:
p.000215:
p.000215:
p.000215: (i) I confirm that I have read and understood the information sheet dated _ for the above clinical investigation
p.000215: and have had the opportunity to ask questions.
p.000215: (ii) I understand that my participation in the clinical investigation is voluntary and that I am free to withdraw at
p.000215: any time, without giving any reason, without my medical care or legal rights being affected.
p.000215: Place initial box (Subject) [ ]
p.000215:
p.000215: [ ]
p.000215: (iii) I understand that the Sponsor of the clinical investigation, others working on the [ ]
p.000215:
p.000215: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000217: 217
p.000217: Sponsor’s behalf, the Ethics Committee and the regulatory authorities will not need my permission to look
p.000217: at my health records both in respect of the current clinical investigation and any further research that may be
p.000217: conducted in relation to it, even if I withdraw from the clinical investigation. I agree to this access.
...
p.000237: _ (name of the disease) at ……………………………….(name and address of the hospital).
p.000237:
p.000237: 2. Details of medical device to be imported:
p.000237:
p.000237: Name of medical device Quantities which may be imported
p.000237:
p.000237:
p.000237:
p.000237: 3. This licence shall, unless previously suspended or revoked, be in force for a period of one year from the date of
p.000237: issue specified above.
p.000237:
p.000237:
p.000237: Place: Date: _
p.000237: Central Licensing Authority
p.000237: Seal or Stamp
p.000237:
p.000237:
p.000237: Form MD-20
p.000237: [See sub-rule (2) of rule 43]
p.000237: Application for permission to import small quantity of medical devices for personal use
p.000237:
p.000237: To
p.000237: The Central Licensing Authority,
p.000237:
p.000237:
p.000237:
p.000237: Sir/Madam,
p.000237:
p.000237: 1. I …………………………………… resident of………………….. by occupation hereby apply for a
p.000237: permission to import the medical device specified below for personal use manufactured by
p.000237: (Name
p.000237: and full address of manufacturer) for the treatment of (name of the disease).
p.000237:
p.000237: Name of medical device Quantity which may be imported
p.000237:
p.000237:
p.000237: 2. The prescription from a registered medical practitioner prescribing the need for the said medical device is
p.000237: attached.
p.000237: 3. The particular of the patients is specified below.
p.000237: Name Age Gender Complete Address
p.000237:
p.000237:
p.000237:
p.000237:
p.000237:
p.000237: Place: Date: _
p.000237:
p.000237: Signature of applicant
p.000237:
p.000237: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000239: 239
p.000239:
p.000239:
p.000239: Form MD-21
p.000239: [See sub-rule (3) of rule 43]
p.000239: Permission to import of small quantity of medical devices for personal use
p.000239:
p.000239: Permit No.
p.000239: Date
p.000239:
p.000239: 1. ………………………………is hereby permitted to import the medical device manufactured by
p.000239: (Name and full address of manufacturer) specified below for personal use.
p.000239:
p.000239: Name of the medical device Quantity
p.000239:
p.000239:
p.000239: 2. This licence is subject to conditions prescribed in the Medical Devices Rules, 2017.
p.000239: 3. This licence shall, unless previously suspended or revoked, be in force for a period of one hundred and eighty days
p.000239: from the date of issue specified above.
p.000239:
p.000239:
p.000239: Central Licensing Authority
p.000239: Seal or Stamp
p.000239:
p.000239: Form MD-22
p.000239: [See sub-rule (1) of rule 51]
p.000239: Application for Grant of permission to conduct clinical investigation of an investigational medical device
p.000239:
p.000239: 1. Name of Applicant:
p.000239: 2. Nature and constitution of applicant:
p.000239: (i.e. proprietorship, partnership including Limited Liability Partnership, company, society, trust, other to be
p.000239: specified)
...
Social / Child
Searching for indicator child:
(return to top)
p.000205: of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this
p.000205: situation, continued parental or legal guardian consent will be sufficient to allow participation in the study.
p.000205: (g) For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall
p.000205: include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.
p.000205: (iii) Pregnant or nursing women:
p.000205: (a) Pregnant or nursing women shall be included in clinical investigation only when the medical device
p.000205: is intended for use by pregnant or nursing women or fetuses or nursing infants and where the data generated from women
p.000205: who are not pregnant or nursing, would not be suitable.
p.000205: (b) For medical device intended for use during pregnancy, follow-up data pertaining to a period appropriate for that
p.000205: medical device on the pregnancy, foetus and child will be required.
p.000205: 3. Post Marketing Surveillance:
p.000205: (i) Subsequent to approval of an Investigational medical device, it shall be closely monitored for
p.000205: their clinical safety once they are marketed. The applicants shall furnish Periodic Safety Update Reports (PSURs) in
p.000205: order to,-
p.000205: (a) report all the relevant new information from appropriate sources;
p.000205: (b) relate these data to patient exposure;
p.000205: (c) summarise the market authorisation status in different countries and any significant variations related to
p.000205: safety; and
p.000205: (d) indicate whether changes will be made to product information in order to optimize the use of the product.
p.000205:
p.000205: (ii) One medical device should be covered in one PSUR. Within the single PSUR separate presentation of data for
p.000205: different indications or separate population need to be given.
p.000205: (iii) All relevant clinical and non-clinical safety data will cover only the period of the report (interval data).
p.000205: The PSURs shall be submitted every six months for the first two years after marketing approval of the
p.000205: medical device. For subsequent two years, the PSURs need to be submitted annually. The Central Licensing Authority may
p.000205: extend the total duration for submission of PSURs if it is considered necessary in the interest of public health. PSURs
p.000205: due for a period must be submitted within thirty calendar days of the last day of the reporting period. However, all
p.000205: cases involving suspected unexpected serious adverse event shall be reported to the licensing authority
...
Searching for indicator children:
(return to top)
p.000205: permission of para 6 above. Prior to conduct of pivotal clinical investigation in Indian subjects, the Central
p.000205: Licensing Authority may require making the pilot study data available to assess whether the pilot data is in
p.000205: conformity to the data already generated outside the country.
p.000205: (iii) If the application is for conduct of clinical investigation as part of a Global Clinical Investigation of
p.000205: medical device, the number of sites and patients as well as justification for undertaking such clinical
p.000205: investigation in India shall be provided to the Central Licensing Authority.
p.000205: (8) Post Marketing Clinical Investigation:
p.000205: Post marketing clinical investigation is the study other than surveillance performed after marketing
p.000205: approval has been given to the medical device in relation to the approved indication. This investigation may
p.000205: not be considered necessary at the time of medical device approval but may be required by the Central
p.000205: Licensing Authority for optimizing the intended use of the medical device. Post Marketing Clinical investigation
p.000205: includes additional drug- device interaction, safety studies, investigation designed to support use under the approved
p.000205: indication e.g. mortality or morbidity studies, etc,.
p.000205: (9) Studies in special populations:
p.000205: The clinical investigation data of the medical device is required to be submitted to support the claim sought to be
p.000205: made for use of medical device in children, pregnant women, nursing women, elderly patients with renal or other
p.000205: organ system failure as given below:
p.000205: (i) Geriatrics:
p.000205: Geriatrics patients can be included in pivotal study (and in pilot study at the sponsor’s option) in meaningful
p.000205: numbers, if-
p.000205: (a) the disease intended to be treated is characteristically a disease of aging; or
p.000205: (b) the population to be treated is known to be included in substantial numbers of geriatric patients; or
p.000205: (c) there is specific reason to expect that conditions common in the elderly are likely to be encountered; or
p.000205: (d) the investigational medical device is likely to alter the geriatric patient’s response in regard to
p.000205: safety or performance compared with that of non-geriatric patient.
p.000205: (ii) Paediatrics:
p.000205: (a) The timing of pediatric studies in the medical device development program shall depend on the device, the type of
p.000205: disease being treated, safety consideration, and the safety and effectiveness of available treatment.
p.000205: (b) The medical device expected to be used in children; the performance and safety shall be made in
p.000205: the appropriate age group. When clinical investigation is required to be conducted in children, it is
p.000205: usually
p.000205:
p.000205: 206 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000205: II—SEC. 3(i)]
p.000205:
p.000205: appropriate to begin with older children before extending the investigation to younger children and then infants.
p.000205: (c) If the medical device is predominantly or exclusively used in paediatric patients, clinical investigation data
p.000205: should be generated in paediatric population except for initial safety and performance data, which will
p.000205: usually be obtained in adults unless such initial safety studies in adults would yield little useful information or
p.000205: expose them to inappropriate risk.
p.000205: (d) If the medical device is intended to treat serious or life-threatening diseases, occurring in both adults and
p.000205: paediatric patients, for which there are currently no or limited therapeutic options, paediatric
p.000205: population may be included in the clinical investigation early, following assessment of initial safety
p.000205: data and reasonable evidence of potential benefit. In circumstances where this is not possible, lack of data has to be
p.000205: justified.
p.000205: (e) If the medical device has a potential for use in paediatric patient, paediatric studies may be
p.000205: conducted. These studies may be initiated at various stages of clinical development or after
p.000205: post-marketing surveillance in adults, if a safety concern exists. In cases where there is limited paediatric data at
p.000205: the time of submission of application, more data in paediatric patients would be expected after
p.000205: marketing authorization for use in children is granted.
p.000205: (f) Paediatric subjects are legally unable to provide written informed consent, and are dependent on
p.000205: their parents or legal guardian to assume responsibility for their participation in clinical investigation. Written
p.000205: informed consent shall be obtained from the parent or legal guardian. However, all paediatric participants shall be
p.000205: informed to the fullest extent possible about the study in a language and in terms that they are able to understand.
p.000205: Where appropriate, paediatric participants should additionally assent to enroll in the study. Mature minors and
p.000205: adolescents should personally sign and date a separately designed written consent form. Although a participant’s wish
p.000205: to withdraw from a study shall be respected, there may be circumstances in therapeutic studies for serious or
p.000205: life-threatening diseases in which, in the opinion of the investigator and parent or legal guardian, the welfare
p.000205: of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this
p.000205: situation, continued parental or legal guardian consent will be sufficient to allow participation in the study.
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.000205: conformity to the data already generated outside the country.
p.000205: (iii) If the application is for conduct of clinical investigation as part of a Global Clinical Investigation of
p.000205: medical device, the number of sites and patients as well as justification for undertaking such clinical
p.000205: investigation in India shall be provided to the Central Licensing Authority.
p.000205: (8) Post Marketing Clinical Investigation:
p.000205: Post marketing clinical investigation is the study other than surveillance performed after marketing
p.000205: approval has been given to the medical device in relation to the approved indication. This investigation may
p.000205: not be considered necessary at the time of medical device approval but may be required by the Central
p.000205: Licensing Authority for optimizing the intended use of the medical device. Post Marketing Clinical investigation
p.000205: includes additional drug- device interaction, safety studies, investigation designed to support use under the approved
p.000205: indication e.g. mortality or morbidity studies, etc,.
p.000205: (9) Studies in special populations:
p.000205: The clinical investigation data of the medical device is required to be submitted to support the claim sought to be
p.000205: made for use of medical device in children, pregnant women, nursing women, elderly patients with renal or other
p.000205: organ system failure as given below:
p.000205: (i) Geriatrics:
p.000205: Geriatrics patients can be included in pivotal study (and in pilot study at the sponsor’s option) in meaningful
p.000205: numbers, if-
p.000205: (a) the disease intended to be treated is characteristically a disease of aging; or
p.000205: (b) the population to be treated is known to be included in substantial numbers of geriatric patients; or
p.000205: (c) there is specific reason to expect that conditions common in the elderly are likely to be encountered; or
p.000205: (d) the investigational medical device is likely to alter the geriatric patient’s response in regard to
p.000205: safety or performance compared with that of non-geriatric patient.
p.000205: (ii) Paediatrics:
p.000205: (a) The timing of pediatric studies in the medical device development program shall depend on the device, the type of
p.000205: disease being treated, safety consideration, and the safety and effectiveness of available treatment.
p.000205: (b) The medical device expected to be used in children; the performance and safety shall be made in
p.000205: the appropriate age group. When clinical investigation is required to be conducted in children, it is
p.000205: usually
p.000205:
p.000205: 206 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000205: II—SEC. 3(i)]
p.000205:
p.000205: appropriate to begin with older children before extending the investigation to younger children and then infants.
p.000205: (c) If the medical device is predominantly or exclusively used in paediatric patients, clinical investigation data
p.000205: should be generated in paediatric population except for initial safety and performance data, which will
p.000205: usually be obtained in adults unless such initial safety studies in adults would yield little useful information or
p.000205: expose them to inappropriate risk.
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000203: right to claim compensation in case of investigation related injury or death. He shall also inform the subject or his/
p.000203: her nominee(s) of their rights to contact the Sponsor or his representative whosoever had obtained permission from the
p.000203: Central Licensing Authority for conduct of the clinical investigation for making claims in case of
p.000203: investigation related injury or death.
p.000203:
p.000203: (4) Responsibilities of the Ethics Committee:
p.000203: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical
p.000203: Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should
p.000203: exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the
p.000203: study. Explanation.- The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners,
p.000203: armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with
p.000203: incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority
p.000203: groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics
p.000203: committee(s) get documented ‘standard operating procedures’ and should maintain a record of its proceedings.
p.000203: (ii) Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation
p.000203: of the Clinical Investigation Plan. Such review may be based on periodic study progress reports
p.000203: furnished by investigators or monitoring and internal audit reports furnished by the Sponsor.
p.000203: (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record
p.000203: the reasons for doing so and at once, communicate such a decision to the Investigator as well as to the
p.000203: Central Licensing Authority.
p.000203: (iv) Any report of serious adverse event occurring during clinical investigation, after due analysis,
p.000203: shall be forwarded by the Chairman of Ethics Committee to the Central Licensing Authority and to the
p.000203: Head of institution where the clinical investigation has been conducted within 14 calendar days of the
...
p.000219: points:
p.000219: (a) a confirmation that the CIP and any amendments to it were reviewed by the EC;
p.000219: (b) a list of all ECs consulted.
p.000219:
p.000219: 6.4 Clinical investigation team
p.000219:
p.000219: Briefly describe the administrative structure of the clinical investigation (Investigators, site staff, Sponsor/
p.000219: designates, Central laboratory etc.).
p.000219:
p.000219: 7. Results
p.000219: The results should include the following points:
p.000219: (a) the clinical investigation initiation date;
p.000219: (b) the clinical investigation completion/suspension date;
p.000219: (c) the disposal of subjects and investigational medical devices;
p.000219: (d) the subject demographics;
p.000219: (e) Clinical investigation Plan compliance;
p.000219: (f) an analysis, which includes,-
p.000219: (i) a performance analysis as provided in the clinical investigation plan;
p.000219: (ii) a summary of all adverse events and adverse device effects, including a discussion of the
p.000219: severity, treatment needed, resolution and relevant principal investigator's judgment concerning the causal
p.000219: relationship with the investigational medical devices or procedure;
p.000219: (iii) a table compiling all observed device deficiencies that could have led to a serious adverse effect, and any
p.000219: corrective actions taken during the clinical investigation, if any;
p.000219: (iv) any needed subgroup analysis for special populations (i.e. gender, racial/cultural/ethnic subgroups), as
p.000219: appropriate;
p.000219: (v) an accountability of all subjects with a description of how missing data or deviation(s) were
p.000219: dealt within the analysis, including subjects:-
p.000219: (A) not passing screening tests;
p.000219: (B) lost to follow-up;
p.000219: (C) withdrawn or discontinued from the clinical investigation and the reason.
p.000219:
p.000219: 8. Discussion and overall conclusions
p.000219: The conclusions may include the following points:
p.000219: (a) the safety and performance results and any other endpoints;
p.000219: (b) an assessment of risks and benefits;
p.000219: (c) a discussion of the clinical relevance and importance of the results in the light of other existing data;
p.000219: (d) any specific benefits or special precautions required for individual subjects or groups considered to be at risk;
p.000219: (e) any implications for the conduct of future clinical investigations;
p.000219: (f) any limitations of the clinical investigation.
p.000219:
p.000219: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000221: 221
p.000221: 9. Abbreviated terms and definitions
p.000221: A list of abbreviated terms and definitions of specialized or unusual terms should be provided.
p.000221:
p.000221: 10. List of appendices to the clinical investigation report
p.000221: (a) Protocols and amendments;
p.000221: (b) Specimen of Case Record Form;
p.000221: (c) Investigators’ name(s) with contact addresses, phone, e-mail etc.;
p.000221: (d) Patient data listings (e) List of participants treated with investigational product;
p.000221: (e) Discontinued participants;
p.000221: (f) Protocol deviations ;
p.000221: (g) CRFs of cases involving death and life threatening adverse event cases;
p.000221: (h) Publications from the investigation;
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.000215: event of any injury
p.000215: 11. The anticipated prorated payment, if any, to the Subject for participating in the clinical investigation
p.000215: 12. Subject's responsibilities on participation in the clinical investigation
p.000215: 13. Statement that participation is voluntary, that the Subject can withdraw from the clinical investigation at any
p.000215: time and that refusal to participate will not involve any penalty or loss of benefits to which the Subject is otherwise
p.000215: entitled
p.000215: 14. Statement that there is a possibility of failure of investigational medical device to provide intended
p.000215: therapeutic effect.
p.000215: 15. Any other pertinent information.
p.000215:
p.000215: 1.2 Additional elements, which may be required
p.000215: (a) Statement of foreseeable circumstances under which the Subject's participation may be terminated by the
p.000215: Investigator without the Subject's consent.
p.000215: (b) Additional costs to the Subject that may result from participation in the clinical investigation.
p.000215: (c) The consequences of a Subject’s decision to withdraw from the investigation and procedures for orderly termination
p.000215: of participation by Subject.
p.000215: (d) Statement that the Subject or Subject's representative will be notified in a timely manner if significant
p.000215: new findings are developed during the course of the investigation which may affect the Subject's
p.000215: willingness to continue participation will be provided.
p.000215: (e). A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or
p.000215: fetus, if the Subject is or may become pregnant), which are currently unforeseeable
p.000215: (f) Approximate number of Subjects enrolled in the clinical investigation
p.000215: 2. Format of informed consent form for Subjects participating in a clinical investigation - Informed Consent form to
p.000215: participate in a clinical investigation
p.000215: Clinical investigation Title: Clinical investigation Number:
p.000215: Subject’s Initials: Subject’s Name:
p.000215: _
p.000215: Date of Birth / Age: _ Gender:
p.000215: _ Address of the Subject: _
p.000215: Qualification: _
p.000215: Occupation: Student/Self-employed/Service/Housewife/Others (Please tick as appropriate) Annual income of the subject:
p.000215: _
p.000215: Name and address of the nominee(s) and his relation to the subject (for the purpose of
p.000215: compensation in case of clinical investigation related death).
p.000215:
p.000215:
p.000215:
p.000215: (i) I confirm that I have read and understood the information sheet dated _ for the above clinical investigation
p.000215: and have had the opportunity to ask questions.
p.000215: (ii) I understand that my participation in the clinical investigation is voluntary and that I am free to withdraw at
...
Searching for indicator fetuses:
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p.000205: Where appropriate, paediatric participants should additionally assent to enroll in the study. Mature minors and
p.000205: adolescents should personally sign and date a separately designed written consent form. Although a participant’s wish
p.000205: to withdraw from a study shall be respected, there may be circumstances in therapeutic studies for serious or
p.000205: life-threatening diseases in which, in the opinion of the investigator and parent or legal guardian, the welfare
p.000205: of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this
p.000205: situation, continued parental or legal guardian consent will be sufficient to allow participation in the study.
p.000205: (g) For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall
p.000205: include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.
p.000205: (iii) Pregnant or nursing women:
p.000205: (a) Pregnant or nursing women shall be included in clinical investigation only when the medical device
p.000205: is intended for use by pregnant or nursing women or fetuses or nursing infants and where the data generated from women
p.000205: who are not pregnant or nursing, would not be suitable.
p.000205: (b) For medical device intended for use during pregnancy, follow-up data pertaining to a period appropriate for that
p.000205: medical device on the pregnancy, foetus and child will be required.
p.000205: 3. Post Marketing Surveillance:
p.000205: (i) Subsequent to approval of an Investigational medical device, it shall be closely monitored for
p.000205: their clinical safety once they are marketed. The applicants shall furnish Periodic Safety Update Reports (PSURs) in
p.000205: order to,-
p.000205: (a) report all the relevant new information from appropriate sources;
p.000205: (b) relate these data to patient exposure;
p.000205: (c) summarise the market authorisation status in different countries and any significant variations related to
p.000205: safety; and
p.000205: (d) indicate whether changes will be made to product information in order to optimize the use of the product.
p.000205:
p.000205: (ii) One medical device should be covered in one PSUR. Within the single PSUR separate presentation of data for
p.000205: different indications or separate population need to be given.
p.000205: (iii) All relevant clinical and non-clinical safety data will cover only the period of the report (interval data).
p.000205: The PSURs shall be submitted every six months for the first two years after marketing approval of the
...
Searching for indicator foetus:
(return to top)
p.000171: medical device reagent.
p.000171: (g) If several rules apply to the same device, based on the performance specified for the device by
p.000171: the manufacturer, the stringent rules resulting in the higher classification shall apply.
p.000171: 2. The parameters for classification of in vitro diagnostic medical devices as follows:-
p.000171: (i) In vitro diagnostic medical devices for detecting transmissible agents, etc.:
p.000171: (a) An in vitro diagnostic medical device shall be assigned to Class D, if it is intended to be used for detecting
p.000171: the presence of, or exposure to, a transmissible agent that,-
p.000171: (1) is in any blood, blood component, blood derivative, cell, tissue or organ, in order to assess the
p.000171: suitability of the blood, blood component, blood derivative, cell, tissue or organ, as the case may be, for transfusion
p.000171: or transplantation; or
p.000171: (2) causes a life-threatening disease with a high risk of propagation.
p.000171: (b) An in vitro diagnostic medical device shall be assigned to Class C, if it is intended for use in,-
p.000171: (1) detecting the presence of, or exposure to, a sexually transmitted agent;
p.000171: (2) detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation
p.000171: (for example, Cryptococcus neoformans or Neisseria meningitidis);
p.000171: (3) detecting the presence of an infectious agent, where there is a significant risk that an erroneous
p.000171: result will cause death or severe disability to the individual or foetus being tested (for example, a diagnostic
p.000171: assay for Chlamydia pneumoniae, Cytomegalovirus or Methicillin-resistant Staphylococcus aureus);
p.000171: (4) pre-natal screening of women in order to determine their immune status towards transmissible agents
p.000171: such as immune status tests for Rubella or Toxoplasmosis;
p.000171: (5) determining infective disease status or immune status, where there is a risk that an erroneous result will lead to
p.000171: a patient management decision resulting in an imminent life-threatening situation for the patient being tested (for
p.000171: example, Cytomegalovirus, Enterovirus or Herpes simplex virus in transplant patients);
p.000171: (6) screening for disease stages, for the selection of patients for selective therapy and management, or in the
p.000171: diagnosis of cancer;
p.000171: (7) human genetic testing, such as the testing for cystic fibrosis or Huntington's disease;
p.000171: (8) monitoring levels of medicinal products, substances or biological components, where there is a risk
p.000171: that an erroneous result will lead to a patient management decision resulting in an immediate life-threatening
p.000171: situation for the patient being tested (for example, cardiac markers, cyclosporin or prothrombin time testing);
p.000171: (9) management of patients suffering from a life-threatening infectious disease such as viral load of Human
p.000171: immunodeficiency virus or Hepatitis C virus, or genotyping and sub-typing Hepatitis C virus or Human
p.000171: immunodeficiency virus);or
p.000171: (10) screening for congenital disorders in the foetus such as Down’s syndrome or spina bifida.
p.000171: (ii) In vitro diagnostic medical devices for blood grouping or tissue typing:
p.000171: (a) Subject to clause (b), an in vitro diagnostic medical device shall be assigned to Class C, if it is intended to
p.000171: be used for blood grouping or tissue typing to ensure the immunological compatibility of any blood,
p.000171: blood component, blood derivative, cell, tissue or organ that is intended for transfusion or transplantation, as the
p.000171: case may be.
p.000171: (b) An in vitro diagnostic medical device referred to in clause (a) shall be assigned to Class D,
p.000171: if it is intended to be used for blood grouping or tissue typing according to the ABO system, the,
p.000171: the Duffy system, the Kell system, the Kidd system, the rhesus system (for example, HLA, Anti-Duffy, Anti-Kidd).
p.000171:
p.000171: 172 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000171: II—SEC. 3(i)]
p.000171:
p.000171: (iii) In vitro diagnostic medical devices for self-testing:
p.000171: (a) Subject to clause (b), an in vitro diagnostic medical device shall be assigned to Class C, if it is intended to be
p.000171: used for self-testing.
p.000171: (b) An in vitro diagnostic medical device referred to in clause (a) shall be assigned to Class B, if
p.000171: it is intended to be used to obtain,-
p.000171: (1) test results that are not for the determination of a medically-critical status; or
p.000171: (2) preliminary test results which require confirmation by appropriate laboratory tests.
p.000171: (iv) In vitro diagnostic medical devices for near-patient testing:
p.000171: An in vitro diagnostic medical device shall be assigned to Class C, if it is to be used for near-patient testing in a
...
p.000205: of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this
p.000205: situation, continued parental or legal guardian consent will be sufficient to allow participation in the study.
p.000205: (g) For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall
p.000205: include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.
p.000205: (iii) Pregnant or nursing women:
p.000205: (a) Pregnant or nursing women shall be included in clinical investigation only when the medical device
p.000205: is intended for use by pregnant or nursing women or fetuses or nursing infants and where the data generated from women
p.000205: who are not pregnant or nursing, would not be suitable.
p.000205: (b) For medical device intended for use during pregnancy, follow-up data pertaining to a period appropriate for that
p.000205: medical device on the pregnancy, foetus and child will be required.
p.000205: 3. Post Marketing Surveillance:
p.000205: (i) Subsequent to approval of an Investigational medical device, it shall be closely monitored for
p.000205: their clinical safety once they are marketed. The applicants shall furnish Periodic Safety Update Reports (PSURs) in
p.000205: order to,-
p.000205: (a) report all the relevant new information from appropriate sources;
p.000205: (b) relate these data to patient exposure;
p.000205: (c) summarise the market authorisation status in different countries and any significant variations related to
p.000205: safety; and
p.000205: (d) indicate whether changes will be made to product information in order to optimize the use of the product.
p.000205:
p.000205: (ii) One medical device should be covered in one PSUR. Within the single PSUR separate presentation of data for
p.000205: different indications or separate population need to be given.
p.000205: (iii) All relevant clinical and non-clinical safety data will cover only the period of the report (interval data).
p.000205: The PSURs shall be submitted every six months for the first two years after marketing approval of the
p.000205: medical device. For subsequent two years, the PSURs need to be submitted annually. The Central Licensing Authority may
p.000205: extend the total duration for submission of PSURs if it is considered necessary in the interest of public health. PSURs
p.000205: due for a period must be submitted within thirty calendar days of the last day of the reporting period. However, all
...
Social / Homeless Persons
Searching for indicator homeless:
(return to top)
p.000203: her nominee(s) of their rights to contact the Sponsor or his representative whosoever had obtained permission from the
p.000203: Central Licensing Authority for conduct of the clinical investigation for making claims in case of
p.000203: investigation related injury or death.
p.000203:
p.000203: (4) Responsibilities of the Ethics Committee:
p.000203: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical
p.000203: Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should
p.000203: exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the
p.000203: study. Explanation.- The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners,
p.000203: armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with
p.000203: incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority
p.000203: groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics
p.000203: committee(s) get documented ‘standard operating procedures’ and should maintain a record of its proceedings.
p.000203: (ii) Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation
p.000203: of the Clinical Investigation Plan. Such review may be based on periodic study progress reports
p.000203: furnished by investigators or monitoring and internal audit reports furnished by the Sponsor.
p.000203: (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record
p.000203: the reasons for doing so and at once, communicate such a decision to the Investigator as well as to the
p.000203: Central Licensing Authority.
p.000203: (iv) Any report of serious adverse event occurring during clinical investigation, after due analysis,
p.000203: shall be forwarded by the Chairman of Ethics Committee to the Central Licensing Authority and to the
p.000203: Head of institution where the clinical investigation has been conducted within 14 calendar days of the
p.000203: knowledge of occurrence of the serious adverse event.
p.000203: (5) Informed consent:
...
Social / In Nursing Home
Searching for indicator nursing home:
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p.000215: 215
p.000215: 3. Procedural issues
p.000215: A system shall be established to enable cross-referencing of CRFs and CIP versions.
p.000215: Supplemental CRFs may be developed for collecting additional data at individual investigation sites in
p.000215: multicenter investigations.
p.000215:
p.000215: Table 7
p.000215: Data elements for reporting serious adverse events occurring in a clinical investigation
p.000215: 1. Patient details:
p.000215: (a) Initials and other relevant identifier (hospital/Out Patient Department’s record number etc.);
p.000215: (b) Gender;
p.000215: (c) Age and date of birth;
p.000215: (d) Weight;
p.000215: (e) Height.
p.000215: 2. Suspected device(s):
p.000215: (a) Name of the Device;
p.000215: (b) Indication(s) for which suspect device was prescribed;
p.000215: (c) Device details including model number/size/lot number, if applicable;
p.000215: (d) Starting date and time of day;
p.000215: (e) Stopping date and time, or duration of treatment;
p.000215: 3. Other treatment(s):
p.000215: Provide the same information for concomitant treatment.
p.000215: 4. Details of suspected adverse device reaction(s)
p.000215: (a) Full description of reaction(s) including body site and severity, as well as the criterion (or
p.000215: criteria) for regarding the report as serious. In addition to a description of the reported signs and
p.000215: symptoms, whenever possible, describe a specific diagnosis for the reaction.
p.000215: (b) Start date (and time) of onset of reaction.
p.000215: (c) Stop date (and time) or duration of reaction.
p.000215: (d) Setting (e.g., hospital, out-patient clinic, home, nursing home).
p.000215: 5. Outcome
p.000215: (a) Information on recovery and any sequel; results of specific tests and/or treatment that may have
p.000215: been conducted.
p.000215: (b) For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; any
p.000215: post-mortem findings.
p.000215: (c) Other information: anything relevant to facilitate assessment of the case, such as medical history including
p.000215: allergy, drug or alcohol abuse; family history; findings from special investigations etc.
p.000215: 6. Details about the Investigator:
p.000215: (a) Name;
p.000215: (b) Address;
p.000215: (c) Telephone number;
p.000215: (d) Profession (specialty);
p.000215: (e) Date of reporting the event to Central Licensing Authority;
p.000215: (f) Date of reporting the event to Ethics Committee overseeing the site;
p.000215: (g) Signature of the Investigator.
p.000215:
p.000215:
p.000215:
p.000215: Table 8 Informed Consent Form
p.000215: Checklist for clinical investigation Subject’s informed consent documents
p.000215: 1.1 Essential elements:
p.000215: 1. Statement that the study involves research and explanation of the purpose of the research
p.000215: 2. Expected duration of the Subject's participation
p.000215: 3. Description of the procedures to be followed, including all invasive procedures
p.000215: 4. Description of any reasonably foreseeable risks or discomforts to the Subject
p.000215:
...
Social / Incarcerated
Searching for indicator restricted:
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p.000191: (b) a quality manual;
p.000191: (c) documented procedures required by this schedule;
p.000191:
p.000191: 192 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000191: II—SEC. 3(i)]
p.000191:
p.000191: (d) documents needed by the manufacturer to ensure the effective planning, operation and control of its processes;
p.000191: (e) records required by this Schedule, and
p.000191: where this Schedule specifies that a requirement, procedure, activity or special arrangement be “documented”, it shall,
p.000191: in addition, be implemented and maintained.
p.000191: For each type of medical device or in vitro diagnostic medical devices, the manufacturer shall establish and maintain a
p.000191: file either containing or identifying documents defining product specifications and quality
p.000191: management system requirements. These documents shall define the complete manufacturing process and, if applicable,
p.000191: installation.
p.000191: The manufacture shall prepare documentation for device or in vitro diagnostic medical devices in a form of
p.000191: a Device Master File containing specific information as referred to in Fourth Schedule.
p.000191: Data may be recorded by electronic data processing systems or other reliable means, but documents and record relating
p.000191: to the system in use shall also be available in a hard copy to facilitate checking of the accuracy of the records.
p.000191: Wherever documentation is handled by electronic data processing methods, authorized persons shall enter or
p.000191: modify data in the computer. There shall be record of changes and deletions. Access shall be restricted by ‘passwords’
p.000191: or other means and the result of entry of critical data shall be independently checked. Batch records electronically
p.000191: stored shall be protected by a suitable back-up. During the period of retention, all relevant data shall be readily
p.000191: available.
p.000191: 4.2.2 Quality manual.-
p.000191: The manufacturer shall establish and maintain a quality manual that includes:-
p.000191: (a) the scope of the quality management system, including details of and justification for any
p.000191: exclusion or non- application or both;
p.000191: (b) the documented procedures established for the quality management system, or reference to them; and
p.000191: (c) a description of the interaction between the processes of the quality management system.
p.000191: The quality manual shall outline the structure of the documentation used in the quality management system.
p.000191: The manufacturer shall prepare documentation in a form of a Plant Master File containing specific information about the
p.000191: facilities, personnel and other details as prescribed in Fourth.
p.000191: 4.2.3 Control of documents.-
p.000191: Documents required by the quality management system shall be controlled. Records are a special type of document and
p.000191: shall be controlled according to the requirements given in the control of records. Documents shall be approved, signed
p.000191: and dated by the appropriate and the authorised person.
p.000191: A documented procedure shall be established to define the controls needed.-
p.000191: (a) to review and approve documents for adequacy prior to issue;
p.000191: (b) to review and update as necessary and re-approve documents;
p.000191: (c) to ensure that changes and the current revision status of documents are identified;
p.000191: (d) to ensure that relevant versions of applicable documents are available at points of use;
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.000203: (ii) Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation
p.000203: of the Clinical Investigation Plan. Such review may be based on periodic study progress reports
p.000203: furnished by investigators or monitoring and internal audit reports furnished by the Sponsor.
p.000203: (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record
p.000203: the reasons for doing so and at once, communicate such a decision to the Investigator as well as to the
p.000203: Central Licensing Authority.
p.000203: (iv) Any report of serious adverse event occurring during clinical investigation, after due analysis,
p.000203: shall be forwarded by the Chairman of Ethics Committee to the Central Licensing Authority and to the
p.000203: Head of institution where the clinical investigation has been conducted within 14 calendar days of the
p.000203: knowledge of occurrence of the serious adverse event.
p.000203: (5) Informed consent:
p.000203: (i) In all investigations, a freely given, informed, written consent is required to be obtained from
p.000203: each study subject. The investigator shall provide information about the study verbally and
p.000203: through the patient information sheet, in a language that is non-technical and is understandable by the study
p.000203: subject. The Subject’s consent must be obtained in writing using an ‘Informed Consent Form’. The patient information
p.000203: sheet as well as the Informed Consent Form shall be approved by the Ethics Committee and furnished to
p.000203: the Central Licensing Authority. Any change in the informed consent documents should be approved by the
p.000203: Ethics Committee and submitted to the Central Licensing Authority before such changes are implemented.
p.000203: (ii) Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering
p.000203: from severe mental illness or disability), the same may be obtained from a legally acceptable representative. If the
p.000203: subject or his legally acceptable representative is unable to read or write, an impartial witness should be present
p.000203: during the entire informed consent process who must append his signatures to the consent form. Explanation: a legally
...
p.000205: (d) If the medical device is intended to treat serious or life-threatening diseases, occurring in both adults and
p.000205: paediatric patients, for which there are currently no or limited therapeutic options, paediatric
p.000205: population may be included in the clinical investigation early, following assessment of initial safety
p.000205: data and reasonable evidence of potential benefit. In circumstances where this is not possible, lack of data has to be
p.000205: justified.
p.000205: (e) If the medical device has a potential for use in paediatric patient, paediatric studies may be
p.000205: conducted. These studies may be initiated at various stages of clinical development or after
p.000205: post-marketing surveillance in adults, if a safety concern exists. In cases where there is limited paediatric data at
p.000205: the time of submission of application, more data in paediatric patients would be expected after
p.000205: marketing authorization for use in children is granted.
p.000205: (f) Paediatric subjects are legally unable to provide written informed consent, and are dependent on
p.000205: their parents or legal guardian to assume responsibility for their participation in clinical investigation. Written
p.000205: informed consent shall be obtained from the parent or legal guardian. However, all paediatric participants shall be
p.000205: informed to the fullest extent possible about the study in a language and in terms that they are able to understand.
p.000205: Where appropriate, paediatric participants should additionally assent to enroll in the study. Mature minors and
p.000205: adolescents should personally sign and date a separately designed written consent form. Although a participant’s wish
p.000205: to withdraw from a study shall be respected, there may be circumstances in therapeutic studies for serious or
p.000205: life-threatening diseases in which, in the opinion of the investigator and parent or legal guardian, the welfare
p.000205: of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this
p.000205: situation, continued parental or legal guardian consent will be sufficient to allow participation in the study.
p.000205: (g) For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall
p.000205: include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.
p.000205: (iii) Pregnant or nursing women:
p.000205: (a) Pregnant or nursing women shall be included in clinical investigation only when the medical device
...
Social / Marital Status
Searching for indicator single:
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p.000155: this behalf to enter, with or without prior notice, the premises where the medical devices are stocked and to inspect
p.000155: the premises and relevant records and investigate the manner in which the medical device is being used and to take, if
p.000155: required, samples thereof.
p.000155: (6) The quantity considered necessary shall be determined by the Central Licensing Authority after taking
p.000155: into account the recommendation of the hospital concerned for treatment of patient suffering from a life
p.000155: threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical
p.000155: need.
p.000155: (7) Where the Central Licensing Authority is satisfied, it may, in exceptional and special circumstances, allow import
p.000155: of larger quantity of medical devices for use by the patient.
p.000155: (8) The consignment of medical device shall be accompanied by an invoice or a statement showing the name
p.000155: and quantity of medical device.
p.000155:
p.000155: 43. Import of medical device for personal use.—(1) Small quantity of medical device, the import of
p.000155: which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to
p.000155: the following conditions, namely,-
p.000155: (i) the medical device shall form part of a personal baggage of a passenger and be intended for the exclusive use of
p.000155: such passenger;
p.000155: (ii) the medical device shall be declared as personal baggage of the passenger to the customs authorities, if they so
p.000155: direct;
p.000155: (iii) the quantity of any single medical device so imported shall not exceed the quantity specified by the registered
p.000155: medical practitioner;
p.000155: (iv) the medical device has been prescribed by a registered medical practitioner; and
p.000155: (v) the medical device so imported shall be accompanied with an invoice or a statement showing the
p.000155: name and quantity of medical device.
p.000155: (2) Small quantity of medical device, the import of which is otherwise prohibited under section 10 of the Act, and
p.000155: which is not forming a part of bona fide personal baggage, may be imported for personal use, on an application made by
p.000155: the applicant in Form MD-20 and such application shall be accompanied by documents confirming that the device is for
p.000155: bona fide personal use and a prescription to that effect by a registered medical practitioner.
p.000155: (3) On receipt of an application under sub-rule (2), the Central Licensing Authority shall, on being satisfied about
p.000155: the information and the documents enclosed with the application, grant permission in Form MD-21 or may
p.000155: reject the application for reasons to be recorded in writing within a period of seven days from the date of
p.000155: application under sub- rule (2).
p.000155: (4) Medical devices as referred to in sub-rule (2) shall be subject to the following conditions, namely,-
p.000155: (i) the medical device shall be declared to the Customs Authorities if they so direct;
p.000155: (ii) the consignment of the medical device so imported shall be accompanied with an invoice or
p.000155: statement showing the name and quantity of medical device.
p.000155:
p.000155: CHAPTER VI LABELLING OF MEDICAL DEVICES
p.000155:
...
p.000155: (e) the month and year of manufacture and expiry (alternately the label shall bear the shelf life of the product):
p.000155: Provided that in case of sterile devices, the date of sterilization may be given as date of manufacture of the
p.000155: device:
p.000155: Provided further that where the device is made up of stable materials such as stainless steel or titanium, and
p.000155: supplied non-sterile or in case of medical equipment or instruments or apparatus, the date of expiry
p.000155: may not be necessary.
p.000155:
p.000155: 156 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000155: II—SEC. 3(i)]
p.000155:
p.000155: Explanation.- For the purposes of this clause, the date of expiry shall be in terms of the month and the year and it
p.000155: shall mean that the medical device is recommended till the last day of the month and the date of
p.000155: expiry shall be preceded by the words “Expiry date” or “Shelf Life”;
p.000155: (f) to provide, wherever required, an indication that the device contains medicinal or biological substance;
p.000155: (g) to provide, a distinctive batch number or lot number preceded by the word “Lot No.” or “Lot” or “Batch No.” or “B.
p.000155: No.”;
p.000155: (h) to indicate, wherever required, any special storage or handling conditions applicable to the device;
p.000155: (i) to indicate, if the device is supplied as a sterile product, its sterile state and the sterilisation method;
p.000155: (j) to give, if considered relevant, warnings or precautions to draw the attention of the user of medical device;
p.000155: (k) to label the device appropriately, if the device is intended for single use;
p.000155: (l) to overprint on the label of the device, the words “Physician’s Sample—Not to be sold”, if a medical
p.000155: device is intended for distribution to the medical professional as a free sample;
p.000155: (m) to provide, except for imported devices, the manufacturing licence number by preceding
p.000155: the words “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M. L”;
p.000155: (n) to provide on the label, in case of imported devices, by way of stickering, where such details
p.000155: are not already printed, the import licence number, name and address of the importer, address of the actual
p.000155: manufacturing premises and the date of manufacture:
p.000155: Provided that the label may bear symbols recognised by the Bureau of Indian Standards or International
p.000155: Organisation for Standardisation (ISO) in lieu of the text and the device safety is not compromised by
p.000155: a lack of understanding on the part of the user, in case the meaning of the symbol is not obvious to the device user;
p.000155: (o) in case of small sized medical devices on which information cannot be printed legibly, shall
p.000155: include the information necessary for product identification and safety such as information covered by clauses (a),
p.000155: (b), (c), (d), (e), (g), (k), and (m) shall be included.
p.000155:
p.000155: 45. Exemption of labelling requirements for export of medical devices.— The labels on packages or container of
p.000155: devices for export shall be adopted to meet the specific requirements of law of the country to which the device is to
p.000155: be exported, but the following particulars shall appear in a conspicuous manner on the label of the inner most pack or
...
p.000205: (a) Pregnant or nursing women shall be included in clinical investigation only when the medical device
p.000205: is intended for use by pregnant or nursing women or fetuses or nursing infants and where the data generated from women
p.000205: who are not pregnant or nursing, would not be suitable.
p.000205: (b) For medical device intended for use during pregnancy, follow-up data pertaining to a period appropriate for that
p.000205: medical device on the pregnancy, foetus and child will be required.
p.000205: 3. Post Marketing Surveillance:
p.000205: (i) Subsequent to approval of an Investigational medical device, it shall be closely monitored for
p.000205: their clinical safety once they are marketed. The applicants shall furnish Periodic Safety Update Reports (PSURs) in
p.000205: order to,-
p.000205: (a) report all the relevant new information from appropriate sources;
p.000205: (b) relate these data to patient exposure;
p.000205: (c) summarise the market authorisation status in different countries and any significant variations related to
p.000205: safety; and
p.000205: (d) indicate whether changes will be made to product information in order to optimize the use of the product.
p.000205:
p.000205: (ii) One medical device should be covered in one PSUR. Within the single PSUR separate presentation of data for
p.000205: different indications or separate population need to be given.
p.000205: (iii) All relevant clinical and non-clinical safety data will cover only the period of the report (interval data).
p.000205: The PSURs shall be submitted every six months for the first two years after marketing approval of the
p.000205: medical device. For subsequent two years, the PSURs need to be submitted annually. The Central Licensing Authority may
p.000205: extend the total duration for submission of PSURs if it is considered necessary in the interest of public health. PSURs
p.000205: due for a period must be submitted within thirty calendar days of the last day of the reporting period. However, all
p.000205: cases involving suspected unexpected serious adverse event shall be reported to the licensing authority
p.000205: within fifteen days of initial receipt of information by the applicant. If marketing of the
p.000205:
p.000205: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000207: 207
p.000207: medical device is delayed by the applicant after obtaining approval to market, such data will have to
p.000207: be provided on the deferred basis beginning from the time the medical device is marketed.
p.000207: (iv) New studies specifically planned or conducted to examine a safety issue should be described in the PSURs.
p.000207: (v) A PSUR should be structured as follows:
p.000207: (a) Title Page:
p.000207: The title page of PSUR shall capture the name of the Medical device; reporting interval; approved
p.000207: indication of Medical devices; date of approval of the medical device; date of marketing of medical device; licence
p.000207: name and address.
...
p.000213: clinical investigation in one or more investigation sites.
p.000213: (b) Criteria for access to and breaking the blinding or masking code in case of suspension or premature termination of
p.000213: the clinical investigation, if the clinical investigation involves a blinding or masking technique.
p.000213: (c) Requirements for subject follow-up.
p.000213: 1.17 Publication policy.
p.000213: (a) Statement indicating whether the results of the clinical investigation will be submitted for publication.
p.000213: (b) Statement indicating the conditions under which the results of the clinical investigation will be
p.000213: offered for publication.
p.000213: Table 6
p.000213: Case Report Form (CRF)
p.000213: 1. General
p.000213: (i) Case Report Forms are established to implement the clinical investigation plan, to facilitate
p.000213: subject observation and to record subject and investigational medical device data during the clinical
p.000213: investigation according to the clinical investigation plan. They can exist as printed, optical, or electronic
p.000213: documents and can be organized into a separate section for each subject.
p.000213:
p.000213: 214 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000213: II—SEC. 3(i)]
p.000213:
p.000213: (ii) The Case Report Forms should reflect the clinical investigation plan and take account of the nature
p.000213: of the investigational medical device.
p.000213: 2. Content and format
p.000213: 2.1 Overall considerations
p.000213: (i) The Case Report Forms can be organized such that they reflect all the data from a single procedure or a
p.000213: single visit or other grouping that makes clinical or chronological sense.
p.000213: (ii) The format of Case Report Forms shall be such as to minimize errors that can be made by those who enter
p.000213: data and those who transcribe the data into other systems.
p.000213: (iii) The data categories and format listed in this Table can be considered when designing a Case Report Form.
p.000213: 2.2 Cover page or login screen
p.000213: (1) Name of sponsor or sponsor logo.
p.000213: (2) Clinical investigation plan version and date (if required).
p.000213: (3) Version number of Case Report Forms.
p.000213: (4) Name of clinical investigation or reference number (if applicable).
p.000213: 2.3 Header or footer or Case Report Form identifier
p.000213: (a) Name of the clinical investigation or reference number.
p.000213: (b) Version number of Case Report Forms.
p.000213: (c) Investigation site/principal investigator identification number.
p.000213: (d) Subject identification number and additional identification such as date of birth or initials, if allowed by
p.000213: national regulations.
p.000213: (e) Case Report Form number or date of visit or visit number.
p.000213: (f) Page/screen number of CRF and total number of pages/screens (e.g. “page x of xx”).
p.000213: 2.4 Types of Case Report Forms
p.000213: The following is a suggested list of CRFs that may be developed to support a clinical investigation.
p.000213: This is not an exhaustive list and is intended to be used as a guideline.
p.000213: (a) Screening.
p.000213: (b) Documentation of subject's informed consent.
p.000213: (c) Inclusion/exclusion.
p.000213: (d) Baseline visit:
p.000213: (1) demographics;
p.000213: (2) medical diagnosis;
...
p.000217: justification to the satisfaction of the Central Licensing Authority. I also agree to report the serious
p.000217: adverse events, after due analysis, to the Central Licensing Authority, Chairman of the Ethics
p.000217: Committee and head of the institution where the investigation has been conducted within fourteen days of the occurrence
p.000217: of serious adverse events.
p.000217: (xi) I will maintain confidentiality of the identification of all participating clinical investigation patients
p.000217: and assure security and confidentiality of clinical investigation data.
p.000217: (xii) I agree to comply with all other requirements, guidelines and statutory obligations as
p.000217: applicable to clinical Investigators participating in clinical Investigations
p.000217:
p.000217:
p.000217: Date:
p.000217: Signature of Investigator
p.000217:
p.000217: Table 10
p.000217: Clinical Investigation Report
p.000217:
p.000217: 1. General
p.000217: This table specifies the contents of the clinical investigation report that describes the design, execution,
p.000217: statistical analysis and results of a clinical investigation.
p.000217:
p.000217: 2. Cover page
p.000217: The page shall be contain the following information:-
p.000217: (a) title of the clinical investigation;
p.000217: (b) identification of the investigational medical devices, including names, models, etc. as relevant for
p.000217: complete identification;
p.000217: (c) if not clear from the title, a single sentence describing the design, comparison, period, usage method, and
p.000217: subject population;
p.000217: (d) name and contact details of sponsor or sponsor's representative;
p.000217: (e) CIP identification/protocol code;
p.000217: (f) name and department of coordinating investigator and names of other relevant parties,
p.000217: e.g. experts, biostatistician, laboratory personnel;
p.000217: (g) statement indicating whether the clinical investigation was performed in accordance with declaration
p.000217: of Helsinki, Good Clinical Practice guidelines and applicable regulations;
p.000217: (h) Brief description of investigation design;
p.000217:
p.000217: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000219: 219
p.000219: (i) Start and end date of patient accrual and names of the sponsor and the participating institutes;
p.000219: (j) author(s) of report.
p.000219: 3. Table of contents
p.000219: The table of contents may include the following information:
p.000219: (a) the page number or locating information of each section, including summary tables, figures, and graphs;
p.000219: (b) a list of appendices and their location.
p.000219: 4. Summary
p.000219: The summary may contain the following items:
p.000219: (a) the title of the clinical investigation;
p.000219: (b) an introduction;
p.000219: (c) the purpose of the clinical investigation;
p.000219: (d) description of the clinical investigation population;
p.000219: (e) the clinical investigation method used;
p.000219: (f) the results of the clinical investigation;
p.000219: (g) the conclusion;
p.000219: (h) the date of the clinical investigation initiation;
p.000219: (i) the completion date of the clinical investigation or, if the clinical investigation is discontinued, the date of
...
Social / Occupation
Searching for indicator occupation:
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p.000215: (c) The consequences of a Subject’s decision to withdraw from the investigation and procedures for orderly termination
p.000215: of participation by Subject.
p.000215: (d) Statement that the Subject or Subject's representative will be notified in a timely manner if significant
p.000215: new findings are developed during the course of the investigation which may affect the Subject's
p.000215: willingness to continue participation will be provided.
p.000215: (e). A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or
p.000215: fetus, if the Subject is or may become pregnant), which are currently unforeseeable
p.000215: (f) Approximate number of Subjects enrolled in the clinical investigation
p.000215: 2. Format of informed consent form for Subjects participating in a clinical investigation - Informed Consent form to
p.000215: participate in a clinical investigation
p.000215: Clinical investigation Title: Clinical investigation Number:
p.000215: Subject’s Initials: Subject’s Name:
p.000215: _
p.000215: Date of Birth / Age: _ Gender:
p.000215: _ Address of the Subject: _
p.000215: Qualification: _
p.000215: Occupation: Student/Self-employed/Service/Housewife/Others (Please tick as appropriate) Annual income of the subject:
p.000215: _
p.000215: Name and address of the nominee(s) and his relation to the subject (for the purpose of
p.000215: compensation in case of clinical investigation related death).
p.000215:
p.000215:
p.000215:
p.000215: (i) I confirm that I have read and understood the information sheet dated _ for the above clinical investigation
p.000215: and have had the opportunity to ask questions.
p.000215: (ii) I understand that my participation in the clinical investigation is voluntary and that I am free to withdraw at
p.000215: any time, without giving any reason, without my medical care or legal rights being affected.
p.000215: Place initial box (Subject) [ ]
p.000215:
p.000215: [ ]
p.000215: (iii) I understand that the Sponsor of the clinical investigation, others working on the [ ]
p.000215:
p.000215: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000217: 217
p.000217: Sponsor’s behalf, the Ethics Committee and the regulatory authorities will not need my permission to look
p.000217: at my health records both in respect of the current clinical investigation and any further research that may be
p.000217: conducted in relation to it, even if I withdraw from the clinical investigation. I agree to this access.
p.000217: However, I understand that my identity will not be revealed in any information released to third parties or published.
p.000217: (iv) I agree not to restrict the use of any data or results that arise from this clinical
p.000217: [ ] investigation provided such a use is only for scientific purpose(s).
...
p.000237: II—SEC. 3(i)]
p.000237:
p.000237: Form MD-19
p.000237: [See sub-rule (2) of rule 42]
p.000237:
p.000237: Licence to import investigational medical device by a government hospital or statutory medical institution for the
p.000237: treatment of patients
p.000237:
p.000237:
p.000237: Licence No.
p.000237:
p.000237: 1. Dr _ (Name and designation) of
p.000237: (Name of Hospital or Statutory Medical Institution) here by grant licence to import from M/s
p.000237: (Name and full
p.000237: address of manufacturer) the medical devices specified below for the purpose of treatment of patients for the disease
p.000237: _ (name of the disease) at ……………………………….(name and address of the hospital).
p.000237:
p.000237: 2. Details of medical device to be imported:
p.000237:
p.000237: Name of medical device Quantities which may be imported
p.000237:
p.000237:
p.000237:
p.000237: 3. This licence shall, unless previously suspended or revoked, be in force for a period of one year from the date of
p.000237: issue specified above.
p.000237:
p.000237:
p.000237: Place: Date: _
p.000237: Central Licensing Authority
p.000237: Seal or Stamp
p.000237:
p.000237:
p.000237: Form MD-20
p.000237: [See sub-rule (2) of rule 43]
p.000237: Application for permission to import small quantity of medical devices for personal use
p.000237:
p.000237: To
p.000237: The Central Licensing Authority,
p.000237:
p.000237:
p.000237:
p.000237: Sir/Madam,
p.000237:
p.000237: 1. I …………………………………… resident of………………….. by occupation hereby apply for a
p.000237: permission to import the medical device specified below for personal use manufactured by
p.000237: (Name
p.000237: and full address of manufacturer) for the treatment of (name of the disease).
p.000237:
p.000237: Name of medical device Quantity which may be imported
p.000237:
p.000237:
p.000237: 2. The prescription from a registered medical practitioner prescribing the need for the said medical device is
p.000237: attached.
p.000237: 3. The particular of the patients is specified below.
p.000237: Name Age Gender Complete Address
p.000237:
p.000237:
p.000237:
p.000237:
p.000237:
p.000237: Place: Date: _
p.000237:
p.000237: Signature of applicant
p.000237:
p.000237: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000239: 239
p.000239:
p.000239:
p.000239: Form MD-21
p.000239: [See sub-rule (3) of rule 43]
p.000239: Permission to import of small quantity of medical devices for personal use
p.000239:
p.000239: Permit No.
p.000239: Date
p.000239:
p.000239: 1. ………………………………is hereby permitted to import the medical device manufactured by
p.000239: (Name and full address of manufacturer) specified below for personal use.
p.000239:
p.000239: Name of the medical device Quantity
p.000239:
p.000239:
p.000239: 2. This licence is subject to conditions prescribed in the Medical Devices Rules, 2017.
p.000239: 3. This licence shall, unless previously suspended or revoked, be in force for a period of one hundred and eighty days
...
p.000245:
p.000245:
p.000245: 1. It is certified that the samples having serial number of memorandum or receipt number
p.000245: dated:
p.000245: ……………… purporting to be sample of ……………………. received on …………….. from has
p.000245: been tested or evaluated and the results of tests or evaluation is as stated below.
p.000245:
p.000245: 2. The conditions of seals on the packet or on portion of sample or container were as follows …………….
p.000245:
p.000245: 2. Based upon the test or evaluation and in the opinion of undersigned the sample is of standard quality/ not of
p.000245: standard quality/ adulterated/misbranded/spurious, as defined in the Drugs and Cosmetics Act, 1940 (23 of
p.000245: 1940) for the reasons given below:-
p.000245:
p.000245:
p.000245:
p.000245: Date……………….
p.000245: Medical Device Testing Officer
p.000245: Seal or Stamp
p.000245:
p.000245: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000247: 247
p.000247:
p.000247:
p.000247: Form MD-33
p.000247: [See rule 69]
p.000247: Application from a purchaser for test or evaluation of a Medical Device under section 26 of the Drugs and Cosmetics
p.000247: Act, 1940 (23 of 1940)
p.000247:
p.000247: To
p.000247: The Central Licensing Authority,
p.000247:
p.000247:
p.000247:
p.000247:
p.000247: Sir/Madam,
p.000247:
p.000247:
p.000247: 1. Full name and address of the applicant
p.000247: ....................................................................................
p.000247: 2.
p.000247: Occupation..............................................................................................................
p.000247: .................
p.000247: 3. Name of medical device purporting to be contained in the sample..........................................
p.000247: 4. Name and full address of the pharmacy or concern where the medical device was purchased. 5. Date on which
p.000247: purchased (invoice attached)
p.000247: 6. Reasons why the medical device is being submitted for test or evaluation………………………….
p.000247: 7. A fee of rupees as charged by medical device
p.000247: testing laboratory has been paid
p.000247: under receipt number ………….. dated: ………..
p.000247:
p.000247: I hereby declare that the medical device being submitted for test or evaluation was purchased by or for me. I further
p.000247: declare that the sample of the medical device being sent for test or evaluation is exactly as it was purchased and has
p.000247: not been tampered with in any way to reduce its potency.
p.000247:
p.000247:
p.000247:
p.000247:
p.000247: Date:……………….
p.000247: Signature
p.000247: Seal or Stamp
p.000247:
p.000247:
p.000247:
p.000247: Form MD-34
p.000247: [See rule 72]
p.000247:
p.000247: Order under clause (c) of sub-section (1) of section of the Drugs and Cosmetics Act, 1940, (23 of 1940) requiring a
p.000247: person not to dispose of stock in his possession
p.000247:
p.000247: Whereas, I have reason to believe that the stocks of medical devices in your possession, detailed below contravenes the
p.000247: provisions of Section 18 of the Drugs and Cosmetics Act, 1940 (23 of 1940);
p.000247: Now, therefore, I hereby require you under clause (c) of sub-section (1) of Section 22 of the said Act, not to dispose
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Social / Police Officer
Searching for indicator officer:
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p.000143: (i) an in vitro diagnostic medical device, is all the information derived from specimen collected from
p.000143: human that supports the scientific validity and performance for its intended use;
p.000143: (ii) a medical device, the clinical data and the clinical evaluation report that supports the scientific validity and
p.000143: performance for its intended use;
p.000143: (l) “clinical investigation” means the systematic study of an investigational medical device in or on
p.000143: human participants to assess its safety, performance or effectiveness;
p.000143: (m) “clinical investigation plan” means a document which contains the information about the rationale,
p.000143: aims and objective, design and the proposed analysis, conduct, methodology including performance,
p.000143: management, adverse event, withdrawal and statistical consideration and record keeping pertaining to clinical
p.000143: investigation;
p.000143: (n) “clinical performance evaluation” means the systematic performance study of a new in vitro diagnostic medical
p.000143: device on a specimen collected from human participants to assess its performance;
p.000143: (o) “clinical research organisation” means any entity to whom a sponsor may transfer or delegate one or more of its
p.000143: functions and duties regarding conduct of clinical investigation or clinical performance evaluation;
p.000143: (p) “conformity assessment” means the systematic examination of evidence generated and procedures undertaken, by the
p.000143: manufacturer to determine that a medical device is safe and performs as intended by the manufacturer and therefore
p.000143: conforms to the essential principles of safety and performance for medical devices;
p.000143: (q) “controlling officer” means the officer designated under rule 10;
p.000143: (r) “custom made medical device” means a medical device made specifically in accordance with a
p.000143: written prescription of a registered medical practitioner, specialised in the relevant area, under his responsibility
p.000143: for the sole use of a particular patient, but does not include a mass production of such device;
p.000143: (s) “Ethics Committee” means the committee referred to in rule 50;
p.000143: (t) “Form” means forms specified in Appendix to these rules;
p.000143: (u) “Good Clinical Practices Guidelines” means Good Clinical Practices Guidelines issued by Central
p.000143: Drugs Standards Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare,
p.000143: Government of India;
p.000143: (v) “intended use” means the use for which the medical device is intended according to the data supplied
p.000143: by the manufacturer on the labelling or in the document containing instructions for use of such device
p.000143: or in promotional material relating to such device, which is as per approval obtained from the Central
p.000143: Licensing Authority;
p.000143: (w) “invasive device” means a device which, in whole or part, penetrates inside the body, either
p.000143: through a body orifice or through the surface of the body;
p.000143: (x) “investigational medical device” in relation to a medical device, other than in vitro diagnostic medical
p.000143: device, means a medical device specified in clause (zb),-
p.000143: (i) which does not have its predicate device as defined in clause (zm); or
...
p.000143: (z) “loan licence” means a licence issued for manufacturing a medical device by the State Licensing Authority or
p.000143: the Central Licensing Authority, as the case may be, to a person who intends to utilise the manufacturing site of other
p.000143: licencee for manufacturing the same medical device as manufactured by the licencee at that site;
p.000143: (za) “long term use” means intended continuous use of a medical device for more than thirty days; (zb) “medical device”
p.000143: means,-
p.000143: (A) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical
p.000143: sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause
p.000143: (i),
p.000143: (B) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and
p.000143: insecticides notified in the Official Gazette under sub-clause (ii),
p.000143: (C) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act;
p.000143: Explanation: For the purpose of these rules, substances used for in vitro diagnosis shall be referred
p.000143: as in vitro
p.000143: diagnostic medical device.
p.000143:
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p.000145: 145
p.000145: (zc) “medical device grouping” means a set of devices having same or similar intended uses or
p.000145: commonality of technology allowing them to be classified in a group not reflecting specific characteristics;
p.000145: (zd) “Medical Device Officer” means an officer appointed or designated by the Central Government or the
p.000145: State Government, as the case may be, under sub-rule (2) of rule 18;
p.000145: (ze) “medical devices testing laboratory” means any institute, organisation registered under sub-rule (3) of rule 83
p.000145: for carrying out testing or evaluation of any medical device on behalf of a licencee for manufacture for sale;
p.000145: (zf) “Medical Device Testing Officer” means an officer appointed or designated by the Central Government
p.000145: under sub-rule (1) of rule 18;
p.000145: (zg) "near-patient testing" means any investigation carried out in a clinical setting or at the patient's home for
p.000145: which the result is available without reference to a laboratory and rapidly enough to affect immediate
p.000145: patient management;
p.000145: (zh) “new in vitro diagnostic medical device” means any medical device as referred to in sub-clause (A) of clause (zb)
p.000145: used for in vitro diagnosis that has not been approved for manufacture for sale or for import by the
p.000145: Central Licensing Authority and is being tested to establish its performance for relevant analyte or
p.000145: other parameter related thereto including details of technology and procedure required;
p.000145:
p.000145:
p.000145: (zi) “notified” means notified in the Official Gazette by the Central Government.
p.000145: (zj) “Notified Body” means a body corporate or other legal entity, registered under rule 13 as a body competent to
p.000145: carry out the audit of manufacturing site, assessment, and verification of specified category of medical devices for
p.000145: establishing conformity with standards;
p.000145: (zk) “performance evaluation” in relation to in vitro diagnostic medical device means any systematic investigation by
p.000145: which data is assessed and analysed to establish or verify performance of the in vitro diagnostic medical device for
p.000145: its intended use;
p.000145: (zl) “Post Marketing Surveillance” means systematic process to collect and analyse information gained from medical
p.000145: device that have been placed in the market;
...
p.000145: device shall conform to the validated manufacturer’s standards.
p.000145:
p.000145: CHAPTER III AUTHORITIES, OFFICERS AND BODIES.
p.000145: 8. Licensing Authorities.— (1) The Central Licensing Authority shall be the competent authority for enforcement of
p.000145: these rules in matters relating to,-
p.000145: (i) import of all Classes of medical devices;
p.000145: (ii) manufacture of Class C and Class D medical devices;
p.000145: (iii) clinical investigation and approval of investigational medical devices;
p.000145: (iv) clinical performance evaluation and approval of new in vitro diagnostic medical devices and;
p.000145: (v) co-ordination with the State Licensing Authorities.
p.000145: (2) The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and
p.000145: shall be the competent authority for enforcement of these rules in matters relating to,-
p.000145: (i) manufacture for sale or distribution of Class A or Class B medical devices;
p.000145: (ii) sale, stock, exhibit or offer for sale or distribution of medical devices of all classes.
p.000145:
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p.000147: 147
p.000147:
p.000147:
p.000147: 9. Delegation of powers of Licensing Authorities.— (1) The Central Licensing Authority, may with the
p.000147: prior approval of the Central Government, by an order in writing, delegate all or any of its powers to any other
p.000147: officer of the Central Drugs Standard Control Organisation not below the rank of Assistant Drugs Controller.
p.000147: (2) The officer to whom the powers have been delegated under sub-rule (1) shall exercise the powers of the Central
p.000147: Licensing Authority under its name and seal.
p.000147: (3) The State Licensing Authority, may, with the prior approval of the State Government, by an order
p.000147: in writing, delegate all or any of its powers to any officer under its control.
p.000147: (4) The officer to whom the powers have been delegated under sub-rule (3) shall exercise the powers of
p.000147: the State Licensing Authority under its name and seal.
p.000147:
p.000147: 10. Controlling officer.— Any officer not below the rank of Assistant Drugs Controller, by whatever name called, shall
p.000147: be the controlling officer to supervise and give instructions to any officer subordinate to such controlling officer to
p.000147: exercise powers and functions under these rules for areas and purposes specified, by an order, of the
p.000147: Drugs Controller General of India or the Drugs Controller, by whatever name called, of the State concerned.
p.000147:
p.000147: 11. National Accreditation Body.— (1) The Central Government may, by notification, designate such institute, firm or a
p.000147: Government aided or Government organisation, which fulfills the criteria specified from time to time by
p.000147: the Government, as the National Accreditation Body:
p.000147: Provided that the National Accreditation Board for Certification Bodies under the Quality Council of India, registered
p.000147: under the Societies Registration Act, 1860 (21 of 1860) set up by the Ministry of Commerce and Industry in the
p.000147: Government of India shall act as the National Accreditation Body for the purposes of accrediting Notified Bodies
p.000147: referred to in rule 13, till such time any other body for the purpose is notified, with immediate effect.
p.000147: (2) The National Accreditation Body shall have the required number of competent persons for proper performance of its
p.000147: functions
p.000147: (3)The designated National Accreditation Body referred to in sub-rule (1) shall be responsible for carrying out
p.000147: the assessment of such entities who may apply for accreditation to become a Notified Body for the purpose of these
p.000147: rules.
p.000147: (4) The National Accreditation Body referred to in sub-rule (1), shall, after carrying out the assessment of the entity
p.000147: which applied for accreditation, issue a certificate to such entity in respect of specified categories of
p.000147: standards for which such entity has been assessed and found qualified:
p.000147: Provided that where the entity has been found not possessing the requisite qualification and
...
p.000147: either by itself or by any other qualified person on its behalf as per specified procedure as detailed in Part II of
p.000147: the Third Schedule.
p.000147:
p.000147: 16. Fees to be charged by Notified Body.— A registered Notified Body may charge fee from the applicant for the services
p.000147: rendered by it as may be determined by the Central Government.
p.000147:
p.000147: 17. Suspension and cancellation of registration certificate of Notified Body. — (1) The Central Licensing
p.000147: Authority may, after giving an opportunity to show cause as to why such an order should not be passed, by an order in
p.000147: writing stating the reasons therefor, cancel the registration of a Notified Body or suspend it for such period as the
p.000147: Central Licensing Authority thinks fit, if in its opinion, the Notified Body has failed to comply with any provision of
p.000147: these rules.
p.000147: (2) A registered Notified Body whose registration has been suspended or cancelled under sub-rule (1) may,
p.000147: within thirty days of the receipt of a copy of the order by it, prefer an appeal to the Central Government
p.000147: and the Central Government may, after giving the Notified Body an opportunity of being heard, confirm,
p.000147: reverse or modify such order.
p.000147: (3) The registration of a Notified Body with the Central Licensing Authority shall be deemed to have been cancelled
p.000147: with effect from the expiry of the date of the validity of its accreditation by a National Accreditation Body.
p.000147:
p.000147: 18. Medical Device Testing Officer and Medical Device Officer.— (1) The Central Government may designate a Government
p.000147: Analyst appointed under section 20 of the Act as Medical Device Testing Officer.
p.000147: (2) The Central Government or, as the case may be, the State Government, may designate an Inspector
p.000147: appointed under section 21 of the Act as Medical Device Officer.
p.000147: (3) The Medical Device Testing Officer and Medical Device Officer designated under sub-rule (1) and sub-rule (2)
p.000147: respectively, while exercising powers and duties under the Act and these rules, shall be deemed to have
p.000147: been appointed as the Government Analyst and the Inspector, respectively.
p.000147:
p.000147: 19. Central medical device testing laboratory.— (1) The Central Government may, by notification, establish
p.000147: Central medical devices testing laboratory for the purpose of,—
p.000147: (a) testing and evaluation of medical devices; or
p.000147: (b) functioning as an appellate laboratory; or
p.000147: (c) to carry out any other function as may be specifically assigned to it.
p.000147: (2) Without prejudice to sub-rule (1), the Central Government may also designate any laboratory having facility for
p.000147: carrying out test and evaluation of medical devices as central medical devices testing laboratory for
p.000147: the purposes specified in sub-rule (1):
p.000147: Provided that no medical devices testing laboratory, shall be so designated unless it has been duly accredited by the
p.000147: National Accreditation Body for Testing and Calibration Laboratories.
p.000147:
p.000147: CHAPTER IV
p.000147: MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION
p.000147:
p.000147: 20. Application for manufacture for sale or for distribution of Class A or Class B medical device.— (1)
p.000147: Any person who intends to manufacture a Class A or Class B medical device including in vitro diagnostic medical device
p.000147: shall make an application for grant of licence or loan licence to manufacture for sale or for distribution to the State
p.000147: Licensing Authority.
p.000147: (2) The application under sub-rule (1) shall be made through an identified online portal of the Ministry of Health and
p.000147:
...
p.000149: (i) the manufacturing site shall comply with the requirements of the Quality Management System as specified under the
p.000149: Fifth Schedule;
p.000149: (ii) appoint competent technical staff under whose direction and supervision the manufacturing activity of
p.000149: a medical device shall be undertaken and such staff shall possess the following educational qualification
p.000149: and experience,-
p.000149: (a) degree in engineering in relevant branch or in pharmacy or in science in appropriate subject from
p.000149: a recognised University and shall have experience of not less than two years in manufacturing or testing of medical
p.000149: devices; or
p.000149: (b) diploma in engineering (in relevant branch) or in pharmacy from a recognised institute and shall have the
p.000149: experience of not less than four years in manufacturing or testing of medical devices;
p.000149: (iii) appoint competent technical staff with degree or diploma in engineering (in relevant branch) or in pharmacy or in
p.000149: science in relevant subject and having experience of not less than two years in testing of medical devices under whose
p.000149: direction and supervision, the testing activity of a medical device shall be undertaken.
p.000149:
p.000149: 23. Inspection for grant of licence or loan licence for Class C or Class D medical device.— (1) Before grant of
p.000149: licence to manufacture for sale or for distribution in respect of Class C or D medical device, the manufacturing site
p.000149: shall be inspected within a period of sixty days from the date of application by a team comprising not less than two
p.000149: Medical Device Officers which may include any officer senior to the Medical Device Officer with or
p.000149: without an expert, or a Notified Body referred to in sub-rule (4) of rule 13:
p.000149: Provided that no inspection of a medical device manufacturing site for grant of loan licence to
p.000149: manufacture such medical device shall be required to be carried out if the manufacturing site is already licenced to
p.000149: manufacture such medical device for sale or for distribution.
p.000149: (2) The composition of the inspection team referred to in sub-rule (1) shall be determined by the controlling officer
p.000149: and no inspection shall be carried out without prior approval of the controlling officer.
p.000149:
p.000149: 24. Inspection report.— After completion of inspection as referred to in rule 23, the inspection team shall forward
p.000149: a descriptive report containing findings on each aspect of inspection along with the recommendations to the Central
p.000149: Licensing Authority, through online portal of the Ministry of Health and Family Welfare in the Central Government and
p.000149: forward a copy of the same to the applicant.
p.000149:
p.000149: 25. Grant of licence or loan licence to manufacture for sale or for distribution.— (1) If the Central Licensing
p.000149: Authority, after receipt of the report as referred to in rule 24, and such further enquiry, if any, as may be
p.000149: considered necessary, is satisfied that the requirements of these rules have been complied, that Authority shall grant
p.000149: a licence in Form MD-9, or loan licence in Form MD-10 or may reject the application for reasons to be recorded in
p.000149: writing, within a period of forty five days from the date the inspection report has been received.
p.000149: (2) If the application for grant of licence or loan licence to manufacture for sale or for distribution is rejected
p.000149: under sub-rule (1), the aggrieved person may file an appeal before the Central Government within forty five days from
p.000149: the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to
p.000149: the appellant, be disposed of within a period of sixty days.
p.000149: (3) In case, a licencee or loan licencee intends to manufacture additional medical devices
p.000149: in the licensed manufacturing site, the manufacturer shall make an application for grant of permission to
p.000149: manufacture such medical devices to the Central Licensing Authority or State Licensing Authority, as the case may
p.000149: be, along with the fee as specified in the Second Schedule and the documents as referred to in rule 20 or rule 21, as
p.000149: the case may be.
p.000149: (4) In case of investigational medical device or new in vitro diagnostic medical device, the applicant shall obtain
p.000149: prior permission in Form MD-27 or Form MD-29 from the Central Licensing Authority and no licence to manufacture any
p.000149: class of such medical device shall be granted without such permission.
p.000149:
p.000149: 26. Conditions for manufacturing licence or loan licence.— After grant of licence or loan licence in Form MD-5, Form
p.000149: MD-6, Form MD-9 or MD-10, as the case may be, the licence holder shall comply with the following
p.000149: conditions, namely:-
p.000149: (i) licence shall be produced when requested by the Medical Device Officer or any other senior officer under the
p.000149: control of Central Licensing Authority or State Licensing Authority, as the case may be;
p.000149: (ii) the licence holder shall inform the State Licensing Authority or the Central Licensing Authority, as the case may
p.000149: be, of the occurrence of any suspected unexpected serious adverse event and action taken thereon including any recall
p.000149: within fifteen days of such event coming to the notice of licence holder;
p.000149: (iii) the licence holder shall obtain prior approval from the Central Licensing Authority or the State
p.000149: Licensing Authority, as the case may be, before any major change as specified in the Sixth Schedule is carried out and
p.000149: the Central Licensing Authority or the State Licensing Authority, as the case may be, shall indicate its approval or
p.000149: rejection within forty five days and in case where no communication is received within the stipulated time from
p.000149:
p.000149: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000151: 151
p.000151: such Authority, such change shall be deemed to have been approved;
p.000151: (iv) the licence holder shall inform any minor change as specified in the Sixth Schedule to the State
p.000151: Licensing Authority or Central Licensing Authority, as the case may be, within a period of thirty days after such
p.000151: minor change take place;
p.000151: (v) the licence holder shall carry out test of each batch of product manufactured prior to its release for compliance
p.000151: with specifications either in his own laboratory or in any other laboratory registered under sub-rule (3) of rule 83;
p.000151: (vi) the licence holder shall, on being informed by the Central Licensing Authority or State Licensing Authority, as
p.000151: the case may be, that any part of any lot of the medical device has been found not conforming with
p.000151: the provisions specified under the Act and these rules, and on being directed so to do by such licensing authority,
p.000151: withdraw the remainder of that lot from sale and, so far as may, in the particular circumstances of the case, be
p.000151: practicable, recall the issues already made from that lot;
p.000151: (vii) the licence holder shall maintain an audit or inspection book in Form MD-11 to enable the Notified
p.000151: Body or Medical Device Officer to record his observations and non-conformity, if any;
p.000151: (viii) the licence holder shall maintain at least one unit of sample from each batch of invasive medical device and
p.000151: in vitro diagnostic medical device manufactured for reference purpose for a period of one hundred and eighty days after
p.000151: the date of expiry of such batch;
p.000151: (ix) the licence holder shall maintain records of manufacturing and sales which shall be open to
p.000151: inspection by a Medical Device Officer;
p.000151: (x) the medical device, when offered for sale, shall be accompanied by either its package insert or
p.000151: user manual, wherever applicable;
p.000151: (xi) the manufacturing or testing activity of medical device shall be undertaken only under the
p.000151: direction and supervision of the competent technical staff;
p.000151: (xii) if the manufacturer has stopped manufacturing activity or closed the manufacturing site for a period of
p.000151: thirty days or more, the same shall be intimated to the Central Licensing Authority or the State Licensing Authority,
p.000151: as the case may be.
p.000151:
p.000151: 27. Change in constitution.— In case of change in constitution of a licencee, after grant of licence under sub-rule (4)
p.000151: of rule 20 or sub-rule (6) of rule 20 or sub-rule (1) of rule 25, as the case may be, the manufacturer inform the
p.000151: Central Licensing Authority or the State Licensing Authority, as the case may be, within forty five days and shall
p.000151: shall make an application under sub-rule (1) of rule 20 or sub-rule (1) of rule 21, as the case may be, for grant of
p.000151: licence within a period of one hundred eighty days from the date of such change in constitution:
p.000151: Provided that the existing licence shall be deemed to be valid till such time, a fresh licence is issued or application
p.000151: is rejected by the State Licensing Authority or the Central Licensing Authority, as the case may be:
p.000151: Provided further that if the application is rejected, the manufacturer may appeal to the Central
p.000151: Government or the State Government, as the case may be, within a period of sixty days.
p.000151:
p.000151: 28. Unannounced inspection by State Licensing Authority.— The State Licensing Authority shall, in cases where licence
p.000151: has been granted for manufacturing Class A and Class B medical devices under rule 20, cause an inspection of the
p.000151: manufacturing site to be carried out by a Medical Device Officer on a random basis and such inspection shall not be
p.000151: less than two per cent. of the total audits carried out by Notified Bodies within that State for that class of medical
p.000151: device.
p.000151:
p.000151: 29. Validity of licence.— (1) A licence or loan licence issued in Form MD-5, Form MD-6, Form MD-9 or Form MD- 10 shall
p.000151: remain valid in perpetuity, subject to payment of licence retention fee as specified in the Second Schedule before
p.000151: completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by State
p.000151: Licensing Authority or the Central Licensing Authority, as the case may be.
p.000151: (2) If the licence holder fails to pay the required licence retention fee on or before due date as referred to in
p.000151: sub-rule (1), the licence holder shall, in addition to the licence retention fee, be liable to pay a late fee
p.000151: calculated at the rate of two per cent. of the licence retention fee for every month or part thereof within one hundred
p.000151: and eighty days and in the event of non-payment of such fee during that period, the licence shall be deemed to have
p.000151: been cancelled.
p.000151:
p.000151: 30. Suspension and cancellation of licence.— (1) Where the licencee contravenes any provision of the Act and these
p.000151: rules, the State Licensing Authority or the Central Licensing Authority, as the case may be, shall, after
p.000151: giving the licencee an opportunity to show cause as to why such an order should not be passed, shall by an order and
p.000151: for reasons to be recorded in writing, suspend it for such period as it considers necessary either wholly or in respect
...
p.000151: to manufacture such medical devices;
p.000151: (b) list of equipment, instruments;
p.000151: (c) list of qualified personnel;
p.000151: (d) copy of manufacturing licence issued under these rules, if any;
p.000151: (e) approval letter authorising to undertake research and development activities issued by any Government
p.000151: organisation, if any.
p.000151: (3) The Central Licensing Authority, after enquiry, if any, as may be considered necessary, on being satisfied that the
p.000151: requirements of these rules have been complied, shall grant a test licence in Form MD-13, or may
p.000151: reject the application for reasons to be recorded in writing, within a period of thirty days from the date the
p.000151: application is made under sub-rule (1).
p.000151: (4) The licencee shall maintain a record of the details of quantity of the product manufactured under test licence.
p.000151: (5) A licence granted under sub-rule (3) shall, unless cancelled earlier, remain in force for a period of
p.000151: three years from the date of its issuance.
p.000151:
p.000151: 32. Conditions of test licence to manufacture for test, evaluation, clinical investigations, etc.,— A
p.000151: licence in Form MD-13 under rule 31 shall be subject to the following conditions, namely:—
p.000151: (a) the licencee shall use the medical device manufactured under licence granted under sub-rule (3) of
p.000151: rule 31 exclusively for the purpose of clinical investigations, test, evaluation, examination, demonstration or
p.000151: training at the place specified in the licence;
p.000151: (b) the licencee shall allow any Medical Device Officer to enter, with or without notice, the premises
p.000151: where the medical device are manufactured and to satisfy himself that only clinical investigations, test, evaluation,
p.000151: examination, demonstration or training is being conducted on such device;
p.000151: (c) the licencee shall maintain a record of the quantity of medical device manufactured, tested and stocked and
p.000151: its disposition.
p.000151:
p.000151: 33. Cancellation of test licence to manufacture for test, evaluation, clinical investigations, etc.,— (1)
p.000151: Where any licencee under rule 31 contravenes any provision of these rules, the Central Licensing Authority,
p.000151: shall, issue a show cause notice to such licencee asking, as to why an order should not be made to cancel the licence.
p.000151: (2) The Central Licensing Authority shall, after giving an opportunity to the licencee to explain in writing licencee’s
p.000151: defence, pass an order for cancellation or otherwise and record the reasons therefor in the said order.
p.000151: (3) A licencee, whose licence has been cancelled, may appeal to the Central Government within forty five days from the
p.000151: date of the order.
p.000151:
p.000151: CHAPTER V
p.000151: IMPORT OF MEDICAL DEVICES
p.000151:
p.000151: 34. Application for grant of import licence.— (1) An authorised agent having licence to manufacture for sale or
p.000151: distribution or wholesale licence for sale or distribution under these rules, shall make an application
p.000151: for grant of import licence for medical device to the Central Licensing Authority through an identified
...
p.000153: published safety and performance data or through clinical investigation in the country of origin and a
p.000153: free sale certificate from the country of origin is furnished.
p.000153: (6) In case of investigational medical device or new in vitro diagnostic medical device, the applicant shall obtain
p.000153: prior permission in Form MD-27 or in Form MD-29 from the Central Licensing Authority and no licence to import any
p.000153: class of such medical device shall be granted without such permission.
p.000153:
p.000153: 37. Validity of licence.— A licence granted under sub-rule (1) of rule 36 shall remain valid in perpetuity, unless,
p.000153: it has been cancelled or surrendered, provided the authorised agent deposits the licence retention fee with the
p.000153: Central Licensing Authority as specified in the Second Schedule for each overseas manufacturing site and for each
p.000153: licenced medical device after completion of every five years from the date of its issue:
p.000153: Provided that the Central Licensing Authority may permit to deposit the licence retention fee after due date
p.000153: but before expiry of ninety days with a late fee calculated at the rate of two per cent. per mensem:
p.000153: Provided further that if the licencee fails to deposit the licence retention fee within the above stipulated period,
p.000153: the licence shall be deemed to have been cancelled.
p.000153:
p.000153: 38. Conditions to be complied with by Licence holder.— (1) The licencee shall comply with the
p.000153: following conditions, namely:-
p.000153: (i) licence shall be produced when requested by the Medical Device Officer or any other senior officer
p.000153: under the control of Central Licensing Authority or the State Licensing Authority, as the case may be;
p.000153: (ii) the licencee shall inform the licensing authority forthwith and, in all circumstances, within a period of fifteen
p.000153: days of any administrative action taken on account of any adverse reaction, such as market withdrawal,
p.000153: regulatory restrictions, cancellation of authorisation or declaration of the medical device as not of
p.000153: standards quality by the regulatory authority of the country of origin or by any regulatory authority of any other
p.000153: country, where the medical device is marketed, sold or distributed;
p.000153: (iii) authorised agent in cases referred in clause (ii), shall stop immediately the despatch and marketing of the
p.000153: medical device referred in that clause;
p.000153: (iv) the Central Licensing Authority, after due consideration of the information as referred in clause (ii), may
p.000153: issue directions to the licencee in respect of marketing, sale or distribution of the medical device including
p.000153: withdrawal of medical device from the Indian market within a period as may be specified by the Central Licensing
p.000153: Authority;
p.000153: (v) the authorised agent shall obtain prior approval from the Central Licensing Authority before any major change, as
...
p.000153: its issue.
p.000153: (6) The medical devices including in vitro diagnostic medical device referred to in sub-rule (2) that are not used, may
p.000153: be permitted to be exported or destroyed under intimation to the Central Licensing Authority.
p.000153: (7) Where any licencee under sub-rule (1) contravenes any provision of these rules, the Central Licensing Authority,
p.000153: shall, issue a show cause notice to such licencee asking, as to why an order should not be made to cancel the licence.
p.000153: (8) The Central Licensing Authority shall after giving an opportunity to the licencee to explain, in writing,
p.000153: licencee’s defence, pass an order for cancellation or otherwise and record the reasons therefor in the said order.
p.000153: (9) A licencee, whose licence has been cancelled under sub-rule (8), may appeal to the Central Government within forty
p.000153: five days from the date of such order.
p.000153:
p.000153: 42. Import of investigational medical device by Government hospital or statutory medical institution for
p.000153: treatment of patient.— (1) Small quantity of investigational medical device, the import of which is not allowed, but
p.000153: approved in the country of origin, may be allowed to be imported by the Central Licensing Authority for treatment of a
p.000153: patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring
p.000153: therapy for unmet medical need, on an application made by a Medical Officer through the medical superintendent of a
p.000153: Government hospital or a statutory medical institution in Form MD-18 and such application shall be accompanied by
p.000153: documents required and the fee as specified in the Second Schedule.
p.000153:
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p.000155: 155
p.000155: (2) On receipt of an application under sub-rule (1), the Central Licensing Authority shall, on being satisfied about
p.000155: the information and the documents enclosed with the application, grant import licence for treatment of patient in
p.000155: Form MD-19.
p.000155: (3) The medical device for which the licence is granted under sub-rule (2), shall, be used exclusively for the purpose
p.000155: of treatment of the patient referred to in sub-rule (1).
p.000155: (4) The holder of licence shall maintain record of the name of the manufacturer, quantity imported and used, date of
p.000155: import, name and address of the patient and diagnosis.
p.000155: (5) The holder of the licence shall allow the medical device officer authorised by the Central Licensing Authority in
p.000155: this behalf to enter, with or without prior notice, the premises where the medical devices are stocked and to inspect
p.000155: the premises and relevant records and investigate the manner in which the medical device is being used and to take, if
p.000155: required, samples thereof.
p.000155: (6) The quantity considered necessary shall be determined by the Central Licensing Authority after taking
p.000155: into account the recommendation of the hospital concerned for treatment of patient suffering from a life
p.000155: threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical
p.000155: need.
p.000155: (7) Where the Central Licensing Authority is satisfied, it may, in exceptional and special circumstances, allow import
p.000155: of larger quantity of medical devices for use by the patient.
p.000155: (8) The consignment of medical device shall be accompanied by an invoice or a statement showing the name
p.000155: and quantity of medical device.
p.000155:
p.000155: 43. Import of medical device for personal use.—(1) Small quantity of medical device, the import of
p.000155: which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to
p.000155: the following conditions, namely,-
p.000155: (i) the medical device shall form part of a personal baggage of a passenger and be intended for the exclusive use of
p.000155: such passenger;
p.000155: (ii) the medical device shall be declared as personal baggage of the passenger to the customs authorities, if they so
...
p.000157: (c) suspend the permission for such period as it thinks fit or cancel either wholly or partly the permission.
p.000157: (2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days of the
p.000157: receipt of such order before the Central Government, which may, after such enquiry and after giving an opportunity of
p.000157: being heard to the appellant, dispose of the appeal within a period of sixty days.
p.000157:
p.000157: 55. Medical management and compensation related to clinical investigation.—(1) Where any participant is
p.000157: injured on account of participation in clinical investigation, the sponsor permitted under rule 52 shall
p.000157: provide medical management to that participant.
p.000157: (2) Where an injury is caused to the participant in a clinical investigation of any investigational medical device and
p.000157: such injury is attributable to the use of investigational medical device, the sponsor permitted under
p.000157: rule 52 shall provide to that participant, medical management and such compensation in the manner as
p.000157: specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945.
p.000157: (3) Where death of a participant is related to clinical investigation and is attributable to the use of an
p.000157: investigational medical device, the sponsor, permitted under rule 52 shall provide to the legal heir of
p.000157: that participant, such compensation, in such manner as specified under rule 122DAB of the Drugs and Cosmetics Rules,
p.000157: 1945.
p.000157:
p.000157: 56. Powers of search and seizure, etc.—The Medical Devices Officer may enter any premises related to
p.000157: clinical investigation or clinical performance evaluation, with or without an expert, with prior approval
p.000157: of the Central Licensing Authority, with or without prior notice, to inspect the facilities, search and seize,
p.000157: record, data, documents, books, and medical devices including investigational medical devices or new in vitro
p.000157: diagnostic medical device.
p.000157:
p.000157: 57. Maintenance of record.—Every person, sponsor, clinical research organisation, any other organisation or
p.000157: investigator conducting a clinical investigation or his agent holding a permission under this Chapter shall
p.000157: maintain such data, record, registers and other documents for a period of seven years after completion of such
p.000157: investigation and shall furnish such information as may be required by the Central Licensing Authority or any other
p.000157: officer authorised by it in this behalf under rule 56.
p.000157:
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p.000159: 159
p.000159:
p.000159: 58. Disclosure of name, address, etc., of persons involved in clinical investigation or clinical
p.000159: performance evaluation.—Every person, sponsor, clinical research organisation, any other organisation or investigator
p.000159: conducting a clinical investigation or clinical performance evaluation or any agent authorised by any of them, as the
p.000159: case may be, shall, if so required, disclose to the Medical Device Officer or any other officer authorised by the
p.000159: Central Licensing Authority, the names, addresses and other particulars of persons involved in clinical investigation.
p.000159:
p.000159: 59. Permission to conduct clinical performance evaluation for new in vitro diagnostic medical device.— (1) No person
p.000159: or sponsor shall conduct any clinical performance evaluation in respect of a new in vitro diagnostic medical device on
p.000159: any specimen, including blood or tissue derived from human body except under, and in accordance with, the permission
p.000159: granted by the Central Licensing Authority subject to such conditions and in such form and manner as specified in these
p.000159: rules.
p.000159: (2) An application for grant of permission to conduct, clinical performance evaluation of new in vitro
p.000159: diagnostic medical device shall be made to the Central Licensing Authority in Form MD-24 by the sponsor
p.000159: and shall be accompanied with a fee as specified in the Second Schedule along with information specified in
p.000159: sub-rule (3) duly signed by the sponsor in India:
p.000159: Provided that no fee shall be required to be paid by the institutes, organisation, hospitals, run by the Central
p.000159: Government or the State Government, involved in conduct of clinical performance evaluation of new in
p.000159: vitro diagnostic medical devices.
p.000159: (3) The information required under sub-rule (2) shall contain the following, namely,-
p.000159: (i) approval from an Ethics Committee, which is registered with the Central Licensing Authority,
...
p.000161: Licensing Authority within ninety days from the date of intimation and the said Authority is satisfied
p.000161: that the information sought was possible to be furnished within the said period, it may reject the application for
p.000161: reasons to be recorded in writing.
p.000161:
p.000161: 65. Condition of permission to import or manufacture medical device which does not have its predicate device and
p.000161: new in vitro diagnostic medical device.—A Permission under rules 63 in Form MD-27 and rule 64 in Form
p.000161: MD-29 shall be subject to the following conditions, namely:—
p.000161: (a) the medical device shall conform to the specifications submitted along with the application;
p.000161: (b) the permission holder of Form MD-27 shall submit the Periodic Safety Update Report to the Central Licensing
p.000161: Authority from the date of launch in the market and such report shall be submitted every six months for first two years
p.000161: followed by submission of the said report annually for the two more successive years;
p.000161: (c) the permission holder shall inform the date of launch of medical device in the market to the Central
p.000161: Licensing Authority;
p.000161: (d) the permission holder of Form MD-27 shall submit the suspected unexpected serious adverse event within fifteen
p.000161: days of the awareness of the event to the Central Licensing Authority.
p.000161:
p.000161: CHAPTER IX
p.000161: DUTIES OF MEDICAL DEVICE OFFICER, MEDICAL DEVICE TESTING OFFICER AND NOTIFIED BODY
p.000161:
p.000161: 66. Duties of Medical Device Testing Officer.—The Medical Device Testing Officer shall cause the sample
p.000161: of medical device or portion thereof tested or evaluated as may be sent in a sealed package by the
p.000161: Medical Device Officer or any other person under the provisions of Chapters IV, V, VII and XI of these rules, and
p.000161: shall furnish the report of the result of the test or evaluation in accordance with these rules.
p.000161:
p.000161: 162 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000161: II—SEC. 3(i)]
p.000161:
p.000161: 67. Test or evaluation of sample under sub-section (4) of section 25 of the Act.—(1) The sample of
p.000161: medical device for test or evaluation under sub-section (4) of section 25 of the Act shall be sent by registered post
p.000161: in the outer cover addressed to the Director of central medical device testing laboratory in a sealed packet with a
p.000161: memorandum in Form MD-30.
p.000161: (2) The packet as well as the outer cover shall be marked with a distinguishing number.
p.000161: (3) A copy of the memorandum in Form MD-30 and a specimen impression of the seal used to seal the packet shall be
p.000161: separately sent by registered post to the Director of central medical device testing laboratory.
p.000161: (4) After test or evaluation, the result of the test or evaluation shall be sent forthwith to the sender in Form MD-31.
p.000161:
p.000161: 68. Procedure to be adopted by medical device testing officer on receipt of sample.—(1) On receipt of the sealed
p.000161: package of medical device or portion thereof, from a Medical Device Officer or any other person for
p.000161: test or evaluation, the Medical Device Testing Officer shall compare the seals on the packet or on portion thereof
p.000161: with the specimen impression received separately and shall note the condition of the seals on the packet or on portion
p.000161: thereof.
p.000161: (2) After completion of test or evaluation, the Medical Device Testing Officer shall forthwith furnish a report to the
p.000161: Medical Device Officer in triplicate in Form MD-32 of the result of the test or evaluation along with full protocols of
p.000161: the test or evaluation applied.
p.000161:
p.000161: 69. Application for test or evaluation of medical device.—For the purpose of these rules, an application
p.000161: from a purchaser for test or evaluation of a medical device or portion of medical device under section 26 of the Act
p.000161: shall be made in Form MD-33 and the report of such test or evaluation of the medical device which is
p.000161: prepared on such application shall be supplied to the applicant in Form MD-32.
p.000161:
p.000161: 70. Duties of Medical Device Officer.—Subject to the instructions of the Central Licensing Authority or
p.000161: State Licensing Authority, as the case may be, it shall be the duty of Medical Device Officer to,—
p.000161: (i) Inspect, not less than once in a year, all manufacturing sites licenced by the Central Licensing Authority or
p.000161: State Licensing Authority, as the case may be, within the area assigned to him;
p.000161: (ii) conform that the conditions of licence are being observed;
p.000161: (iii) take samples of medical device manufactured or imported for sale, or stocked or exhibited for sale in respect
p.000161: of which the Medical Device Officer has reason to suspect contravention of the provisions of the Act or these rules and
p.000161: send them for test or evaluation:
p.000161: Provided that in case of large sized medical device, wherein the opinion of the Medical Device Officer drawing
p.000161: samples of such a device may not be physically practical, such large sized medical device shall be
p.000161: inspected at the place where these are kept by the Medical Device Officer with or without expert and evaluated or
p.000161: tested by the Medical Device Testing Officer, for any suspect contravention, after approval of the
p.000161: Central Licensing Authority or the State Licensing Authority, as the case may be;
p.000161: (iv) maintain a record of all inspections undertaken, drawing of samples, seizure of stocks and action
p.000161: taken by Medical Device Officer in exercise and performance of duties and to furnish copies of such record to the
p.000161: Central Licensing Authority or the State Licensing Authority, as the case may be;
p.000161: (v) make such enquiries and inspections as may be necessary to detect the manufacture or sale of medical device in
p.000161: contravention of any provision of the Act and these rules;
p.000161: (vi) investigate any complaint made in writing relating to medical device to the Medical Device Officer or any other
p.000161: senior officer in accordance with the direction of the controlling officer;
p.000161: (vii) institute prosecution in relation to contravention of the provisions of the Act and these rules;
p.000161: (viii) review technical dossier of medical device furnished with the application under these rules or any other
p.000161: duties assigned by the Central Licensing Authority or State Licensing Authority, as the case may be, related to
p.000161: these rules.
p.000161:
p.000161: 71. Prohibition of disclosure of information.—Except for the purpose of official business or when required by a
p.000161: Court, a Medical Device Officer or Medical Device Testing Officer shall not, without the previous
p.000161: sanction, in writing, of his official superior, disclose to any person any information acquired while exercising such
p.000161: official duties.
p.000161:
p.000161: 72. Form of order not to dispose of stock.—An order in writing by a Medical Device Officer under clause (c) of
p.000161: sub-section (1) of section 22 of the Act requiring a person not to dispose of any stock in his possession shall be in
p.000161: Form MD-34.
p.000161:
p.000161: 73. Prohibition of sale.—No person in possession of a medical device in respect of which a Medical Device Officer has
p.000161: made an order under clause (c) of sub-section (1) of section 22 of the Act shall, in contravention of that order, sell
p.000161: or otherwise dispose of any stock of such medical device.
p.000161:
p.000161: 74. Form of receipt for seized medical devices, record, register, documents or any other material objects.—A receipt
p.000161: by a Medical Device Officer for the stock of any medical device or for any record, register, document or any other
p.000161: material object seized under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act shall be in Form
p.000161: MD-35.
p.000161:
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p.000163: 163
p.000163:
p.000163:
p.000163: 75. Manner of certifying copies of seized documents.—The Medical Device Officer shall return the
p.000163: document, seized under section 22 of the Act, within a period of twenty days from the date of such seizure, to the
p.000163: person from whom they were recovered or produced, after copies thereof or extracts therefrom have been signed by the
p.000163: concerned Medical Device Officer and the person from whom they were recovered or produced.
p.000163:
p.000163: 76. Purpose for which samples have been taken.—When a Medical Device Officer takes a sample of a medical
p.000163: device other than medical device specified in proviso to clause (iii) of rule 70 for the purpose of test or evaluation,
p.000163: the Medical Device Officer shall inform such purpose in writing in Form MD-36 to the person from whom the sample has
p.000163: been taken and shall tender the fair price thereof under a written acknowledgement.
p.000163:
p.000163: 77. Form of receipt for samples of medical devices where fair price tendered is refused.—Where the fair price tendered
p.000163: under sub-section (1) of section 23 of the Act for sample of medical device or portion thereof taken for the purposes
p.000163: of test or evaluation has been refused by the person from whom such sample has been taken, the Medical Device Officer
p.000163: shall tender a receipt thereof to such person in Form MD-37.
p.000163:
p.000163: 78. Procedure for dispatch of sample to medical device testing officer.—(1) The sample of medical device
p.000163: or portion thereof sent by the Medical Device Officer to the Medical Device Testing Officer for test or evaluation
p.000163: under sub-section (4) of section 23 of the Act shall be sent by registered post or by courier or by hand in a sealed
p.000163: packet, enclosed with a memorandum in Form MD-38, in an outer cover addressed to the Medical Device Testing Officer.
p.000163: (2) A copy of the memorandum and a specimen impression of the seal used to seal the packet shall be sent to
p.000163: the Medical Device Testing Officer separately by registered post or handed over by hand and a copy of the memorandum
p.000163: shall be endorsed to the manufacturer.
p.000163:
p.000163: 79. Confiscation of medical devices, implements, machinery, etc.—(1) Where any person has been convicted for
p.000163: contravening any provisions of the Act or any these rules, the stock of medical device in respect of
p.000163: which the contravention has been made, shall be liable to confiscation.
p.000163: (2) Where any person has been convicted for manufacturing any medical device which is misbranded, adulterated or
p.000163: spurious for sale, stocking or exhibiting for sale or distribution without a valid licence, any implements or machinery
p.000163: used in such manufacture, sale or distribution and any receptable, package or covering in which such medical device is
p.000163: contained and the animals, vehicles, vessels or other conveyances used in carrying such medical device shall
p.000163: be liable to confiscation.
p.000163:
p.000163: 80. Procedure for disposal of confiscated medical device.—(1) The Court may refer the confiscated medical device to
p.000163: the Medical Device Officer concerned for report as to whether they are of standard quality or
p.000163: contravene the provisions of the Act or the rules in any respect.
p.000163: (2) If the Medical Device Officer, on the basis of Medical Device Testing Officer’s report, finds the
p.000163: confiscated medical device to be not of standard quality or to contravene any of the provisions of the
p.000163: Act or rules made thereunder, the Medical Device Officer shall, with the approval of the Central Licensing Authority
p.000163: or State Licensing Authority, as the case may be, report to the Court accordingly and the Court shall thereupon order
p.000163: destruction of such medical devices, which shall take place under the supervision of the Medical Device Officer in the
p.000163: presence of such authority, if any, as may be directed by the Court:
p.000163: Provided that the convicted person shall be liable to bear the cost of destruction of seized articles.
p.000163: (3) If the Medical Device Officer finds that the confiscated medical devices are of standard quality
p.000163: and do not contravene the provisions of the Act or the rules made thereunder, the Medical Device Officer shall, after
p.000163: keeping the Central Licensing Authority or the State Licensing Authority, as the case may be, informed,
p.000163: report to the Court accordingly.
p.000163: (4) The Court may return the confiscated devices to the rightful owner, and in case, the ownership is not established,
p.000163: the same may be given to a hospital or a dispensary maintained or supported by the Government or to a charitable
p.000163: institution.
p.000163:
p.000163: CHAPTER X
p.000163: REGISTRATION OF LABORATORY FOR CARRYING OUT TEST OR EVALUATION
p.000163:
p.000163: 81. Application for registration of medical device testing laboratory.—(1) An application for grant of registration of
p.000163: a medical device testing laboratory to carry out testing or evaluation of a medical device on behalf
p.000163: of a manufacturer shall be made to the Central Licensing Authority through online portal of the Central Government in
p.000163: Form MD-39 accompanied with a fee as specified in the Second Schedule along with the information specified in
p.000163: sub-rule (2).
p.000163: (2) The application made under sub-rule (1) shall be accompanied with the following information, namely:-
p.000163: (i) constitution of the medical device testing laboratory;
p.000163: (ii) premises showing location and area of the different sections;
p.000163:
p.000163: 164 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000163: II—SEC. 3(i)]
p.000163:
p.000163: (iii) qualification, experience of technical staff employed for testing and the person in-charge of testing;
p.000163: (iv) list of equipment; and
...
p.000163: continues to be adequate;
p.000163: (iii) if it is intended to carry out tests requiring the use of animals, the applicant shall provide for an animal
p.000163: house and comply with the following requirements:-
p.000163: (a) the animal house shall be adequate in area, well lighted and properly ventilated and the animals undergoing tests
p.000163: shall be kept in air conditioned area;
p.000163: (b) the animals shall be suitably housed in hygienic surroundings and necessary provisions made for
p.000163: removal of excreta and foul smell;
p.000163: (c) the applicant shall provide for suitable arrangements for preparation of animal feed;
p.000163: (d) the applicant shall provide for suitable arrangements for quarantining of all animals immediately on their arrival
p.000163: in the institution;
p.000163: (e) the animals shall be periodically examined for their physical fitness;
p.000163: (f) the applicant shall provide for isolation of sick animals as well as animals under test;
p.000163: (g) the applicant shall ensure compliance with the requirements of the Prevention of Cruelty to Animals Act, 1960 (59
p.000163: of 1960);
p.000163: (h) the applicant shall make proper arrangements for disposal of the carcasses of animals in a manner as not to cause
p.000163: hazard to public health.
p.000163:
p.000163: 83. Registration of medical device testing laboratory.—(1) Before grant of registration to any medical
p.000163: device testing laboratory by the Central Licensing Authority, the premises shall be inspected by the Medical Device
p.000163: Officer appointed by the Central Government with or without an expert in the concerned field for adequacy and
p.000163: suitability.
p.000163: (2) The Medical Device Officer, after completion of the inspection, shall forward a detailed descriptive report giving
p.000163: findings on each aspect of inspection along with recommendations to the Central Licensing Authority with a copy to the
p.000163: applicant.
p.000163: (3) If on receipt of the application and the report referred to in sub-rule (2), the Central Licensing
p.000163: Authority, is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules, the
p.000163: Central Licencing Authority may grant registration in Form MD-40 or if not satisfied, may, reject the
p.000163: application, for reasons to be recorded in writing, within a period of forty five days from the date of
p.000163: application.
p.000163: (4) The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of
p.000163: medical devices intended to be tested which shall be adequate in the opinion of the Central Licensing Authority.
p.000163: (5) The testing and evaluation of medical devices shall be under active direction of a person whose qualification and
p.000163: experience is considered adequate and who shall be held responsible for reports of test or evaluation issued.
p.000163: (6) The applicant shall provide standards recognised under the provisions of the Act and these rules
p.000163: and such standards of reference as may be required in connection with the testing or evaluation of the devices for the
p.000163: testing of which approval has been applied for.
p.000163:
p.000163: 84. Validity of registration.—A registration granted under sub-rule (3) of rule 83 in Form MD-40, shall remain valid in
p.000163: perpetuity, unless, it is suspended or cancelled, provided the registration holder deposits a registration retention
p.000163: fee to the Central Licensing Authority as specified in the Second Schedule after completion of every five years from
p.000163: the date of its issue:
p.000163: Provided, that the Central Licensing Authority may permit to deposit the registration retention fee after due date but
p.000163: before the expiry of six months with a late fee at the rate of two per cent. per mensem or part thereof:
p.000163: Provided further that, if the registration holder fails to deposit the registration retention fee within
p.000163: the above stipulated period, the registration shall be deemed to have been cancelled for all purposes.
p.000163:
p.000163: 85. Conditions of registration.—A registration granted under sub-rule (3) of rule 83 in Form MD-40,
p.000163: shall be subject to the following conditions, namely:—
p.000163: (i) the registration certificate shall be kept on the approved premises and shall be produced at the
p.000163: request of the medical device officer;
p.000163:
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p.000165: 165
p.000165: (ii) the person holding registration certificate shall provide and maintain necessary qualified staff, adequate
p.000165: premises and equipment;
p.000165: (iii) the person holding registration certificate shall provide proper facilities for storage so as to preserve the
p.000165: properties of samples picked up for testing;
p.000165: (iv) the person holding registration certificate shall maintain records of tests for evaluation and performance carried
p.000165: out on all samples of medical devices and the results thereof together with protocols of tests and the reports showing
p.000165: readings and calculations and such records shall be retained, in case of substances for which an expiry
p.000165: date is assigned, for a period of two years beyond the expiry date, and in the case of other substances, for
p.000165: a period of six years;
p.000165: (v) the person holding registration certificate shall allow the medical device officer appointed under this Act to
p.000165: enter, with or without prior notice, the premises where the testing is carried out and to inspect the
p.000165: premises and the equipment used for test and the testing procedures employed.
p.000165: (vi) The person holding registration certificate shall allow the medical device officer to inspect records maintained
p.000165: and shall make available such information as may be required for ascertaining whether the provisions of the Act and
p.000165: these rules have been complied with;
p.000165: (vii) the registration holder shall inform forthwith, any change of existing expert staff or
p.000165: person-in-charge of the testing or evaluation to the Central Licensing Authority for its approval;
p.000165: (viii) in case, any sample of a medical device is found on test, to be not of standard quality, the person in-charge of
p.000165: the registered medical device testing laboratory shall furnish a copy of the test or evaluation report on the sample
p.000165: with the protocols of tests applied to the Central Licensing Authority;
p.000165: (ix) the person holding registration certificate shall maintain an inspection book to enable the Medical Device Officer
p.000165: to record non-compliance with the provisions of the Act and these rules;
p.000165: (x) the registered medical device testing laboratory shall inform to the Central Licensing Authority in writing in the
p.000165: event of any change in its constitution and where such change in the constitution takes place, the current registration
p.000165: shall be deemed to be valid for a maximum period of ninety days from the date on which the change
p.000165: took place unless, in the meantime, a fresh approval has been taken from the Central Licensing Authority
p.000165: with the changed constitution;
p.000165:
p.000165: 86. Suspension and cancellation of registration.—(1) Where any registered medical device testing laboratory fails to
p.000165: comply with any of the conditions of approval, or any provisions of the Act and these rules, the Central Licensing
p.000165: Authority, may issue a show cause notice for suspension or cancellation of the registration of the said medical device
p.000165: testing laboratory.
p.000165: (2) On receipt of the show cause notice under sub-rule (1), the registered medical device testing
p.000165: laboratory shall, furnish its reply in writing, within fifteen days of the receipt of such show cause notice.
p.000165: (3) After considering the reply of the registered medical device testing laboratory furnished under sub-rule
p.000165: (2), the Central Licensing Authority may pass an order in writing for suspension or cancellation of the registration
p.000165: of the said medical device testing laboratory registered under sub-rule (3) of rule 83.
...
p.000003: individual patient provided the registered medical practitioner is not
p.000003: (a) keeping an open shop or (b) selling across the counter, for distribution or sale of medical
p.000003: devices in
p.000003: Extent and conditions of exemption
p.000003: All provisions of Chapter IV and Chapter V of these rules, subject to the condition that the device is
p.000003: being specifically made in accordance with a duly qualified medical practitioner’s written prescription under his
p.000003: responsibility, in accordance with specific design, characteristics and the same is intended for the sole use of a
p.000003: particular patient and the label contains the words ‘custom made device’.
p.000003: Explanation.- Mass produced devices, which only need adoption to meet the specific requirement of a medical
p.000003: practitioner or any other professional user, shall not be considered as custom made device.
p.000003: The provisions of Chapter XI of these rules which require them to be covered by a sale licence, subject to
p.000003: condition that such products have been manufactured by licenced manufacturers.
p.000003: All provisions of Chapter XI of these rules which require them to be covered by a sale licence subject to the following
p.000003: conditions:-
p.000003: (a) The medical devices shall be purchased only from a licenced manufacturer or licenced whole seller or retailer
p.000003: under these rules and records of such purchases showing the name and quantities of such medical devices, together
p.000003: with their batch numbers and names and addresses of the manufacturers shall be maintained. Such records shall be
p.000003: open to inspection by medical device officer appointed under this Act, who may, if necessary make enquiries about
p.000003: purchase of medical device and may also take samples for test.
p.000003: (b) Medical device shall be stored under proper storage conditions as specified in the label.
p.000003: (c) No medical device shall be sold or supplied or dispensed after the date of expiration recorded on its label or
p.000003: in violation of any statement or direction recorded on such label.
p.000003:
p.000003: 222 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000003: II—SEC. 3(i)]
p.000003:
p.000003:
p.000003: India to a degree which render him liable to the provisions of Chapter IV of the Act and the
p.000003: rules made thereunder.
p.000003: 4 Medical devices supplied by a hospital or dispensary maintained or supported by Government or local
p.000003: body.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 5 Mechanical contraceptives.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: 6 Import of small quantity of medical devices donated to a charitable hospital for treatment of
p.000003: patients free of cost by that hospital.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: All provisions of Chapter XI of these rules which requires them to be covered by a sale licence subject to the
p.000003: following conditions:-
p.000003: (a) The dispensing and supply of medical devices shall be carried out by or under the supervision of
p.000003: qualified person;
p.000003: (b) The premises where medical devices are supplied or stocked shall be open to inspection by a medical device officer
p.000003: appointed under this Act who can, if necessary, take samples for test.
p.000003: (c) The medical devices shall be stored under proper storage conditions.
p.000003: (d) The medical devices shall be purchased from a manufacturer or a whole seller or retailer licenced
p.000003: under these rules or received as transferred stocks from hospital stores for distribution. Records of
p.000003: such purchases or receipts shall be maintained.
p.000003: (e) No medical device shall be sold or supplied or dispensed after the date of expiration recorded on its label or
p.000003: in violation of any statement or direction recorded on such label.
p.000003: The provisions of Chapter XI of these rules which require them to be covered by a sale licence subject to the condition
p.000003: that the provisions of condition that no medical device shall be sold or supplied or dispensed after the
p.000003: date of expiration recorded on its label or in violation of any statement or direction recorded on such
p.000003: label.
p.000003: The provisions of Chapter V of these rules which require them to be covered by a licence for import provided that
p.000003: the Central Licensing Authority shall issue a No Objection Certificate for such purpose to the applicant.
p.000003:
p.000003:
p.000003: Appendix Form MD-1
p.000003: [See sub-rule (5) of rule 13]
p.000003: Application for grant of Certificate of Registration of a Notified Body
p.000003:
p.000003: 1. Name of Applicant:
p.000003: 2. Nature and constitution of Body:
p.000003: (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust,
p.000003: other to be specified)
p.000003: 3. Corporate/ registered office address including telephone number, mobile number, fax number and e-mail id:
...
p.000231:
p.000231:
p.000231:
p.000231: Place: _ Date: _
p.000231: State Licensing Authority [To be signed digitally]
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231: S.N. Generic
p.000231: name
p.000231:
p.000231:
p.000231: Model No.
p.000231:
p.000231:
p.000231: Intended use
p.000231:
p.000231:
p.000231: Class of medical device
p.000231:
p.000231:
p.000231: Material of construction
p.000231:
p.000231:
p.000231: Dimension (if any)
p.000231:
p.000231:
p.000231: Shelf life
p.000231:
p.000231:
p.000231: Sterile or Non sterile
p.000231:
p.000231: Annexure: Brand
p.000231: Name (if
p.000231: registered under the Trade Marks Act, 1999)
p.000231:
p.000231: 232 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000231: II—SEC. 3(i)]
p.000231:
p.000231: Form MD-11
p.000231: [See clause (vii) of rule 26]
p.000231: Form in which the Audit or Inspection Book shall be maintained.
p.000231: (A) The cover of the audit or inspection book shall contain the following particulars, namely:-
p.000231: 1. The name and address of the licencee _
p.000231: 2. Licence Number
p.000231:
p.000231:
p.000231: (B) (i) The pages of the audit or inspection book shall be serially numbered and duly stamped by the
p.000231: Central Licensing Authority*/State Licensing Authority*. The pages, other than the first and the last pages, shall
p.000231: have the following particulars:-
p.000231:
p.000231: Name and designation of the auditor or medical device officer who audited or inspected the premises: Date of audit or
p.000231: inspection _
p.000231: Observations of the auditor or medical device officer
p.000231:
p.000231: Signature of the auditor or medical device officer
p.000231:
p.000231: (ii) The first and last pages of the audit or inspection book shall be endorsed by the Central
p.000231: Licensing Authority*/State Licensing Authority* with the following words, namely:-
p.000231: Audit or inspection book maintained by M/s _ situated at
p.000231: for licence number _ _ in Form under the Medical
p.000231: Devices Rules, 2017.
p.000231:
p.000231: *Central Licensing Authority/
p.000231: *State Licensing Authority [To be signed digitally]
p.000231: *Delete whichever is not applicable.
p.000231:
p.000231: Notes:
p.000231: (i) Printed copy of the Inspection Book may be obtained by the licencee from the Licensing Authority on payment of fee
p.000231: as may be specified by the concerned Licensing Authority from time to time.
p.000231: (ii) The audit or inspection book shall be maintained at the premises of the licencee.
p.000231: (iii) The original copy of observations made by the auditor or medical device officer shall be maintained in the
p.000231: premises of the licencee and duplicate copy shall be sent to the Central Licensing Authority/ State
p.000231: Licensing Authority. The triplicate copy shall be taken as record by the auditor or medical device officer.
p.000231:
p.000231:
p.000231: Form MD-12
p.000231: [See sub-rule (1) of rule 31]
p.000231: Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation,
p.000231: examination, demonstration or training
p.000231:
p.000231: 1. Name of Applicant:
p.000231: 2. Nature and constitution of manufacturer:
p.000231: (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust,
p.000231: other to be specified)
p.000231: 3. (i) Corporate/ registered office address including telephone number, mobile number, fax number and e-mail id:
p.000231: (ii) Testing or evaluation site address including telephone number, mobile number, fax number and e-mail id:
p.000231: (iii) Address for correspondence: [corporate office/ testing site]
p.000231: 4. Details of medical device(s) to be manufactured [Annexed]:
p.000231: 5. Fee paid on Rs receipt/challan/transaction
p.000231: id_ .
p.000231:
p.000231: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000233: 233
p.000233: 6. I hereby state and undertake that, I shall comply with all applicable provisions of the Drugs and Cosmetics Act,
p.000233: 1940 (23 of 1940) and the Medical Devices Rules, 2017.
p.000233:
p.000233:
p.000233:
p.000233:
p.000233:
p.000233:
p.000233: Place: Date: _
p.000233:
p.000233:
p.000233:
p.000233:
p.000233:
p.000233: Signature (Name and designation) [To be signed digitally]
p.000233:
p.000233:
p.000233:
p.000233:
p.000233: S.N. Generic name Class of medical device
p.000233:
p.000233:
p.000233: Quantity proposed to be manufactured
p.000233:
p.000233: Annexure:
p.000233:
p.000233:
...
p.000245:
p.000245: 2. The distinguishing number on the packet is ………………………………………………………..
p.000245:
p.000245: 3. Particulars of offence alleged ……………………………………………………………………….
p.000245:
p.000245: 4. Matter on which opinion is required …………………………………………………………………
p.000245:
p.000245: 246 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000245: II—SEC. 3(i)]
p.000245:
p.000245: 5. A fee of Rs has been deposited in Court.
p.000245:
p.000245: Date………………..
p.000245:
p.000245: ……………………..
p.000245: Magistrate
p.000245:
p.000245: Form MD-31
p.000245: [See sub-rule (4) of rule 67]
p.000245: Certificate of test or evaluation by the Central Medical Device Testing Laboratory
p.000245:
p.000245: 1. Certified that the samples, bearing number
p.000245: purporting to be a sample of
p.000245: …………………………… received on ………………………….. with memorandum No. ……………………..
p.000245: dated ………………………. from has been tested/evaluated and that the
p.000245: result of such
p.000245: test/evaluation is as stated below.
p.000245:
p.000245:
p.000245: 2. The condition of the seals on the packet on receipt was as follow.
p.000245:
p.000245: *3. In the opinion of the undersigned the sample is of standard quality/not of standard quality as defined in the Drugs
p.000245: and Cosmetics Act, 1940 (23 of 1940) and Medical Devices Rules, 2017 for the reasons given below.
p.000245:
p.000245:
p.000245:
p.000245: Date……………….. Director of
p.000245: Central Medical Device Testing Laboratory/ other Authorised Officer
p.000245:
p.000245: Details of results of testing or evaluation with protocols of test or evaluation applied
p.000245:
p.000245:
p.000245: Date……………….. Director of
p.000245: Central Medical Device Testing Laboratory/ other Authorised Officer
p.000245:
p.000245: *If opinion is required on any other matter, the paragraph should be suitably amended.
p.000245:
p.000245:
p.000245: Form MD-32
p.000245: [See sub-rule (2) of rule 68]
p.000245:
p.000245: Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer
p.000245:
p.000245:
p.000245: 1. It is certified that the samples having serial number of memorandum or receipt number
p.000245: dated:
p.000245: ……………… purporting to be sample of ……………………. received on …………….. from has
p.000245: been tested or evaluated and the results of tests or evaluation is as stated below.
p.000245:
p.000245: 2. The conditions of seals on the packet or on portion of sample or container were as follows …………….
p.000245:
p.000245: 2. Based upon the test or evaluation and in the opinion of undersigned the sample is of standard quality/ not of
p.000245: standard quality/ adulterated/misbranded/spurious, as defined in the Drugs and Cosmetics Act, 1940 (23 of
p.000245: 1940) for the reasons given below:-
p.000245:
p.000245:
p.000245:
p.000245: Date……………….
p.000245: Medical Device Testing Officer
p.000245: Seal or Stamp
p.000245:
p.000245: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000247: 247
p.000247:
p.000247:
p.000247: Form MD-33
p.000247: [See rule 69]
p.000247: Application from a purchaser for test or evaluation of a Medical Device under section 26 of the Drugs and Cosmetics
p.000247: Act, 1940 (23 of 1940)
p.000247:
p.000247: To
p.000247: The Central Licensing Authority,
p.000247:
p.000247:
p.000247:
p.000247:
p.000247: Sir/Madam,
p.000247:
p.000247:
p.000247: 1. Full name and address of the applicant
p.000247: ....................................................................................
p.000247: 2.
p.000247: Occupation..............................................................................................................
p.000247: .................
p.000247: 3. Name of medical device purporting to be contained in the sample..........................................
p.000247: 4. Name and full address of the pharmacy or concern where the medical device was purchased. 5. Date on which
p.000247: purchased (invoice attached)
p.000247: 6. Reasons why the medical device is being submitted for test or evaluation………………………….
p.000247: 7. A fee of rupees as charged by medical device
p.000247: testing laboratory has been paid
p.000247: under receipt number ………….. dated: ………..
p.000247:
p.000247: I hereby declare that the medical device being submitted for test or evaluation was purchased by or for me. I further
p.000247: declare that the sample of the medical device being sent for test or evaluation is exactly as it was purchased and has
p.000247: not been tampered with in any way to reduce its potency.
p.000247:
p.000247:
p.000247:
p.000247:
p.000247: Date:……………….
p.000247: Signature
p.000247: Seal or Stamp
p.000247:
p.000247:
p.000247:
p.000247: Form MD-34
p.000247: [See rule 72]
p.000247:
p.000247: Order under clause (c) of sub-section (1) of section of the Drugs and Cosmetics Act, 1940, (23 of 1940) requiring a
p.000247: person not to dispose of stock in his possession
p.000247:
p.000247: Whereas, I have reason to believe that the stocks of medical devices in your possession, detailed below contravenes the
p.000247: provisions of Section 18 of the Drugs and Cosmetics Act, 1940 (23 of 1940);
p.000247: Now, therefore, I hereby require you under clause (c) of sub-section (1) of Section 22 of the said Act, not to dispose
p.000247: of the said stock for a period of days from the date of this order.
p.000247:
p.000247: Date:.....................
p.000247: Medical Device Officer
p.000247: Seal or Stamp
p.000247: Details of stock of medical devices.
p.000247:
p.000247:
p.000247: Date:.....................
p.000247: Medical Device Officer
p.000247: Seal or Stamp
p.000247:
p.000247: 248 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000247: II—SEC. 3(i)]
p.000247:
p.000247: Form MD-35
p.000247: [See rule 74]
p.000247: Receipt for stock of medical devices for record, register, document or material object seized under clause (c) or
p.000247: clause (cc) of sub-section (1) of Section 22 of the Drugs and Cosmetics Act (23 of 1940)
p.000247:
p.000247: The stock of medical devices or records, registers, documents or material objects, detailed below has/have this day
p.000247: been seized by me under the provisions of clause (c) or clause (cc) of sub-section (1) of section 22
p.000247: of the Drugs and Cosmetics Act, 1940 (23 of 1940), from the premises of
p.000247: .................................................. situated at
p.000247: ..........................................
p.000247:
p.000247: Date:.....................
p.000247: Medical Device Officer
p.000247: Seal or Stamp
p.000247: Details of stock of medical devices or records, registers, documents or material objects seized.
p.000247:
p.000247:
p.000247: Date:.....................
p.000247: Medical Device Officer
p.000247: Seal or Stamp
p.000247:
p.000247: Form MD-36
p.000247: [See rule 76]
p.000247:
p.000247: Intimation of Person from Whom Sample is taken
p.000247:
p.000247: To
p.000247: ……………..
p.000247: I have this day taken from the premises of ………………. situated at samples of medical devices
p.000247: specified below for the purpose of test or evaluation.
p.000247:
p.000247: Date: .....................
p.000247: Medical Device Officer
p.000247: Seal or Stamp
p.000247: Details of sample of medical devices.
p.000247:
p.000247:
p.000247: Date:.....................
p.000247: Medical Device Officer
p.000247: Seal or Stamp
p.000247:
p.000247:
p.000247: Form MD-37
p.000247: [See rule 77]
p.000247:
p.000247: Receipt for Sample of medical device(s) taken where fair price tendered thereof under sub-section (1) of Section 23 of
p.000247: the Drugs and Cosmetics Act, 1940 is refused
p.000247:
p.000247: To
p.000247: ……………..
p.000247: Whereas I, this …………….. day of ……………., have taken from the premises situated at ……. samples of medical devices as
p.000247: specified below:
p.000247: Details of samples-
p.000247:
p.000247: And whereas I had offered to you rupees as the fair price of the samples of aforesaid medical
p.000247: devices taken:
p.000247: And whereas, you have refused to accept the fair price tendered thereof;
p.000247: Now, therefore, I give you this receipt as the fair price tendered for the samples of the medical devices taken by me.
p.000247:
p.000247: Date:....................
p.000247: Medical Device Officer
p.000247: Seal or Stamp
p.000247:
p.000247: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000249: 249
p.000249:
p.000249:
p.000249: Form MD-38
p.000249: [See sub-rule (1) rule 78]
p.000249: Memorandum to Medical Device Testing Officer
p.000249: Serial No. of Memorandum ……. From
p.000249: To
p.000249: The Medical Device Testing Officer
p.000249:
p.000249: The sample of medical device described below is enclosed for test or evaluation under the provisions of clause
p.000249: (i) of sub-section (4) of section 23 of the Drugs and Cosmetics Act, 1940 (23 of 1940). The sample of medical device
p.000249: has been marked by me with following mark.
p.000249: ……………………………
p.000249: Details of sample of medical device with name of medical device which is purports to contain-
p.000249: …………………………..
p.000249:
p.000249: Date: _
p.000249: Medical Device Officer
p.000249: Seal or Stamp
p.000249:
p.000249: Form MD-39
p.000249: [See sub-rule (1) of rule 81]
p.000249: Application for grant of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a
p.000249: medical device on behalf of manufacturer
p.000249: 1. Name of Applicant:
p.000249: 2. Nature and constitution of applicant:
p.000249: (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust,
p.000249: other to be specified)
p.000249: 3. (i) Corporate/ registered office address including telephone number, mobile number, fax number and e- mail id:
p.000249: (ii) Testing laboratory address including telephone number, mobile number, fax number and e-mail id:
p.000249: (iii) Address for correspondence: [corporate office/ testing laboratory]
p.000249: 4. Details of medical device(s) to be tested or evaluated [Annexed].
p.000249: 5. Fee paid on Rs receipt/challan/transaction
p.000249: id_ .
p.000249: 6. I have enclosed the documents as specified in the sub-rule (2) of rule 82 of Medical Devices Rules, 2017.
p.000249: 7. I hereby state and undertake that:
p.000249: (i) the testing laboratory is ready for inspection or shall be ready for inspection on
p.000249: in
p.000249: accordance with the requirements of Medical Devices Rules, 2017.
p.000249:
p.000249: (ii) I shall comply with the applicable provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940),
p.000249: and the Medical Devices Rules, 2017.
p.000249:
p.000249:
p.000249:
p.000249: Place: Date: _
p.000249:
p.000249: Signature (Name and designation) [To be signed digitally]
p.000249:
p.000249:
p.000249: Annexure:
p.000249:
p.000249:
p.000249: S.N.
p.000249: Generic name
...
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p.000143: (i),
p.000143: (B) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and
p.000143: insecticides notified in the Official Gazette under sub-clause (ii),
p.000143: (C) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act;
p.000143: Explanation: For the purpose of these rules, substances used for in vitro diagnosis shall be referred
p.000143: as in vitro
p.000143: diagnostic medical device.
p.000143:
p.000143: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000145: 145
p.000145: (zc) “medical device grouping” means a set of devices having same or similar intended uses or
p.000145: commonality of technology allowing them to be classified in a group not reflecting specific characteristics;
p.000145: (zd) “Medical Device Officer” means an officer appointed or designated by the Central Government or the
p.000145: State Government, as the case may be, under sub-rule (2) of rule 18;
p.000145: (ze) “medical devices testing laboratory” means any institute, organisation registered under sub-rule (3) of rule 83
p.000145: for carrying out testing or evaluation of any medical device on behalf of a licencee for manufacture for sale;
p.000145: (zf) “Medical Device Testing Officer” means an officer appointed or designated by the Central Government
p.000145: under sub-rule (1) of rule 18;
p.000145: (zg) "near-patient testing" means any investigation carried out in a clinical setting or at the patient's home for
p.000145: which the result is available without reference to a laboratory and rapidly enough to affect immediate
p.000145: patient management;
p.000145: (zh) “new in vitro diagnostic medical device” means any medical device as referred to in sub-clause (A) of clause (zb)
p.000145: used for in vitro diagnosis that has not been approved for manufacture for sale or for import by the
p.000145: Central Licensing Authority and is being tested to establish its performance for relevant analyte or
p.000145: other parameter related thereto including details of technology and procedure required;
p.000145:
p.000145:
p.000145: (zi) “notified” means notified in the Official Gazette by the Central Government.
p.000145: (zj) “Notified Body” means a body corporate or other legal entity, registered under rule 13 as a body competent to
p.000145: carry out the audit of manufacturing site, assessment, and verification of specified category of medical devices for
p.000145: establishing conformity with standards;
p.000145: (zk) “performance evaluation” in relation to in vitro diagnostic medical device means any systematic investigation by
p.000145: which data is assessed and analysed to establish or verify performance of the in vitro diagnostic medical device for
p.000145: its intended use;
p.000145: (zl) “Post Marketing Surveillance” means systematic process to collect and analyse information gained from medical
p.000145: device that have been placed in the market;
p.000145: (zm) “predicate device” means a device, first time and first of its kind, approved for manufacture for sale or for
p.000145: import by the Central Licensing Authority and has the similar intended use, material of construction, and
...
p.000215: 215
p.000215: 3. Procedural issues
p.000215: A system shall be established to enable cross-referencing of CRFs and CIP versions.
p.000215: Supplemental CRFs may be developed for collecting additional data at individual investigation sites in
p.000215: multicenter investigations.
p.000215:
p.000215: Table 7
p.000215: Data elements for reporting serious adverse events occurring in a clinical investigation
p.000215: 1. Patient details:
p.000215: (a) Initials and other relevant identifier (hospital/Out Patient Department’s record number etc.);
p.000215: (b) Gender;
p.000215: (c) Age and date of birth;
p.000215: (d) Weight;
p.000215: (e) Height.
p.000215: 2. Suspected device(s):
p.000215: (a) Name of the Device;
p.000215: (b) Indication(s) for which suspect device was prescribed;
p.000215: (c) Device details including model number/size/lot number, if applicable;
p.000215: (d) Starting date and time of day;
p.000215: (e) Stopping date and time, or duration of treatment;
p.000215: 3. Other treatment(s):
p.000215: Provide the same information for concomitant treatment.
p.000215: 4. Details of suspected adverse device reaction(s)
p.000215: (a) Full description of reaction(s) including body site and severity, as well as the criterion (or
p.000215: criteria) for regarding the report as serious. In addition to a description of the reported signs and
p.000215: symptoms, whenever possible, describe a specific diagnosis for the reaction.
p.000215: (b) Start date (and time) of onset of reaction.
p.000215: (c) Stop date (and time) or duration of reaction.
p.000215: (d) Setting (e.g., hospital, out-patient clinic, home, nursing home).
p.000215: 5. Outcome
p.000215: (a) Information on recovery and any sequel; results of specific tests and/or treatment that may have
p.000215: been conducted.
p.000215: (b) For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; any
p.000215: post-mortem findings.
p.000215: (c) Other information: anything relevant to facilitate assessment of the case, such as medical history including
p.000215: allergy, drug or alcohol abuse; family history; findings from special investigations etc.
p.000215: 6. Details about the Investigator:
p.000215: (a) Name;
p.000215: (b) Address;
p.000215: (c) Telephone number;
p.000215: (d) Profession (specialty);
p.000215: (e) Date of reporting the event to Central Licensing Authority;
p.000215: (f) Date of reporting the event to Ethics Committee overseeing the site;
p.000215: (g) Signature of the Investigator.
p.000215:
p.000215:
p.000215:
p.000215: Table 8 Informed Consent Form
p.000215: Checklist for clinical investigation Subject’s informed consent documents
p.000215: 1.1 Essential elements:
p.000215: 1. Statement that the study involves research and explanation of the purpose of the research
p.000215: 2. Expected duration of the Subject's participation
p.000215: 3. Description of the procedures to be followed, including all invasive procedures
p.000215: 4. Description of any reasonably foreseeable risks or discomforts to the Subject
...
Searching for indicator property:
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p.000197: extent of product traceability and the records required.
p.000197: Where traceability is a requirement, the manufacturer shall control and record the unique identification of the
p.000197: product.
p.000197: NOTE.-Configuration management is a means by which identification and traceability can be maintained.
p.000197: 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices:
p.000197: In defining the records required for traceability, the manufacturer shall include records of all components, materials
p.000197: and work environment conditions, if these could cause the medical device not to satisfy its specified requirements.
p.000197:
p.000197: 198 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000197: II—SEC. 3(i)]
p.000197:
p.000197: The manufacturer shall require that its agents or distributors maintain records of the distribution of active
p.000197: implantable medical devices and implantable medical devices to allow traceability and that such records are available
p.000197: for inspection. Records of the name and address of the shipping package consignee shall be maintained.
p.000197: 7.5.3.3 Status identification:
p.000197: The manufacturer shall identify the product status with respect to monitoring and measurement
p.000197: requirements. The identification of product status shall be maintained throughout production, storage, implant, usage
p.000197: and installation of the product to ensure that only product that has passed the required inspections and tests (or
p.000197: released under an authorized concession) is despatched, used or installed.
p.000197: 7.5.4 Customer property:
p.000197: The manufacturer shall exercise care with customer property while it is under the manufacturer’s control or being used
p.000197: by the manufacturer. The manufacturer shall identify, verify, protect and safeguard customer property provided for use
p.000197: or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for
p.000197: use, this shall be reported to the customer and records maintained.
p.000197: NOTE.-Customer property can include intellectual property or confidential health information.
p.000197: 7.5.5 Preservation of product:
p.000197: The manufacturer shall establish documented procedures or documented work instructions for preserving the conformity of
p.000197: product during internal processing and delivery to the intended destination. This preservation
p.000197: shall include identification, handling, packaging, storage and protection. Preservation shall also apply to
p.000197: the constituent parts of a product.
p.000197: The manufacturer shall establish documented procedures or documented work instructions for the control of product with
p.000197: a limited shelf-life or requiring special storage conditions. Such special storage conditions shall be
p.000197: controlled and recorded.
p.000197: 7.6 Control of monitoring and measuring devices:
p.000197: The manufacturer shall determine the monitoring and measurement to be undertaken and the monitoring and measuring
p.000197: devices needed to provide evidence of conformity of product to determined requirements.
p.000197: The manufacturer shall establish documented procedures to ensure that monitoring and measurement can be carried out and
p.000197: are carried out in a manner that is consistent with the monitoring and measurement requirements.
p.000197: Where necessary to ensure valid results, measuring equipment shall be:-
p.000197: (a) calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to Bureau
p.000197: of Indian Standards wherever available ; where no such standards exist, the basis used for calibration
p.000197: or verification shall be recorded;
p.000197: (b) adjusted or re-adjusted as necessary;
p.000197: (c) identified to enable the calibration status to be determined;
...
Social / Racial Minority
Searching for indicator minority:
(return to top)
p.000203: right to claim compensation in case of investigation related injury or death. He shall also inform the subject or his/
p.000203: her nominee(s) of their rights to contact the Sponsor or his representative whosoever had obtained permission from the
p.000203: Central Licensing Authority for conduct of the clinical investigation for making claims in case of
p.000203: investigation related injury or death.
p.000203:
p.000203: (4) Responsibilities of the Ethics Committee:
p.000203: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical
p.000203: Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should
p.000203: exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the
p.000203: study. Explanation.- The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners,
p.000203: armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with
p.000203: incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority
p.000203: groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics
p.000203: committee(s) get documented ‘standard operating procedures’ and should maintain a record of its proceedings.
p.000203: (ii) Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation
p.000203: of the Clinical Investigation Plan. Such review may be based on periodic study progress reports
p.000203: furnished by investigators or monitoring and internal audit reports furnished by the Sponsor.
p.000203: (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record
p.000203: the reasons for doing so and at once, communicate such a decision to the Investigator as well as to the
p.000203: Central Licensing Authority.
p.000203: (iv) Any report of serious adverse event occurring during clinical investigation, after due analysis,
p.000203: shall be forwarded by the Chairman of Ethics Committee to the Central Licensing Authority and to the
p.000203: Head of institution where the clinical investigation has been conducted within 14 calendar days of the
p.000203: knowledge of occurrence of the serious adverse event.
...
Searching for indicator racial:
(return to top)
p.000219: issued by Indian Council of Medical Research have been followed. The ethics report shall include the following
p.000219: points:
p.000219: (a) a confirmation that the CIP and any amendments to it were reviewed by the EC;
p.000219: (b) a list of all ECs consulted.
p.000219:
p.000219: 6.4 Clinical investigation team
p.000219:
p.000219: Briefly describe the administrative structure of the clinical investigation (Investigators, site staff, Sponsor/
p.000219: designates, Central laboratory etc.).
p.000219:
p.000219: 7. Results
p.000219: The results should include the following points:
p.000219: (a) the clinical investigation initiation date;
p.000219: (b) the clinical investigation completion/suspension date;
p.000219: (c) the disposal of subjects and investigational medical devices;
p.000219: (d) the subject demographics;
p.000219: (e) Clinical investigation Plan compliance;
p.000219: (f) an analysis, which includes,-
p.000219: (i) a performance analysis as provided in the clinical investigation plan;
p.000219: (ii) a summary of all adverse events and adverse device effects, including a discussion of the
p.000219: severity, treatment needed, resolution and relevant principal investigator's judgment concerning the causal
p.000219: relationship with the investigational medical devices or procedure;
p.000219: (iii) a table compiling all observed device deficiencies that could have led to a serious adverse effect, and any
p.000219: corrective actions taken during the clinical investigation, if any;
p.000219: (iv) any needed subgroup analysis for special populations (i.e. gender, racial/cultural/ethnic subgroups), as
p.000219: appropriate;
p.000219: (v) an accountability of all subjects with a description of how missing data or deviation(s) were
p.000219: dealt within the analysis, including subjects:-
p.000219: (A) not passing screening tests;
p.000219: (B) lost to follow-up;
p.000219: (C) withdrawn or discontinued from the clinical investigation and the reason.
p.000219:
p.000219: 8. Discussion and overall conclusions
p.000219: The conclusions may include the following points:
p.000219: (a) the safety and performance results and any other endpoints;
p.000219: (b) an assessment of risks and benefits;
p.000219: (c) a discussion of the clinical relevance and importance of the results in the light of other existing data;
p.000219: (d) any specific benefits or special precautions required for individual subjects or groups considered to be at risk;
p.000219: (e) any implications for the conduct of future clinical investigations;
p.000219: (f) any limitations of the clinical investigation.
p.000219:
p.000219: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000221: 221
p.000221: 9. Abbreviated terms and definitions
p.000221: A list of abbreviated terms and definitions of specialized or unusual terms should be provided.
p.000221:
p.000221: 10. List of appendices to the clinical investigation report
p.000221: (a) Protocols and amendments;
p.000221: (b) Specimen of Case Record Form;
p.000221: (c) Investigators’ name(s) with contact addresses, phone, e-mail etc.;
p.000221: (d) Patient data listings (e) List of participants treated with investigational product;
p.000221: (e) Discontinued participants;
p.000221: (f) Protocol deviations ;
...
Social / Student
Searching for indicator student:
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p.000215: (c) The consequences of a Subject’s decision to withdraw from the investigation and procedures for orderly termination
p.000215: of participation by Subject.
p.000215: (d) Statement that the Subject or Subject's representative will be notified in a timely manner if significant
p.000215: new findings are developed during the course of the investigation which may affect the Subject's
p.000215: willingness to continue participation will be provided.
p.000215: (e). A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or
p.000215: fetus, if the Subject is or may become pregnant), which are currently unforeseeable
p.000215: (f) Approximate number of Subjects enrolled in the clinical investigation
p.000215: 2. Format of informed consent form for Subjects participating in a clinical investigation - Informed Consent form to
p.000215: participate in a clinical investigation
p.000215: Clinical investigation Title: Clinical investigation Number:
p.000215: Subject’s Initials: Subject’s Name:
p.000215: _
p.000215: Date of Birth / Age: _ Gender:
p.000215: _ Address of the Subject: _
p.000215: Qualification: _
p.000215: Occupation: Student/Self-employed/Service/Housewife/Others (Please tick as appropriate) Annual income of the subject:
p.000215: _
p.000215: Name and address of the nominee(s) and his relation to the subject (for the purpose of
p.000215: compensation in case of clinical investigation related death).
p.000215:
p.000215:
p.000215:
p.000215: (i) I confirm that I have read and understood the information sheet dated _ for the above clinical investigation
p.000215: and have had the opportunity to ask questions.
p.000215: (ii) I understand that my participation in the clinical investigation is voluntary and that I am free to withdraw at
p.000215: any time, without giving any reason, without my medical care or legal rights being affected.
p.000215: Place initial box (Subject) [ ]
p.000215:
p.000215: [ ]
p.000215: (iii) I understand that the Sponsor of the clinical investigation, others working on the [ ]
p.000215:
p.000215: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000217: 217
p.000217: Sponsor’s behalf, the Ethics Committee and the regulatory authorities will not need my permission to look
p.000217: at my health records both in respect of the current clinical investigation and any further research that may be
p.000217: conducted in relation to it, even if I withdraw from the clinical investigation. I agree to this access.
p.000217: However, I understand that my identity will not be revealed in any information released to third parties or published.
p.000217: (iv) I agree not to restrict the use of any data or results that arise from this clinical
p.000217: [ ] investigation provided such a use is only for scientific purpose(s).
p.000217: (v) I agree to take part in the above clinical investigation.
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000153: Central Licensing Authority, may cause an inspection of the overseas manufacturing site either by itself or
p.000153: by any other person or body to whom the power has been delegated for the purpose.
p.000153: (2) The applicant shall be liable to pay a fee as specified under the Second Schedule in respect of expenditure
p.000153: required in connection with the visit to the overseas manufacturing site under sub-rule (1).
p.000153:
p.000153: 36. Grant of import licence.— (1) After examination of documents furnished with the application under sub-rule
p.000153: (1) of rule 34 and on the basis of the inspection report, if inspection has been carried out, the
p.000153: Central Licensing Authority may, on being satisfied, grant licence in Form MD-15 or, may reject such
p.000153: application for which reasons shall be recorded in writing, within a period of nine months from the date of
p.000153: application.
p.000153: (2) In the event of rejection, the applicant may appeal to the Central Government within a period of forty five days
p.000153: and that Government, may, after such enquiry into the matter, as considered necessary, pass orders in relation thereto
p.000153: within a period of ninety days from the date of appeal.
p.000153: (3) Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory
p.000153: authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European
p.000153: Union Countries, or the United States of America, a licence shall be granted under sub-rule (1) to the
p.000153: applicant without carrying out clinical investigation.
p.000153: (4) Where a medical device is imported from countries other than those referred to in sub-rule (3), the licence in case
p.000153: of Class C and Class D medical devices may be granted after its safety and effectiveness has been established through
p.000153: clinical investigation in India as specified under provisions of Chapter VII of these rules.
p.000153: (5) Where a medical device, is imported from countries other than those referred to in sub-rule (3), the licence in
p.000153: case of Class A or Class B medical devices may be granted after its safety and performance has been established through
p.000153: published safety and performance data or through clinical investigation in the country of origin and a
p.000153: free sale certificate from the country of origin is furnished.
p.000153: (6) In case of investigational medical device or new in vitro diagnostic medical device, the applicant shall obtain
p.000153: prior permission in Form MD-27 or in Form MD-29 from the Central Licensing Authority and no licence to import any
p.000153: class of such medical device shall be granted without such permission.
p.000153:
p.000153: 37. Validity of licence.— A licence granted under sub-rule (1) of rule 36 shall remain valid in perpetuity, unless,
p.000153: it has been cancelled or surrendered, provided the authorised agent deposits the licence retention fee with the
p.000153: Central Licensing Authority as specified in the Second Schedule for each overseas manufacturing site and for each
p.000153: licenced medical device after completion of every five years from the date of its issue:
...
p.000155: (o) in case of small sized medical devices on which information cannot be printed legibly, shall
p.000155: include the information necessary for product identification and safety such as information covered by clauses (a),
p.000155: (b), (c), (d), (e), (g), (k), and (m) shall be included.
p.000155:
p.000155: 45. Exemption of labelling requirements for export of medical devices.— The labels on packages or container of
p.000155: devices for export shall be adopted to meet the specific requirements of law of the country to which the device is to
p.000155: be exported, but the following particulars shall appear in a conspicuous manner on the label of the inner most pack or
p.000155: shelf pack of the medical device in which the device is packed and every other outer covering in which the container is
p.000155: packed:-
p.000155: (a) name of the device;
p.000155: (b) the distinctive batch number or lot number or serial number preceded by the word “Lot No.” or “Lot” or “Batch No.”
p.000155: or “B. No.” or “Serial No.”;
p.000155: (c) date of expiry, if any;
p.000155: (d) the name and address of manufacturer and address of actual premises where the device has been manufactured;
p.000155: (e) licence number preceded by letters “Licence No. or Lic. No.”;
p.000155: (f) internationally recognised symbols in lieu of text, wherever required:
p.000155: Provided that where a device is required by the consignee not to be labeled with the name and address
p.000155: of manufacturer, the label on the package or container shall bear a code number as approved by the Central Licensing
p.000155: Authority and the code number shall bear the name of the State or Union territory, in abbreviation, followed by the
p.000155: word “Device” and “manufacturing licence number”:
p.000155: Provided further that where a device is required by the consignee not to be labeled with the code number
p.000155: also, the label on the packages or container shall bear a special code number, as requested by the
p.000155: consignee, and approved by the Central Licensing Authority.
p.000155:
p.000155: 46. Unique device identification of the medical device.— With effect from 1st day of January, 2022, a
p.000155: medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification
p.000155: which shall contain device identifier and production identifier.
p.000155: Explanation.— For the purposes of this rule,-
p.000155: (i) “device identifier” means a global trade item number;.
p.000155: (ii) “production identifier” means a serial number, lot or batch number, software as a medical device
p.000155: version, manufacturing and or expiration date.
p.000155:
p.000155: 47. Shelf life of medical devices.— The shelf life of the medical devices, shall be determined keeping in view the
p.000155: technical parameters and shall ordinarily not exceed sixty months from the date of manufacture to be reckoned from
p.000155: month to month (i.e. January to January), except in cases where satisfactory evidence is produced by the manufacturer
p.000155: to justify a shelf life of more than sixty months of a device to the satisfaction of the Central Licensing Authority:
p.000155:
p.000155: Provided that any medical device, whose total shelf life claim is less than ninety days, shall not be allowed to be
...
p.000179: DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDICAL DEVICES
p.000179: EXECUTIVE SUMMARY:
p.000179: 1. An executive summary shall be provided by the manufacturer and shall contain:
p.000179: 1.1 Introductory descriptive information on the medical device, the intended use and indication for
p.000179: use, class of device, novel features of the device (if any), shelf life of the device and a synopsis on the content
p.000179: of the dossier.
p.000179: 1.2 Information regarding sterilization of the device (whether it is sterile or non-sterile; if
p.000179: sterile, mode of sterilization).
p.000179: 1.3 Risk Management Plan, Risk Analysis, evaluation and control documents.
p.000179: 1.4 Clinical Evidence and evaluation (if applicable).
p.000179: 1.5 Regulatory status of the similar device in India (approved or not approved in India).
p.000179: 1.6 Design Examination Certificate, Declaration of Conformity, Mark of Conformity Certificate, Design
p.000179: Certificate (if applicable). Copy of such certificate(s) shall be enclosed.
p.000179: 1.7 Marketing history of the device from the date of introducing the device in the market.
p.000179: 1.8 Domestic price of the device in the currency followed in the country of origin.
p.000179: 1.9 List of regulatory approvals or marketing clearance obtained (submit respective copies of approval
p.000179: Certificates):
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: USA
p.000179: Country
p.000179: Approved Indication
p.000179: Approved Shelf life
p.000179: Class of Device
p.000179: Date of First Approval
p.000179: Australia Japan Canada
p.000179: European Union Others*
p.000179: *Optional
p.000179:
p.000179: Status of market clearance pending, rejected or withdrawn
p.000179:
p.000179:
p.000179: Regulatory Agency of the country
p.000179: Indication for use
p.000179: Registration status and date
p.000179: Reason for rejection/ withdrawal, if any
p.000179:
p.000179:
p.000179:
p.000179: 1.10 Safety and performance related information on the device:
p.000179: (a) Summary of reportable event and field safety corrective action from the date of introduction:-
p.000179:
p.000179: 180 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000179: II—SEC. 3(i)]
p.000179:
p.000179: For Serious Adverse Event:
p.000179:
p.000179:
p.000179: S.N.
p.000179: Serious Adverse Event
p.000179: Duration From To
p.000179: Number of the SAE reported
p.000179: Total Units sold
p.000179: Lot/Batch No.
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179:
p.000179: For Field Safety Corrective Action (FSCA):
p.000179:
p.000179:
p.000179: Date of FSCA
p.000179: Reason for FSCA
p.000179: Countries where FSCA was conducted
p.000179: Description of the action taken
p.000179:
p.000179:
p.000179:
p.000179: (b) If the device contains any of the followings, then descriptive information on the following need to be
p.000179: provided.
p.000179: 1. Animal or human cells tissues or derivatives thereof, rendered non-viable (e.g. Porcine Heart Valves).
p.000179: 2. Cells, tissues or derivatives of microbial recombinant origin (e.g. Dermal fillers based on
p.000179: Hyaluronic acid derived from bacterial fermentation process).
p.000179: 3. Irradiating components, ionising or non-ionizing.
p.000179:
p.000179: 2. Device description and product specification, including variants and accessories
...
Social / Unemployment
Searching for indicator unemployed:
(return to top)
p.000203: consent process as provided in Table 8 about the essential elements of the clinical investigation and the subject's
p.000203: right to claim compensation in case of investigation related injury or death. He shall also inform the subject or his/
p.000203: her nominee(s) of their rights to contact the Sponsor or his representative whosoever had obtained permission from the
p.000203: Central Licensing Authority for conduct of the clinical investigation for making claims in case of
p.000203: investigation related injury or death.
p.000203:
p.000203: (4) Responsibilities of the Ethics Committee:
p.000203: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical
p.000203: Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should
p.000203: exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the
p.000203: study. Explanation.- The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners,
p.000203: armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with
p.000203: incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority
p.000203: groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics
p.000203: committee(s) get documented ‘standard operating procedures’ and should maintain a record of its proceedings.
p.000203: (ii) Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation
p.000203: of the Clinical Investigation Plan. Such review may be based on periodic study progress reports
p.000203: furnished by investigators or monitoring and internal audit reports furnished by the Sponsor.
p.000203: (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record
p.000203: the reasons for doing so and at once, communicate such a decision to the Investigator as well as to the
p.000203: Central Licensing Authority.
p.000203: (iv) Any report of serious adverse event occurring during clinical investigation, after due analysis,
...
Social / Victim of Abuse
Searching for indicator abuse:
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p.000215: (c) Age and date of birth;
p.000215: (d) Weight;
p.000215: (e) Height.
p.000215: 2. Suspected device(s):
p.000215: (a) Name of the Device;
p.000215: (b) Indication(s) for which suspect device was prescribed;
p.000215: (c) Device details including model number/size/lot number, if applicable;
p.000215: (d) Starting date and time of day;
p.000215: (e) Stopping date and time, or duration of treatment;
p.000215: 3. Other treatment(s):
p.000215: Provide the same information for concomitant treatment.
p.000215: 4. Details of suspected adverse device reaction(s)
p.000215: (a) Full description of reaction(s) including body site and severity, as well as the criterion (or
p.000215: criteria) for regarding the report as serious. In addition to a description of the reported signs and
p.000215: symptoms, whenever possible, describe a specific diagnosis for the reaction.
p.000215: (b) Start date (and time) of onset of reaction.
p.000215: (c) Stop date (and time) or duration of reaction.
p.000215: (d) Setting (e.g., hospital, out-patient clinic, home, nursing home).
p.000215: 5. Outcome
p.000215: (a) Information on recovery and any sequel; results of specific tests and/or treatment that may have
p.000215: been conducted.
p.000215: (b) For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; any
p.000215: post-mortem findings.
p.000215: (c) Other information: anything relevant to facilitate assessment of the case, such as medical history including
p.000215: allergy, drug or alcohol abuse; family history; findings from special investigations etc.
p.000215: 6. Details about the Investigator:
p.000215: (a) Name;
p.000215: (b) Address;
p.000215: (c) Telephone number;
p.000215: (d) Profession (specialty);
p.000215: (e) Date of reporting the event to Central Licensing Authority;
p.000215: (f) Date of reporting the event to Ethics Committee overseeing the site;
p.000215: (g) Signature of the Investigator.
p.000215:
p.000215:
p.000215:
p.000215: Table 8 Informed Consent Form
p.000215: Checklist for clinical investigation Subject’s informed consent documents
p.000215: 1.1 Essential elements:
p.000215: 1. Statement that the study involves research and explanation of the purpose of the research
p.000215: 2. Expected duration of the Subject's participation
p.000215: 3. Description of the procedures to be followed, including all invasive procedures
p.000215: 4. Description of any reasonably foreseeable risks or discomforts to the Subject
p.000215:
p.000215: 216 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000215: II—SEC. 3(i)]
p.000215:
p.000215: 5. Description of any benefits to the Subject or others reasonably expected from research. If no benefit is expected,
p.000215: subject should be made aware of this.
p.000215: 6. Disclosure of specific appropriate alternative procedures or therapies available to the Subject.
p.000215: 7. Statement describing the extent to which confidentiality of records identifying the subject will be maintained and
...
Social / Women
Searching for indicator women:
(return to top)
p.000171: 2. The parameters for classification of in vitro diagnostic medical devices as follows:-
p.000171: (i) In vitro diagnostic medical devices for detecting transmissible agents, etc.:
p.000171: (a) An in vitro diagnostic medical device shall be assigned to Class D, if it is intended to be used for detecting
p.000171: the presence of, or exposure to, a transmissible agent that,-
p.000171: (1) is in any blood, blood component, blood derivative, cell, tissue or organ, in order to assess the
p.000171: suitability of the blood, blood component, blood derivative, cell, tissue or organ, as the case may be, for transfusion
p.000171: or transplantation; or
p.000171: (2) causes a life-threatening disease with a high risk of propagation.
p.000171: (b) An in vitro diagnostic medical device shall be assigned to Class C, if it is intended for use in,-
p.000171: (1) detecting the presence of, or exposure to, a sexually transmitted agent;
p.000171: (2) detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation
p.000171: (for example, Cryptococcus neoformans or Neisseria meningitidis);
p.000171: (3) detecting the presence of an infectious agent, where there is a significant risk that an erroneous
p.000171: result will cause death or severe disability to the individual or foetus being tested (for example, a diagnostic
p.000171: assay for Chlamydia pneumoniae, Cytomegalovirus or Methicillin-resistant Staphylococcus aureus);
p.000171: (4) pre-natal screening of women in order to determine their immune status towards transmissible agents
p.000171: such as immune status tests for Rubella or Toxoplasmosis;
p.000171: (5) determining infective disease status or immune status, where there is a risk that an erroneous result will lead to
p.000171: a patient management decision resulting in an imminent life-threatening situation for the patient being tested (for
p.000171: example, Cytomegalovirus, Enterovirus or Herpes simplex virus in transplant patients);
p.000171: (6) screening for disease stages, for the selection of patients for selective therapy and management, or in the
p.000171: diagnosis of cancer;
p.000171: (7) human genetic testing, such as the testing for cystic fibrosis or Huntington's disease;
p.000171: (8) monitoring levels of medicinal products, substances or biological components, where there is a risk
p.000171: that an erroneous result will lead to a patient management decision resulting in an immediate life-threatening
p.000171: situation for the patient being tested (for example, cardiac markers, cyclosporin or prothrombin time testing);
p.000171: (9) management of patients suffering from a life-threatening infectious disease such as viral load of Human
p.000171: immunodeficiency virus or Hepatitis C virus, or genotyping and sub-typing Hepatitis C virus or Human
p.000171: immunodeficiency virus);or
p.000171: (10) screening for congenital disorders in the foetus such as Down’s syndrome or spina bifida.
p.000171: (ii) In vitro diagnostic medical devices for blood grouping or tissue typing:
p.000171: (a) Subject to clause (b), an in vitro diagnostic medical device shall be assigned to Class C, if it is intended to
...
p.000205: Licensing Authority may require making the pilot study data available to assess whether the pilot data is in
p.000205: conformity to the data already generated outside the country.
p.000205: (iii) If the application is for conduct of clinical investigation as part of a Global Clinical Investigation of
p.000205: medical device, the number of sites and patients as well as justification for undertaking such clinical
p.000205: investigation in India shall be provided to the Central Licensing Authority.
p.000205: (8) Post Marketing Clinical Investigation:
p.000205: Post marketing clinical investigation is the study other than surveillance performed after marketing
p.000205: approval has been given to the medical device in relation to the approved indication. This investigation may
p.000205: not be considered necessary at the time of medical device approval but may be required by the Central
p.000205: Licensing Authority for optimizing the intended use of the medical device. Post Marketing Clinical investigation
p.000205: includes additional drug- device interaction, safety studies, investigation designed to support use under the approved
p.000205: indication e.g. mortality or morbidity studies, etc,.
p.000205: (9) Studies in special populations:
p.000205: The clinical investigation data of the medical device is required to be submitted to support the claim sought to be
p.000205: made for use of medical device in children, pregnant women, nursing women, elderly patients with renal or other
p.000205: organ system failure as given below:
p.000205: (i) Geriatrics:
p.000205: Geriatrics patients can be included in pivotal study (and in pilot study at the sponsor’s option) in meaningful
p.000205: numbers, if-
p.000205: (a) the disease intended to be treated is characteristically a disease of aging; or
p.000205: (b) the population to be treated is known to be included in substantial numbers of geriatric patients; or
p.000205: (c) there is specific reason to expect that conditions common in the elderly are likely to be encountered; or
p.000205: (d) the investigational medical device is likely to alter the geriatric patient’s response in regard to
p.000205: safety or performance compared with that of non-geriatric patient.
p.000205: (ii) Paediatrics:
p.000205: (a) The timing of pediatric studies in the medical device development program shall depend on the device, the type of
p.000205: disease being treated, safety consideration, and the safety and effectiveness of available treatment.
p.000205: (b) The medical device expected to be used in children; the performance and safety shall be made in
p.000205: the appropriate age group. When clinical investigation is required to be conducted in children, it is
p.000205: usually
p.000205:
p.000205: 206 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000205: II—SEC. 3(i)]
p.000205:
...
p.000205: informed consent shall be obtained from the parent or legal guardian. However, all paediatric participants shall be
p.000205: informed to the fullest extent possible about the study in a language and in terms that they are able to understand.
p.000205: Where appropriate, paediatric participants should additionally assent to enroll in the study. Mature minors and
p.000205: adolescents should personally sign and date a separately designed written consent form. Although a participant’s wish
p.000205: to withdraw from a study shall be respected, there may be circumstances in therapeutic studies for serious or
p.000205: life-threatening diseases in which, in the opinion of the investigator and parent or legal guardian, the welfare
p.000205: of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this
p.000205: situation, continued parental or legal guardian consent will be sufficient to allow participation in the study.
p.000205: (g) For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall
p.000205: include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.
p.000205: (iii) Pregnant or nursing women:
p.000205: (a) Pregnant or nursing women shall be included in clinical investigation only when the medical device
p.000205: is intended for use by pregnant or nursing women or fetuses or nursing infants and where the data generated from women
p.000205: who are not pregnant or nursing, would not be suitable.
p.000205: (b) For medical device intended for use during pregnancy, follow-up data pertaining to a period appropriate for that
p.000205: medical device on the pregnancy, foetus and child will be required.
p.000205: 3. Post Marketing Surveillance:
p.000205: (i) Subsequent to approval of an Investigational medical device, it shall be closely monitored for
p.000205: their clinical safety once they are marketed. The applicants shall furnish Periodic Safety Update Reports (PSURs) in
p.000205: order to,-
p.000205: (a) report all the relevant new information from appropriate sources;
p.000205: (b) relate these data to patient exposure;
p.000205: (c) summarise the market authorisation status in different countries and any significant variations related to
p.000205: safety; and
p.000205: (d) indicate whether changes will be made to product information in order to optimize the use of the product.
p.000205:
p.000205: (ii) One medical device should be covered in one PSUR. Within the single PSUR separate presentation of data for
p.000205: different indications or separate population need to be given.
p.000205: (iii) All relevant clinical and non-clinical safety data will cover only the period of the report (interval data).
p.000205: The PSURs shall be submitted every six months for the first two years after marketing approval of the
p.000205: medical device. For subsequent two years, the PSURs need to be submitted annually. The Central Licensing Authority may
...
Social / Youth/Minors
Searching for indicator minor:
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p.000149: control of Central Licensing Authority or State Licensing Authority, as the case may be;
p.000149: (ii) the licence holder shall inform the State Licensing Authority or the Central Licensing Authority, as the case may
p.000149: be, of the occurrence of any suspected unexpected serious adverse event and action taken thereon including any recall
p.000149: within fifteen days of such event coming to the notice of licence holder;
p.000149: (iii) the licence holder shall obtain prior approval from the Central Licensing Authority or the State
p.000149: Licensing Authority, as the case may be, before any major change as specified in the Sixth Schedule is carried out and
p.000149: the Central Licensing Authority or the State Licensing Authority, as the case may be, shall indicate its approval or
p.000149: rejection within forty five days and in case where no communication is received within the stipulated time from
p.000149:
p.000149: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000151: 151
p.000151: such Authority, such change shall be deemed to have been approved;
p.000151: (iv) the licence holder shall inform any minor change as specified in the Sixth Schedule to the State
p.000151: Licensing Authority or Central Licensing Authority, as the case may be, within a period of thirty days after such
p.000151: minor change take place;
p.000151: (v) the licence holder shall carry out test of each batch of product manufactured prior to its release for compliance
p.000151: with specifications either in his own laboratory or in any other laboratory registered under sub-rule (3) of rule 83;
p.000151: (vi) the licence holder shall, on being informed by the Central Licensing Authority or State Licensing Authority, as
p.000151: the case may be, that any part of any lot of the medical device has been found not conforming with
p.000151: the provisions specified under the Act and these rules, and on being directed so to do by such licensing authority,
p.000151: withdraw the remainder of that lot from sale and, so far as may, in the particular circumstances of the case, be
p.000151: practicable, recall the issues already made from that lot;
p.000151: (vii) the licence holder shall maintain an audit or inspection book in Form MD-11 to enable the Notified
p.000151: Body or Medical Device Officer to record his observations and non-conformity, if any;
p.000151: (viii) the licence holder shall maintain at least one unit of sample from each batch of invasive medical device and
p.000151: in vitro diagnostic medical device manufactured for reference purpose for a period of one hundred and eighty days after
p.000151: the date of expiry of such batch;
p.000151: (ix) the licence holder shall maintain records of manufacturing and sales which shall be open to
p.000151: inspection by a Medical Device Officer;
...
p.000153: regulatory restrictions, cancellation of authorisation or declaration of the medical device as not of
p.000153: standards quality by the regulatory authority of the country of origin or by any regulatory authority of any other
p.000153: country, where the medical device is marketed, sold or distributed;
p.000153: (iii) authorised agent in cases referred in clause (ii), shall stop immediately the despatch and marketing of the
p.000153: medical device referred in that clause;
p.000153: (iv) the Central Licensing Authority, after due consideration of the information as referred in clause (ii), may
p.000153: issue directions to the licencee in respect of marketing, sale or distribution of the medical device including
p.000153: withdrawal of medical device from the Indian market within a period as may be specified by the Central Licensing
p.000153: Authority;
p.000153: (v) the authorised agent shall obtain prior approval from the Central Licensing Authority before any major change, as
p.000153: specified in the Sixth Schedule, is carried out and the Central Licensing Authority shall indicate its
p.000153: approval or rejection within sixty days;
p.000153: (vi) in case, no communication of approval or rejection as referred to in clause (v) is received within the stipulated
p.000153: time from the Central Licensing Authority, such change shall be deemed to have been approved;
p.000153: (vii) licencee shall inform, any minor change as specified in the Sixth Schedule to the Central Licensing Authority
p.000153:
p.000153: 154 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000153: II—SEC. 3(i)]
p.000153:
p.000153: within a period of thirty days, after such minor change took place;
p.000153: (viii) authorised agent shall inform the Central Licensing Authority in writing within a period of thirty days
p.000153: in the event of any change in the constitution of the overseas manufacturer or the authorised agent;
p.000153: (ix) the consignment of medical device shall be accompanied by an invoice or statement showing the name
p.000153: and quantity of the medical device;
p.000153: (x) the licencee shall supply the medical device for sale or offer it for sale along with its package
p.000153: insert or user manual, wherever applicable.
p.000153: (2) Where the Central Licensing Authority is satisfied that any medical device is not in conformity with the provisions
p.000153: of the Act and these rules, it may issue directions that the entire batch of such medical device may not
p.000153: be sold or offered for sale or may be recalled from the market including hospitals, if any, where it has been stocked:
p.000153: Provided that where the Central Licensing Authority considers it necessary or expedient, more than one
p.000153: batch or all batches of such medical device may be directed to be recalled.
p.000153:
p.000153: 39. Fresh application in case of change in constitution. — In case of change in constitution of a licencee, after
p.000153: grant of licence under sub-rule (1) of rule 36, an application shall be made under sub-rule (1) of rule 34 for grant of
p.000153: licence within a period of one hundred and eighty days from the date of such change in constitution:
p.000153: Provided that the existing licence shall be deemed to be valid till such time, the fresh licence is
...
p.000009:
p.000009:
p.000009:
p.000009: Secondary Packing Storage
p.000009: Well Lighted and Ventilated controlled temperature & humidity as per process or product requirement
p.000009:
p.000009:
p.000009: Well Lighted and Ventilated controlled temperature and humidity as per process or product requirement. Provision of
p.000009: Laminar hood if required, Clean Room class 8 or class 9 as per product/process requirement
p.000009: Well Lighted and Ventilated controlled temperature if required
p.000009: As per recommended storage condition of the product
p.000009:
p.000009: Sixth Schedule
p.000009: [See rules 26(iii), 26(iv), 38(v) and 38(vii)]
p.000009: Post approval change
p.000009: (A) Changes in respect of following shall be considered as major change in,-
p.000009: 1. material of construction;
p.000009: 2. design which shall affect quality in respect of its specifications, indication for use; performance and stability
p.000009: of the medical device;
p.000009: 3. the intended use or indication for use ;
p.000009: 4. the method of sterilization;
p.000009: 5. the approved Shelf life;
p.000009: 6. the name or address of,-
p.000009: (i) the domestic manufacturer or its manufacturing site;
p.000009: (ii) overseas manufacturer or its manufacturing site (for import only);
p.000009: (iii) authorised agent (for import only);
p.000009: 7. label excluding change in font size, font type, color, label design;
p.000009: 8. manufacturing process, equipment or testing which shall affect quality of the device;
p.000009: 9. primary packaging material.
p.000009:
p.000009: 202 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000009: II—SEC. 3(i)]
p.000009:
p.000009: (B) Changes in respect of following shall be considered as minor change in,-
p.000009: 1. design which shall not affect quality in respect of its specifications, indication for use, performance and
p.000009: stability of the medical device;
p.000009: 2. in the manufacturing process, equipment, or testing which shall not affect quality of the device;
p.000009: 3. packaging specifications excluding primary packaging material.
p.000009:
p.000009: Seventh Schedule
p.000009: [See rules 51(1), 51(2), 53(ii), 53(v), 59(3)]
p.000009:
p.000009: Requirements for permission to import or manufacture investigational medical device for conducting clinical
p.000009: investigation
p.000009:
p.000009: 1. Application for permission.-
p.000009: (1) an application in Form MD-22 shall be made to the Central Licensing Authority along with following data in
p.000009: accordance with tables, namely:-
p.000009: (i) Design analysis data as per Table 1.
p.000009: (ii) Biocompatibility and Animal Performance Study as per Table 2.
p.000009: (iii) Information specified in Table 3 shall be submitted along with Investigator’s Brochure as
p.000009: prescribed in Table 4, Clinical Investigational Plan as prescribed in Table 5, Case Report Form as prescribed in Table
p.000009: 6, Serious adverse event reported, if any, as prescribed in Table 7, Informed Consent Form as prescribed in Table 8,
p.000009: investigator’s undertaking as prescribed in Table 9, of this schedule and Ethics Committee approval, if available, as
p.000009: prescribed in Appendix VIII of Schedule Y of the Drugs and Cosmetics Rules, 1945.
p.000009: (iv) Regulatory status in other countries, including information in respect of restrictions imposed, if
...
p.000203: knowledge of occurrence of the serious adverse event.
p.000203: (5) Informed consent:
p.000203: (i) In all investigations, a freely given, informed, written consent is required to be obtained from
p.000203: each study subject. The investigator shall provide information about the study verbally and
p.000203: through the patient information sheet, in a language that is non-technical and is understandable by the study
p.000203: subject. The Subject’s consent must be obtained in writing using an ‘Informed Consent Form’. The patient information
p.000203: sheet as well as the Informed Consent Form shall be approved by the Ethics Committee and furnished to
p.000203: the Central Licensing Authority. Any change in the informed consent documents should be approved by the
p.000203: Ethics Committee and submitted to the Central Licensing Authority before such changes are implemented.
p.000203: (ii) Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering
p.000203: from severe mental illness or disability), the same may be obtained from a legally acceptable representative. If the
p.000203: subject or his legally acceptable representative is unable to read or write, an impartial witness should be present
p.000203: during the entire informed consent process who must append his signatures to the consent form. Explanation: a legally
p.000203: acceptable representative means a person who is able to give consent or authorise an intervention in the
p.000203: patient as provided by the law in India.
p.000203:
p.000203: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000205: 205
p.000205: (iii) A checklist of essential elements to be included in the study subject’s informed consent document as well as a
p.000205: format for the Informed Consent Form for study Subjects is given in Table 8 of this schedule.
p.000205: (iv) The informed consent process, in case of vulnerable subjects in clinical investigations of an innovative medical
p.000205: device which is not approved anywhere in the world, shall be audio-video recorded.
p.000205:
p.000205: (6) Pilot Clinical Investigation
p.000205: (i) Pilot clinical investigation is defined as those clinical investigations which are used to acquire specific
...
Social / education
Searching for indicator education:
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p.000193: improvement and the need for changes to the quality management system, including the quality policy and quality
p.000193: objectives. Records from management reviews shall be maintained.
p.000193: 5.6.2 Review input:
p.000193: The input to management review shall include information on:-
p.000193: (a) results of audits,
p.000193: (b) customer feedback,
p.000193: (c) process performance and product conformity,
p.000193: (d) status of preventive and corrective actions,
p.000193: (e) follow-up actions from previous management reviews,
p.000193: (f) changes that could affect the quality management system,
p.000193: (g) recommendations for improvement, and
p.000193: (h) new or revised regulatory requirements as and when issued.
p.000193: 5.6.3 Review output:
p.000193: The output from the management review shall include any decisions and actions related to:-
p.000193: (a) improvements needed to maintain the effectiveness of the quality management system and its processes,
p.000193: (b) improvement of product related to customer requirements, and
p.000193: (c) resource needs.
p.000193:
p.000193: 194 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000193: II—SEC. 3(i)]
p.000193:
p.000193: 6 Resource management.-
p.000193: 6.1 Provision of resources:
p.000193: The manufacturing organization shall determine and provide the resources needed
p.000193: (a) to implement the quality management system and to maintain its effectiveness, and
p.000193: (b) to meet regulatory and customer requirements.
p.000193: 6.2 Human resources.-
p.000193: 6.2.1 General:
p.000193: Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training,
p.000193: skills and experience. Number of personnel employed shall be adequate and in direct proportion to the workload. Prior
p.000193: to employment, all personnel, shall undergo medical examination including eye examination, and shall be
p.000193: free from communicable or contagious diseases. Thereafter, they should be medically examined periodically, at least
p.000193: once a year. Records shall be maintained thereof.
p.000193: 6.2.2 Competence, awareness and training:
p.000193: The manufacturer shall:-
p.000193: (a) determine the necessary competence for personnel performing work affecting product quality,
p.000193: (b) provide training or take other actions to satisfy these needs,
p.000193: (c) evaluate the effectiveness of the actions taken,
p.000193: (d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute
p.000193: to the achievement of the quality objectives,
p.000193: (e) maintain appropriate records of education, training, skills and experience, and
p.000193: (f) establish documented procedures for identifying training needs and ensure that all personnel are
p.000193: trained to adequately perform their assigned responsibilities.
p.000193: 6.3 Infrastructure:
p.000193: The organisation shall determine, provide and maintain the infrastructure needed to achieve conformity to
p.000193: product requirements. Infrastructure includes, as applicable:-
p.000193: (a) buildings, workspace and associated utilities,
p.000193: (b) process equipment (both hardware and software), and
p.000193: (c) supporting services (such as transport or communication).
p.000193: The manufacturer shall establish documented requirements for maintenance activities, including their frequency,
p.000193: when such activities or lack thereof can affect product quality. Records of such maintenance shall be maintained.
p.000193: 6.4 Work environment:
p.000193: The organisation shall determine and manage the work environment needed to achieve conformity
p.000193: to product requirements. Following requirements shall apply, namely:-
p.000193: (a) the manufacturer shall establish documented requirements for health, cleanliness and clothing of
p.000193: personnel if contact between such personnel and the product or work environment could adversely affect the quality of
p.000193: the product;
p.000193: (b) if work environment conditions can have an adverse effect on product quality, the manufacturer shall establish
p.000193: documented requirements as per Annexure- ‘A’ of this Schedule for the work environment conditions and
p.000193: documented procedures or work instructions to monitor and control these work environment condition;
p.000193: (c) the manufacturer shall ensure that all personnel who are required to work temporarily
...
p.000217: [ ]
p.000217:
p.000217: (vi) I understand that in case of an injury occurring during the clinical investigation, free medical management shall
p.000217: be given as long as required.
p.000217: (vii) I understand that in the event of an investigation related injury or death, financial compensation for such
p.000217: injury or death shall be provided in accordance with the provisions of the Medical Device Rules, 2017.
p.000217:
p.000217: Signature (or Thumb impression) of the Subject/Legally Acceptable Representative:_
p.000217:
p.000217: Date: _/_ /_
p.000217: Signatory’s Name: _
p.000217:
p.000217: Signature of the Investigator: _
p.000217: Contact Details (Telephone Number/ mobile) on which subject may contact: Date:
p.000217: _/_ /_
p.000217:
p.000217: Clinical investigation Investigator’s Name:
p.000217:
p.000217:
p.000217: Signature of the Witness Date:_ / / _
p.000217: Name of the Witness: _
p.000217: Address and contact details of the Witness:
p.000217: _
p.000217:
p.000217: (Copy of the Patient Information Sheet and duly filled Informed Consent Form shall be handed over to the subject or
p.000217: his/her attendant).
p.000217:
p.000217: Table 9 Undertaking by the Investigator
p.000217: 1. Full name, address and title of the Principal Investigator (or Investigator(s) when there is no
p.000217: Principal Investigator)
p.000217: 2. Name and address of the medical college, hospital or other facility where the Clinical Investigation will be
p.000217: conducted: Education, training & experience that qualify the Investigator for the clinical investigation
p.000217: (Attach details including medical council registration number, or any other statement(s) of qualification(s))
p.000217: 3. Name and address of all clinical facilities to be used in the clinical investigation.
p.000217: 4. Name and address of the Ethics Committee that is responsible for approval and continuing review of
p.000217: the clinical investigation.
p.000217: 5. Names of the other members of the research team (Co-Investigators or sub-Investigators) who will be
p.000217: assisting the Investigator in the conduct of the investigation (s).
p.000217: 6. Clinical Investigation Plan, Title and Clinical investigation number (if any) of the clinical investigation to be
p.000217: conducted by the Investigator.
p.000217: 7. Commitments:
p.000217: (i) I have reviewed the clinical investigation plan and agree that it contains all the necessary information
p.000217: to conduct the investigation. I will not begin the clinical investigation until all necessary Ethics Committee and
p.000217: regulatory approvals have been obtained.
p.000217: (ii) I agree to conduct the investigation in accordance with the current Clinical investigation plan. I will
p.000217: not implement any deviation from or changes of the Clinical investigation plan without agreement by the Sponsor
p.000217: and prior review and documented approval / favorable opinion from the Ethics Committee of
p.000217:
p.000217: 218 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000217: II—SEC. 3(i)]
...
Searching for indicator educational:
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p.000149: may be considered necessary.
p.000149: (6) The Central Licensing Authority may, where required, avail the services of a Notified Body referred to in sub-rule
p.000149: (4) of rule 13 for inspecting the manufacturing site of Class C and Class D medical devices.
p.000149: (7) In case, where the documents furnished with the application referred to in sub-rule (1) are not
p.000149: found to be complete and in order, the Central Licensing Authority shall reject the application and inform
p.000149: the applicant of the reasons for such rejection electronically:
p.000149: Provided that where deficiencies that can be rectified, are pointed out by the Central Licensing
p.000149: Authority within the stipulated period, the period referred to in sub-rule (4) shall reckon from the date these
p.000149: deficiencies have been removed.
p.000149:
p.000149: 150 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000149: II—SEC. 3(i)]
p.000149:
p.000149: 22. Requirements for grant of manufacturing licence or loan licence.— While making application for grant of
p.000149: licence or loan licence under rule 20 or rule 21, the applicant shall meet the following requirements, namely:—
p.000149: (i) the manufacturing site shall comply with the requirements of the Quality Management System as specified under the
p.000149: Fifth Schedule;
p.000149: (ii) appoint competent technical staff under whose direction and supervision the manufacturing activity of
p.000149: a medical device shall be undertaken and such staff shall possess the following educational qualification
p.000149: and experience,-
p.000149: (a) degree in engineering in relevant branch or in pharmacy or in science in appropriate subject from
p.000149: a recognised University and shall have experience of not less than two years in manufacturing or testing of medical
p.000149: devices; or
p.000149: (b) diploma in engineering (in relevant branch) or in pharmacy from a recognised institute and shall have the
p.000149: experience of not less than four years in manufacturing or testing of medical devices;
p.000149: (iii) appoint competent technical staff with degree or diploma in engineering (in relevant branch) or in pharmacy or in
p.000149: science in relevant subject and having experience of not less than two years in testing of medical devices under whose
p.000149: direction and supervision, the testing activity of a medical device shall be undertaken.
p.000149:
p.000149: 23. Inspection for grant of licence or loan licence for Class C or Class D medical device.— (1) Before grant of
p.000149: licence to manufacture for sale or for distribution in respect of Class C or D medical device, the manufacturing site
p.000149: shall be inspected within a period of sixty days from the date of application by a team comprising not less than two
p.000149: Medical Device Officers which may include any officer senior to the Medical Device Officer with or
p.000149: without an expert, or a Notified Body referred to in sub-rule (4) of rule 13:
p.000149: Provided that no inspection of a medical device manufacturing site for grant of loan licence to
p.000149: manufacture such medical device shall be required to be carried out if the manufacturing site is already licenced to
p.000149: manufacture such medical device for sale or for distribution.
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000215: 10. An explanation about whom to contact for clinical investigation related queries, rights of Subjects and in the
p.000215: event of any injury
p.000215: 11. The anticipated prorated payment, if any, to the Subject for participating in the clinical investigation
p.000215: 12. Subject's responsibilities on participation in the clinical investigation
p.000215: 13. Statement that participation is voluntary, that the Subject can withdraw from the clinical investigation at any
p.000215: time and that refusal to participate will not involve any penalty or loss of benefits to which the Subject is otherwise
p.000215: entitled
p.000215: 14. Statement that there is a possibility of failure of investigational medical device to provide intended
p.000215: therapeutic effect.
p.000215: 15. Any other pertinent information.
p.000215:
p.000215: 1.2 Additional elements, which may be required
p.000215: (a) Statement of foreseeable circumstances under which the Subject's participation may be terminated by the
p.000215: Investigator without the Subject's consent.
p.000215: (b) Additional costs to the Subject that may result from participation in the clinical investigation.
p.000215: (c) The consequences of a Subject’s decision to withdraw from the investigation and procedures for orderly termination
p.000215: of participation by Subject.
p.000215: (d) Statement that the Subject or Subject's representative will be notified in a timely manner if significant
p.000215: new findings are developed during the course of the investigation which may affect the Subject's
p.000215: willingness to continue participation will be provided.
p.000215: (e). A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or
p.000215: fetus, if the Subject is or may become pregnant), which are currently unforeseeable
p.000215: (f) Approximate number of Subjects enrolled in the clinical investigation
p.000215: 2. Format of informed consent form for Subjects participating in a clinical investigation - Informed Consent form to
p.000215: participate in a clinical investigation
p.000215: Clinical investigation Title: Clinical investigation Number:
p.000215: Subject’s Initials: Subject’s Name:
p.000215: _
p.000215: Date of Birth / Age: _ Gender:
p.000215: _ Address of the Subject: _
p.000215: Qualification: _
p.000215: Occupation: Student/Self-employed/Service/Housewife/Others (Please tick as appropriate) Annual income of the subject:
p.000215: _
p.000215: Name and address of the nominee(s) and his relation to the subject (for the purpose of
p.000215: compensation in case of clinical investigation related death).
p.000215:
p.000215:
p.000215:
p.000215: (i) I confirm that I have read and understood the information sheet dated _ for the above clinical investigation
p.000215: and have had the opportunity to ask questions.
p.000215: (ii) I understand that my participation in the clinical investigation is voluntary and that I am free to withdraw at
...
Social / employees
Searching for indicator employees:
(return to top)
p.000157: (ii) clinical investigation shall be conducted in accordance with the approved clinical investigation
p.000157: plan, Good Clinical Practices Guidelines issued by the Central Drugs Standard Control Organisation and
p.000157: provisions of the Seventh Schedule;
p.000157: (iii) clinical investigation shall be registered with the Clinical Trial Registry of India before
p.000157: enrolling the first participant for such clinical investigation;
p.000157: (iv) annual status report of each clinical investigation, as to whether it is ongoing, completed or terminated,
p.000157: shall be submitted to the Central Licensing Authority by the sponsor, and, in case of termination of any
p.000157: clinical investigation, the detailed reasons for the same shall be communicated to the Central Licensing Authority
p.000157: within thirty days of such termination;
p.000157: (v) information about any report of suspected unexpected serious adverse event occurring during
p.000157: clinical investigation on the subject shall, after due analysis, be submitted by the sponsor to the
p.000157: Central Licensing Authority within fourteen days of the knowledge of its occurrence as specified in the
p.000157: Seventh Schedule and in compliance with the procedure specified in these rules;
p.000157: (vi) in case of an injury or death during clinical investigation of a subject of a clinical investigation, the
p.000157: applicant shall provide complete medical management or compensation in accordance with these rules;
p.000157: (vii) the premises of the sponsor including their employees, subsidiaries and branches, their agents, contractors
p.000157: and sub-contractors and clinical investigation sites shall be open for inspection by officers of the Central Licensing
p.000157: Authority who may be accompanied by officers of the State Licensing Authority or outside experts, to verify
p.000157: compliance of the requirements of these rules for conduct of clinical investigation;
p.000157: (viii) the clinical investigation shall be initiated by enrolling first participant within a period of one year
p.000157: from the date of grant of permission, failing which prior permission from the Central Licensing Authority shall be
p.000157: required to initiate clinical investigation;
p.000157: (ix) the Central Licensing Authority may impose or exempt any condition while granting permission in
p.000157: respect of specific clinical investigations, if considered necessary, regarding the objective, design,
p.000157: subject population, subject eligibility, assessment, conduct and treatment of clinical investigation.
p.000157:
p.000157: 54. Suspension, cancellation, etc. of permission.—(1) If any person to whom permission has been granted under rule
p.000157: 52 fails to comply with any of the conditions of permission or any of the provisions of the Act or these rules, the
p.000157: Central Licensing Authority may,—
p.000157: (a) issue warning letter giving details of deficiency found; or
p.000157: (b) debar the investigator or sponsor including their employees, subsidiaries and branches, their agents,
p.000157: contractors and sub-contractors to conduct any clinical investigation for such period as it thinks fit; or
p.000157: (c) suspend the permission for such period as it thinks fit or cancel either wholly or partly the permission.
p.000157: (2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days of the
p.000157: receipt of such order before the Central Government, which may, after such enquiry and after giving an opportunity of
p.000157: being heard to the appellant, dispose of the appeal within a period of sixty days.
p.000157:
p.000157: 55. Medical management and compensation related to clinical investigation.—(1) Where any participant is
p.000157: injured on account of participation in clinical investigation, the sponsor permitted under rule 52 shall
p.000157: provide medical management to that participant.
p.000157: (2) Where an injury is caused to the participant in a clinical investigation of any investigational medical device and
p.000157: such injury is attributable to the use of investigational medical device, the sponsor permitted under
p.000157: rule 52 shall provide to that participant, medical management and such compensation in the manner as
p.000157: specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945.
p.000157: (3) Where death of a participant is related to clinical investigation and is attributable to the use of an
p.000157: investigational medical device, the sponsor, permitted under rule 52 shall provide to the legal heir of
p.000157: that participant, such compensation, in such manner as specified under rule 122DAB of the Drugs and Cosmetics Rules,
p.000157: 1945.
p.000157:
...
p.000159: application, for reasons to be recorded in writing, within a period of ninety days from the date of application.
p.000159:
p.000159: 60. Conditions for permission to conduct of clinical performance evaluation.— After grant of permission
p.000159: referred to in sub-rule (5) of rule 59, the following conditions shall be complied with by the applicant,—
p.000159: (i) clinical performance evaluation shall be conducted in accordance with the approved clinical
p.000159: performance evaluation plan and Good Clinical Practices Guidelines;
p.000159: (ii) clinical performance evaluation shall be initiated after approval of clinical investigation plan by
p.000159: the registered Ethics Committee;
p.000159:
p.000159: 160 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000159: II—SEC. 3(i)]
p.000159:
p.000159: (iii) clinical performance evaluation shall be registered with the Clinical Trial Registry of India before enrolling
p.000159: the first participant for such clinical performance evaluation;
p.000159: (iv) annual status report of each clinical performance evaluation, as to whether it is ongoing, completed or
p.000159: terminated, shall be submitted to the Central Licensing Authority by the sponsor, and in case of
p.000159: termination of any clinical performance evaluation, the detailed reasons for the same shall be communicated to the
p.000159: Central Licensing Authority within thirty days of the date of termination;
p.000159: (v) the laboratories or other institutions taking part in the evaluation study or the sponsor including their
p.000159: employees, subsidiaries and branches, their agents, contractors and sub-contractors, and clinical investigation sites
p.000159: shall be open for inspection by officers of the Central Licensing Authority authorised in this behalf who may be
p.000159: accompanied by officers of State Licensing Authority or outside experts under these rules to verify compliance of the
p.000159: requirements of these rules for conduct of clinical performance evaluation;
p.000159: (vi) the clinical performance evaluation shall be initiated within a period of one year from the date
p.000159: of grant of permission, failing which prior permission from the Central Licensing Authority shall be
p.000159: required to initiate such clinical performance evaluation;
p.000159: (vii) the Central Licensing Authority may impose or exempt any condition while granting permission in respect of
p.000159: specific clinical performance evaluation, if considered necessary, regarding the objective, design, subject population,
p.000159: subject eligibility, assessment, conduct and treatment of clinical performance evaluation.
p.000159:
p.000159: 61. Suspension or cancellation of permission.—(1) If any person to whom permission has been granted under sub- rule
p.000159: (5) of rule 59 fails to comply with any of the conditions of permission, the Central Licensing Authority may,
p.000159: suspend the permission for such period as it thinks fit or cancel either wholly or partly.
p.000159: (2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days before
...
p.000177: any;
p.000177: (f) Undertaking signed stating that the manufacturing site is in compliance with the provisions of the
p.000177: Fifth Schedule.
p.000177: (g) Documents as specified in the clause (b) of paragraph (i) of this part.
p.000177: (h) In case of in vitro diagnostic medical devices, a copy of performance evaluation report issued by
p.000177: the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of
p.000177: rule 83.
p.000177:
p.000177: 178 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000177: II—SEC. 3(i)]
p.000177:
p.000177: Part III Appendix I
p.000177: Contents of a site or plant master file
p.000177: The manufacturer shall prepare a succinct document in the form of site master file containing specific information
p.000177: about the production and/or control of device manufacturing carried out at the premises. It shall contain
p.000177: the following information,-
p.000177: 1. General Information:
p.000177: (i) brief information on the site (including name and address), relation to other sites;
p.000177: (ii) manufacturing activities;
p.000177: (iii) any other operations carried out on the site
p.000177: (iv) name and exact address of the site, including telephone, fax numbers, web site URL and e-mail address;
p.000177: (v) type of medical devices handled on the site and information about specifically toxic or hazardous substances
p.000177: handled, mentioning the way they are handled and precautions taken;
p.000177: (vi) short description of the site (size, location and immediate environment and other activities on the site);
p.000177: (vii) number of employees engaged in production, quality control, warehousing, and distribution;
p.000177: (viii) use of outside scientific, analytical or other technical assistance in relation to the design, manufacture
p.000177: and testing;
p.000177: (ix) short description of the quality management system of the company;
p.000177: (x) devices details registered with foreign countries;
p.000177: (xi) brief description of testing facility;
p.000177: 2. Personnel:
p.000177: (i) organisation chart showing the arrangements for key personnel
p.000177: (ii) qualifications, experience and responsibilities of key personnel;
p.000177: (iii) outline of arrangements for basic and in-service training and how records are maintained;
p.000177: (iv) health requirements for personnel engaged in production
p.000177: (v) personnel hygiene requirements, including clothing.
p.000177: 3. Premises and Facilities:
p.000177: (i) layout of premises with indication of scale;
p.000177: (ii) nature of construction, finishes/fixtures and fittings;
p.000177: (iii) brief description of ventilation systems. More details should be given for critical areas with potential risks
p.000177: of airborne contamination (including schematic drawings of the systems). Classification of the rooms used for the
p.000177: manufacture of sterile products should be mentioned;
p.000177: (iv) special areas for the handling of highly toxic, hazardous and sensitizing materials;
p.000177: (v) brief description of water systems (schematic drawings of the systems are desirable) including sanitation;
p.000177: (vi) maintenance (description of planned preventive maintenance programmes for premises and recording
p.000177: system);
p.000177: 4. Equipment:
p.000177: (i) Brief description of major production and quality control laboratories equipment (a list of the equipment is
p.000177: required);
...
p.000189: (a) to be totally or partially introduced into the human or animal body or a natural orifice; or
p.000189: (b) to replace an epithelial surface or the surface of the eye;
p.000189:
p.000189: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000191: 191
p.000191: by surgical intervention, and which is intended to remain after the procedure for at least thirty days, and which can
p.000191: only be removed by medical or surgical intervention.
p.000191: 3.6 Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly
p.000191: which is intended to be included as part of the finished, packaged, and labeled device.
p.000191: 3.7 Design input means the physical and performance requirements of a device that are used as a
p.000191: basis for device design.
p.000191: 3.8 Design output means the results of a design effort at each design phase and at the end of the total design
p.000191: effort. The finished design output is the basis for the device master record. The total finished design
p.000191: output consists of the device, its packaging and labeling, and the device master record.
p.000191: 3.9 Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of
p.000191: the design requirements, to evaluate the capability of the design to meet these requirements, and to
p.000191: identify problems.
p.000191: 3.10 Finished device means any device or accessory to any device that is suitable for use or capable
p.000191: of functioning, whether or not it is packaged, labeled or sterilized.
p.000191: 3.11 Management with executive responsibility means those senior employees of a manufacturer who have the authority
p.000191: to establish or make changes to the manufacturer's quality policy and quality system.
p.000191: 3.12 Medical device including substances used for in vitro diagnosis referred to in rule 3 of these rules.
p.000191: 3.13 Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed
p.000191: at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of
p.000191: such activities comply with quality system procedures, that these procedures are implemented effectively, and that
p.000191: these procedures are suitable to achieve quality system objectives.
p.000191: 3.14 Quality policy means the overall intention and direction of an organization with respect to quality, as
p.000191: established by management with executive responsibility.
p.000191: 3.15 Quality system means the organizational structure, responsibilities, procedures, processes, and
p.000191: resources for implementing quality management.
p.000191: 3.16 Rework means action taken on a nonconforming product that will fulfill the specified Device
p.000191: Master File requirements before it is released for distribution.
p.000191: 3.17 Specification means any requirement with which a product, process, service, or other activity must conform.
p.000191: 3.18 Validation means confirmation by examination and provision of objective evidence that the particular
p.000191: requirement for a specific intended use can be consistently fulfilled.
p.000191: 3.18.1 Process validation means establishing by objective evidence that a process consistently produces a result
p.000191: or product meeting its predetermined specifications.
...
p.000191: to base its decisions.
p.000191: The manufacturer shall define the period for which at least one copy of obsolete controlled documents shall be
p.000191: retained. This period shall ensure that documents to which medical devices or in vitro diagnostic medical
p.000191: devices have been manufactured and tested are retained for at least one year after the date of expiry
p.000191: of the medical device or in vitro diagnostic medical devices as defined by the manufacturer.
p.000191: 4.2.4 Control of records.-
p.000191: Records shall be established and maintained to provide evidence of conformity to the requirements and of the effective
p.000191: operation of the quality management system. Records shall remain legible, readily identifiable and
p.000191: retrievable. A documented procedure shall be established to define the controls needed for the
p.000191: identification, storage, protection, retrieval, retention time and disposition of records.
p.000191: The manufacturer shall retain the records for a period of time at least one year after the date of expiry of the
p.000191: medical device or in vitro diagnostic medical devices as defined by the manufacturer, but not less than two years from
p.000191: the date of product release by the manufacturer.
p.000191: 5 Management responsibility.-
p.000191: 5.1 Management commitment:
p.000191: Top management of the manufacturer shall provide evidence of its commitment to the development and implementation of
p.000191: the quality management system and maintaining its effectiveness by:-
p.000191: (a) communicating to the employees the importance of meeting customer as well as statutory and
p.000191: regulatory requirements;
p.000191: (b) establishing the quality policy;
p.000191:
p.000191: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000193: 193
p.000193: (c) ensuring that quality objectives are established;
p.000193: (d) conducting management reviews; and
p.000193: (e) ensuring the availability of resources.
p.000193: 5.2 Customer focus:
p.000193: Top management of the manufacturer shall ensure that customer requirements are determined and are met.
p.000193: 5.3 Quality policy:
p.000193: Top management of the manufacturer shall ensure that the quality policy:-
p.000193: (a) is appropriate to the purpose of the manufacturing facility;
p.000193: (b) includes a commitment to comply with requirements and to maintain the effectiveness of
p.000193: the quality management system;
p.000193: (c) provides a framework for establishing and reviewing quality objectives;
p.000193: (d) is communicated and understood within the manufacturer’s organisation; and
p.000193: (e) is reviewed for continuing suitability.
p.000193: 5.4 Planning.-
p.000193: 5.4.1 Quality objectives:
p.000193: Top management of the manufacturer shall ensure that quality objectives, including those needed to meet requirements
p.000193: for product, are established at relevant functions and levels within the manufacturing organization. The quality
p.000193: objectives shall be measurable and consistent with the quality policy.
p.000193: 5.4.2 Quality management system planning:
p.000193: Top management of the manufacturer shall ensure that.-
p.000193: (a) the planning of the quality management system is carried out in order to meet the specified requirements, as
p.000193: well as the quality objectives; and
...
p.000217: not implement any deviation from or changes of the Clinical investigation plan without agreement by the Sponsor
p.000217: and prior review and documented approval / favorable opinion from the Ethics Committee of
p.000217:
p.000217: 218 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000217: II—SEC. 3(i)]
p.000217:
p.000217: the amendment, except where necessary to eliminate an immediate hazard(s) to the clinical investigation participant or
p.000217: when the change(s) involved are only logistical or administrative in nature.
p.000217: (iii) I agree to personally conduct and/or supervise the clinical investigation at my site.
p.000217: (iv) I agree to inform all Subjects that the medical devices are being used for investigational purposes and I
p.000217: will ensure that the requirements relating to obtaining informed consent and Ethics Committee review and approval
p.000217: specified in this Schedule are met.
p.000217: (v) I agree to report to the Sponsor all adverse experiences that occur in the course of the investigation(s)
p.000217: in accordance with the regulatory and Good Clinical practice guidelines.
p.000217: (vi) I have read and understood the information in the Investigator's brochure, including the potential risks
p.000217: and side effects of the medical device.
p.000217: (vii) I agree to ensure that all associates, colleagues and employees assisting in the conduct of the
p.000217: clinical investigation are suitably qualified and experienced and they have been informed about their obligations in
p.000217: meeting their commitments in the clinical investigation.
p.000217: (viii) I agree to maintain adequate and accurate records and to make those records available for
p.000217: audit / inspection by the Sponsor, Ethics Committee, Licensing Authority or their authorized representatives, in
p.000217: accordance with regulatory and provisions of these rules. I will fully cooperate with any clinical
p.000217: investigation related audit conducted by regulatory officials or authorized representatives of the
p.000217: Sponsor.
p.000217: (ix) I agree to promptly report to the Ethics Committee all changes in the CIP activities and all unanticipated
p.000217: problems involving risks to human Subjects or others.
p.000217: (x) I agree to inform all serious adverse events to the Sponsor, Central Licensing Authority as well as the
p.000217: Ethics Committee within forty eight hours of their occurrence. In case of failure, I will submit the
p.000217: justification to the satisfaction of the Central Licensing Authority. I also agree to report the serious
p.000217: adverse events, after due analysis, to the Central Licensing Authority, Chairman of the Ethics
...
Social / gender
Searching for indicator gender:
(return to top)
p.000213: (a) Screening.
p.000213: (b) Documentation of subject's informed consent.
p.000213: (c) Inclusion/exclusion.
p.000213: (d) Baseline visit:
p.000213: (1) demographics;
p.000213: (2) medical diagnosis;
p.000213: (3) relevant previous medications or procedures;
p.000213: (4) date of enrolment;
p.000213: (5) other characteristics.
p.000213: (e) Intervention(s) or treatment(s).
p.000213: (f) Follow-up visit(s).
p.000213: (g) Clinical investigation procedure(s).
p.000213: (h) Adverse event(s).
p.000213: (i) Device deficiencies.
p.000213: (j) Concomitant illness(es)/medication(s).
p.000213: (k) Unscheduled visit(s).
p.000213: (l) Subject diary.
p.000213: (m) Subject withdrawal or lost to follow-up.
p.000213: (n) Form signifying the end of the clinical investigation, signed by the principal investigator or his/her
p.000213: authorised designee.
p.000213: (o) CIP deviation(s).
p.000213:
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p.000215: 215
p.000215: 3. Procedural issues
p.000215: A system shall be established to enable cross-referencing of CRFs and CIP versions.
p.000215: Supplemental CRFs may be developed for collecting additional data at individual investigation sites in
p.000215: multicenter investigations.
p.000215:
p.000215: Table 7
p.000215: Data elements for reporting serious adverse events occurring in a clinical investigation
p.000215: 1. Patient details:
p.000215: (a) Initials and other relevant identifier (hospital/Out Patient Department’s record number etc.);
p.000215: (b) Gender;
p.000215: (c) Age and date of birth;
p.000215: (d) Weight;
p.000215: (e) Height.
p.000215: 2. Suspected device(s):
p.000215: (a) Name of the Device;
p.000215: (b) Indication(s) for which suspect device was prescribed;
p.000215: (c) Device details including model number/size/lot number, if applicable;
p.000215: (d) Starting date and time of day;
p.000215: (e) Stopping date and time, or duration of treatment;
p.000215: 3. Other treatment(s):
p.000215: Provide the same information for concomitant treatment.
p.000215: 4. Details of suspected adverse device reaction(s)
p.000215: (a) Full description of reaction(s) including body site and severity, as well as the criterion (or
p.000215: criteria) for regarding the report as serious. In addition to a description of the reported signs and
p.000215: symptoms, whenever possible, describe a specific diagnosis for the reaction.
p.000215: (b) Start date (and time) of onset of reaction.
p.000215: (c) Stop date (and time) or duration of reaction.
p.000215: (d) Setting (e.g., hospital, out-patient clinic, home, nursing home).
p.000215: 5. Outcome
p.000215: (a) Information on recovery and any sequel; results of specific tests and/or treatment that may have
p.000215: been conducted.
p.000215: (b) For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; any
p.000215: post-mortem findings.
p.000215: (c) Other information: anything relevant to facilitate assessment of the case, such as medical history including
...
p.000215: Investigator without the Subject's consent.
p.000215: (b) Additional costs to the Subject that may result from participation in the clinical investigation.
p.000215: (c) The consequences of a Subject’s decision to withdraw from the investigation and procedures for orderly termination
p.000215: of participation by Subject.
p.000215: (d) Statement that the Subject or Subject's representative will be notified in a timely manner if significant
p.000215: new findings are developed during the course of the investigation which may affect the Subject's
p.000215: willingness to continue participation will be provided.
p.000215: (e). A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or
p.000215: fetus, if the Subject is or may become pregnant), which are currently unforeseeable
p.000215: (f) Approximate number of Subjects enrolled in the clinical investigation
p.000215: 2. Format of informed consent form for Subjects participating in a clinical investigation - Informed Consent form to
p.000215: participate in a clinical investigation
p.000215: Clinical investigation Title: Clinical investigation Number:
p.000215: Subject’s Initials: Subject’s Name:
p.000215: _
p.000215: Date of Birth / Age: _ Gender:
p.000215: _ Address of the Subject: _
p.000215: Qualification: _
p.000215: Occupation: Student/Self-employed/Service/Housewife/Others (Please tick as appropriate) Annual income of the subject:
p.000215: _
p.000215: Name and address of the nominee(s) and his relation to the subject (for the purpose of
p.000215: compensation in case of clinical investigation related death).
p.000215:
p.000215:
p.000215:
p.000215: (i) I confirm that I have read and understood the information sheet dated _ for the above clinical investigation
p.000215: and have had the opportunity to ask questions.
p.000215: (ii) I understand that my participation in the clinical investigation is voluntary and that I am free to withdraw at
p.000215: any time, without giving any reason, without my medical care or legal rights being affected.
p.000215: Place initial box (Subject) [ ]
p.000215:
p.000215: [ ]
p.000215: (iii) I understand that the Sponsor of the clinical investigation, others working on the [ ]
p.000215:
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p.000217: 217
p.000217: Sponsor’s behalf, the Ethics Committee and the regulatory authorities will not need my permission to look
p.000217: at my health records both in respect of the current clinical investigation and any further research that may be
p.000217: conducted in relation to it, even if I withdraw from the clinical investigation. I agree to this access.
p.000217: However, I understand that my identity will not be revealed in any information released to third parties or published.
...
p.000219: Drugs Standard Control Organization and Ethical Guidelines for Biomedical Research on Human Subjects,
p.000219: issued by Indian Council of Medical Research have been followed. The ethics report shall include the following
p.000219: points:
p.000219: (a) a confirmation that the CIP and any amendments to it were reviewed by the EC;
p.000219: (b) a list of all ECs consulted.
p.000219:
p.000219: 6.4 Clinical investigation team
p.000219:
p.000219: Briefly describe the administrative structure of the clinical investigation (Investigators, site staff, Sponsor/
p.000219: designates, Central laboratory etc.).
p.000219:
p.000219: 7. Results
p.000219: The results should include the following points:
p.000219: (a) the clinical investigation initiation date;
p.000219: (b) the clinical investigation completion/suspension date;
p.000219: (c) the disposal of subjects and investigational medical devices;
p.000219: (d) the subject demographics;
p.000219: (e) Clinical investigation Plan compliance;
p.000219: (f) an analysis, which includes,-
p.000219: (i) a performance analysis as provided in the clinical investigation plan;
p.000219: (ii) a summary of all adverse events and adverse device effects, including a discussion of the
p.000219: severity, treatment needed, resolution and relevant principal investigator's judgment concerning the causal
p.000219: relationship with the investigational medical devices or procedure;
p.000219: (iii) a table compiling all observed device deficiencies that could have led to a serious adverse effect, and any
p.000219: corrective actions taken during the clinical investigation, if any;
p.000219: (iv) any needed subgroup analysis for special populations (i.e. gender, racial/cultural/ethnic subgroups), as
p.000219: appropriate;
p.000219: (v) an accountability of all subjects with a description of how missing data or deviation(s) were
p.000219: dealt within the analysis, including subjects:-
p.000219: (A) not passing screening tests;
p.000219: (B) lost to follow-up;
p.000219: (C) withdrawn or discontinued from the clinical investigation and the reason.
p.000219:
p.000219: 8. Discussion and overall conclusions
p.000219: The conclusions may include the following points:
p.000219: (a) the safety and performance results and any other endpoints;
p.000219: (b) an assessment of risks and benefits;
p.000219: (c) a discussion of the clinical relevance and importance of the results in the light of other existing data;
p.000219: (d) any specific benefits or special precautions required for individual subjects or groups considered to be at risk;
p.000219: (e) any implications for the conduct of future clinical investigations;
p.000219: (f) any limitations of the clinical investigation.
p.000219:
p.000219: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000221: 221
p.000221: 9. Abbreviated terms and definitions
p.000221: A list of abbreviated terms and definitions of specialized or unusual terms should be provided.
p.000221:
p.000221: 10. List of appendices to the clinical investigation report
p.000221: (a) Protocols and amendments;
p.000221: (b) Specimen of Case Record Form;
p.000221: (c) Investigators’ name(s) with contact addresses, phone, e-mail etc.;
p.000221: (d) Patient data listings (e) List of participants treated with investigational product;
p.000221: (e) Discontinued participants;
...
p.000237:
p.000237: 2. Details of medical device to be imported:
p.000237:
p.000237: Name of medical device Quantities which may be imported
p.000237:
p.000237:
p.000237:
p.000237: 3. This licence shall, unless previously suspended or revoked, be in force for a period of one year from the date of
p.000237: issue specified above.
p.000237:
p.000237:
p.000237: Place: Date: _
p.000237: Central Licensing Authority
p.000237: Seal or Stamp
p.000237:
p.000237:
p.000237: Form MD-20
p.000237: [See sub-rule (2) of rule 43]
p.000237: Application for permission to import small quantity of medical devices for personal use
p.000237:
p.000237: To
p.000237: The Central Licensing Authority,
p.000237:
p.000237:
p.000237:
p.000237: Sir/Madam,
p.000237:
p.000237: 1. I …………………………………… resident of………………….. by occupation hereby apply for a
p.000237: permission to import the medical device specified below for personal use manufactured by
p.000237: (Name
p.000237: and full address of manufacturer) for the treatment of (name of the disease).
p.000237:
p.000237: Name of medical device Quantity which may be imported
p.000237:
p.000237:
p.000237: 2. The prescription from a registered medical practitioner prescribing the need for the said medical device is
p.000237: attached.
p.000237: 3. The particular of the patients is specified below.
p.000237: Name Age Gender Complete Address
p.000237:
p.000237:
p.000237:
p.000237:
p.000237:
p.000237: Place: Date: _
p.000237:
p.000237: Signature of applicant
p.000237:
p.000237: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000239: 239
p.000239:
p.000239:
p.000239: Form MD-21
p.000239: [See sub-rule (3) of rule 43]
p.000239: Permission to import of small quantity of medical devices for personal use
p.000239:
p.000239: Permit No.
p.000239: Date
p.000239:
p.000239: 1. ………………………………is hereby permitted to import the medical device manufactured by
p.000239: (Name and full address of manufacturer) specified below for personal use.
p.000239:
p.000239: Name of the medical device Quantity
p.000239:
p.000239:
p.000239: 2. This licence is subject to conditions prescribed in the Medical Devices Rules, 2017.
p.000239: 3. This licence shall, unless previously suspended or revoked, be in force for a period of one hundred and eighty days
p.000239: from the date of issue specified above.
p.000239:
p.000239:
p.000239: Central Licensing Authority
p.000239: Seal or Stamp
p.000239:
p.000239: Form MD-22
p.000239: [See sub-rule (1) of rule 51]
p.000239: Application for Grant of permission to conduct clinical investigation of an investigational medical device
p.000239:
p.000239: 1. Name of Applicant:
p.000239: 2. Nature and constitution of applicant:
p.000239: (i.e. proprietorship, partnership including Limited Liability Partnership, company, society, trust, other to be
p.000239: specified)
p.000239: 3. (i) Sponsor address including telephone number, mobile number, fax number and e-mail id:
...
Social / parents
Searching for indicator parent:
(return to top)
p.000205: expose them to inappropriate risk.
p.000205: (d) If the medical device is intended to treat serious or life-threatening diseases, occurring in both adults and
p.000205: paediatric patients, for which there are currently no or limited therapeutic options, paediatric
p.000205: population may be included in the clinical investigation early, following assessment of initial safety
p.000205: data and reasonable evidence of potential benefit. In circumstances where this is not possible, lack of data has to be
p.000205: justified.
p.000205: (e) If the medical device has a potential for use in paediatric patient, paediatric studies may be
p.000205: conducted. These studies may be initiated at various stages of clinical development or after
p.000205: post-marketing surveillance in adults, if a safety concern exists. In cases where there is limited paediatric data at
p.000205: the time of submission of application, more data in paediatric patients would be expected after
p.000205: marketing authorization for use in children is granted.
p.000205: (f) Paediatric subjects are legally unable to provide written informed consent, and are dependent on
p.000205: their parents or legal guardian to assume responsibility for their participation in clinical investigation. Written
p.000205: informed consent shall be obtained from the parent or legal guardian. However, all paediatric participants shall be
p.000205: informed to the fullest extent possible about the study in a language and in terms that they are able to understand.
p.000205: Where appropriate, paediatric participants should additionally assent to enroll in the study. Mature minors and
p.000205: adolescents should personally sign and date a separately designed written consent form. Although a participant’s wish
p.000205: to withdraw from a study shall be respected, there may be circumstances in therapeutic studies for serious or
p.000205: life-threatening diseases in which, in the opinion of the investigator and parent or legal guardian, the welfare
p.000205: of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this
p.000205: situation, continued parental or legal guardian consent will be sufficient to allow participation in the study.
p.000205: (g) For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall
p.000205: include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.
p.000205: (iii) Pregnant or nursing women:
p.000205: (a) Pregnant or nursing women shall be included in clinical investigation only when the medical device
p.000205: is intended for use by pregnant or nursing women or fetuses or nursing infants and where the data generated from women
p.000205: who are not pregnant or nursing, would not be suitable.
p.000205: (b) For medical device intended for use during pregnancy, follow-up data pertaining to a period appropriate for that
p.000205: medical device on the pregnancy, foetus and child will be required.
p.000205: 3. Post Marketing Surveillance:
...
Searching for indicator parents:
(return to top)
p.000205: (c) If the medical device is predominantly or exclusively used in paediatric patients, clinical investigation data
p.000205: should be generated in paediatric population except for initial safety and performance data, which will
p.000205: usually be obtained in adults unless such initial safety studies in adults would yield little useful information or
p.000205: expose them to inappropriate risk.
p.000205: (d) If the medical device is intended to treat serious or life-threatening diseases, occurring in both adults and
p.000205: paediatric patients, for which there are currently no or limited therapeutic options, paediatric
p.000205: population may be included in the clinical investigation early, following assessment of initial safety
p.000205: data and reasonable evidence of potential benefit. In circumstances where this is not possible, lack of data has to be
p.000205: justified.
p.000205: (e) If the medical device has a potential for use in paediatric patient, paediatric studies may be
p.000205: conducted. These studies may be initiated at various stages of clinical development or after
p.000205: post-marketing surveillance in adults, if a safety concern exists. In cases where there is limited paediatric data at
p.000205: the time of submission of application, more data in paediatric patients would be expected after
p.000205: marketing authorization for use in children is granted.
p.000205: (f) Paediatric subjects are legally unable to provide written informed consent, and are dependent on
p.000205: their parents or legal guardian to assume responsibility for their participation in clinical investigation. Written
p.000205: informed consent shall be obtained from the parent or legal guardian. However, all paediatric participants shall be
p.000205: informed to the fullest extent possible about the study in a language and in terms that they are able to understand.
p.000205: Where appropriate, paediatric participants should additionally assent to enroll in the study. Mature minors and
p.000205: adolescents should personally sign and date a separately designed written consent form. Although a participant’s wish
p.000205: to withdraw from a study shall be respected, there may be circumstances in therapeutic studies for serious or
p.000205: life-threatening diseases in which, in the opinion of the investigator and parent or legal guardian, the welfare
p.000205: of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this
p.000205: situation, continued parental or legal guardian consent will be sufficient to allow participation in the study.
p.000205: (g) For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall
p.000205: include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000147: (11) An applicant who is aggrieved by the decision of the Central Licensing Authority under sub-rule (10), may file an
p.000147: appeal within forty five days from the date of receipt of such rejection before the Central Government, which may after
p.000147: such enquiry and after giving an opportunity of being heard to the appellant, dispose of the appeal
p.000147: within a period of sixty days.
p.000147:
p.000147: 14. Duties of Notified Body.— A registered Notified Body, referred to in rule 13, shall carry out its
p.000147: duties and functions, in respect of Class A or Class B medical devices as specified in Part II of the Third Schedule.
p.000147:
p.000147: 15. Procedure to be adopted by Notified Body.— A registered Notified Body shall carry out its duties and functions
p.000147: either by itself or by any other qualified person on its behalf as per specified procedure as detailed in Part II of
p.000147: the Third Schedule.
p.000147:
p.000147: 16. Fees to be charged by Notified Body.— A registered Notified Body may charge fee from the applicant for the services
p.000147: rendered by it as may be determined by the Central Government.
p.000147:
p.000147: 17. Suspension and cancellation of registration certificate of Notified Body. — (1) The Central Licensing
p.000147: Authority may, after giving an opportunity to show cause as to why such an order should not be passed, by an order in
p.000147: writing stating the reasons therefor, cancel the registration of a Notified Body or suspend it for such period as the
p.000147: Central Licensing Authority thinks fit, if in its opinion, the Notified Body has failed to comply with any provision of
p.000147: these rules.
p.000147: (2) A registered Notified Body whose registration has been suspended or cancelled under sub-rule (1) may,
p.000147: within thirty days of the receipt of a copy of the order by it, prefer an appeal to the Central Government
p.000147: and the Central Government may, after giving the Notified Body an opportunity of being heard, confirm,
p.000147: reverse or modify such order.
p.000147: (3) The registration of a Notified Body with the Central Licensing Authority shall be deemed to have been cancelled
p.000147: with effect from the expiry of the date of the validity of its accreditation by a National Accreditation Body.
p.000147:
p.000147: 18. Medical Device Testing Officer and Medical Device Officer.— (1) The Central Government may designate a Government
p.000147: Analyst appointed under section 20 of the Act as Medical Device Testing Officer.
p.000147: (2) The Central Government or, as the case may be, the State Government, may designate an Inspector
p.000147: appointed under section 21 of the Act as Medical Device Officer.
p.000147: (3) The Medical Device Testing Officer and Medical Device Officer designated under sub-rule (1) and sub-rule (2)
p.000147: respectively, while exercising powers and duties under the Act and these rules, shall be deemed to have
p.000147: been appointed as the Government Analyst and the Inspector, respectively.
p.000147:
...
p.000161: the test or evaluation applied.
p.000161:
p.000161: 69. Application for test or evaluation of medical device.—For the purpose of these rules, an application
p.000161: from a purchaser for test or evaluation of a medical device or portion of medical device under section 26 of the Act
p.000161: shall be made in Form MD-33 and the report of such test or evaluation of the medical device which is
p.000161: prepared on such application shall be supplied to the applicant in Form MD-32.
p.000161:
p.000161: 70. Duties of Medical Device Officer.—Subject to the instructions of the Central Licensing Authority or
p.000161: State Licensing Authority, as the case may be, it shall be the duty of Medical Device Officer to,—
p.000161: (i) Inspect, not less than once in a year, all manufacturing sites licenced by the Central Licensing Authority or
p.000161: State Licensing Authority, as the case may be, within the area assigned to him;
p.000161: (ii) conform that the conditions of licence are being observed;
p.000161: (iii) take samples of medical device manufactured or imported for sale, or stocked or exhibited for sale in respect
p.000161: of which the Medical Device Officer has reason to suspect contravention of the provisions of the Act or these rules and
p.000161: send them for test or evaluation:
p.000161: Provided that in case of large sized medical device, wherein the opinion of the Medical Device Officer drawing
p.000161: samples of such a device may not be physically practical, such large sized medical device shall be
p.000161: inspected at the place where these are kept by the Medical Device Officer with or without expert and evaluated or
p.000161: tested by the Medical Device Testing Officer, for any suspect contravention, after approval of the
p.000161: Central Licensing Authority or the State Licensing Authority, as the case may be;
p.000161: (iv) maintain a record of all inspections undertaken, drawing of samples, seizure of stocks and action
p.000161: taken by Medical Device Officer in exercise and performance of duties and to furnish copies of such record to the
p.000161: Central Licensing Authority or the State Licensing Authority, as the case may be;
p.000161: (v) make such enquiries and inspections as may be necessary to detect the manufacture or sale of medical device in
p.000161: contravention of any provision of the Act and these rules;
p.000161: (vi) investigate any complaint made in writing relating to medical device to the Medical Device Officer or any other
p.000161: senior officer in accordance with the direction of the controlling officer;
...
p.000163: hazard to public health.
p.000163:
p.000163: 83. Registration of medical device testing laboratory.—(1) Before grant of registration to any medical
p.000163: device testing laboratory by the Central Licensing Authority, the premises shall be inspected by the Medical Device
p.000163: Officer appointed by the Central Government with or without an expert in the concerned field for adequacy and
p.000163: suitability.
p.000163: (2) The Medical Device Officer, after completion of the inspection, shall forward a detailed descriptive report giving
p.000163: findings on each aspect of inspection along with recommendations to the Central Licensing Authority with a copy to the
p.000163: applicant.
p.000163: (3) If on receipt of the application and the report referred to in sub-rule (2), the Central Licensing
p.000163: Authority, is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules, the
p.000163: Central Licencing Authority may grant registration in Form MD-40 or if not satisfied, may, reject the
p.000163: application, for reasons to be recorded in writing, within a period of forty five days from the date of
p.000163: application.
p.000163: (4) The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of
p.000163: medical devices intended to be tested which shall be adequate in the opinion of the Central Licensing Authority.
p.000163: (5) The testing and evaluation of medical devices shall be under active direction of a person whose qualification and
p.000163: experience is considered adequate and who shall be held responsible for reports of test or evaluation issued.
p.000163: (6) The applicant shall provide standards recognised under the provisions of the Act and these rules
p.000163: and such standards of reference as may be required in connection with the testing or evaluation of the devices for the
p.000163: testing of which approval has been applied for.
p.000163:
p.000163: 84. Validity of registration.—A registration granted under sub-rule (3) of rule 83 in Form MD-40, shall remain valid in
p.000163: perpetuity, unless, it is suspended or cancelled, provided the registration holder deposits a registration retention
p.000163: fee to the Central Licensing Authority as specified in the Second Schedule after completion of every five years from
p.000163: the date of its issue:
p.000163: Provided, that the Central Licensing Authority may permit to deposit the registration retention fee after due date but
p.000163: before the expiry of six months with a late fee at the rate of two per cent. per mensem or part thereof:
p.000163: Provided further that, if the registration holder fails to deposit the registration retention fee within
p.000163: the above stipulated period, the registration shall be deemed to have been cancelled for all purposes.
p.000163:
p.000163: 85. Conditions of registration.—A registration granted under sub-rule (3) of rule 83 in Form MD-40,
p.000163: shall be subject to the following conditions, namely:—
...
p.000205: conducted. These studies may be initiated at various stages of clinical development or after
p.000205: post-marketing surveillance in adults, if a safety concern exists. In cases where there is limited paediatric data at
p.000205: the time of submission of application, more data in paediatric patients would be expected after
p.000205: marketing authorization for use in children is granted.
p.000205: (f) Paediatric subjects are legally unable to provide written informed consent, and are dependent on
p.000205: their parents or legal guardian to assume responsibility for their participation in clinical investigation. Written
p.000205: informed consent shall be obtained from the parent or legal guardian. However, all paediatric participants shall be
p.000205: informed to the fullest extent possible about the study in a language and in terms that they are able to understand.
p.000205: Where appropriate, paediatric participants should additionally assent to enroll in the study. Mature minors and
p.000205: adolescents should personally sign and date a separately designed written consent form. Although a participant’s wish
p.000205: to withdraw from a study shall be respected, there may be circumstances in therapeutic studies for serious or
p.000205: life-threatening diseases in which, in the opinion of the investigator and parent or legal guardian, the welfare
p.000205: of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this
p.000205: situation, continued parental or legal guardian consent will be sufficient to allow participation in the study.
p.000205: (g) For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall
p.000205: include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.
p.000205: (iii) Pregnant or nursing women:
p.000205: (a) Pregnant or nursing women shall be included in clinical investigation only when the medical device
p.000205: is intended for use by pregnant or nursing women or fetuses or nursing infants and where the data generated from women
p.000205: who are not pregnant or nursing, would not be suitable.
p.000205: (b) For medical device intended for use during pregnancy, follow-up data pertaining to a period appropriate for that
...
p.000217: Principal Investigator)
p.000217: 2. Name and address of the medical college, hospital or other facility where the Clinical Investigation will be
p.000217: conducted: Education, training & experience that qualify the Investigator for the clinical investigation
p.000217: (Attach details including medical council registration number, or any other statement(s) of qualification(s))
p.000217: 3. Name and address of all clinical facilities to be used in the clinical investigation.
p.000217: 4. Name and address of the Ethics Committee that is responsible for approval and continuing review of
p.000217: the clinical investigation.
p.000217: 5. Names of the other members of the research team (Co-Investigators or sub-Investigators) who will be
p.000217: assisting the Investigator in the conduct of the investigation (s).
p.000217: 6. Clinical Investigation Plan, Title and Clinical investigation number (if any) of the clinical investigation to be
p.000217: conducted by the Investigator.
p.000217: 7. Commitments:
p.000217: (i) I have reviewed the clinical investigation plan and agree that it contains all the necessary information
p.000217: to conduct the investigation. I will not begin the clinical investigation until all necessary Ethics Committee and
p.000217: regulatory approvals have been obtained.
p.000217: (ii) I agree to conduct the investigation in accordance with the current Clinical investigation plan. I will
p.000217: not implement any deviation from or changes of the Clinical investigation plan without agreement by the Sponsor
p.000217: and prior review and documented approval / favorable opinion from the Ethics Committee of
p.000217:
p.000217: 218 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000217: II—SEC. 3(i)]
p.000217:
p.000217: the amendment, except where necessary to eliminate an immediate hazard(s) to the clinical investigation participant or
p.000217: when the change(s) involved are only logistical or administrative in nature.
p.000217: (iii) I agree to personally conduct and/or supervise the clinical investigation at my site.
p.000217: (iv) I agree to inform all Subjects that the medical devices are being used for investigational purposes and I
p.000217: will ensure that the requirements relating to obtaining informed consent and Ethics Committee review and approval
p.000217: specified in this Schedule are met.
p.000217: (v) I agree to report to the Sponsor all adverse experiences that occur in the course of the investigation(s)
p.000217: in accordance with the regulatory and Good Clinical practice guidelines.
p.000217: (vi) I have read and understood the information in the Investigator's brochure, including the potential risks
p.000217: and side effects of the medical device.
p.000217: (vii) I agree to ensure that all associates, colleagues and employees assisting in the conduct of the
p.000217: clinical investigation are suitably qualified and experienced and they have been informed about their obligations in
p.000217: meeting their commitments in the clinical investigation.
p.000217: (viii) I agree to maintain adequate and accurate records and to make those records available for
...
p.000245: 3. This permission is subject to conditions as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the
p.000245: Medical Devices Rules, 2017.
p.000245:
p.000245:
p.000245:
p.000245:
p.000245: Place: Date: _
p.000245: Central Licensing Authority [To be signed digitally]
p.000245:
p.000245:
p.000245:
p.000245: S.N. Generic
p.000245:
p.000245: Brand
p.000245:
p.000245: Model
p.000245:
p.000245: Dimensi
p.000245:
p.000245: Intended
p.000245:
p.000245: Shelf life Sterile/
p.000245:
p.000245: Class of
p.000245: Annexure:
p.000245:
p.000245: Name
p.000245: name
p.000245: No. on
p.000245: Use
p.000245: Non Sterile
p.000245: medical device
p.000245:
p.000245:
p.000245:
p.000245: Form MD-30
p.000245: [See sub-rule (1) of rule 67]
p.000245:
p.000245: Memorandum to the Central Medical Device Testing Laboratory
p.000245:
p.000245: Serial Number ………………………….
p.000245:
p.000245: To
p.000245: The Director,
p.000245: Central Medical Device Testing Laboratory,
p.000245: ………………………………….
p.000245: ………………………………….
p.000245:
p.000245: From……...........................................
p.000245:
p.000245: 1. I send herewith, under the provisions of sub-section (4) of section 25 of the Drugs and Cosmetics Act, 1940 (23 of
p.000245: 1940), sample(s) of a medical device purporting to be for test or
p.000245: evaluation and request
p.000245: that a report of the result of the test or evaluation may be supplied to this Court.
p.000245:
p.000245: 2. The distinguishing number on the packet is ………………………………………………………..
p.000245:
p.000245: 3. Particulars of offence alleged ……………………………………………………………………….
p.000245:
p.000245: 4. Matter on which opinion is required …………………………………………………………………
p.000245:
p.000245: 246 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000245: II—SEC. 3(i)]
p.000245:
p.000245: 5. A fee of Rs has been deposited in Court.
p.000245:
p.000245: Date………………..
p.000245:
p.000245: ……………………..
p.000245: Magistrate
p.000245:
p.000245: Form MD-31
p.000245: [See sub-rule (4) of rule 67]
p.000245: Certificate of test or evaluation by the Central Medical Device Testing Laboratory
p.000245:
p.000245: 1. Certified that the samples, bearing number
p.000245: purporting to be a sample of
p.000245: …………………………… received on ………………………….. with memorandum No. ……………………..
p.000245: dated ………………………. from has been tested/evaluated and that the
p.000245: result of such
p.000245: test/evaluation is as stated below.
p.000245:
p.000245:
p.000245: 2. The condition of the seals on the packet on receipt was as follow.
p.000245:
p.000245: *3. In the opinion of the undersigned the sample is of standard quality/not of standard quality as defined in the Drugs
p.000245: and Cosmetics Act, 1940 (23 of 1940) and Medical Devices Rules, 2017 for the reasons given below.
p.000245:
p.000245:
p.000245:
p.000245: Date……………….. Director of
p.000245: Central Medical Device Testing Laboratory/ other Authorised Officer
p.000245:
p.000245: Details of results of testing or evaluation with protocols of test or evaluation applied
p.000245:
p.000245:
p.000245: Date……………….. Director of
p.000245: Central Medical Device Testing Laboratory/ other Authorised Officer
p.000245:
p.000245: *If opinion is required on any other matter, the paragraph should be suitably amended.
p.000245:
p.000245:
p.000245: Form MD-32
p.000245: [See sub-rule (2) of rule 68]
p.000245:
p.000245: Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer
p.000245:
p.000245:
p.000245: 1. It is certified that the samples having serial number of memorandum or receipt number
p.000245: dated:
p.000245: ……………… purporting to be sample of ……………………. received on …………….. from has
p.000245: been tested or evaluated and the results of tests or evaluation is as stated below.
p.000245:
p.000245: 2. The conditions of seals on the packet or on portion of sample or container were as follows …………….
p.000245:
p.000245: 2. Based upon the test or evaluation and in the opinion of undersigned the sample is of standard quality/ not of
p.000245: standard quality/ adulterated/misbranded/spurious, as defined in the Drugs and Cosmetics Act, 1940 (23 of
p.000245: 1940) for the reasons given below:-
p.000245:
p.000245:
p.000245:
p.000245: Date……………….
p.000245: Medical Device Testing Officer
p.000245: Seal or Stamp
p.000245:
p.000245: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000247: 247
p.000247:
p.000247:
p.000247: Form MD-33
p.000247: [See rule 69]
p.000247: Application from a purchaser for test or evaluation of a Medical Device under section 26 of the Drugs and Cosmetics
p.000247: Act, 1940 (23 of 1940)
p.000247:
p.000247: To
p.000247: The Central Licensing Authority,
p.000247:
p.000247:
p.000247:
p.000247:
p.000247: Sir/Madam,
p.000247:
p.000247:
p.000247: 1. Full name and address of the applicant
p.000247: ....................................................................................
p.000247: 2.
p.000247: Occupation..............................................................................................................
p.000247: .................
p.000247: 3. Name of medical device purporting to be contained in the sample..........................................
p.000247: 4. Name and full address of the pharmacy or concern where the medical device was purchased. 5. Date on which
p.000247: purchased (invoice attached)
p.000247: 6. Reasons why the medical device is being submitted for test or evaluation………………………….
p.000247: 7. A fee of rupees as charged by medical device
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000195: performance of the medical device or in vitro diagnostic medical devices.
p.000195: NOTE 1.-If a medical device or in vitro diagnostic medical devices can only be validated following
p.000195: assembly and installation at point of use, delivery is not considered to be complete until the product has been
p.000195: formally transferred to the customer.
p.000195: NOTE 2.-Provision of the medical device for purposes of clinical evaluations and/or evaluation of performance is
p.000195: not considered to be delivery.
p.000195: 7.3.7 Control of design and development changes:
p.000195: Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and
p.000195: validated, as appropriate, and approved before implementation. The review of design and development
p.000195: changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
p.000195: Records of the results of the review of changes and any necessary actions shall be maintained.
p.000195: Note.-Each manufacturer shall establish and maintain a Design History File for each type of device. The Design History
p.000195: File shall contain or reference the records necessary to demonstrate that the design was developed in accordance with
p.000195: the approved design plan and the requirements of design and development.
p.000195: 7.4 Purchasing,-
p.000195: 7.4.1 Purchasing process:
p.000195: The manufacturer organisation shall establish documented procedures to ensure that purchased product
p.000195: conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased
p.000195: product shall be dependent upon the effect of the purchased product on subsequent product realisation or the final
p.000195: product.
p.000195: The manufacturer shall evaluate and select suppliers based on their ability to supply product in
p.000195: accordance with the manufacturer’s requirements. Criteria for selection, evaluation and re-evaluation shall be
p.000195: established.
p.000195: Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.
p.000195: 7.4.2 Purchasing information:
p.000195: Purchasing information shall describe the product to be purchased, including where appropriate:-
p.000195: (a) requirements for approval of product, procedures, processes and equipment;
p.000195: (b) requirements for qualification of personnel; and
p.000195: (c) quality management system requirements.
p.000195: The manufacturer shall ensure the adequacy of specified purchase requirements prior to their communication
p.000195: to the supplier.
p.000195: To the extent required for traceability, the manufacturer shall maintain documents and records of
p.000195: relevant purchasing information.
p.000195: 7.4.3 Verification of purchased product:
p.000195: The manufacturer shall establish and implement the inspection or other activities necessary for ensuring that purchased
p.000195: product meets specified purchase requirements. Where the manufacturer intends to perform verification at the supplier’s
p.000195: premises, the manufacturer shall state the intended verification arrangements and method of product
p.000195: release in the purchasing information. Records of the verification shall be maintained.
p.000195: 7.5 Production and service provision.-
p.000195: 7.5.1 Control of production and service provision:
p.000195: 7.5.1.1 General requirements:
...
p.000205: (c) If the medical device is predominantly or exclusively used in paediatric patients, clinical investigation data
p.000205: should be generated in paediatric population except for initial safety and performance data, which will
p.000205: usually be obtained in adults unless such initial safety studies in adults would yield little useful information or
p.000205: expose them to inappropriate risk.
p.000205: (d) If the medical device is intended to treat serious or life-threatening diseases, occurring in both adults and
p.000205: paediatric patients, for which there are currently no or limited therapeutic options, paediatric
p.000205: population may be included in the clinical investigation early, following assessment of initial safety
p.000205: data and reasonable evidence of potential benefit. In circumstances where this is not possible, lack of data has to be
p.000205: justified.
p.000205: (e) If the medical device has a potential for use in paediatric patient, paediatric studies may be
p.000205: conducted. These studies may be initiated at various stages of clinical development or after
p.000205: post-marketing surveillance in adults, if a safety concern exists. In cases where there is limited paediatric data at
p.000205: the time of submission of application, more data in paediatric patients would be expected after
p.000205: marketing authorization for use in children is granted.
p.000205: (f) Paediatric subjects are legally unable to provide written informed consent, and are dependent on
p.000205: their parents or legal guardian to assume responsibility for their participation in clinical investigation. Written
p.000205: informed consent shall be obtained from the parent or legal guardian. However, all paediatric participants shall be
p.000205: informed to the fullest extent possible about the study in a language and in terms that they are able to understand.
p.000205: Where appropriate, paediatric participants should additionally assent to enroll in the study. Mature minors and
p.000205: adolescents should personally sign and date a separately designed written consent form. Although a participant’s wish
p.000205: to withdraw from a study shall be respected, there may be circumstances in therapeutic studies for serious or
p.000205: life-threatening diseases in which, in the opinion of the investigator and parent or legal guardian, the welfare
p.000205: of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this
p.000205: situation, continued parental or legal guardian consent will be sufficient to allow participation in the study.
p.000205: (g) For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall
p.000205: include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.
...
General/Other / Natural Hazards
Searching for indicator hazard:
(return to top)
p.000163: performance of special tests such as sterility tests, microbiological tests, etc;
p.000163: (ii) the applicant shall provide adequate space having regard to the nature and number of samples of medical devices
p.000163: proposed to be tested and evaluated:
p.000163: Provided that the approving authority shall determine from time to time whether the space provided
p.000163: continues to be adequate;
p.000163: (iii) if it is intended to carry out tests requiring the use of animals, the applicant shall provide for an animal
p.000163: house and comply with the following requirements:-
p.000163: (a) the animal house shall be adequate in area, well lighted and properly ventilated and the animals undergoing tests
p.000163: shall be kept in air conditioned area;
p.000163: (b) the animals shall be suitably housed in hygienic surroundings and necessary provisions made for
p.000163: removal of excreta and foul smell;
p.000163: (c) the applicant shall provide for suitable arrangements for preparation of animal feed;
p.000163: (d) the applicant shall provide for suitable arrangements for quarantining of all animals immediately on their arrival
p.000163: in the institution;
p.000163: (e) the animals shall be periodically examined for their physical fitness;
p.000163: (f) the applicant shall provide for isolation of sick animals as well as animals under test;
p.000163: (g) the applicant shall ensure compliance with the requirements of the Prevention of Cruelty to Animals Act, 1960 (59
p.000163: of 1960);
p.000163: (h) the applicant shall make proper arrangements for disposal of the carcasses of animals in a manner as not to cause
p.000163: hazard to public health.
p.000163:
p.000163: 83. Registration of medical device testing laboratory.—(1) Before grant of registration to any medical
p.000163: device testing laboratory by the Central Licensing Authority, the premises shall be inspected by the Medical Device
p.000163: Officer appointed by the Central Government with or without an expert in the concerned field for adequacy and
p.000163: suitability.
p.000163: (2) The Medical Device Officer, after completion of the inspection, shall forward a detailed descriptive report giving
p.000163: findings on each aspect of inspection along with recommendations to the Central Licensing Authority with a copy to the
p.000163: applicant.
p.000163: (3) If on receipt of the application and the report referred to in sub-rule (2), the Central Licensing
p.000163: Authority, is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules, the
p.000163: Central Licencing Authority may grant registration in Form MD-40 or if not satisfied, may, reject the
p.000163: application, for reasons to be recorded in writing, within a period of forty five days from the date of
p.000163: application.
p.000163: (4) The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of
p.000163: medical devices intended to be tested which shall be adequate in the opinion of the Central Licensing Authority.
...
p.000183: of in vitro diagnostic medical device, novel features (if any), claimed shelf life and a synopsis on the content of the
p.000183: dossier.
p.000183: 1.2 Regulatory status of the similar device in India (approved or new in vitro diagnostic medical device).
p.000183: 1.3 Domestic price of the in vitro diagnostic medical device in the currency followed in the country of origin.
p.000183: 1.4 Marketing history of the in vitro diagnostic medical device from the date of introducing the in vitro diagnostic
p.000183: medical device in the market.
p.000183: 1.5 List of regulatory approvals or marketing clearance obtained in below format (submit respective
p.000183: copy of approval certificate).
p.000183:
p.000183:
p.000183:
p.000183:
p.000183:
p.000183: S.N.
p.000183: Name of the country
p.000183: Approved indication
p.000183: Approved shelf life
p.000183:
p.000183: Composition
p.000183:
p.000183: Risk Class
p.000183: Date of first approval
p.000183:
p.000183: 184 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000183: II—SEC. 3(i)]
p.000183:
p.000183: 1.6 Status of pending request for market clearance
p.000183:
p.000183:
p.000183: Regulatory Agency of the country
p.000183: Intended use
p.000183: Indication for use
p.000183: Registration status and date
p.000183: Reason for rejection/withdrawal, if any
p.000183:
p.000183:
p.000183:
p.000183:
p.000183: 1.7 Safety and performance related information on the in vitro diagnostic medical device:
p.000183: (a) Summary of reportable events and field safety corrective action from the date of introduction For adverse event
p.000183: (false diagnosis or any other hazard during its use)
p.000183:
p.000183: Adverse event (false diagnosis)
p.000183: Frequency of occurrence during the period (number of report/total units sold)
p.000183:
p.000183:
p.000183:
p.000183:
p.000183: For Field Safety Corrective Action (FSCA)
p.000183:
p.000183:
p.000183: Date of FSCA
p.000183: Reason for FSCA
p.000183: Countries where FSCA was conducted
p.000183: Description of the action taken
p.000183:
p.000183:
p.000183:
p.000183:
p.000183: (b) If the in vitro diagnostic medical device contains any of the following then descriptive information on the
p.000183: following need to be provided.
p.000183: (1) Animal or human fluids or derivatives thereof, rendered non-viable.
p.000183: (2) Cells, tissues and/or derivatives of microbial recombinant origin.
p.000183: 2. Description and specification, including variants and accessories of the in vitro diagnostic medical device
p.000183: 2.1 Description
p.000183: The device master file should include the following device descriptive information:
p.000183: (a) it may include:-
p.000183: (1) what is detected;
p.000183: (2) its function (for example screening, monitoring, diagnostic or aid to diagnosis, staging or aid to staging
p.000183: of disease);
p.000183: (3) the specific disorder, condition or risk factor of interest that it is intended to detect,
p.000183: define or differentiate;
p.000183: (4) whether it is automated or not;
p.000183: (5) whether it is qualitative or quantitative;
p.000183: (6) the type of specimen required (eg. serum, plasma, whole blood, tissue biopsy, urine);
p.000183: (7) testing population;
p.000183: (b) the intended user (lay person or professional);
p.000183: (c) a general description of the principle of the assay method;
...
p.000217: 3. Name and address of all clinical facilities to be used in the clinical investigation.
p.000217: 4. Name and address of the Ethics Committee that is responsible for approval and continuing review of
p.000217: the clinical investigation.
p.000217: 5. Names of the other members of the research team (Co-Investigators or sub-Investigators) who will be
p.000217: assisting the Investigator in the conduct of the investigation (s).
p.000217: 6. Clinical Investigation Plan, Title and Clinical investigation number (if any) of the clinical investigation to be
p.000217: conducted by the Investigator.
p.000217: 7. Commitments:
p.000217: (i) I have reviewed the clinical investigation plan and agree that it contains all the necessary information
p.000217: to conduct the investigation. I will not begin the clinical investigation until all necessary Ethics Committee and
p.000217: regulatory approvals have been obtained.
p.000217: (ii) I agree to conduct the investigation in accordance with the current Clinical investigation plan. I will
p.000217: not implement any deviation from or changes of the Clinical investigation plan without agreement by the Sponsor
p.000217: and prior review and documented approval / favorable opinion from the Ethics Committee of
p.000217:
p.000217: 218 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000217: II—SEC. 3(i)]
p.000217:
p.000217: the amendment, except where necessary to eliminate an immediate hazard(s) to the clinical investigation participant or
p.000217: when the change(s) involved are only logistical or administrative in nature.
p.000217: (iii) I agree to personally conduct and/or supervise the clinical investigation at my site.
p.000217: (iv) I agree to inform all Subjects that the medical devices are being used for investigational purposes and I
p.000217: will ensure that the requirements relating to obtaining informed consent and Ethics Committee review and approval
p.000217: specified in this Schedule are met.
p.000217: (v) I agree to report to the Sponsor all adverse experiences that occur in the course of the investigation(s)
p.000217: in accordance with the regulatory and Good Clinical practice guidelines.
p.000217: (vi) I have read and understood the information in the Investigator's brochure, including the potential risks
p.000217: and side effects of the medical device.
p.000217: (vii) I agree to ensure that all associates, colleagues and employees assisting in the conduct of the
p.000217: clinical investigation are suitably qualified and experienced and they have been informed about their obligations in
p.000217: meeting their commitments in the clinical investigation.
p.000217: (viii) I agree to maintain adequate and accurate records and to make those records available for
p.000217: audit / inspection by the Sponsor, Ethics Committee, Licensing Authority or their authorized representatives, in
p.000217: accordance with regulatory and provisions of these rules. I will fully cooperate with any clinical
...
General/Other / Other Country
Searching for indicator other country:
(return to top)
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000203: right to claim compensation in case of investigation related injury or death. He shall also inform the subject or his/
p.000203: her nominee(s) of their rights to contact the Sponsor or his representative whosoever had obtained permission from the
p.000203: Central Licensing Authority for conduct of the clinical investigation for making claims in case of
p.000203: investigation related injury or death.
p.000203:
p.000203: (4) Responsibilities of the Ethics Committee:
p.000203: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical
p.000203: Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should
p.000203: exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the
p.000203: study. Explanation.- The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners,
p.000203: armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with
p.000203: incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority
p.000203: groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics
p.000203: committee(s) get documented ‘standard operating procedures’ and should maintain a record of its proceedings.
p.000203: (ii) Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation
p.000203: of the Clinical Investigation Plan. Such review may be based on periodic study progress reports
p.000203: furnished by investigators or monitoring and internal audit reports furnished by the Sponsor.
p.000203: (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record
p.000203: the reasons for doing so and at once, communicate such a decision to the Investigator as well as to the
p.000203: Central Licensing Authority.
p.000203: (iv) Any report of serious adverse event occurring during clinical investigation, after due analysis,
p.000203: shall be forwarded by the Chairman of Ethics Committee to the Central Licensing Authority and to the
...
p.000211: (c) Notification requirements and time frames.
p.000211: (d) Corrective and preventive actions and principal investigator disqualification criteria.
p.000211:
p.000211: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000213: 213
p.000213: 1.11 Device accountability.
p.000213: Description of the procedures for the accountability of investigational medical devices should be maintained.
p.000213: 1.12 Statements of compliance.
p.000213: (a) Statement specifying that the clinical investigation shall be conducted in accordance with the ethical principles
p.000213: as prescribed in Good Clinical Practices.
p.000213: (b) Statement specifying that the clinical investigation shall not begin until the required approval from the
p.000213: Ethics Committee.
p.000213: (c) Statement specifying that any additional requirements imposed by the Ethics Committee or Central Licensing
p.000213: Authority shall be followed, if appropriate.
p.000213: (d) Statement specifying the type of insurance that shall be provided for subjects, if appropriate.
p.000213: 1.13 Informed consent process.
p.000213: (a) Description of the general process for obtaining informed consent, including the process for providing subjects
p.000213: with new information, as needed.
p.000213: (b) Description of the informed consent process in circumstances where the subject is unable to give it; in the case
p.000213: of emergency treatment, process should be clearly specified.
p.000213: 1.14 Adverse events, adverse device effects and device deficiencies.
p.000213: (a) Definitions of adverse events and adverse device effects.
p.000213: (b) Definition of device deficiencies.
p.000213: (c) Definitions of serious adverse events and serious adverse device effects and, where appropriate, unanticipated
p.000213: serious adverse device effects.
p.000213: (d) Time period in which the principal investigator shall report all adverse events and device deficiencies to the
p.000213: sponsor and, where appropriate, to Ethics Committee and the regulatory authority.
p.000213: (e) Details of the process for reporting adverse events (date of the adverse event, treatment, resolution, assessment
p.000213: of both the seriousness and the relationship to the investigational medical device).
p.000213: (f) Details of the process for reporting device deficiencies.
p.000213: (g) List of foreseeable adverse events and anticipated adverse device effects, together with their likely incidence,
p.000213: mitigation or treatment.
p.000213: (h) Emergency contact details for reporting serious adverse events and serious adverse device effects.
p.000213: 1.15 Vulnerable population.
p.000213: (a) Description of the vulnerable population.
p.000213: (b) Description of the specific informed consent process.
p.000213: (c) Description of the Ethics Committee specific responsibility.
p.000213: (d) Description of what medical care, if any, will be provided for subjects after the clinical investigation has been
p.000213: completed.
p.000213: 1.16 Suspension or premature termination of the clinical investigation.
p.000213: (a) Criteria and arrangements for suspension or premature termination of the whole clinical investigation or of the
p.000213: clinical investigation in one or more investigation sites.
p.000213: (b) Criteria for access to and breaking the blinding or masking code in case of suspension or premature termination of
p.000213: the clinical investigation, if the clinical investigation involves a blinding or masking technique.
p.000213: (c) Requirements for subject follow-up.
p.000213: 1.17 Publication policy.
p.000213: (a) Statement indicating whether the results of the clinical investigation will be submitted for publication.
p.000213: (b) Statement indicating the conditions under which the results of the clinical investigation will be
p.000213: offered for publication.
p.000213: Table 6
p.000213: Case Report Form (CRF)
p.000213: 1. General
p.000213: (i) Case Report Forms are established to implement the clinical investigation plan, to facilitate
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000143: (a) “academic clinical study” means a clinical study conducted for academic purpose on a medical device for the
p.000143: approved or a new intended use, new material of construction, new improved design or new population;
p.000143: (b) “Act” means the Drugs and Cosmetics Act, 1940 (23 of 1940);
p.000143: (c) "active diagnostic medical device" means any active medical device used, whether alone or in combination with
p.000143: other medical devices, to supply information for detecting, diagnosing or monitoring, or to provide support in the
p.000143: treatment of, any physiological condition, state of health, illness or congenital deformity;
p.000143: (d) “active medical device” means a medical device, the operation of which depends on a source of electrical energy
p.000143: or any other source of energy other than the energy generated by human or animal body or gravity;
p.000143: (e) “active therapeutic medical device" means any active medical device used, whether alone or in
p.000143: combination with any other medical device, to support, modify, replace or restore biological functions or structures,
p.000143: with a view to the treatment or alleviation of any illness, injury or handicap;
p.000143: (f) “authorised agent” means a person including any firm or organisation who has been appointed by an overseas
p.000143: manufacturer through a power of attorney to undertake import of medical device in India;
p.000143:
p.000143: (g) “body orifice” means any natural opening in a human body including the external surface of any eyeball, or any
p.000143: permanent artificial opening, such as a stoma or permanent tracheotomy;
p.000143: (h) “Central Licensing Authority” means the Drugs Controller General of India appointed by
p.000143: the Central Government;
p.000143: (i) “central medical devices testing laboratory” means a medical devices laboratory established or designated by
p.000143: the Central Government under rule 19 and shall be deemed to be a Central Drug Laboratory established
p.000143: for the purpose of section 6 of the Act;
p.000143: (j) “change in the constitution of a licencee” in relation to,-
p.000143:
p.000143: 144 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000143: II—SEC. 3(i)]
p.000143:
p.000143: (i) a firm means change from proprietorship to partnership including Limited Liability Partnership or vice versa;
p.000143: (ii) a company means-
p.000143: (A) its conversion from a private to a public company, or from a public to a private company; or
p.000143: (B) any change in the ownership of shares of more than fifty per cent. of the voting capital in the body
p.000143: corporate or in case of a body corporate not having a share capital, any change in its membership; and
p.000143: where the managing agent, being a body corporate is a subsidiary of another body corporate, includes a change
p.000143: in the constitution of that other body corporate within the meaning of this clause;
p.000143: (k) “clinical evidence” means, in relation to,-
p.000143: (i) an in vitro diagnostic medical device, is all the information derived from specimen collected from
p.000143: human that supports the scientific validity and performance for its intended use;
p.000143: (ii) a medical device, the clinical data and the clinical evaluation report that supports the scientific validity and
p.000143: performance for its intended use;
...
p.000143: manufacturer to determine that a medical device is safe and performs as intended by the manufacturer and therefore
p.000143: conforms to the essential principles of safety and performance for medical devices;
p.000143: (q) “controlling officer” means the officer designated under rule 10;
p.000143: (r) “custom made medical device” means a medical device made specifically in accordance with a
p.000143: written prescription of a registered medical practitioner, specialised in the relevant area, under his responsibility
p.000143: for the sole use of a particular patient, but does not include a mass production of such device;
p.000143: (s) “Ethics Committee” means the committee referred to in rule 50;
p.000143: (t) “Form” means forms specified in Appendix to these rules;
p.000143: (u) “Good Clinical Practices Guidelines” means Good Clinical Practices Guidelines issued by Central
p.000143: Drugs Standards Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare,
p.000143: Government of India;
p.000143: (v) “intended use” means the use for which the medical device is intended according to the data supplied
p.000143: by the manufacturer on the labelling or in the document containing instructions for use of such device
p.000143: or in promotional material relating to such device, which is as per approval obtained from the Central
p.000143: Licensing Authority;
p.000143: (w) “invasive device” means a device which, in whole or part, penetrates inside the body, either
p.000143: through a body orifice or through the surface of the body;
p.000143: (x) “investigational medical device” in relation to a medical device, other than in vitro diagnostic medical
p.000143: device, means a medical device specified in clause (zb),-
p.000143: (i) which does not have its predicate device as defined in clause (zm); or
p.000143: (ii) which is licenced under sub-rule (4) or sub-rule (6) of rule 20, sub-rule (1) of rule 25, or sub-rule (1) of
p.000143: rule 36 and claims for new intended use or new population or new material or major design change;
p.000143: and is being assessed for safety or performance or effectiveness in a clinical investigation.
p.000143: (y) “licence” means a licence granted by the State Licensing Authority or the Central Licensing Authority in Form
p.000143: MD-5, Form MD-6, Form MD-9, Form MD-10, Form MD-15, Form MD-17 or Form MD-19 as the case may be;
p.000143: (z) “loan licence” means a licence issued for manufacturing a medical device by the State Licensing Authority or
p.000143: the Central Licensing Authority, as the case may be, to a person who intends to utilise the manufacturing site of other
p.000143: licencee for manufacturing the same medical device as manufactured by the licencee at that site;
p.000143: (za) “long term use” means intended continuous use of a medical device for more than thirty days; (zb) “medical device”
p.000143: means,-
p.000143: (A) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical
p.000143: sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause
p.000143: (i),
p.000143: (B) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and
p.000143: insecticides notified in the Official Gazette under sub-clause (ii),
p.000143: (C) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act;
p.000143: Explanation: For the purpose of these rules, substances used for in vitro diagnosis shall be referred
p.000143: as in vitro
p.000143: diagnostic medical device.
p.000143:
p.000143: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000145: 145
p.000145: (zc) “medical device grouping” means a set of devices having same or similar intended uses or
p.000145: commonality of technology allowing them to be classified in a group not reflecting specific characteristics;
p.000145: (zd) “Medical Device Officer” means an officer appointed or designated by the Central Government or the
p.000145: State Government, as the case may be, under sub-rule (2) of rule 18;
p.000145: (ze) “medical devices testing laboratory” means any institute, organisation registered under sub-rule (3) of rule 83
p.000145: for carrying out testing or evaluation of any medical device on behalf of a licencee for manufacture for sale;
p.000145: (zf) “Medical Device Testing Officer” means an officer appointed or designated by the Central Government
p.000145: under sub-rule (1) of rule 18;
p.000145: (zg) "near-patient testing" means any investigation carried out in a clinical setting or at the patient's home for
p.000145: which the result is available without reference to a laboratory and rapidly enough to affect immediate
p.000145: patient management;
p.000145: (zh) “new in vitro diagnostic medical device” means any medical device as referred to in sub-clause (A) of clause (zb)
p.000145: used for in vitro diagnosis that has not been approved for manufacture for sale or for import by the
p.000145: Central Licensing Authority and is being tested to establish its performance for relevant analyte or
p.000145: other parameter related thereto including details of technology and procedure required;
p.000145:
p.000145:
p.000145: (zi) “notified” means notified in the Official Gazette by the Central Government.
p.000145: (zj) “Notified Body” means a body corporate or other legal entity, registered under rule 13 as a body competent to
p.000145: carry out the audit of manufacturing site, assessment, and verification of specified category of medical devices for
p.000145: establishing conformity with standards;
p.000145: (zk) “performance evaluation” in relation to in vitro diagnostic medical device means any systematic investigation by
p.000145: which data is assessed and analysed to establish or verify performance of the in vitro diagnostic medical device for
p.000145: its intended use;
p.000145: (zl) “Post Marketing Surveillance” means systematic process to collect and analyse information gained from medical
p.000145: device that have been placed in the market;
p.000145: (zm) “predicate device” means a device, first time and first of its kind, approved for manufacture for sale or for
p.000145: import by the Central Licensing Authority and has the similar intended use, material of construction, and
p.000145: design characteristics as the device which is proposed for licence in India;
p.000145: (zn) “Quality Management System” means requirements for manufacturing of medical devices as specified in
p.000145: the Fifth Schedule;
p.000145: (zo) “reagent” means a chemical, biological or immunological component, solution or preparation intended
p.000145: by the manufacturer to be used as in vitro diagnostic medical device;
p.000145: (zp) “recall” means any action taken by its manufacturer or authorised agent or supplier to remove the medical device
p.000145: from the market or to retrieve the medical device from any person to whom it has been supplied, because the medical
p.000145: device,—
p.000145: (a) is hazardous to health; or
p.000145: (b) fails to conform to any claim made by its manufacturer relating to its quality, safety or efficacy; or
p.000145: (c) does not meet the requirements of the Act and these rules;
p.000145: (zq) “serious adverse event” means an untoward medical occurrence that leads to,—
p.000145: (i) a death; or
p.000145: (ii) a serious deterioration in the health of the subject that either-
p.000145: (A) resulted in a life-threatening illness or injury; or
p.000145: (B) resulted in a permanent impairment of a body structure or a body function; or
p.000145: (C) required in-patient hospitalisation or prolongation of existing hospitalization; or
p.000145: (D) resulted in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment
p.000145: to a body structure or a body function; or
p.000145: (iii) foetal distress, foetal death or a congenital abnormality or birth defect;
p.000145: (zr) “short term use” means intended continuous use of a medical device for not less than sixty minutes but not more
p.000145: than thirty days;
p.000145: (zs) “specimen receptacle” means a device, whether vacuum type or not, specifically intended by its manufacturer for
p.000145: the primary containment of specimens derived from human or animal body;
p.000145: (zt) “sponsor” includes a person, an investigator, a company or an institution or an organisation responsible for the
p.000145: initiation and management of a clinical investigation or clinical performance evaluation in India;
p.000145: (zu) “State Licensing Authority” means the authority designated by the State Government under sub-rule (2) of rule 8;
p.000145: (zv) “transient use” means a device intended for continuous use for less than sixty minutes;
p.000145: (zw) “transmissible agent”, for the purpose of classification of in vitro diagnostic medical device, means
p.000145: an agent capable of being transmitted to a person, which causes communicable, infectious or contagious disease.
p.000145: (zx) words and expressions used but not defined in these rules, shall have the meanings respectively assigned to them
p.000145: in the Act and the Drugs and Cosmetics Rules, 1945.
p.000145:
p.000145: 146 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000145: II—SEC. 3(i)]
p.000145:
p.000145: CHAPTER II REGULATION OF MEDICAL DEVICE.
p.000145: 4. Classification of medical devices.— (1) Medical devices other than in vitro diagnostic medical devices shall be
p.000145: classified on the basis of parameters specified in Part I of the First Schedule, in the following classes, namely:—
p.000145: (i) low risk - Class A;
p.000145: (ii) low moderate risk- Class B;
p.000145: (iii) moderate high risk- Class C;
p.000145: (iv) high risk- Class D.
p.000145: (2) In vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part II of the
p.000145: First Schedule, in the following classes, namely:—
p.000145: (i) low risk - Class A;
p.000145: (ii) low moderate risk- Class B;
p.000145: (iii) moderate high risk- Class C;
p.000145: (iv) high risk- Class D.
p.000145: (3) The Central Licencing Authority shall, classify medical devices referred to in rule 2, based on the intended use
p.000145: of the device and other parameters specified in the First Schedule.
p.000145: (4) Based on the classification referred to in sub-rule (3), class wise list of medical devices shall be published on
p.000145: the website of the Central Drugs Standard Control Organisation:
p.000145: Provided that the Central Licencing Authority may, from time to time, make additions or deletions in such list of
p.000145: medical devices or modify the class of any medical device.
p.000145:
p.000145: 5. Medical device grouping.— Any person who intends to apply for grant of licence in respect of medical devices for,-
p.000145: (i) import;
p.000145: (ii) manufacture for sale or for distribution; and
p.000145: (iii) sale, stock, exhibit or offer for sale,
p.000145: may group all or any medical device in accordance with the guidelines to be issued from time to time by the Ministry
p.000145: of Health and Family Welfare in the Central Government, by taking into consideration the technological changes or
p.000145: development in the field of medical devices and in vitro diagnostic medical devices.
p.000145:
p.000145: 6. Essential principles for manufacturing medical devices.—Medical device manufacturer shall follow the
p.000145: essential principles of safety and performance of medical devices as may be specified in the guidelines issued by the
p.000145: Ministry of Health and Family Welfare in the Central Government, from time to time keeping in view the
p.000145: contemporary scientific and technological knowledge and development:
p.000145: Provided that the guidelines to be so specified shall be in conformity with the provisions of the Act and these rules.
p.000145:
p.000145: 7. Product standards for medical device.— (1) The medical device shall conform to the standards laid down by the
p.000145: Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as
p.000145: may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.
p.000145: (2) Where no relevant Standard of any medical device has been laid down under sub-rule (1), such
p.000145: device shall conform to the standard laid down by the International Organisation for Standardisation (ISO)
p.000145: or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards.
p.000145: (3) In case of the standards which have not been specified under sub-rule (1) and sub-rule (2), the
p.000145: device shall conform to the validated manufacturer’s standards.
p.000145:
p.000145: CHAPTER III AUTHORITIES, OFFICERS AND BODIES.
p.000145: 8. Licensing Authorities.— (1) The Central Licensing Authority shall be the competent authority for enforcement of
p.000145: these rules in matters relating to,-
p.000145: (i) import of all Classes of medical devices;
p.000145: (ii) manufacture of Class C and Class D medical devices;
p.000145: (iii) clinical investigation and approval of investigational medical devices;
p.000145: (iv) clinical performance evaluation and approval of new in vitro diagnostic medical devices and;
p.000145: (v) co-ordination with the State Licensing Authorities.
p.000145: (2) The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and
p.000145: shall be the competent authority for enforcement of these rules in matters relating to,-
p.000145: (i) manufacture for sale or distribution of Class A or Class B medical devices;
p.000145: (ii) sale, stock, exhibit or offer for sale or distribution of medical devices of all classes.
p.000145:
p.000145: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000147: 147
p.000147:
p.000147:
p.000147: 9. Delegation of powers of Licensing Authorities.— (1) The Central Licensing Authority, may with the
p.000147: prior approval of the Central Government, by an order in writing, delegate all or any of its powers to any other
p.000147: officer of the Central Drugs Standard Control Organisation not below the rank of Assistant Drugs Controller.
p.000147: (2) The officer to whom the powers have been delegated under sub-rule (1) shall exercise the powers of the Central
p.000147: Licensing Authority under its name and seal.
p.000147: (3) The State Licensing Authority, may, with the prior approval of the State Government, by an order
p.000147: in writing, delegate all or any of its powers to any officer under its control.
p.000147: (4) The officer to whom the powers have been delegated under sub-rule (3) shall exercise the powers of
p.000147: the State Licensing Authority under its name and seal.
p.000147:
p.000147: 10. Controlling officer.— Any officer not below the rank of Assistant Drugs Controller, by whatever name called, shall
p.000147: be the controlling officer to supervise and give instructions to any officer subordinate to such controlling officer to
p.000147: exercise powers and functions under these rules for areas and purposes specified, by an order, of the
p.000147: Drugs Controller General of India or the Drugs Controller, by whatever name called, of the State concerned.
p.000147:
p.000147: 11. National Accreditation Body.— (1) The Central Government may, by notification, designate such institute, firm or a
p.000147: Government aided or Government organisation, which fulfills the criteria specified from time to time by
p.000147: the Government, as the National Accreditation Body:
p.000147: Provided that the National Accreditation Board for Certification Bodies under the Quality Council of India, registered
p.000147: under the Societies Registration Act, 1860 (21 of 1860) set up by the Ministry of Commerce and Industry in the
p.000147: Government of India shall act as the National Accreditation Body for the purposes of accrediting Notified Bodies
p.000147: referred to in rule 13, till such time any other body for the purpose is notified, with immediate effect.
p.000147: (2) The National Accreditation Body shall have the required number of competent persons for proper performance of its
p.000147: functions
p.000147: (3)The designated National Accreditation Body referred to in sub-rule (1) shall be responsible for carrying out
...
p.000147: (4) The National Accreditation Body referred to in sub-rule (1), shall, after carrying out the assessment of the entity
p.000147: which applied for accreditation, issue a certificate to such entity in respect of specified categories of
p.000147: standards for which such entity has been assessed and found qualified:
p.000147: Provided that where the entity has been found not possessing the requisite qualification and
p.000147: other requirements, the National Accreditation Body, shall reject the application.
p.000147: (5) The National Accreditation Body shall not act as a Notified Body.
p.000147:
p.000147: 12. Functions of National Accreditation Body.— The National Accreditation Body shall,-
p.000147: (a) lay down the conformity assessment activities for accreditation of Notified Bodies and lay down standards for
p.000147: such accreditation;
p.000147: (b) prepare norms and procedures for accreditation of Notified Body;
p.000147: (c) audit a Notified Body periodically for assessing conformance with these rules and the norms laid down by it.
p.000147:
p.000147: 13. Notified body.— (1) Any institute, organisation or body corporate may seek accreditation, after notification of
p.000147: these rules, as a Notified Body by applying to the National Accreditation Body referred to in rule 11 in such form and
p.000147: manner as may be determined by the National Accreditation Body from time to time.
p.000147: (2) The Notified Body accredited under sub-rule (1) shall be competent to carry out audit of manufacturing sites of
p.000147: Class A and Class B medical devices to verify conformance with the Quality Management System and other
p.000147: applicable standards as specified under these rules in respect of such medical devices as and when so advised by the
p.000147: State Licensing Authority.
p.000147: (3) Any Notified Body accredited under sub-rule (1) shall, if it intends to carry out audit of a manufacturing site of
p.000147: Class A or Class B of medical devices in accordance with sub-rule (2), register with the Central Licensing Authority.
p.000147: (4) Any Notified Body under sub-rule (3), with an experience of at least two years, may apply to the
p.000147: Central Licensing Authority for registration as a Notified Body for carrying out audit of Class C and Class D medical
p.000147: devices, provided it has personnel with requisite qualification and experience.
p.000147: (5) With effect from the 1st day of the July, 2017, the Notified Body accredited in accordance with sub-rule (3) may
p.000147: make an application to the Central Licensing Authority for registration in Form MD-1 through online
p.000147: portal accompanied with a fee specified in the Second Schedule along with documents as specified in Part I of the
p.000147: Third Schedule.
p.000147: (6) The Central Licensing Authority, on being satisfied, shall register the Notified Body and issue a
p.000147: registration certificate in Form MD-2.
p.000147: (7) The Registration Certificate shall remain valid in perpetuity, unless, it is suspended or cancelled,
p.000147: provided the registration certificate holder deposits a registration retention fee as specified in the Second Schedule
p.000147: every five years from the date of its issue.
p.000147:
p.000147: 148 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000147: II—SEC. 3(i)]
p.000147:
p.000147: (8) If the registration certificate holder fails to pay the required registration certificate retention fee on or
p.000147: before due date as referred to in sub-rule (7), the registration certificate holder shall, in addition to the retention
p.000147: fee, be liable to pay a late fee calculated at the rate of two per cent. of the registration certificate retention fee
p.000147: for every month or part thereof within ninety days, and in the event of non-payment of such fee during that period, the
p.000147: registration certificate shall be deemed to have been cancelled.
p.000147: (9) The Notified Body shall perform the functions as specified in Part II of the Third Schedule.
p.000147: (10) The Central Licensing Authority, may, in cases where the requirement specified for registration of Notified Body
p.000147: have not been complied with, reject the application and shall inform the applicant of the reasons for such rejection.
p.000147: (11) An applicant who is aggrieved by the decision of the Central Licensing Authority under sub-rule (10), may file an
p.000147: appeal within forty five days from the date of receipt of such rejection before the Central Government, which may after
p.000147: such enquiry and after giving an opportunity of being heard to the appellant, dispose of the appeal
p.000147: within a period of sixty days.
p.000147:
p.000147: 14. Duties of Notified Body.— A registered Notified Body, referred to in rule 13, shall carry out its
p.000147: duties and functions, in respect of Class A or Class B medical devices as specified in Part II of the Third Schedule.
p.000147:
p.000147: 15. Procedure to be adopted by Notified Body.— A registered Notified Body shall carry out its duties and functions
p.000147: either by itself or by any other qualified person on its behalf as per specified procedure as detailed in Part II of
p.000147: the Third Schedule.
p.000147:
p.000147: 16. Fees to be charged by Notified Body.— A registered Notified Body may charge fee from the applicant for the services
p.000147: rendered by it as may be determined by the Central Government.
p.000147:
p.000147: 17. Suspension and cancellation of registration certificate of Notified Body. — (1) The Central Licensing
p.000147: Authority may, after giving an opportunity to show cause as to why such an order should not be passed, by an order in
p.000147: writing stating the reasons therefor, cancel the registration of a Notified Body or suspend it for such period as the
p.000147: Central Licensing Authority thinks fit, if in its opinion, the Notified Body has failed to comply with any provision of
p.000147: these rules.
p.000147: (2) A registered Notified Body whose registration has been suspended or cancelled under sub-rule (1) may,
p.000147: within thirty days of the receipt of a copy of the order by it, prefer an appeal to the Central Government
p.000147: and the Central Government may, after giving the Notified Body an opportunity of being heard, confirm,
p.000147: reverse or modify such order.
p.000147: (3) The registration of a Notified Body with the Central Licensing Authority shall be deemed to have been cancelled
p.000147: with effect from the expiry of the date of the validity of its accreditation by a National Accreditation Body.
p.000147:
p.000147: 18. Medical Device Testing Officer and Medical Device Officer.— (1) The Central Government may designate a Government
p.000147: Analyst appointed under section 20 of the Act as Medical Device Testing Officer.
p.000147: (2) The Central Government or, as the case may be, the State Government, may designate an Inspector
p.000147: appointed under section 21 of the Act as Medical Device Officer.
p.000147: (3) The Medical Device Testing Officer and Medical Device Officer designated under sub-rule (1) and sub-rule (2)
p.000147: respectively, while exercising powers and duties under the Act and these rules, shall be deemed to have
p.000147: been appointed as the Government Analyst and the Inspector, respectively.
p.000147:
p.000147: 19. Central medical device testing laboratory.— (1) The Central Government may, by notification, establish
p.000147: Central medical devices testing laboratory for the purpose of,—
p.000147: (a) testing and evaluation of medical devices; or
p.000147: (b) functioning as an appellate laboratory; or
p.000147: (c) to carry out any other function as may be specifically assigned to it.
p.000147: (2) Without prejudice to sub-rule (1), the Central Government may also designate any laboratory having facility for
p.000147: carrying out test and evaluation of medical devices as central medical devices testing laboratory for
p.000147: the purposes specified in sub-rule (1):
p.000147: Provided that no medical devices testing laboratory, shall be so designated unless it has been duly accredited by the
p.000147: National Accreditation Body for Testing and Calibration Laboratories.
p.000147:
p.000147: CHAPTER IV
p.000147: MANUFACTURE OF MEDICAL DEVICES FOR SALE OR FOR DISTRIBUTION
p.000147:
p.000147: 20. Application for manufacture for sale or for distribution of Class A or Class B medical device.— (1)
p.000147: Any person who intends to manufacture a Class A or Class B medical device including in vitro diagnostic medical device
p.000147: shall make an application for grant of licence or loan licence to manufacture for sale or for distribution to the State
p.000147: Licensing Authority.
p.000147: (2) The application under sub-rule (1) shall be made through an identified online portal of the Ministry of Health and
p.000147:
p.000147: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000149: 149
p.000149: Family Welfare in the Central Government in Form MD-3 for licence or in Form MD-4 for loan licence accompanied with a
p.000149: fee, as specified in the Second Schedule along with respective documents as specified in Part II of the Fourth
p.000149: Schedule.
p.000149: (3) The application made under sub-rule (1), shall, amongst others, be accompanied with an undertaking to the effect
p.000149: that the requirements of Quality Management System as specified in the Fifth Schedule have been complied with.
p.000149: (4) The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the requirements of
p.000149: these rules have been complied with, grant a licence to manufacture Class A medical devices in Form MD-5 or loan
p.000149: licence in Form MD-6, as the case may be, or if not satisfied, reject the application for reasons to
p.000149: be recorded in writing, within forty five days from the date, the application is made under sub-rule (1).
p.000149: Provided that,—
p.000149: (i) no audit of the manufacturing site shall be necessary prior to grant of licence or loan licence to manufacture for
p.000149: sale or for distribution of Class A medical device; and
p.000149: (ii) the required audit of such manufacturing site by the registered Notified Body in the manner as specified in the
p.000149: Third Schedule shall be carried out within one hundred and twenty days from the date on which the licence was granted
p.000149: by the State Licencing Authority.
p.000149: (5) Manufacturing site of the applicant, in respect of Class B device, shall conform to the requirements of
p.000149: Quality Management System as specified under the Fifth Schedule and applicable standards as specified under these rules
p.000149: and such conformance shall be verified through an audit by a Notified Body as referred under rule 13 before
p.000149: grant of licence.
p.000149: (6) In case of application for grant of licence or loan licence to manufacture for sale or for distribution of
p.000149: Class B medical devices,—
p.000149: (i) the audit of the manufacturing site shall be carried out within ninety days from the date of application by the
p.000149: registered Notified Body in the manner specified in the Third Schedule;
p.000149: (ii) the Notified Body shall furnish its report to the State Licensing Authority within thirty days of the completion
p.000149: of audit;
p.000149: (iii) the State Licensing Authority shall, after scrutiny of documents, audit report as referred to in clause (ii) and
p.000149: on being satisfied that the requirements of these rules have been complied with, grant a licence to manufacture Class B
p.000149: medical devices in Form MD-5 or loan licence in Form MD-6, as the case may be, or if not satisfied,
p.000149: reject the application for reasons to be recorded in writing, within a period of twenty days from the date of receipt
p.000149: of the report of audit by the Notified Body.
p.000149: (7) If the application for grant of licence or loan licence to manufacture for sale or for distribution is rejected
p.000149: under sub-rule (4) or sub-rule (6), the aggrieved person may file an appeal before the State Government within
p.000149: forty-five days from the date of receipt of such rejection, which may, after such enquiry and after giving an
p.000149: opportunity of being heard to the appellant, be disposed of within a period of sixty days.
p.000149: (8) Where the Central Licensing Authority or the State Licensing Authority has reason to believe or it
p.000149: has been alleged or suspected that the medical device does not conform to the standards of quality, or the
p.000149: provisions of the Fifth Schedule are not complied with, the State licensing Authority, in case of Class A or Class B
p.000149: medical device, or the Central Licensing Authority, in case of any Class of medical device, may direct a team of
p.000149: officers referred to in rule 23 to cause inspection of licenced manufacturing site.
p.000149:
p.000149: 21. Application for manufacturing Class C or Class D devices.— (1) An application shall be made to the Central
p.000149: Licensing Authority through an identified online portal of the Central Government for licence or loan
p.000149: licence to manufacture for sale or for distribution, as the case may be, of Class C or Class D medical device in Form
p.000149: MD-7 or Form MD-8, respectively.
p.000149: (2) The application in Form MD-7 or Form MD-8 referred to in sub-rule (1) relating to Class C or Class D medical
p.000149: device, as the case may be, shall be accompanied with a fee as specified in the Second Schedule along
p.000149: with documents as specified in clause (ii) of Part II of the Fourth Schedule.
p.000149: (3) The Central Licensing Authority may, wherever required, in case of Class C or Class D medical devices, use the
p.000149: services of any expert in the relevant field for scrutiny of application and other technical documents.
p.000149: (4) The scrutiny referred to in sub-rule (3) shall be completed by the Central Licensing Authority within a period of
p.000149: forty five days from the date of online submission of application.
p.000149: (5) In case, where the documents are found to be complete and in order, the Central Licensing Authority shall cause an
p.000149: inspection of the manufacturing site carried out under rule 23 by a team of officers accompanied by such experts, as
p.000149: may be considered necessary.
p.000149: (6) The Central Licensing Authority may, where required, avail the services of a Notified Body referred to in sub-rule
p.000149: (4) of rule 13 for inspecting the manufacturing site of Class C and Class D medical devices.
p.000149: (7) In case, where the documents furnished with the application referred to in sub-rule (1) are not
p.000149: found to be complete and in order, the Central Licensing Authority shall reject the application and inform
p.000149: the applicant of the reasons for such rejection electronically:
p.000149: Provided that where deficiencies that can be rectified, are pointed out by the Central Licensing
p.000149: Authority within the stipulated period, the period referred to in sub-rule (4) shall reckon from the date these
p.000149: deficiencies have been removed.
p.000149:
p.000149: 150 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000149: II—SEC. 3(i)]
p.000149:
p.000149: 22. Requirements for grant of manufacturing licence or loan licence.— While making application for grant of
p.000149: licence or loan licence under rule 20 or rule 21, the applicant shall meet the following requirements, namely:—
p.000149: (i) the manufacturing site shall comply with the requirements of the Quality Management System as specified under the
p.000149: Fifth Schedule;
p.000149: (ii) appoint competent technical staff under whose direction and supervision the manufacturing activity of
p.000149: a medical device shall be undertaken and such staff shall possess the following educational qualification
p.000149: and experience,-
p.000149: (a) degree in engineering in relevant branch or in pharmacy or in science in appropriate subject from
p.000149: a recognised University and shall have experience of not less than two years in manufacturing or testing of medical
p.000149: devices; or
p.000149: (b) diploma in engineering (in relevant branch) or in pharmacy from a recognised institute and shall have the
p.000149: experience of not less than four years in manufacturing or testing of medical devices;
p.000149: (iii) appoint competent technical staff with degree or diploma in engineering (in relevant branch) or in pharmacy or in
p.000149: science in relevant subject and having experience of not less than two years in testing of medical devices under whose
p.000149: direction and supervision, the testing activity of a medical device shall be undertaken.
p.000149:
p.000149: 23. Inspection for grant of licence or loan licence for Class C or Class D medical device.— (1) Before grant of
p.000149: licence to manufacture for sale or for distribution in respect of Class C or D medical device, the manufacturing site
p.000149: shall be inspected within a period of sixty days from the date of application by a team comprising not less than two
p.000149: Medical Device Officers which may include any officer senior to the Medical Device Officer with or
p.000149: without an expert, or a Notified Body referred to in sub-rule (4) of rule 13:
p.000149: Provided that no inspection of a medical device manufacturing site for grant of loan licence to
p.000149: manufacture such medical device shall be required to be carried out if the manufacturing site is already licenced to
p.000149: manufacture such medical device for sale or for distribution.
p.000149: (2) The composition of the inspection team referred to in sub-rule (1) shall be determined by the controlling officer
p.000149: and no inspection shall be carried out without prior approval of the controlling officer.
p.000149:
p.000149: 24. Inspection report.— After completion of inspection as referred to in rule 23, the inspection team shall forward
p.000149: a descriptive report containing findings on each aspect of inspection along with the recommendations to the Central
p.000149: Licensing Authority, through online portal of the Ministry of Health and Family Welfare in the Central Government and
p.000149: forward a copy of the same to the applicant.
p.000149:
p.000149: 25. Grant of licence or loan licence to manufacture for sale or for distribution.— (1) If the Central Licensing
p.000149: Authority, after receipt of the report as referred to in rule 24, and such further enquiry, if any, as may be
p.000149: considered necessary, is satisfied that the requirements of these rules have been complied, that Authority shall grant
p.000149: a licence in Form MD-9, or loan licence in Form MD-10 or may reject the application for reasons to be recorded in
p.000149: writing, within a period of forty five days from the date the inspection report has been received.
p.000149: (2) If the application for grant of licence or loan licence to manufacture for sale or for distribution is rejected
p.000149: under sub-rule (1), the aggrieved person may file an appeal before the Central Government within forty five days from
p.000149: the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to
p.000149: the appellant, be disposed of within a period of sixty days.
p.000149: (3) In case, a licencee or loan licencee intends to manufacture additional medical devices
p.000149: in the licensed manufacturing site, the manufacturer shall make an application for grant of permission to
p.000149: manufacture such medical devices to the Central Licensing Authority or State Licensing Authority, as the case may
p.000149: be, along with the fee as specified in the Second Schedule and the documents as referred to in rule 20 or rule 21, as
p.000149: the case may be.
p.000149: (4) In case of investigational medical device or new in vitro diagnostic medical device, the applicant shall obtain
p.000149: prior permission in Form MD-27 or Form MD-29 from the Central Licensing Authority and no licence to manufacture any
p.000149: class of such medical device shall be granted without such permission.
p.000149:
p.000149: 26. Conditions for manufacturing licence or loan licence.— After grant of licence or loan licence in Form MD-5, Form
p.000149: MD-6, Form MD-9 or MD-10, as the case may be, the licence holder shall comply with the following
p.000149: conditions, namely:-
p.000149: (i) licence shall be produced when requested by the Medical Device Officer or any other senior officer under the
p.000149: control of Central Licensing Authority or State Licensing Authority, as the case may be;
p.000149: (ii) the licence holder shall inform the State Licensing Authority or the Central Licensing Authority, as the case may
p.000149: be, of the occurrence of any suspected unexpected serious adverse event and action taken thereon including any recall
p.000149: within fifteen days of such event coming to the notice of licence holder;
p.000149: (iii) the licence holder shall obtain prior approval from the Central Licensing Authority or the State
p.000149: Licensing Authority, as the case may be, before any major change as specified in the Sixth Schedule is carried out and
p.000149: the Central Licensing Authority or the State Licensing Authority, as the case may be, shall indicate its approval or
p.000149: rejection within forty five days and in case where no communication is received within the stipulated time from
p.000149:
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p.000151: 151
p.000151: such Authority, such change shall be deemed to have been approved;
p.000151: (iv) the licence holder shall inform any minor change as specified in the Sixth Schedule to the State
p.000151: Licensing Authority or Central Licensing Authority, as the case may be, within a period of thirty days after such
p.000151: minor change take place;
p.000151: (v) the licence holder shall carry out test of each batch of product manufactured prior to its release for compliance
p.000151: with specifications either in his own laboratory or in any other laboratory registered under sub-rule (3) of rule 83;
p.000151: (vi) the licence holder shall, on being informed by the Central Licensing Authority or State Licensing Authority, as
p.000151: the case may be, that any part of any lot of the medical device has been found not conforming with
p.000151: the provisions specified under the Act and these rules, and on being directed so to do by such licensing authority,
p.000151: withdraw the remainder of that lot from sale and, so far as may, in the particular circumstances of the case, be
p.000151: practicable, recall the issues already made from that lot;
p.000151: (vii) the licence holder shall maintain an audit or inspection book in Form MD-11 to enable the Notified
p.000151: Body or Medical Device Officer to record his observations and non-conformity, if any;
p.000151: (viii) the licence holder shall maintain at least one unit of sample from each batch of invasive medical device and
p.000151: in vitro diagnostic medical device manufactured for reference purpose for a period of one hundred and eighty days after
p.000151: the date of expiry of such batch;
p.000151: (ix) the licence holder shall maintain records of manufacturing and sales which shall be open to
p.000151: inspection by a Medical Device Officer;
p.000151: (x) the medical device, when offered for sale, shall be accompanied by either its package insert or
p.000151: user manual, wherever applicable;
p.000151: (xi) the manufacturing or testing activity of medical device shall be undertaken only under the
p.000151: direction and supervision of the competent technical staff;
p.000151: (xii) if the manufacturer has stopped manufacturing activity or closed the manufacturing site for a period of
p.000151: thirty days or more, the same shall be intimated to the Central Licensing Authority or the State Licensing Authority,
p.000151: as the case may be.
p.000151:
p.000151: 27. Change in constitution.— In case of change in constitution of a licencee, after grant of licence under sub-rule (4)
p.000151: of rule 20 or sub-rule (6) of rule 20 or sub-rule (1) of rule 25, as the case may be, the manufacturer inform the
p.000151: Central Licensing Authority or the State Licensing Authority, as the case may be, within forty five days and shall
p.000151: shall make an application under sub-rule (1) of rule 20 or sub-rule (1) of rule 21, as the case may be, for grant of
p.000151: licence within a period of one hundred eighty days from the date of such change in constitution:
p.000151: Provided that the existing licence shall be deemed to be valid till such time, a fresh licence is issued or application
p.000151: is rejected by the State Licensing Authority or the Central Licensing Authority, as the case may be:
p.000151: Provided further that if the application is rejected, the manufacturer may appeal to the Central
p.000151: Government or the State Government, as the case may be, within a period of sixty days.
p.000151:
p.000151: 28. Unannounced inspection by State Licensing Authority.— The State Licensing Authority shall, in cases where licence
p.000151: has been granted for manufacturing Class A and Class B medical devices under rule 20, cause an inspection of the
p.000151: manufacturing site to be carried out by a Medical Device Officer on a random basis and such inspection shall not be
p.000151: less than two per cent. of the total audits carried out by Notified Bodies within that State for that class of medical
p.000151: device.
p.000151:
p.000151: 29. Validity of licence.— (1) A licence or loan licence issued in Form MD-5, Form MD-6, Form MD-9 or Form MD- 10 shall
p.000151: remain valid in perpetuity, subject to payment of licence retention fee as specified in the Second Schedule before
p.000151: completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by State
p.000151: Licensing Authority or the Central Licensing Authority, as the case may be.
p.000151: (2) If the licence holder fails to pay the required licence retention fee on or before due date as referred to in
p.000151: sub-rule (1), the licence holder shall, in addition to the licence retention fee, be liable to pay a late fee
p.000151: calculated at the rate of two per cent. of the licence retention fee for every month or part thereof within one hundred
p.000151: and eighty days and in the event of non-payment of such fee during that period, the licence shall be deemed to have
p.000151: been cancelled.
p.000151:
p.000151: 30. Suspension and cancellation of licence.— (1) Where the licencee contravenes any provision of the Act and these
p.000151: rules, the State Licensing Authority or the Central Licensing Authority, as the case may be, shall, after
p.000151: giving the licencee an opportunity to show cause as to why such an order should not be passed, shall by an order and
p.000151: for reasons to be recorded in writing, suspend it for such period as it considers necessary either wholly or in respect
p.000151: of any of the medical device or cancel the licence or loan licence.
p.000151: (2) A licencee whose licence or loan licence has been suspended or cancelled by the State Licensing Authority or the
p.000151: Central Licensing Authority, as the case may be, under sub-rule (1), may within forty-five days of the receipt of a
p.000151: copy of the order by such authority, prefer an appeal to the State Government or the Central Government, as the case
p.000151: may be, and the State Government or the Central Government, shall after giving the licencee an opportunity of being
p.000151: heard, confirm, reverse or modify such order.
p.000151:
p.000151: 152 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000151: II—SEC. 3(i)]
p.000151:
p.000151: (3) The State Licensing Authority or the Central Licensing Authority, as the case may be, may revoke
p.000151: suspension order issued under sub-rule (2) for reasons to be recorded in writing.
p.000151: (4) Orders of suspension issued or revoked; or cancellation of licence shall be duly published on the
p.000151: concerned websites of the State Licensing Authority or the Central Licensing Authority, as the case may be.
p.000151:
p.000151: 31. Test licence to manufacture for test, evaluation, clinical investigations, etc.,—(1) Small quantity of Class A or
p.000151: Class B or Class C or Class D of medical devices may be manufactured for the purpose of clinical investigations, test,
p.000151: evaluation, examination, demonstration or training for which an application shall be made in Form MD-12
p.000151: to the Central Licensing Authority and shall be accompanied with a fee as specified in the Second Schedule.
p.000151: (2) The application made under sub-rule (1) shall also be accompanied with the following documents, namely:—
p.000151: (a) brief description of the medical device including intended use, material of construction, design and
p.000151: an undertaking stating that the required facilities including equipment, instruments, and personnel have been provided
p.000151: to manufacture such medical devices;
p.000151: (b) list of equipment, instruments;
p.000151: (c) list of qualified personnel;
p.000151: (d) copy of manufacturing licence issued under these rules, if any;
p.000151: (e) approval letter authorising to undertake research and development activities issued by any Government
p.000151: organisation, if any.
p.000151: (3) The Central Licensing Authority, after enquiry, if any, as may be considered necessary, on being satisfied that the
p.000151: requirements of these rules have been complied, shall grant a test licence in Form MD-13, or may
p.000151: reject the application for reasons to be recorded in writing, within a period of thirty days from the date the
p.000151: application is made under sub-rule (1).
p.000151: (4) The licencee shall maintain a record of the details of quantity of the product manufactured under test licence.
p.000151: (5) A licence granted under sub-rule (3) shall, unless cancelled earlier, remain in force for a period of
p.000151: three years from the date of its issuance.
p.000151:
p.000151: 32. Conditions of test licence to manufacture for test, evaluation, clinical investigations, etc.,— A
p.000151: licence in Form MD-13 under rule 31 shall be subject to the following conditions, namely:—
p.000151: (a) the licencee shall use the medical device manufactured under licence granted under sub-rule (3) of
p.000151: rule 31 exclusively for the purpose of clinical investigations, test, evaluation, examination, demonstration or
p.000151: training at the place specified in the licence;
p.000151: (b) the licencee shall allow any Medical Device Officer to enter, with or without notice, the premises
p.000151: where the medical device are manufactured and to satisfy himself that only clinical investigations, test, evaluation,
p.000151: examination, demonstration or training is being conducted on such device;
p.000151: (c) the licencee shall maintain a record of the quantity of medical device manufactured, tested and stocked and
p.000151: its disposition.
p.000151:
p.000151: 33. Cancellation of test licence to manufacture for test, evaluation, clinical investigations, etc.,— (1)
p.000151: Where any licencee under rule 31 contravenes any provision of these rules, the Central Licensing Authority,
p.000151: shall, issue a show cause notice to such licencee asking, as to why an order should not be made to cancel the licence.
p.000151: (2) The Central Licensing Authority shall, after giving an opportunity to the licencee to explain in writing licencee’s
p.000151: defence, pass an order for cancellation or otherwise and record the reasons therefor in the said order.
p.000151: (3) A licencee, whose licence has been cancelled, may appeal to the Central Government within forty five days from the
p.000151: date of the order.
p.000151:
p.000151: CHAPTER V
p.000151: IMPORT OF MEDICAL DEVICES
p.000151:
p.000151: 34. Application for grant of import licence.— (1) An authorised agent having licence to manufacture for sale or
p.000151: distribution or wholesale licence for sale or distribution under these rules, shall make an application
p.000151: for grant of import licence for medical device to the Central Licensing Authority through an identified
p.000151: online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-14 for obtaining a
p.000151: licence.
p.000151: (2) The application under sub-rule (1) shall be accompanied with the fee as specified in the Second Schedule along with
p.000151: respective documents as specified in the Fourth Schedule:
p.000151: Provided that any change in the documents submitted at the time of application and prior to grant of
p.000151: licence shall be informed, in writing, to the Central Licensing Authority.
p.000151: (3) Where the Central Licensing Authority, has reason to believe that the quality of the medical device
p.000151: is compromised, and decides to subject it to evaluation, test or examination, the authorised agent shall pay a fee for
p.000151: such evaluation, test or examination, to the testing laboratory as specified by the Central Licensing Authority.
p.000151: (4) Any subsequent application for,-
p.000151: (i) grant of licence for additional manufacturing site for the same medical device by the same authorised agent
p.000151:
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p.000153: 153
p.000153: shall be accompanied with a fee and documents as referred in sub-rule (2);
p.000153: (ii) licence for additional medical device manufactured at the same manufacturing site shall be made by the same
p.000153: authorised agent accompanied with fee as specified in the Second Schedule and respective documents as
p.000153: specified in the Fourth Schedule.
p.000153:
p.000153: 35. Inspection of overseas manufacturing site.— (1) On receipt of an application under sub-rule (1) of rule 34, the
p.000153: Central Licensing Authority, may cause an inspection of the overseas manufacturing site either by itself or
p.000153: by any other person or body to whom the power has been delegated for the purpose.
p.000153: (2) The applicant shall be liable to pay a fee as specified under the Second Schedule in respect of expenditure
p.000153: required in connection with the visit to the overseas manufacturing site under sub-rule (1).
p.000153:
p.000153: 36. Grant of import licence.— (1) After examination of documents furnished with the application under sub-rule
p.000153: (1) of rule 34 and on the basis of the inspection report, if inspection has been carried out, the
p.000153: Central Licensing Authority may, on being satisfied, grant licence in Form MD-15 or, may reject such
p.000153: application for which reasons shall be recorded in writing, within a period of nine months from the date of
p.000153: application.
p.000153: (2) In the event of rejection, the applicant may appeal to the Central Government within a period of forty five days
p.000153: and that Government, may, after such enquiry into the matter, as considered necessary, pass orders in relation thereto
p.000153: within a period of ninety days from the date of appeal.
p.000153: (3) Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory
p.000153: authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European
p.000153: Union Countries, or the United States of America, a licence shall be granted under sub-rule (1) to the
p.000153: applicant without carrying out clinical investigation.
p.000153: (4) Where a medical device is imported from countries other than those referred to in sub-rule (3), the licence in case
p.000153: of Class C and Class D medical devices may be granted after its safety and effectiveness has been established through
p.000153: clinical investigation in India as specified under provisions of Chapter VII of these rules.
p.000153: (5) Where a medical device, is imported from countries other than those referred to in sub-rule (3), the licence in
p.000153: case of Class A or Class B medical devices may be granted after its safety and performance has been established through
p.000153: published safety and performance data or through clinical investigation in the country of origin and a
p.000153: free sale certificate from the country of origin is furnished.
p.000153: (6) In case of investigational medical device or new in vitro diagnostic medical device, the applicant shall obtain
p.000153: prior permission in Form MD-27 or in Form MD-29 from the Central Licensing Authority and no licence to import any
p.000153: class of such medical device shall be granted without such permission.
p.000153:
p.000153: 37. Validity of licence.— A licence granted under sub-rule (1) of rule 36 shall remain valid in perpetuity, unless,
p.000153: it has been cancelled or surrendered, provided the authorised agent deposits the licence retention fee with the
p.000153: Central Licensing Authority as specified in the Second Schedule for each overseas manufacturing site and for each
p.000153: licenced medical device after completion of every five years from the date of its issue:
p.000153: Provided that the Central Licensing Authority may permit to deposit the licence retention fee after due date
p.000153: but before expiry of ninety days with a late fee calculated at the rate of two per cent. per mensem:
p.000153: Provided further that if the licencee fails to deposit the licence retention fee within the above stipulated period,
p.000153: the licence shall be deemed to have been cancelled.
p.000153:
p.000153: 38. Conditions to be complied with by Licence holder.— (1) The licencee shall comply with the
p.000153: following conditions, namely:-
p.000153: (i) licence shall be produced when requested by the Medical Device Officer or any other senior officer
p.000153: under the control of Central Licensing Authority or the State Licensing Authority, as the case may be;
p.000153: (ii) the licencee shall inform the licensing authority forthwith and, in all circumstances, within a period of fifteen
p.000153: days of any administrative action taken on account of any adverse reaction, such as market withdrawal,
p.000153: regulatory restrictions, cancellation of authorisation or declaration of the medical device as not of
p.000153: standards quality by the regulatory authority of the country of origin or by any regulatory authority of any other
p.000153: country, where the medical device is marketed, sold or distributed;
p.000153: (iii) authorised agent in cases referred in clause (ii), shall stop immediately the despatch and marketing of the
p.000153: medical device referred in that clause;
p.000153: (iv) the Central Licensing Authority, after due consideration of the information as referred in clause (ii), may
p.000153: issue directions to the licencee in respect of marketing, sale or distribution of the medical device including
p.000153: withdrawal of medical device from the Indian market within a period as may be specified by the Central Licensing
p.000153: Authority;
p.000153: (v) the authorised agent shall obtain prior approval from the Central Licensing Authority before any major change, as
p.000153: specified in the Sixth Schedule, is carried out and the Central Licensing Authority shall indicate its
p.000153: approval or rejection within sixty days;
p.000153: (vi) in case, no communication of approval or rejection as referred to in clause (v) is received within the stipulated
p.000153: time from the Central Licensing Authority, such change shall be deemed to have been approved;
p.000153: (vii) licencee shall inform, any minor change as specified in the Sixth Schedule to the Central Licensing Authority
p.000153:
p.000153: 154 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000153: II—SEC. 3(i)]
p.000153:
p.000153: within a period of thirty days, after such minor change took place;
p.000153: (viii) authorised agent shall inform the Central Licensing Authority in writing within a period of thirty days
p.000153: in the event of any change in the constitution of the overseas manufacturer or the authorised agent;
p.000153: (ix) the consignment of medical device shall be accompanied by an invoice or statement showing the name
p.000153: and quantity of the medical device;
p.000153: (x) the licencee shall supply the medical device for sale or offer it for sale along with its package
p.000153: insert or user manual, wherever applicable.
p.000153: (2) Where the Central Licensing Authority is satisfied that any medical device is not in conformity with the provisions
p.000153: of the Act and these rules, it may issue directions that the entire batch of such medical device may not
p.000153: be sold or offered for sale or may be recalled from the market including hospitals, if any, where it has been stocked:
p.000153: Provided that where the Central Licensing Authority considers it necessary or expedient, more than one
p.000153: batch or all batches of such medical device may be directed to be recalled.
p.000153:
p.000153: 39. Fresh application in case of change in constitution. — In case of change in constitution of a licencee, after
p.000153: grant of licence under sub-rule (1) of rule 36, an application shall be made under sub-rule (1) of rule 34 for grant of
p.000153: licence within a period of one hundred and eighty days from the date of such change in constitution:
p.000153: Provided that the existing licence shall be deemed to be valid till such time, the fresh licence is
p.000153: issued or application is rejected by the Central Licensing Authority.
p.000153: Explanation.- For the purpose of this rule, the licencee shall include overseas manufacturer who executed the power of
p.000153: attorney in favour of authorised agent.
p.000153:
p.000153: 40. Test licence for import for test, evaluation, clinical investigations, etc.— (1) Notwithstanding
p.000153: anything contained in these rules, any medical device or in vitro diagnostic medical device may be imported for the
p.000153: purpose of clinical investigations or test or evaluation or demonstration or training.
p.000153: (2) The person who desires to import medical device under sub-rule (1), shall apply for an import licence for
p.000153: test, evaluation or demonstration or training to the Central Licensing Authority in Form MD-16, accompanied by such
p.000153: fee as specified in the Second Schedule.
p.000153: (3) On receipt of the application under sub-rule (2), the Central Licensing Authority shall determine, the quantity of
p.000153: the medical devices, after taking into account the requirement for clinical investigation,
p.000153: approved clinical investigation plan, and information and documents submitted by the applicant.
p.000153:
p.000153: 41. Grant of test licence for import for test, evaluation, clinical investigations, etc.— (1) If the Central
p.000153: Licensing Authority, after such enquiry, if any, is satisfied that the requirements of these rules have
p.000153: been complied, the said authority shall grant a test licence in Form MD-17, or may reject the application for
p.000153: reasons to be recorded in writing, within a period of thirty days from the date the application under sub-rule (2) of
p.000153: rule 40.
p.000153: (2) The medical device for which a test licence has been granted under sub-rule (1), shall be used
p.000153: exclusively for purposes of clinical investigation, test, evaluation, demonstration or training, as the case may
p.000153: be, and such clinical investigations or test or evaluation or training, shall be conducted at a place specified in such
p.000153: test licence:
p.000153: Provided that in cases where the medical device is required to be taken to any place other than the ones mentioned in
p.000153: the test licence, the Central Licensing Authority shall be informed in writing before doing so.
p.000153: (3) The holder of the test licence shall maintain record of the activities undertaken including the
p.000153: name of manufacturer, quantity imported and date of import.
p.000153: (4) The consignment of medical device shall be accompanied by an invoice or statement showing the name
p.000153: and quantity of medical device.
p.000153: (5) A licence in Form MD-17 shall, unless cancelled earlier, be in force for a period of three years from the date of
p.000153: its issue.
p.000153: (6) The medical devices including in vitro diagnostic medical device referred to in sub-rule (2) that are not used, may
p.000153: be permitted to be exported or destroyed under intimation to the Central Licensing Authority.
p.000153: (7) Where any licencee under sub-rule (1) contravenes any provision of these rules, the Central Licensing Authority,
p.000153: shall, issue a show cause notice to such licencee asking, as to why an order should not be made to cancel the licence.
p.000153: (8) The Central Licensing Authority shall after giving an opportunity to the licencee to explain, in writing,
p.000153: licencee’s defence, pass an order for cancellation or otherwise and record the reasons therefor in the said order.
p.000153: (9) A licencee, whose licence has been cancelled under sub-rule (8), may appeal to the Central Government within forty
p.000153: five days from the date of such order.
p.000153:
p.000153: 42. Import of investigational medical device by Government hospital or statutory medical institution for
p.000153: treatment of patient.— (1) Small quantity of investigational medical device, the import of which is not allowed, but
p.000153: approved in the country of origin, may be allowed to be imported by the Central Licensing Authority for treatment of a
p.000153: patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring
p.000153: therapy for unmet medical need, on an application made by a Medical Officer through the medical superintendent of a
p.000153: Government hospital or a statutory medical institution in Form MD-18 and such application shall be accompanied by
p.000153: documents required and the fee as specified in the Second Schedule.
p.000153:
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p.000155: 155
p.000155: (2) On receipt of an application under sub-rule (1), the Central Licensing Authority shall, on being satisfied about
p.000155: the information and the documents enclosed with the application, grant import licence for treatment of patient in
p.000155: Form MD-19.
p.000155: (3) The medical device for which the licence is granted under sub-rule (2), shall, be used exclusively for the purpose
p.000155: of treatment of the patient referred to in sub-rule (1).
p.000155: (4) The holder of licence shall maintain record of the name of the manufacturer, quantity imported and used, date of
p.000155: import, name and address of the patient and diagnosis.
p.000155: (5) The holder of the licence shall allow the medical device officer authorised by the Central Licensing Authority in
p.000155: this behalf to enter, with or without prior notice, the premises where the medical devices are stocked and to inspect
p.000155: the premises and relevant records and investigate the manner in which the medical device is being used and to take, if
p.000155: required, samples thereof.
p.000155: (6) The quantity considered necessary shall be determined by the Central Licensing Authority after taking
p.000155: into account the recommendation of the hospital concerned for treatment of patient suffering from a life
p.000155: threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical
p.000155: need.
p.000155: (7) Where the Central Licensing Authority is satisfied, it may, in exceptional and special circumstances, allow import
p.000155: of larger quantity of medical devices for use by the patient.
p.000155: (8) The consignment of medical device shall be accompanied by an invoice or a statement showing the name
p.000155: and quantity of medical device.
p.000155:
p.000155: 43. Import of medical device for personal use.—(1) Small quantity of medical device, the import of
p.000155: which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to
p.000155: the following conditions, namely,-
p.000155: (i) the medical device shall form part of a personal baggage of a passenger and be intended for the exclusive use of
p.000155: such passenger;
p.000155: (ii) the medical device shall be declared as personal baggage of the passenger to the customs authorities, if they so
p.000155: direct;
p.000155: (iii) the quantity of any single medical device so imported shall not exceed the quantity specified by the registered
p.000155: medical practitioner;
p.000155: (iv) the medical device has been prescribed by a registered medical practitioner; and
p.000155: (v) the medical device so imported shall be accompanied with an invoice or a statement showing the
p.000155: name and quantity of medical device.
p.000155: (2) Small quantity of medical device, the import of which is otherwise prohibited under section 10 of the Act, and
p.000155: which is not forming a part of bona fide personal baggage, may be imported for personal use, on an application made by
p.000155: the applicant in Form MD-20 and such application shall be accompanied by documents confirming that the device is for
p.000155: bona fide personal use and a prescription to that effect by a registered medical practitioner.
p.000155: (3) On receipt of an application under sub-rule (2), the Central Licensing Authority shall, on being satisfied about
p.000155: the information and the documents enclosed with the application, grant permission in Form MD-21 or may
p.000155: reject the application for reasons to be recorded in writing within a period of seven days from the date of
p.000155: application under sub- rule (2).
p.000155: (4) Medical devices as referred to in sub-rule (2) shall be subject to the following conditions, namely,-
p.000155: (i) the medical device shall be declared to the Customs Authorities if they so direct;
p.000155: (ii) the consignment of the medical device so imported shall be accompanied with an invoice or
p.000155: statement showing the name and quantity of medical device.
p.000155:
p.000155: CHAPTER VI LABELLING OF MEDICAL DEVICES
p.000155:
p.000155: 44. Labelling of medical devices.—The following particulars shall be printed in indelible ink on the label, on the
p.000155: shelf pack of the medical device or on the outer cover of the medical device and on every outer covering in which the
p.000155: medical device is packed, namely,-
p.000155: (a) name of the medical device;
p.000155: (b) the details necessary for the user to identify the device and its use;
p.000155: (c) the name of manufacturer and address of manufacturing premises where the device has been manufactured;
p.000155: (d) the correct statement about the net quantity in terms of weight, measure, volume, number of units, as the case may
p.000155: be, and the number of the devices contained in the package expressed in metric system;
p.000155: (e) the month and year of manufacture and expiry (alternately the label shall bear the shelf life of the product):
p.000155: Provided that in case of sterile devices, the date of sterilization may be given as date of manufacture of the
p.000155: device:
...
p.000155: a lack of understanding on the part of the user, in case the meaning of the symbol is not obvious to the device user;
p.000155: (o) in case of small sized medical devices on which information cannot be printed legibly, shall
p.000155: include the information necessary for product identification and safety such as information covered by clauses (a),
p.000155: (b), (c), (d), (e), (g), (k), and (m) shall be included.
p.000155:
p.000155: 45. Exemption of labelling requirements for export of medical devices.— The labels on packages or container of
p.000155: devices for export shall be adopted to meet the specific requirements of law of the country to which the device is to
p.000155: be exported, but the following particulars shall appear in a conspicuous manner on the label of the inner most pack or
p.000155: shelf pack of the medical device in which the device is packed and every other outer covering in which the container is
p.000155: packed:-
p.000155: (a) name of the device;
p.000155: (b) the distinctive batch number or lot number or serial number preceded by the word “Lot No.” or “Lot” or “Batch No.”
p.000155: or “B. No.” or “Serial No.”;
p.000155: (c) date of expiry, if any;
p.000155: (d) the name and address of manufacturer and address of actual premises where the device has been manufactured;
p.000155: (e) licence number preceded by letters “Licence No. or Lic. No.”;
p.000155: (f) internationally recognised symbols in lieu of text, wherever required:
p.000155: Provided that where a device is required by the consignee not to be labeled with the name and address
p.000155: of manufacturer, the label on the package or container shall bear a code number as approved by the Central Licensing
p.000155: Authority and the code number shall bear the name of the State or Union territory, in abbreviation, followed by the
p.000155: word “Device” and “manufacturing licence number”:
p.000155: Provided further that where a device is required by the consignee not to be labeled with the code number
p.000155: also, the label on the packages or container shall bear a special code number, as requested by the
p.000155: consignee, and approved by the Central Licensing Authority.
p.000155:
p.000155: 46. Unique device identification of the medical device.— With effect from 1st day of January, 2022, a
p.000155: medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification
p.000155: which shall contain device identifier and production identifier.
p.000155: Explanation.— For the purposes of this rule,-
p.000155: (i) “device identifier” means a global trade item number;.
p.000155: (ii) “production identifier” means a serial number, lot or batch number, software as a medical device
p.000155: version, manufacturing and or expiration date.
p.000155:
p.000155: 47. Shelf life of medical devices.— The shelf life of the medical devices, shall be determined keeping in view the
p.000155: technical parameters and shall ordinarily not exceed sixty months from the date of manufacture to be reckoned from
p.000155: month to month (i.e. January to January), except in cases where satisfactory evidence is produced by the manufacturer
p.000155: to justify a shelf life of more than sixty months of a device to the satisfaction of the Central Licensing Authority:
p.000155:
p.000155: Provided that any medical device, whose total shelf life claim is less than ninety days, shall not be allowed to be
p.000155: imported by the licensing authority if it has less than forty per cent. residual shelf-life on the date of import:
p.000155: Provided further that any medical device, whose total shelf life claim is between ninety days and one year,
p.000155: shall not be allowed to be imported by the licensing authority if it has less than fifty per cent. residual shelf-life
p.000155: on the date of import:
p.000155:
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p.000157: 157
p.000157: Provided also that any medical device, whose total shelf life claim is more than one year, shall not be allowed to be
p.000157: imported by the licensing authority if it has less than sixty per cent. residual shelf-life on the date of import.
p.000157:
p.000157: 48. Labelling medical device or a new in vitro diagnostic medical device for purpose of test,
p.000157: evaluation, clinical investigations, etc.,—Any medical device or new in vitro diagnostic medical
p.000157: device imported or manufactured, for the purpose of clinical investigation or clinical
p.000157: performance evaluation, test, evaluation, demonstration and training, shall be kept in containers bearing
p.000157: labels, indicating the name of the product or code number, batch or lot number, serial number wherever
p.000157: applicable, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and
p.000157: the purpose for which it has been manufactured.
p.000157:
p.000157: CHAPTER VII
p.000157: CLINICAL INVESTIGATION OF MEDICAL DEVICE AND CLINICAL PERFORMANCE EVALUATION OF NEW IN VITRO
p.000157: DIAGNOSTIC MEDICAL DEVICE
p.000157:
p.000157: 49. Conduct of clinical investigation.—No person or sponsor shall conduct any clinical investigation in respect of
p.000157: investigational medical device in human participants except in accordance with these rules and in accordance with the
p.000157: permission granted by the Central Licensing Authority.
p.000157:
p.000157: 50. Application of rule 122DD of Drugs and Cosmetics Rules, 1945 with regard to Ethics Committee.—
p.000157: (1) The Ethics Committee constituted under rule 122DD of the Drugs and Cosmetics Rules, 1945 shall perform the
p.000157: functions and duties under these rules and shall be deemed to be constituted under these rules.
p.000157: (2) The provisions of Ethics Committee provided in rule 122DD of the Drugs and Cosmetics Rules, 1945
p.000157: shall, except where specifically provided under these rules, be applicable mutatis mutandis, for the
p.000157: purpose of clinical investigation and clinical performance evaluation under this Chapter.
p.000157:
p.000157: 51. Application for grant of permission to conduct clinical investigation.—(1) An application for grant
p.000157: of permission to conduct clinical investigation for investigational medical device shall be made to the Central
p.000157: Licensing Authority in Form MD-22 by a sponsor and shall be accompanied with information specified in the Seventh
p.000157: Schedule.
p.000157: (2) An application for grant of permission to conduct,-
p.000157: (a) a pilot clinical investigation on an investigational medical device as referred to in sub-rule (1)
p.000157: shall be accompanied with a fee as specified in the Second Schedule along with information as specified
p.000157: in the Seventh Schedule.
p.000157: Explanation.— For the purposes of these rules, the pilot clinical investigation means clinical investigation to be
p.000157: carried out for the first time in human participants;
p.000157: (b) a pivotal clinical investigation on an investigational medical device shall be made on the basis of
p.000157: data emerging from pilot clinical investigation, accompanied with a fee as specified in the Second Schedule:
p.000157: Provided that no fee shall be payable by any institute, organisation, hospital run or funded by the Central
p.000157: Government or the State Government, as the case may be, for conduct of clinical investigation.
p.000157: (3) No permission for conduct of academic clinical study on licenced medical device shall be required, where,-
p.000157: (a) the Ethics Committee approves such a study; and
p.000157: (b) the data generated during the study shall not be used to furnish to the Central Licensing
p.000157: Authority to manufacture or to import for marketing any investigational medical device in the country.
p.000157: (4) The Central Licensing Authority may, in public interest, abbreviate, defer, or waive the requirement of animal data
p.000157: or clinical data for conducting clinical investigation for reasons to be recorded in writing before granting permission
p.000157: to conduct clinical investigation.
p.000157: (5) Medical devices requiring clinical investigation but claiming substantial equivalence to a predicate device shall
p.000157: not be marketed unless the Central Licensing Authority has approved it.
p.000157: Explanation 1.- For the purposes of this sub-rule, a device shall be deemed to be substantially
p.000157: equivalent in comparison to a predicate device, if it has.—
p.000157: (i) the same intended use and technological characteristics; or
p.000157: (ii) same intended use and different technological characteristics, and demonstrate that the device is as safe and
p.000157: effective as the predicate device.
p.000157: Explanation 2.- A claim of substantial equivalence does not mean that the proposed medical device and
p.000157: predicate device are identical. Substantial equivalence shall be established with respect to intended use, design,
p.000157: energy used or delivered, materials, chemical composition, manufacturing process, performance, safety,
p.000157: effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.
p.000157:
p.000157: 52. Permission to conduct clinical investigation.—The Central Licensing Authority, after such further enquiry, if
p.000157: any, as considered necessary, may,-
p.000157: (i) if satisfied, that the requirements of these rules have been complied with, grant permission to conduct clinical
p.000157: investigation for an investigational medical device in Form MD-23;
p.000157: (ii) if not satisfied with the requirements as referred to in sub-clause (i), reject the application, for reasons to
p.000157: be recorded in writing,
p.000157: within a period of ninety days, from the date of application made under sub-rule (1) of rule 51.
p.000157:
p.000157: 158 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000157: II—SEC. 3(i)]
p.000157:
p.000157: 53. Conditions for permission.—After grant of permission referred to in rule 52, the following conditions shall be
p.000157: complied with by the applicant, namely:—
p.000157: (i) clinical investigation shall be initiated after approval of clinical investigation plan by the
p.000157: registered Ethics Committee;
p.000157: (ii) clinical investigation shall be conducted in accordance with the approved clinical investigation
p.000157: plan, Good Clinical Practices Guidelines issued by the Central Drugs Standard Control Organisation and
p.000157: provisions of the Seventh Schedule;
p.000157: (iii) clinical investigation shall be registered with the Clinical Trial Registry of India before
p.000157: enrolling the first participant for such clinical investigation;
p.000157: (iv) annual status report of each clinical investigation, as to whether it is ongoing, completed or terminated,
p.000157: shall be submitted to the Central Licensing Authority by the sponsor, and, in case of termination of any
p.000157: clinical investigation, the detailed reasons for the same shall be communicated to the Central Licensing Authority
p.000157: within thirty days of such termination;
p.000157: (v) information about any report of suspected unexpected serious adverse event occurring during
p.000157: clinical investigation on the subject shall, after due analysis, be submitted by the sponsor to the
p.000157: Central Licensing Authority within fourteen days of the knowledge of its occurrence as specified in the
p.000157: Seventh Schedule and in compliance with the procedure specified in these rules;
p.000157: (vi) in case of an injury or death during clinical investigation of a subject of a clinical investigation, the
p.000157: applicant shall provide complete medical management or compensation in accordance with these rules;
p.000157: (vii) the premises of the sponsor including their employees, subsidiaries and branches, their agents, contractors
p.000157: and sub-contractors and clinical investigation sites shall be open for inspection by officers of the Central Licensing
p.000157: Authority who may be accompanied by officers of the State Licensing Authority or outside experts, to verify
p.000157: compliance of the requirements of these rules for conduct of clinical investigation;
p.000157: (viii) the clinical investigation shall be initiated by enrolling first participant within a period of one year
p.000157: from the date of grant of permission, failing which prior permission from the Central Licensing Authority shall be
p.000157: required to initiate clinical investigation;
p.000157: (ix) the Central Licensing Authority may impose or exempt any condition while granting permission in
p.000157: respect of specific clinical investigations, if considered necessary, regarding the objective, design,
p.000157: subject population, subject eligibility, assessment, conduct and treatment of clinical investigation.
p.000157:
p.000157: 54. Suspension, cancellation, etc. of permission.—(1) If any person to whom permission has been granted under rule
p.000157: 52 fails to comply with any of the conditions of permission or any of the provisions of the Act or these rules, the
p.000157: Central Licensing Authority may,—
p.000157: (a) issue warning letter giving details of deficiency found; or
p.000157: (b) debar the investigator or sponsor including their employees, subsidiaries and branches, their agents,
p.000157: contractors and sub-contractors to conduct any clinical investigation for such period as it thinks fit; or
p.000157: (c) suspend the permission for such period as it thinks fit or cancel either wholly or partly the permission.
p.000157: (2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days of the
p.000157: receipt of such order before the Central Government, which may, after such enquiry and after giving an opportunity of
p.000157: being heard to the appellant, dispose of the appeal within a period of sixty days.
p.000157:
p.000157: 55. Medical management and compensation related to clinical investigation.—(1) Where any participant is
p.000157: injured on account of participation in clinical investigation, the sponsor permitted under rule 52 shall
p.000157: provide medical management to that participant.
p.000157: (2) Where an injury is caused to the participant in a clinical investigation of any investigational medical device and
p.000157: such injury is attributable to the use of investigational medical device, the sponsor permitted under
p.000157: rule 52 shall provide to that participant, medical management and such compensation in the manner as
p.000157: specified under rule 122DAB of the Drugs and Cosmetics Rules, 1945.
p.000157: (3) Where death of a participant is related to clinical investigation and is attributable to the use of an
p.000157: investigational medical device, the sponsor, permitted under rule 52 shall provide to the legal heir of
p.000157: that participant, such compensation, in such manner as specified under rule 122DAB of the Drugs and Cosmetics Rules,
p.000157: 1945.
p.000157:
p.000157: 56. Powers of search and seizure, etc.—The Medical Devices Officer may enter any premises related to
p.000157: clinical investigation or clinical performance evaluation, with or without an expert, with prior approval
p.000157: of the Central Licensing Authority, with or without prior notice, to inspect the facilities, search and seize,
p.000157: record, data, documents, books, and medical devices including investigational medical devices or new in vitro
p.000157: diagnostic medical device.
p.000157:
p.000157: 57. Maintenance of record.—Every person, sponsor, clinical research organisation, any other organisation or
p.000157: investigator conducting a clinical investigation or his agent holding a permission under this Chapter shall
p.000157: maintain such data, record, registers and other documents for a period of seven years after completion of such
p.000157: investigation and shall furnish such information as may be required by the Central Licensing Authority or any other
p.000157: officer authorised by it in this behalf under rule 56.
p.000157:
p.000157: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000159: 159
p.000159:
p.000159: 58. Disclosure of name, address, etc., of persons involved in clinical investigation or clinical
p.000159: performance evaluation.—Every person, sponsor, clinical research organisation, any other organisation or investigator
p.000159: conducting a clinical investigation or clinical performance evaluation or any agent authorised by any of them, as the
p.000159: case may be, shall, if so required, disclose to the Medical Device Officer or any other officer authorised by the
p.000159: Central Licensing Authority, the names, addresses and other particulars of persons involved in clinical investigation.
p.000159:
p.000159: 59. Permission to conduct clinical performance evaluation for new in vitro diagnostic medical device.— (1) No person
p.000159: or sponsor shall conduct any clinical performance evaluation in respect of a new in vitro diagnostic medical device on
p.000159: any specimen, including blood or tissue derived from human body except under, and in accordance with, the permission
p.000159: granted by the Central Licensing Authority subject to such conditions and in such form and manner as specified in these
p.000159: rules.
p.000159: (2) An application for grant of permission to conduct, clinical performance evaluation of new in vitro
p.000159: diagnostic medical device shall be made to the Central Licensing Authority in Form MD-24 by the sponsor
p.000159: and shall be accompanied with a fee as specified in the Second Schedule along with information specified in
p.000159: sub-rule (3) duly signed by the sponsor in India:
p.000159: Provided that no fee shall be required to be paid by the institutes, organisation, hospitals, run by the Central
p.000159: Government or the State Government, involved in conduct of clinical performance evaluation of new in
p.000159: vitro diagnostic medical devices.
p.000159: (3) The information required under sub-rule (2) shall contain the following, namely,-
p.000159: (i) approval from an Ethics Committee, which is registered with the Central Licensing Authority,
p.000159: as specified in Appendix VIII of the Schedule Y of the Drugs and Cosmetics Rules, 1945 and referred to in the Seventh
p.000159: Schedule;
p.000159: (ii) source and quantity of samples which shall be used during evaluation;
p.000159: (iii) device description including specification of raw material and finished product, data
p.000159: allowing identification of the device in question, proposed instruction for use, labels and regulatory status in
p.000159: other countries, if any;
p.000159: (iv) in house performance evaluation data used to establish stability, specificity, sensitivity, repeatability
p.000159: and reproducibility;
p.000159: (v) clinical performance evaluation plan stating in particular the purpose, scientific, technical
p.000159: or medical grounds and scope of evaluation;
p.000159: (vi) Case Report Form as specified in Table 6 of the Seventh Schedule;
p.000159: (vii) undertaking by investigators as specified in Table 9 of the Seventh Schedule;
p.000159: (viii) the list of laboratories or other institutions taking part in the evaluation study;
p.000159: (ix) the scheduled duration for evaluation and, in case of devices for self-testing, the location and number
p.000159: of lay persons involved;
p.000159: (x) an undertaking that the device in question conforms to the requirements of these rules,
p.000159: apart from aspects covered by evaluation and apart from those specifically itemised in the undertaking,
p.000159: and that every precaution has been taken to protect the health and safety of the patient, user and other persons.
p.000159: (xi) performance evaluation report from a laboratory designated under sub-rule (1) of rule 19.
p.000159:
p.000159: (4) The Central Licensing Authority may, in public interest, abbreviate, defer, or waive the requirements
p.000159: of conducting clinical performance evaluation for reasons to be recorded in writing for grant of permission to conduct
p.000159: clinical performance evaluation.
p.000159: (5) If the Central Licensing Authority, after such further enquiry, if any, as may be considered necessary, is
p.000159: satisfied that the requirements of these rules have been complied, may grant permission to conduct
p.000159: clinical performance evaluation for a new in vitro diagnostic medical device in Form MD-25 or may reject the
p.000159: application, for reasons to be recorded in writing, within a period of ninety days from the date of application.
p.000159:
p.000159: 60. Conditions for permission to conduct of clinical performance evaluation.— After grant of permission
p.000159: referred to in sub-rule (5) of rule 59, the following conditions shall be complied with by the applicant,—
p.000159: (i) clinical performance evaluation shall be conducted in accordance with the approved clinical
p.000159: performance evaluation plan and Good Clinical Practices Guidelines;
p.000159: (ii) clinical performance evaluation shall be initiated after approval of clinical investigation plan by
p.000159: the registered Ethics Committee;
p.000159:
p.000159: 160 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000159: II—SEC. 3(i)]
p.000159:
p.000159: (iii) clinical performance evaluation shall be registered with the Clinical Trial Registry of India before enrolling
p.000159: the first participant for such clinical performance evaluation;
p.000159: (iv) annual status report of each clinical performance evaluation, as to whether it is ongoing, completed or
p.000159: terminated, shall be submitted to the Central Licensing Authority by the sponsor, and in case of
p.000159: termination of any clinical performance evaluation, the detailed reasons for the same shall be communicated to the
p.000159: Central Licensing Authority within thirty days of the date of termination;
p.000159: (v) the laboratories or other institutions taking part in the evaluation study or the sponsor including their
p.000159: employees, subsidiaries and branches, their agents, contractors and sub-contractors, and clinical investigation sites
p.000159: shall be open for inspection by officers of the Central Licensing Authority authorised in this behalf who may be
p.000159: accompanied by officers of State Licensing Authority or outside experts under these rules to verify compliance of the
p.000159: requirements of these rules for conduct of clinical performance evaluation;
p.000159: (vi) the clinical performance evaluation shall be initiated within a period of one year from the date
p.000159: of grant of permission, failing which prior permission from the Central Licensing Authority shall be
p.000159: required to initiate such clinical performance evaluation;
p.000159: (vii) the Central Licensing Authority may impose or exempt any condition while granting permission in respect of
p.000159: specific clinical performance evaluation, if considered necessary, regarding the objective, design, subject population,
p.000159: subject eligibility, assessment, conduct and treatment of clinical performance evaluation.
p.000159:
p.000159: 61. Suspension or cancellation of permission.—(1) If any person to whom permission has been granted under sub- rule
p.000159: (5) of rule 59 fails to comply with any of the conditions of permission, the Central Licensing Authority may,
p.000159: suspend the permission for such period as it thinks fit or cancel either wholly or partly.
p.000159: (2) Any person who is aggrieved by the order passed under sub-rule (1), may file an appeal within thirty days before
p.000159: the Central Government, which may, after such enquiry and after giving an opportunity of being heard to
p.000159: the appellant, dispose of the appeal within a period of sixty days.
p.000159:
p.000159: 62. Medical management.—Where any participant is injured on account of his participation in the clinical
p.000159: performance evaluation, the sponsor permitted under sub-rule (5) of rule 59 shall provide medical management to that
p.000159: participant.
p.000159:
p.000159:
p.000159: CHAPTER VIII
p.000159: IMPORT OR MANUFACTURE MEDICAL DEVICE WHICH DOES NOT HAVE PREDICATE DEVICE
p.000159:
p.000159: 63. Permission to import or manufacture medical device which does not have its predicate device.—(1) Save as otherwise
p.000159: provided in these rules, for import or manufacture of medical device which does not have predicate medical device, an
p.000159: application for grant of permission for such medical device after completion of its clinical investigation under
p.000159: Chapter VII shall be made to the Central Licensing Authority in Form MD-26 either by an authorised agent in case of
p.000159: import or a manufacturer, as the case may be, which shall be accompanied with fee as specified in the Second Schedule
p.000159: along with information specified in Part IV of the Fourth Schedule:
p.000159: Provided that the medical device which does not have predicate medical device indicated in life
p.000159: threatening, serious diseases or diseases of special relevance to the Indian health scenario, national
p.000159: emergencies, extreme urgency, epidemic and medical devices indicated for conditions, diseases for which there is no
p.000159: therapy, the animal data or clinical data requirements may be abbreviated, deferred or omitted, as deemed
p.000159: appropriate by the Central Licensing Authority:
p.000159: Provided further that in respect of investigational medical device of Class A, data on clinical investigation may not
p.000159: be required, except in cases, where depending on the nature of the medical device, the Central Licensing
p.000159: Authority, for reason to be recorded in writing, considers such data necessary:
p.000159: Provided also that subject to other provisions of these rules, in case of medical device of which drugs are also a
p.000159: part, the submission of requirements relating to animal toxicology, reproduction studies, teratogenic
p.000159: studies, perinatal studies, mutagenicity and carcinogenicity may be relaxed in case of drugs already approved and
p.000159: marketed in India and supported by adequate published evidence regarding safety of the drug.
p.000159: Provided also that, the results of clinical investigation may not be required to be submitted where the
p.000159: investigational medical device is approved by the regulatory authorities of either the United Kingdom or the United
p.000159: States of America or Australia or Canada or Japan and the said device has been marketed for at least two years in that
p.000159: country and the Central Licencing Authority is satisfied with the data of safety, performance and pharmacovigilance of
p.000159: the device, and,-
p.000159: (a) there is no evidence or theoretical possibility, on the basis of existing knowledge, of any
p.000159: difference in the behavior and performance in Indian population;
p.000159: (b) the applicant has given an undertaking in writing to conduct post marketing clinical investigation
p.000159: with the objective of safety and performance of such investigational medical device as per protocol
p.000159: approved by the Central Licensing Authority.
p.000159:
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p.000161: 161
p.000161: (2) The Central Licensing Authority, after being satisfied with the information furnished along with application under
p.000161: sub-rule (1), may grant permission to import or manufacture medical device which does not have predicate medical device
p.000161: in Form MD-27, or may reject the application for reasons to be recorded in writing, within a period of one
p.000161: hundred and twenty days or such extended period, not exceeding a further period of thirty days, from
p.000161: the date of application:
p.000161: Provided that the Central Licensing Authority shall, where the information is inadequate with regard to the
p.000161: requirements as referred to in sub-rule (1), intimate the applicant in writing within the said period, for reasons to
p.000161: be recorded in writing, the conditions which shall be satisfied before considering the permission:
p.000161: Provided further that if the applicant has not furnished the required information sought by the Central
p.000161: Licensing Authority within ninety days from the date of intimation and the said Authority is satisfied
p.000161: that the information sought was possible to be furnished within the said period, it may reject the application for
p.000161: reasons to be recorded in writing.
p.000161: (3) If the applicant does not receive permission or if the application is rejected within the specified period as
p.000161: referred to in sub-rule (2), the applicant may appeal to the Central Government and that Government may, after such
p.000161: enquiry, as it considers necessary, pass such orders in relation thereto as it thinks fit within a period of sixty days
p.000161: from the date of appeal.
p.000161:
p.000161: 64. Permission to import or manufacture new in vitro diagnostic medical device.—(1) An application for grant of
p.000161: permission to import or manufacture a new in vitro diagnostic medical device may be made to the Central Licensing
p.000161: Authority in Form MD-28 either by an authorised agent in case of import or a manufacturer himself, as the case may be,
p.000161: and shall be accompanied with fee as specified in the Second Schedule along with information specified in Part IV of
p.000161: the Fourth Schedule:
p.000161: Provided that the new in vitro diagnostic medical device used for diagnosis of life threatening, serious
p.000161: diseases or diseases of special relevance to the Indian health scenario, national emergencies, extreme
p.000161: urgency, epidemic and diagnostic medical devices used for diagnosis of conditions, diseases for which there is no
p.000161: diagnostic medical device available in the country, the clinical data requirements may be abbreviated,
p.000161: deferred or omitted, as deemed appropriate by the Central Licensing Authority:
p.000161: Provided further that for new in vitro diagnostic medical device classified under Class A, data on clinical performance
p.000161: evaluation may not be necessary, except in cases, where the Central Licensing Authority, for reasons to be recorded in
p.000161: writing, considers it necessary depending on the nature of the medical device.
p.000161: (2) The Central Licensing Authority, may, after being satisfied with the information furnished along with application
p.000161: under sub-rule (1), grant permission to import or manufacture new in vitro diagnostic medical device in Form MD-29 or
p.000161: may reject the application, for reasons to be recorded in writing, within a period of ninety days or such extended
p.000161: period, not exceeding a further period of thirty days, from the date of application:
p.000161: Provided that the Central Licensing Authority shall, where the information is inadequate with regard to the
p.000161: requirements as referred to in sub-rule (1), intimate the applicant in writing within the said period, for reasons to
p.000161: be recorded in writing, the conditions which shall be satisfied before considering permission:
p.000161: Provided further that if the applicant has not furnished the required information sought by the Central
p.000161: Licensing Authority within ninety days from the date of intimation and the said Authority is satisfied
p.000161: that the information sought was possible to be furnished within the said period, it may reject the application for
p.000161: reasons to be recorded in writing.
p.000161:
p.000161: 65. Condition of permission to import or manufacture medical device which does not have its predicate device and
p.000161: new in vitro diagnostic medical device.—A Permission under rules 63 in Form MD-27 and rule 64 in Form
p.000161: MD-29 shall be subject to the following conditions, namely:—
p.000161: (a) the medical device shall conform to the specifications submitted along with the application;
p.000161: (b) the permission holder of Form MD-27 shall submit the Periodic Safety Update Report to the Central Licensing
p.000161: Authority from the date of launch in the market and such report shall be submitted every six months for first two years
p.000161: followed by submission of the said report annually for the two more successive years;
p.000161: (c) the permission holder shall inform the date of launch of medical device in the market to the Central
p.000161: Licensing Authority;
p.000161: (d) the permission holder of Form MD-27 shall submit the suspected unexpected serious adverse event within fifteen
p.000161: days of the awareness of the event to the Central Licensing Authority.
p.000161:
p.000161: CHAPTER IX
p.000161: DUTIES OF MEDICAL DEVICE OFFICER, MEDICAL DEVICE TESTING OFFICER AND NOTIFIED BODY
p.000161:
p.000161: 66. Duties of Medical Device Testing Officer.—The Medical Device Testing Officer shall cause the sample
p.000161: of medical device or portion thereof tested or evaluated as may be sent in a sealed package by the
p.000161: Medical Device Officer or any other person under the provisions of Chapters IV, V, VII and XI of these rules, and
p.000161: shall furnish the report of the result of the test or evaluation in accordance with these rules.
p.000161:
p.000161: 162 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000161: II—SEC. 3(i)]
p.000161:
p.000161: 67. Test or evaluation of sample under sub-section (4) of section 25 of the Act.—(1) The sample of
p.000161: medical device for test or evaluation under sub-section (4) of section 25 of the Act shall be sent by registered post
p.000161: in the outer cover addressed to the Director of central medical device testing laboratory in a sealed packet with a
p.000161: memorandum in Form MD-30.
p.000161: (2) The packet as well as the outer cover shall be marked with a distinguishing number.
p.000161: (3) A copy of the memorandum in Form MD-30 and a specimen impression of the seal used to seal the packet shall be
p.000161: separately sent by registered post to the Director of central medical device testing laboratory.
p.000161: (4) After test or evaluation, the result of the test or evaluation shall be sent forthwith to the sender in Form MD-31.
p.000161:
p.000161: 68. Procedure to be adopted by medical device testing officer on receipt of sample.—(1) On receipt of the sealed
p.000161: package of medical device or portion thereof, from a Medical Device Officer or any other person for
p.000161: test or evaluation, the Medical Device Testing Officer shall compare the seals on the packet or on portion thereof
p.000161: with the specimen impression received separately and shall note the condition of the seals on the packet or on portion
p.000161: thereof.
p.000161: (2) After completion of test or evaluation, the Medical Device Testing Officer shall forthwith furnish a report to the
p.000161: Medical Device Officer in triplicate in Form MD-32 of the result of the test or evaluation along with full protocols of
p.000161: the test or evaluation applied.
p.000161:
p.000161: 69. Application for test or evaluation of medical device.—For the purpose of these rules, an application
p.000161: from a purchaser for test or evaluation of a medical device or portion of medical device under section 26 of the Act
p.000161: shall be made in Form MD-33 and the report of such test or evaluation of the medical device which is
p.000161: prepared on such application shall be supplied to the applicant in Form MD-32.
p.000161:
p.000161: 70. Duties of Medical Device Officer.—Subject to the instructions of the Central Licensing Authority or
p.000161: State Licensing Authority, as the case may be, it shall be the duty of Medical Device Officer to,—
p.000161: (i) Inspect, not less than once in a year, all manufacturing sites licenced by the Central Licensing Authority or
p.000161: State Licensing Authority, as the case may be, within the area assigned to him;
p.000161: (ii) conform that the conditions of licence are being observed;
p.000161: (iii) take samples of medical device manufactured or imported for sale, or stocked or exhibited for sale in respect
p.000161: of which the Medical Device Officer has reason to suspect contravention of the provisions of the Act or these rules and
p.000161: send them for test or evaluation:
p.000161: Provided that in case of large sized medical device, wherein the opinion of the Medical Device Officer drawing
p.000161: samples of such a device may not be physically practical, such large sized medical device shall be
p.000161: inspected at the place where these are kept by the Medical Device Officer with or without expert and evaluated or
p.000161: tested by the Medical Device Testing Officer, for any suspect contravention, after approval of the
p.000161: Central Licensing Authority or the State Licensing Authority, as the case may be;
p.000161: (iv) maintain a record of all inspections undertaken, drawing of samples, seizure of stocks and action
p.000161: taken by Medical Device Officer in exercise and performance of duties and to furnish copies of such record to the
p.000161: Central Licensing Authority or the State Licensing Authority, as the case may be;
p.000161: (v) make such enquiries and inspections as may be necessary to detect the manufacture or sale of medical device in
p.000161: contravention of any provision of the Act and these rules;
p.000161: (vi) investigate any complaint made in writing relating to medical device to the Medical Device Officer or any other
p.000161: senior officer in accordance with the direction of the controlling officer;
p.000161: (vii) institute prosecution in relation to contravention of the provisions of the Act and these rules;
p.000161: (viii) review technical dossier of medical device furnished with the application under these rules or any other
p.000161: duties assigned by the Central Licensing Authority or State Licensing Authority, as the case may be, related to
p.000161: these rules.
p.000161:
p.000161: 71. Prohibition of disclosure of information.—Except for the purpose of official business or when required by a
p.000161: Court, a Medical Device Officer or Medical Device Testing Officer shall not, without the previous
p.000161: sanction, in writing, of his official superior, disclose to any person any information acquired while exercising such
p.000161: official duties.
p.000161:
p.000161: 72. Form of order not to dispose of stock.—An order in writing by a Medical Device Officer under clause (c) of
p.000161: sub-section (1) of section 22 of the Act requiring a person not to dispose of any stock in his possession shall be in
p.000161: Form MD-34.
p.000161:
p.000161: 73. Prohibition of sale.—No person in possession of a medical device in respect of which a Medical Device Officer has
p.000161: made an order under clause (c) of sub-section (1) of section 22 of the Act shall, in contravention of that order, sell
p.000161: or otherwise dispose of any stock of such medical device.
p.000161:
p.000161: 74. Form of receipt for seized medical devices, record, register, documents or any other material objects.—A receipt
p.000161: by a Medical Device Officer for the stock of any medical device or for any record, register, document or any other
p.000161: material object seized under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act shall be in Form
p.000161: MD-35.
p.000161:
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p.000163: 163
p.000163:
p.000163:
...
p.000163: shall be endorsed to the manufacturer.
p.000163:
p.000163: 79. Confiscation of medical devices, implements, machinery, etc.—(1) Where any person has been convicted for
p.000163: contravening any provisions of the Act or any these rules, the stock of medical device in respect of
p.000163: which the contravention has been made, shall be liable to confiscation.
p.000163: (2) Where any person has been convicted for manufacturing any medical device which is misbranded, adulterated or
p.000163: spurious for sale, stocking or exhibiting for sale or distribution without a valid licence, any implements or machinery
p.000163: used in such manufacture, sale or distribution and any receptable, package or covering in which such medical device is
p.000163: contained and the animals, vehicles, vessels or other conveyances used in carrying such medical device shall
p.000163: be liable to confiscation.
p.000163:
p.000163: 80. Procedure for disposal of confiscated medical device.—(1) The Court may refer the confiscated medical device to
p.000163: the Medical Device Officer concerned for report as to whether they are of standard quality or
p.000163: contravene the provisions of the Act or the rules in any respect.
p.000163: (2) If the Medical Device Officer, on the basis of Medical Device Testing Officer’s report, finds the
p.000163: confiscated medical device to be not of standard quality or to contravene any of the provisions of the
p.000163: Act or rules made thereunder, the Medical Device Officer shall, with the approval of the Central Licensing Authority
p.000163: or State Licensing Authority, as the case may be, report to the Court accordingly and the Court shall thereupon order
p.000163: destruction of such medical devices, which shall take place under the supervision of the Medical Device Officer in the
p.000163: presence of such authority, if any, as may be directed by the Court:
p.000163: Provided that the convicted person shall be liable to bear the cost of destruction of seized articles.
p.000163: (3) If the Medical Device Officer finds that the confiscated medical devices are of standard quality
p.000163: and do not contravene the provisions of the Act or the rules made thereunder, the Medical Device Officer shall, after
p.000163: keeping the Central Licensing Authority or the State Licensing Authority, as the case may be, informed,
p.000163: report to the Court accordingly.
p.000163: (4) The Court may return the confiscated devices to the rightful owner, and in case, the ownership is not established,
p.000163: the same may be given to a hospital or a dispensary maintained or supported by the Government or to a charitable
p.000163: institution.
p.000163:
p.000163: CHAPTER X
p.000163: REGISTRATION OF LABORATORY FOR CARRYING OUT TEST OR EVALUATION
p.000163:
p.000163: 81. Application for registration of medical device testing laboratory.—(1) An application for grant of registration of
p.000163: a medical device testing laboratory to carry out testing or evaluation of a medical device on behalf
p.000163: of a manufacturer shall be made to the Central Licensing Authority through online portal of the Central Government in
p.000163: Form MD-39 accompanied with a fee as specified in the Second Schedule along with the information specified in
p.000163: sub-rule (2).
p.000163: (2) The application made under sub-rule (1) shall be accompanied with the following information, namely:-
p.000163: (i) constitution of the medical device testing laboratory;
p.000163: (ii) premises showing location and area of the different sections;
p.000163:
p.000163: 164 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000163: II—SEC. 3(i)]
p.000163:
p.000163: (iii) qualification, experience of technical staff employed for testing and the person in-charge of testing;
p.000163: (iv) list of equipment; and
p.000163: (v) valid accreditation certificate issued by the National Accreditation Body for Testing and
p.000163: Calibration Laboratories or any other similar body as may be notified by the Central Government.
p.000163:
p.000163: 82. Conditions for registration of medical device testing laboratory.—The following conditions shall be complied with
p.000163: by the applicant before grant of registration, namely,-
p.000163: (i) the premises where the test or evaluation shall be carried out shall be well lighted and properly ventilated
p.000163: except where the nature of tests of any medical device warrants otherwise, and wherever necessary, the premises shall
p.000163: be air conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the
p.000163: performance of special tests such as sterility tests, microbiological tests, etc;
p.000163: (ii) the applicant shall provide adequate space having regard to the nature and number of samples of medical devices
p.000163: proposed to be tested and evaluated:
p.000163: Provided that the approving authority shall determine from time to time whether the space provided
p.000163: continues to be adequate;
p.000163: (iii) if it is intended to carry out tests requiring the use of animals, the applicant shall provide for an animal
p.000163: house and comply with the following requirements:-
p.000163: (a) the animal house shall be adequate in area, well lighted and properly ventilated and the animals undergoing tests
p.000163: shall be kept in air conditioned area;
p.000163: (b) the animals shall be suitably housed in hygienic surroundings and necessary provisions made for
p.000163: removal of excreta and foul smell;
p.000163: (c) the applicant shall provide for suitable arrangements for preparation of animal feed;
p.000163: (d) the applicant shall provide for suitable arrangements for quarantining of all animals immediately on their arrival
p.000163: in the institution;
p.000163: (e) the animals shall be periodically examined for their physical fitness;
p.000163: (f) the applicant shall provide for isolation of sick animals as well as animals under test;
p.000163: (g) the applicant shall ensure compliance with the requirements of the Prevention of Cruelty to Animals Act, 1960 (59
p.000163: of 1960);
p.000163: (h) the applicant shall make proper arrangements for disposal of the carcasses of animals in a manner as not to cause
p.000163: hazard to public health.
p.000163:
p.000163: 83. Registration of medical device testing laboratory.—(1) Before grant of registration to any medical
p.000163: device testing laboratory by the Central Licensing Authority, the premises shall be inspected by the Medical Device
p.000163: Officer appointed by the Central Government with or without an expert in the concerned field for adequacy and
p.000163: suitability.
p.000163: (2) The Medical Device Officer, after completion of the inspection, shall forward a detailed descriptive report giving
p.000163: findings on each aspect of inspection along with recommendations to the Central Licensing Authority with a copy to the
p.000163: applicant.
p.000163: (3) If on receipt of the application and the report referred to in sub-rule (2), the Central Licensing
p.000163: Authority, is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules, the
p.000163: Central Licencing Authority may grant registration in Form MD-40 or if not satisfied, may, reject the
p.000163: application, for reasons to be recorded in writing, within a period of forty five days from the date of
p.000163: application.
p.000163: (4) The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of
p.000163: medical devices intended to be tested which shall be adequate in the opinion of the Central Licensing Authority.
p.000163: (5) The testing and evaluation of medical devices shall be under active direction of a person whose qualification and
p.000163: experience is considered adequate and who shall be held responsible for reports of test or evaluation issued.
p.000163: (6) The applicant shall provide standards recognised under the provisions of the Act and these rules
p.000163: and such standards of reference as may be required in connection with the testing or evaluation of the devices for the
p.000163: testing of which approval has been applied for.
p.000163:
p.000163: 84. Validity of registration.—A registration granted under sub-rule (3) of rule 83 in Form MD-40, shall remain valid in
p.000163: perpetuity, unless, it is suspended or cancelled, provided the registration holder deposits a registration retention
p.000163: fee to the Central Licensing Authority as specified in the Second Schedule after completion of every five years from
p.000163: the date of its issue:
p.000163: Provided, that the Central Licensing Authority may permit to deposit the registration retention fee after due date but
p.000163: before the expiry of six months with a late fee at the rate of two per cent. per mensem or part thereof:
p.000163: Provided further that, if the registration holder fails to deposit the registration retention fee within
p.000163: the above stipulated period, the registration shall be deemed to have been cancelled for all purposes.
p.000163:
p.000163: 85. Conditions of registration.—A registration granted under sub-rule (3) of rule 83 in Form MD-40,
p.000163: shall be subject to the following conditions, namely:—
p.000163: (i) the registration certificate shall be kept on the approved premises and shall be produced at the
p.000163: request of the medical device officer;
p.000163:
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p.000165: 165
p.000165: (ii) the person holding registration certificate shall provide and maintain necessary qualified staff, adequate
p.000165: premises and equipment;
p.000165: (iii) the person holding registration certificate shall provide proper facilities for storage so as to preserve the
p.000165: properties of samples picked up for testing;
p.000165: (iv) the person holding registration certificate shall maintain records of tests for evaluation and performance carried
p.000165: out on all samples of medical devices and the results thereof together with protocols of tests and the reports showing
p.000165: readings and calculations and such records shall be retained, in case of substances for which an expiry
p.000165: date is assigned, for a period of two years beyond the expiry date, and in the case of other substances, for
p.000165: a period of six years;
p.000165: (v) the person holding registration certificate shall allow the medical device officer appointed under this Act to
p.000165: enter, with or without prior notice, the premises where the testing is carried out and to inspect the
p.000165: premises and the equipment used for test and the testing procedures employed.
p.000165: (vi) The person holding registration certificate shall allow the medical device officer to inspect records maintained
p.000165: and shall make available such information as may be required for ascertaining whether the provisions of the Act and
p.000165: these rules have been complied with;
p.000165: (vii) the registration holder shall inform forthwith, any change of existing expert staff or
p.000165: person-in-charge of the testing or evaluation to the Central Licensing Authority for its approval;
p.000165: (viii) in case, any sample of a medical device is found on test, to be not of standard quality, the person in-charge of
p.000165: the registered medical device testing laboratory shall furnish a copy of the test or evaluation report on the sample
p.000165: with the protocols of tests applied to the Central Licensing Authority;
p.000165: (ix) the person holding registration certificate shall maintain an inspection book to enable the Medical Device Officer
p.000165: to record non-compliance with the provisions of the Act and these rules;
p.000165: (x) the registered medical device testing laboratory shall inform to the Central Licensing Authority in writing in the
p.000165: event of any change in its constitution and where such change in the constitution takes place, the current registration
p.000165: shall be deemed to be valid for a maximum period of ninety days from the date on which the change
p.000165: took place unless, in the meantime, a fresh approval has been taken from the Central Licensing Authority
p.000165: with the changed constitution;
p.000165:
p.000165: 86. Suspension and cancellation of registration.—(1) Where any registered medical device testing laboratory fails to
p.000165: comply with any of the conditions of approval, or any provisions of the Act and these rules, the Central Licensing
p.000165: Authority, may issue a show cause notice for suspension or cancellation of the registration of the said medical device
p.000165: testing laboratory.
p.000165: (2) On receipt of the show cause notice under sub-rule (1), the registered medical device testing
p.000165: laboratory shall, furnish its reply in writing, within fifteen days of the receipt of such show cause notice.
p.000165: (3) After considering the reply of the registered medical device testing laboratory furnished under sub-rule
p.000165: (2), the Central Licensing Authority may pass an order in writing for suspension or cancellation of the registration
p.000165: of the said medical device testing laboratory registered under sub-rule (3) of rule 83.
p.000165: (4) While passing orders under sub-rule (3), the Central Licensing Authority may suspend or cancel the registration
p.000165: wholly or partly in respect of medical device and its variant for testing for such period as may be
p.000165: specified in the order.
p.000165: (5) An applicant, who is aggrieved by an order of suspension or cancellation of registration under sub-rule (3), may
p.000165: file an appeal within thirty days from the date of receipt of such order before the Central Government, which may,
p.000165: after such enquiry and after giving an opportunity of being heard, dispose of the appeal within a period of sixty days.
p.000165:
p.000165: CHAPTER XI
p.000165: SALE OF MEDICAL DEVICES
p.000165:
p.000165: 87. Provisions for sale of medical devices.—(1) Subject to the provisions of these rules, Part VI relating to “Sale of
p.000165: Drugs Other than Homeopathic Medicines” of the Drugs and Cosmetics Rules, 1945, shall be applicable
p.000165: mutatis mutandis in respect of sale of medical devices.
p.000165: (2) The licence granted or renewed under Part VI of the Drugs and Cosmetics Rules, 1945 for sale of drugs, prior to
p.000165: commencement of these rules, shall be deemed to continue to be valid for the purpose of sale of medical devices.
p.000165:
p.000165: 88. Supply of medical device to hospitals against delivery challan.—(1) Notwithstanding anything contained in
p.000165: the Drugs and Cosmetics Rules, 1945, any person having a valid licence to sell, stock, exhibit or offer
p.000165: for sale or distribute by retail or wholesale, may, supply invasive medical devices to be implanted through surgical
p.000165: intervention to a hospital for its patient against a delivery challan:
p.000165: Provided that in respect of supplies made against delivery challan of such medical devices, the licencee shall
p.000165: ensure that specified storage conditions are met.
p.000165: (2) A cash or credit memo shall be generated for such medical devices supplied under sub-rule (1),
p.000165: used in the surgical intervention and record of the same shall be maintained by the licencee as per condition of
p.000165: licence.
p.000165:
p.000165: 166 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000165: II—SEC. 3(i)]
p.000165:
p.000165: 89. Recall of medical device.—(1) If a manufacturer or authorised agent, as the case may be,
p.000165: considers or has reasons to believe that a medical device, which has been imported, manufactured, sold or
p.000165: distributed, is likely to pose risk to the health of a user or patient during its use and therefore may be
p.000165: unsafe, such manufacturer or authorised agent shall immediately initiate procedures to withdraw the medical device
p.000165: in question from the market and patients, indicating reasons for its withdrawal and inform the competent authority the
p.000165: details thereof.
p.000165: (2) A manufacturer or authorised agent, as the case may be, shall immediately inform the competent authority and co-
p.000165: operate with them, if there are reasons to believe that a medical device which has been placed in the market, may be
p.000165: unsafe for the patients.
p.000165: (3) The manufacturer or importer or authorised agent, as the case may be, shall inform the competent authority of the
p.000165: action taken to prevent risk to the patient and shall not prevent or discourage any person from
p.000165: cooperating, in accordance with the provisions of the Act and these rules, with the competent authorities,
p.000165: where this may prevent, reduce or eliminate a risk arising due to use of such medical device.
p.000165:
p.000165: CHAPTER XII MISCELLANEOUS
p.000165:
p.000165: 90. Exemption from provisions related to medical devices.—(1) The medical devices specified in the Eighth
p.000165: Schedule shall be exempt from the provisions of these rules to the extent and subject to the conditions specified in
p.000165: that Schedule.
p.000165: (2) The Central Government may, by notification, from time to time, amend or modify the entries in the
p.000165: Eighth Schedule.
p.000165:
p.000165: 91. Export of medical devices.—Where a person intends to export any medical device, manufactured in India, and for
p.000165: that purpose, requests a certificate in the nature of free sale certificate or a certificate about quality,
p.000165: safety and performance in relation to that medical device as required by the authority concerned of the importing
p.000165: country, such person, may apply to the Central Licensing Authority for the purpose along with a fee as
p.000165: specified in the Second Schedule and the said authority shall, if the requirements are fulfilled, issue a
p.000165: certificate to the applicant.
p.000165:
p.000165: 92. Rejection of application.—If any document submitted by an applicant for grant of licence for import
p.000165: or manufacture or test licence or permit for personal use or permission to import or manufacture investigational
p.000165: medical device or new in vitro diagnostic medical device or permission to conduct of clinical
p.000165: investigation or clinical performance evaluation is found to be misleading, or fake, or fabricated, the application,
p.000165: after giving an opportunity to the applicant of being heard, shall be summarily rejected.
p.000165: 93. Debarment of applicant.—(1) Whoever himself or, any other person on his behalf, or applicant is found to be guilty
p.000165: of submitting misleading, or fake, or fabricated documents, may, after giving him an opportunity to show cause as to
p.000165: why such an order should not be made, in writing, stating the reasons thereof, be debarred by the
p.000165: Central Licensing Authority or the State Licensing Authority, as the case may be, for such period as it may deem
p.000165: proper.
p.000165: (2) Where an applicant is aggrieved by an order made by the Central Licensing Authority or the State
p.000165: Licensing Authority, as the case may be, under sub-rule (1), such applicant may, within thirty days of the receipt of
p.000165: the order, make an appeal to the Central Government or the State Government, as the case may be, and that Government
p.000165: may, after such enquiry as it considers necessary, and after affording an opportunity of being heard, make such order
p.000165: as it may deem proper.
p.000165: 94. Mode of payment of fee.—(1) The fees prescribed under these rules, in case of application made to the Central
p.000165: Licensing Authority, shall be paid through challan or by electronic mode, in the Bank of Baroda, Kasturba Gandhi
p.000165: Marg, New Delhi-110001 or any other branch of Bank of Baroda, or any other bank, notified by the
p.000165: Ministry of Health and Family Welfare in the Central Government, to be credited under the Head of Account “0210-
p.000165: Medical and Public Health, 04-Public Health, 104-Fees and Fines.
p.000165: (2) Where the fee specified is payable to the State Licensing Authority, the same shall be paid through a challan or by
p.000165: electronic mode as may be specified by the State Government concerned.
p.000165: 95. Digitalisation of form.—The Forms prescribed under these rules may be suitably modified for conversion into
p.000165: digital forms by the Central Drugs Standard Control Organization and such modification shall not require
p.000165: any amendment in these rules.
p.000165: 96. Overriding effect.—The provisions of these rules shall have effect, notwithstanding anything
p.000165: inconsistent therewith contained in the Drugs and Cosmetics Rules, 1945.
p.000165:
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p.000167:
p.000167:
p.000167: 97. Savings.—Notwithstanding the non-applicability of the Drugs and Cosmetics Rules 1945, for the substances and
p.000167: devices referred to in rule 2,-
p.000167: (i) the licence or registration certificate, issued under the provisions of the Act and the Drugs and Cosmetics Rules,
p.000167: 1945, prior to commencement of these rules, shall be deemed to be valid till its expiry or for a period of eighteen
p.000167: months from the date these rules are notified, whichever is later, under the corresponding provisions of
p.000167: these rules;
p.000167: (ii) new drug approval, or things done or any action taken or purported to have been done or taken, including any
p.000167: rule, notification, inspection, order or notice made or issued or any appointment or declaration made or
p.000167: any operation undertaken or any direction given or any proceedings taken or any penalty, punishment, forfeiture or
p.000167: fine imposed under the Drugs and Cosmetics Rules, 1945 shall, be deemed to have been done or taken under the
...
p.000500:
p.000500: $1000
p.000500: $10
p.000500: ----
p.000500: $3000
p.000500: $1500
p.000500:
p.000500:
p.000500: $3000
p.000500: $500
p.000500: $6000
p.000500: ----
p.000500: $1000
p.000500:
p.000500: $2000
p.000500:
p.000500: $3000
p.000500:
p.000500: $50
p.000500:
p.000500: $1000
p.000500:
p.000500: $1500
p.000500:
p.000500: $1000
p.000500:
p.000500: $3000
p.000500:
p.000500: $10
p.000500:
p.000500: $500
p.000500:
p.000500: $100
p.000500:
p.000500: 500
p.000500:
p.100000: 100000
p.100000: 100000
p.025000: 25000
p.050000: 50000
p.050000:
p.050000: 174 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.050000: II—SEC. 3(i)]
p.050000:
p.050000:
p.050000:
p.050000: 48.
p.050000:
p.050000: 49.
p.050000:
p.050000: 50.
p.050000: 51.
p.050000:
p.050000: 64(1)
p.050000:
p.050000: 81(1)
p.050000:
p.000084: 84
p.000091: 91
p.000091: Permission to import or manufacture new in vitro diagnostic medical device.
p.000091: Registration of medical device testing laboratory to carry out testing or evaluation of a medical device on behalf of
p.000091: manufacturer.
p.000091: Registration retention fee for medical device testing laboratory Certificate to export of each distinct medical device.
p.000091:
p.025000: 25000
p.025000:
p.020000: 20000
p.020000:
p.020000: 20000
p.001000: 1000
p.001000:
p.001000: Third Schedule
p.001000: [See rules 13(5), 13(9), 14, 15, 20(4), 20(6)]
p.001000: Documents required for registration of Notified Body, its duties and functions.
p.001000: Part I
p.001000: Documents to be furnished along with application in Form MD-1 for grant of certificate of registration
p.001000:
p.001000: 1. A Notified Body shall furnish duly signed copy of the following documents to the Central Licensing Authority.
p.001000: (i) Constitution details of the Notified Body;
p.001000: (ii) Brief profile of the organization and business profile related to audit of medical device manufacturing sites;
p.001000: (iii) Accreditation Certificate issued by the National Accreditation Body referred to in the rule 11.
p.001000: (iv) Quality manual of the organization;
p.001000: (v) List of all Standard Operating Procedures;
p.001000: (vi) List of all technical personnel including any outside experts along with their qualification, experience and
p.001000: responsibilities.
p.001000: 2. Undertaking to be submitted stating that the,-
p.001000: (i) Notified body including its directors, executives and personnel responsible for carrying out evaluation and
p.001000: verification activities shall not be the designer, manufacturer, supplier or installer of devices within the product
p.001000: category for which the body has been designated, nor the authorised representative of any of those parties.
p.001000: (ii) Directors, executives and personnel responsible for carrying out evaluation and verification activities
p.001000: shall be independent of both the manufacturers for whom the notified body conducts assessments and the commercial
p.001000: competitors of those manufacturers, during their employment by the notified body for the product range it is notified
p.001000: for.
p.001000: (iii) Notified body personnel shall not be involved in consultancy activities relating to devices in question, their
p.001000: manufacturing control or test procedures, or their manufacturer.
p.001000:
p.001000:
p.001000:
p.001000:
p.001000: 1. Duties:
p.001000: Part II
p.001000: Duties and functions of Notified Body
p.001000: 1. Notified body shall perform the audit of manufacturer who applied under sub-rule (1) of rule 13. The specific
p.001000: application shall be allotted to the notified body by the State Licensing Authority through the portal
p.001000: of the Central Government. The audit shall relevant to domestic manufacturing site of Class A or Class
p.001000: B medical devices.
p.001000: 2. The notified body shall have standard operating procedure for identification, review and resolution of all cases
p.001000: where conflict of interest is suspected or proven. Record of such review and decision shall be maintained.
p.001000:
p.001000:
p.001000: 2. Functions:
p.001000: A notified body shall,-
p.001000: (i) impart training to its staff covering all the evaluation and verification operations for which
p.001000: the notified body has been designated;
p.001000: (ii) ensure that staff has adequate knowledge and experience of the requirement of the control;
p.001000: (iii) carry out the evaluation and verification operations with the highest degree of professional
p.001000: integrity independently with technical competence;
p.001000: (iv) ensure that manufacturing site and products comply with prescribed standards referred in rule 7;
p.001000: (v) not provide training or consultancy to the manufacturers whose site is being audited;
p.001000:
p.001000: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000175: 175
p.000175: (vi) ensure that their auditors possess required qualification and expertise in the relevant field for carrying
p.000175: out assessments of manufacturing site and medical device that they are undertaking;
p.000175: (vii) establish and maintain procedure and record which demonstrate its compliance with quality management system.
p.000175:
p.000175: 3. Procedure for audit:
p.000175: The notified body shall carry out the audit in the following manner,-
p.000175: (i) technical review of respective documents as prescribed in the Fourth Schedule;
p.000175: (ii) on-site audit of the manufacturer’s quality management system to establish conformity by examination of
p.000175: objective evidence, and that of sub-contractor wherever applicable, the requirements of the Fifth Schedule;
p.000175: (iii) establish conformity by examination and provision of objective evidences to the essential principles laid down
p.000175: by the Central Government from time to time. ;
p.000175: (iv) establish design conformity by review of the design documents during assessment of medical device to ensure its
p.000175: quality, safety, and performance;
p.000175: (v) record post approval changes, if any;
p.000175: (vi) assess conformity to the product and process standards as per provisions of these rules;
p.000175: (vii) inform the manufacturer about the observed noncompliances during audit, if any, and provide a copy of the audit
p.000175: report to the manufacturer;
p.000175: (viii) when any major non-compliance is observed during audit by the notified body which may affect quality of the
p.000175: device, it may provide reasonable time to rectify the non-compliance followed by compliance verification of
p.000175: the manufacturing site;
p.000175: (ix) The Notified Body, after assessment and verification, shall submit detailed report giving its findings on each
p.000175: aspect of audit along with its recommendations after completion of audit to the State Licensing Authority
p.000175: and a copy of the same to the manufacturer.
p.000175:
p.000175:
p.000175: Fourth Schedule
p.000175: [See rule 20(2), 21(2), 34(2), 34(4), 63(1) and 64(1)]
p.000175: Documents required for grant of licence to manufacture for sale or for distribution or import Part I
p.000175: Power of Attorney
p.000175: (To be authenticated in India either by a Magistrate of First Class or by Indian Embassy in the country of origin or by
p.000175: an equivalent authority through apostille)
p.000175:
p.000175: Power of Attorney to accompany an application for issuance of import licence
p.000175: I ……………....… working as ……………………… authorised to sign this Power of Attorney, on behalf of M/s
p.000175: ………………………………… (full address/ telephone no., e-mail) having manufacturing site
p.000175: at
p.000175: ………………….……. (full address, telephone no., e-mail), hereby delegate Power of
p.000175: Attorney to M/s , (full address, as per wholesale licence or manufacturing
p.000175: licence, with telephone, fax and e-
p.000175: mail address), hereinafter to be known as authorised agent, intends to apply for import licence under the provisions of
p.000175: these rules, to import into India for the following medical devices manufactured at below manufacturing site.
p.000175:
p.000175:
p.000175: Sr.
p.000175: No.
p.000175: Name & address of foreign manufacturer (full address with telephone, fax and e- mail address)
p.000175: Name & address of manufacturing site (full address with telephone, fax and e-mail address of the manufacturing site)
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: Following are the details of medical device proposed to be imported (A separate list may be annexed, if
p.000175: required in below given format).
p.000175:
p.000175: 176 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000175: II—SEC. 3(i)]
p.000175:
p.000175:
p.000175:
p.000175: S.
p.000175: No.
p.000175:
p.000175: Generic name
p.000175:
p.000175: Brand Name (if any)
p.000175:
p.000175: Model No.
p.000175: (if any)
p.000175:
p.000175: Dimension
p.000175:
p.000175: Intended use
p.000175:
p.000175: Shelf life
p.000175:
p.000175: Sterile or Non sterile
p.000175:
p.000175: Class of medical device
p.000175:
p.000175: (2) Our Authorised agent shall,-
p.000175:
p.000175: (a) act as the official representative for obtaining import licence in India.
p.000175: (b) submit all necessary documents, as defined in the Fourth Schedule, for the import licence of medical device.
p.000175: (3) I shall comply with all the conditions imposed on the import licence and with provisions of the Medical
p.000175: Devices Rules, 2017.
p.000175: (4) I declare that M/s is carrying on the manufacture of the listed medical device at the
p.000175: manufacturing site
p.000175: specified above.
p.000175: (5) I shall allow the Central Licensing Authority or any person authorized by it in that behalf to enter and
p.000175: inspect or audit the manufacturing premise and to examine the process, procedure and documents in respect
p.000175: of any manufacturing site or to take sample of listed medical device for which the application for import licence has
p.000175: been made.
p.000175: (6) In case of any violation of Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices Rules, 2017,
p.000175: the authorised agent shall continue to be responsible even after withdraw of this Power of Attorney for
p.000175: the devices imported in India.
p.000175: (7) I do hereby state and declare that all the photocopies or scanned copies in the application are true copies
p.000175: of the original documents.
p.000175: (8) I do hereby state and declare that all the documents submitted by the undersigned are true and correct.
p.000175:
p.000175:
p.000175:
p.000175: Place:
p.000175: Date:
p.000175: Signature of the manufacturer
p.000175: (Name and Designation) Seal/Stamp
p.000175:
p.000175: Undertaking from the authorised agent
p.000175:
p.000175: I ……………....…, age……….., working as ……………………… at M/s ……………………… (Full address/ telephone no., e-mail)
p.000175: agrees to act upon the Power of Attorney as the authorized agent on behalf of M/s
p.000175: ………………………………… (Full address/ telephone no., e-mail) having manufacturing site at
p.000175: ………………….……. (Full address, telephone no., e-mail).
p.000175:
p.000175: Place:
p.000175: Date: Signature of the authorised
p.000175: agent
p.000175: (Name and Designation) Seal/Stamp
p.000175:
p.000175: Part II
p.000175: (i) Documents to be submitted with the application for grant of Import Licence or licence to manufacture for sale or
p.000175: for distribution of a Class A medical device,-
p.000175:
p.000175: (a) The applicant shall submit documents as specified in the Table below.-
p.000175:
p.000175:
p.000175: S.N.
p.000175:
p.000175: 1.
p.000175:
p.000175:
p.000175: 2.
p.000175:
p.000175: 3.
p.000175: For medical devices other than in vitro
p.000175: diagnostic medical device
p.000175: device description, intended use of the device, specification including variants and accessories;
p.000175: material of construction;
p.000175:
p.000175: working principle and use of a novel technology (if any);
p.000175: For in vitro diagnostic medical device
p.000175:
p.000175: device description, intended use of the device, specification including variants and accessories;
p.000175: a summary of analytical technology, relevant analytes and test procedure;
p.000175: working principle and use of a novel technology (if any);
p.000175:
p.000175: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000177: 177
p.000177:
p.000177:
p.000177: 4. labels, package inserts (IFU, etc.,), user manual, wherever applicable,
p.000177: 5. summary of any reported Serious Adverse Event in India or in any of the countries where device is
p.000177: marketed and action taken by the manufacturer and National Regulatory Authority concerned;
p.000177: 6. site or plant master file as specified in Appendix I of this Schedule;
p.000177: 7. constitution details of the firm (of domestic manufacturer or authorised agent);
p.000177: 8. essential principles checklist for demonstrating conformity to the essential principles of safety and
p.000177: performance of the medical device;
p.000177:
p.000177: 9. undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the
p.000177: provisions of the Fifth Schedule;
p.000177:
p.000177: labels and package inserts (IFU, etc.,), user manual, wherever applicable;
p.000177: analytical performance summary including sensitivity and specificity;
p.000177:
p.000177:
p.000177:
p.000177: site or plant master file as specified in Appendix I of this Schedule;
p.000177: constitution details of the firm (of domestic manufacturer or authorised agent);
p.000177: essential principles checklist for demonstrating conformity to the essential principles of safety and performance
p.000177: of the in vitro medical device;
p.000177: undertaking signed by the manufacturer stating that the manufacturing site is in compliance with the provisions
p.000177: of the Fifth Schedule;
p.000177:
p.000177: (b) In case of application for import licence, the authorised agent shall submit
p.000177: A. notarized copy of overseas manufacturing site or establishment or plant registration, by whatever name called, in
p.000177: the country of origin issued by the competent authority and Free Sale Certificate issued by the National Regulatory
p.000177: Authority or equivalent competent authority of the country concerned as referred under rule 36.
p.000177: B. notarised copy of Quality Management System certificate or Full Quality Assurance certificate or
p.000177: Production Quality Assurance certificate issued by the competent authority, in respect of the
p.000177: manufacturing site.
p.000177: C. self-attested copy of valid whole sale licence or manufacturing licence issued under these rules.
p.000177: D. copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or
p.000177: Competent Authority within last 3 years, if any.
p.000177:
p.000177: (ii) Documents to be submitted with the application for grant of licence to manufacture or import Class B, Class C or
p.000177: Class D medical device,-
p.000177:
p.000177: The domestic manufacturer or authorised agent shall submit the duly signed following information pertaining to
p.000177: Manufacturing site.
p.000177: (a) Constitution details of domestic manufacturer or authorised agent;
p.000177: (b) Site or plant master file as specified in Appendix I of this Schedule;
p.000177: (c) Device master file as specified in Appendix II for medical devices other than in vitro diagnostic medical
p.000177: devices, or Appendix III for in vitro diagnostic medical devices of this Schedule;
p.000177: (d) Essential Principles checklist for demonstrating conformity to the Essential Principles of Safety
p.000177: and Performance of the Medical Device including in vitro diagnostic medical device;
p.000177: (e) Test licence obtained for testing and generation of quality control data (for domestic manufacturers only), if
p.000177: any;
p.000177: (f) Undertaking signed stating that the manufacturing site is in compliance with the provisions of the
p.000177: Fifth Schedule.
p.000177: (g) Documents as specified in the clause (b) of paragraph (i) of this part.
p.000177: (h) In case of in vitro diagnostic medical devices, a copy of performance evaluation report issued by
p.000177: the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of
p.000177: rule 83.
p.000177:
p.000177: 178 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000177: II—SEC. 3(i)]
p.000177:
p.000177: Part III Appendix I
p.000177: Contents of a site or plant master file
...
p.000187: vitro diagnostic medical device to the Essential Principles that apply to it.
p.000187: 20. Labelling:
p.000187: The device master file should typically contain a complete set of labeling associated with the in vitro medical device
p.000187: as described in Chapter VI.
p.000187:
p.000187: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000189: 189
p.000189: 21. Post marketing surveillance data (vigilance reporting):
p.000189: The dossier should contain the post marketing surveillance or vigilance reporting procedures and data
p.000189: collected by the manufacturer encompassing the details of the complaints received and corrective and
p.000189: Preventive actions taken for the same.
p.000189: 22. Information required to be submitted for the in vitro diagnostic medical device:
p.000189: (1) The details of source antigen or antibody as the case may be and characterization of the
p.000189: same. Process control of coating of antigen or antibody on the base material like Nitrocellulose paper, strips or cards
p.000189: or ELISA wells etc. Detailed composition of the in vitro diagnostic medical device and manufacturing flow chart
p.000189: process of the in vitro diagnostic medical device showing the specific flow diagram of individual
p.000189: components or source of the individual components.
p.000189: (2) Test protocol of the in vitro diagnostic medical device showing the specifications and method of testing. In
p.000189: house evaluation report of sensitivity, specificity and stability studies carried out by the manufacturer.
p.000189: (3) In case of imported diagnostic in vitro diagnostic medical devices, the report of evaluation in details
p.000189: conducted by the National Control Authority of country of origin.
p.000189: (4) Specimen batch test report for at least consecutive 3 batches showing specification of each testing
p.000189: parameter.
p.000189: (5) The detailed test report of all the components used/packed in the finished in vitro diagnostic medical device.
p.000189: (6) Pack size and labeling.
p.000189: (7) Product inserts.
p.000189: (8) Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the
p.000189: in vitro diagnostic medical device.
p.000189: (9) Specific processing like safe handling, material control, area control, process control, and
p.000189: stability studies, storage at quarantine stage and finished stage, packaging should be highlighted in the product
p.000189: dossier.
p.000189: NOTE:
p.000189: 1. All the test reports submitted as a part of the dossier should be signed and dated by the responsible person.
p.000189: 2. Batch Release Certificates and Certificate of Analysis of finished product for minimum 3 consecutive batches
p.000189: should be submitted.
p.000189: 3. All certificates submitted must be within the validity period.
p.000189: 4. Any information which is not relevant for the subject in vitro diagnostic medical device may be stated as ‘Not
p.000189: Applicable’ in the relevant sections/columns of the above format, and reasons for non-applicability should be provided.
p.000189:
p.000189: Part IV
p.000189: Information required to be submitted with the Application Form for import or manufacture of medical devices
p.000189: which does not have predicate device.
p.000189:
p.000189: (a) Data to be submitted along with the application (for medical devices other than new in vitro
p.000189: diagnostic):-
p.000189: 1. Design Analysis data including, (whichever applicable)-
p.000189: (a) design input and design output documents;
...
p.000189: (b) to replace an epithelial surface or the surface of the eye;
p.000189:
p.000189: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000191: 191
p.000191: by surgical intervention, and which is intended to remain after the procedure for at least thirty days, and which can
p.000191: only be removed by medical or surgical intervention.
p.000191: 3.6 Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly
p.000191: which is intended to be included as part of the finished, packaged, and labeled device.
p.000191: 3.7 Design input means the physical and performance requirements of a device that are used as a
p.000191: basis for device design.
p.000191: 3.8 Design output means the results of a design effort at each design phase and at the end of the total design
p.000191: effort. The finished design output is the basis for the device master record. The total finished design
p.000191: output consists of the device, its packaging and labeling, and the device master record.
p.000191: 3.9 Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of
p.000191: the design requirements, to evaluate the capability of the design to meet these requirements, and to
p.000191: identify problems.
p.000191: 3.10 Finished device means any device or accessory to any device that is suitable for use or capable
p.000191: of functioning, whether or not it is packaged, labeled or sterilized.
p.000191: 3.11 Management with executive responsibility means those senior employees of a manufacturer who have the authority
p.000191: to establish or make changes to the manufacturer's quality policy and quality system.
p.000191: 3.12 Medical device including substances used for in vitro diagnosis referred to in rule 3 of these rules.
p.000191: 3.13 Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed
p.000191: at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of
p.000191: such activities comply with quality system procedures, that these procedures are implemented effectively, and that
p.000191: these procedures are suitable to achieve quality system objectives.
p.000191: 3.14 Quality policy means the overall intention and direction of an organization with respect to quality, as
p.000191: established by management with executive responsibility.
p.000191: 3.15 Quality system means the organizational structure, responsibilities, procedures, processes, and
p.000191: resources for implementing quality management.
p.000191: 3.16 Rework means action taken on a nonconforming product that will fulfill the specified Device
p.000191: Master File requirements before it is released for distribution.
p.000191: 3.17 Specification means any requirement with which a product, process, service, or other activity must conform.
p.000191: 3.18 Validation means confirmation by examination and provision of objective evidence that the particular
p.000191: requirement for a specific intended use can be consistently fulfilled.
p.000191: 3.18.1 Process validation means establishing by objective evidence that a process consistently produces a result
p.000191: or product meeting its predetermined specifications.
p.000191: 3.18.2 Design validation means establishing by objective evidence that device specifications conform with user
p.000191: needs and intended use(s).
...
p.000193: 193
p.000193: (c) ensuring that quality objectives are established;
p.000193: (d) conducting management reviews; and
p.000193: (e) ensuring the availability of resources.
p.000193: 5.2 Customer focus:
p.000193: Top management of the manufacturer shall ensure that customer requirements are determined and are met.
p.000193: 5.3 Quality policy:
p.000193: Top management of the manufacturer shall ensure that the quality policy:-
p.000193: (a) is appropriate to the purpose of the manufacturing facility;
p.000193: (b) includes a commitment to comply with requirements and to maintain the effectiveness of
p.000193: the quality management system;
p.000193: (c) provides a framework for establishing and reviewing quality objectives;
p.000193: (d) is communicated and understood within the manufacturer’s organisation; and
p.000193: (e) is reviewed for continuing suitability.
p.000193: 5.4 Planning.-
p.000193: 5.4.1 Quality objectives:
p.000193: Top management of the manufacturer shall ensure that quality objectives, including those needed to meet requirements
p.000193: for product, are established at relevant functions and levels within the manufacturing organization. The quality
p.000193: objectives shall be measurable and consistent with the quality policy.
p.000193: 5.4.2 Quality management system planning:
p.000193: Top management of the manufacturer shall ensure that.-
p.000193: (a) the planning of the quality management system is carried out in order to meet the specified requirements, as
p.000193: well as the quality objectives; and
p.000193: (b) the integrity of the quality management system is maintained when changes to the quality management system are
p.000193: planned and implemented.
p.000193: 5.5 Responsibility, authority and communication.-
p.000193: 5.5.1 Responsibility and authority:
p.000193: Top management of the manufacturer shall ensure that responsibilities and authorities are defined,
p.000193: documented and communicated within the manufacturing organisation.
p.000193: Top management of the manufacturer shall establish the interrelation of all personnel who manage, perform and verify
p.000193: work affecting quality, and shall ensure the independence and authority necessary to perform these tasks.
p.000193: 5.5.2 Management representative:
p.000193: Top management shall appoint a member of management who, irrespective of other responsibilities, shall
p.000193: have responsibility and authority that includes:-
p.000193: (a) ensuring that processes needed for the quality management system are established,
p.000193: implemented and maintained;
p.000193: (b) reporting to top management on the performance of the quality management system and any need for
p.000193: improvement; and
p.000193: (c) ensuring the promotion of awareness of regulatory and customer requirements
p.000193: throughout the manufacturing organization.
p.000193: 5.5.3 Internal communication:
p.000193: Top management shall ensure that appropriate communication processes are established within the
p.000193: Manufacturing organisation and that communication takes place regarding the effectiveness of the quality management
p.000193: system.
p.000193: 5.6 Management review.-
p.000193: 5.6.1 General:
p.000193: Top management shall review the organization’s quality management system, at planned intervals, to ensure
p.000193: its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for
p.000193: improvement and the need for changes to the quality management system, including the quality policy and quality
p.000193: objectives. Records from management reviews shall be maintained.
p.000193: 5.6.2 Review input:
p.000193: The input to management review shall include information on:-
p.000193: (a) results of audits,
p.000193: (b) customer feedback,
p.000193: (c) process performance and product conformity,
p.000193: (d) status of preventive and corrective actions,
p.000193: (e) follow-up actions from previous management reviews,
p.000193: (f) changes that could affect the quality management system,
p.000193: (g) recommendations for improvement, and
p.000193: (h) new or revised regulatory requirements as and when issued.
p.000193: 5.6.3 Review output:
...
p.000199: analysis of data shall provide information relating to:-
p.000199: (a) feedback;
p.000199: (b) conformity to product requirements;
p.000199: (c) characteristics and trends of processes and products including opportunities for preventive action; and
p.000199: (d) suppliers.
p.000199: Records of the results of the analysis of data shall be maintained.
p.000199: 8.5 Improvement.-
p.000199: 8.5.1 General:
p.000199: The manufacturer shall identify and implement any changes necessary to ensure and maintain the continued suitability
p.000199: and effectiveness of the quality management system through the use of the quality policy, quality
p.000199: objectives, audit results, analysis of data, corrective and preventive actions and management review.
p.000199: The manufacturer shall establish documented procedures for the issue and implementation of advisory
p.000199: notices. These procedures shall be capable of being implemented at any time. Records of all customer complaint
p.000199: investigations shall be maintained. If investigation determines that the activities outside the manufacturer’s
p.000199: organisation contributed to the customer complaint, relevant information shall be exchanged between the
p.000199: organisations involved.
p.000199:
p.000199: 200 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000199: II—SEC. 3(i)]
p.000199:
p.000199: If any complaint is not investigated, justification shall be documented. Any correction or corrective action resulting
p.000199: from the compliant handling process shall be documented. Manufacturer shall notify the adverse event to
p.000199: the regulatory authority and establish documented procedures for the same.
p.000199: 8.5.2 Corrective action:
p.000199: The manufacturer shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective
p.000199: actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure
p.000199: shall be established to define requirements for:-
p.000199: (a) reviewing nonconformities (including customer complaints);
p.000199: (b) determining the causes of nonconformities;
p.000199: (c) evaluating the need for action to ensure that nonconformities do not recur;
p.000199: (d) determining and implementing action needed, including, if appropriate, updating documentation;
p.000199: (e) recording of the results of any investigation and of action taken; and
p.000199: (f) reviewing the corrective action taken and its effectiveness.
p.000199: 8.5.3 Preventive action:
p.000199: The manufacturer shall determine action to eliminate the causes of potential nonconformities in order to
p.000199: prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential
p.000199: problems. A documented procedure shall be established to define requirements for
p.000199: (a) determining potential nonconformities and their causes,
p.000199: (b) evaluating the need for action to prevent occurrence of nonconformities,
p.000199: (c) determining and implementing action needed,
p.000199: (d) recording of the results of any investigations and of action taken, and
p.000199: (e) reviewing preventive action taken and its effectiveness.
p.000199:
p.000199: Annexure ‘A’
p.000199: (refer sub-paragraph 6.4 (b))
p.000199: Environmental requirement for medical devices and in vitro diagnostic medical devices Name of Device
...
p.000009: 2. design which shall affect quality in respect of its specifications, indication for use; performance and stability
p.000009: of the medical device;
p.000009: 3. the intended use or indication for use ;
p.000009: 4. the method of sterilization;
p.000009: 5. the approved Shelf life;
p.000009: 6. the name or address of,-
p.000009: (i) the domestic manufacturer or its manufacturing site;
p.000009: (ii) overseas manufacturer or its manufacturing site (for import only);
p.000009: (iii) authorised agent (for import only);
p.000009: 7. label excluding change in font size, font type, color, label design;
p.000009: 8. manufacturing process, equipment or testing which shall affect quality of the device;
p.000009: 9. primary packaging material.
p.000009:
p.000009: 202 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000009: II—SEC. 3(i)]
p.000009:
p.000009: (B) Changes in respect of following shall be considered as minor change in,-
p.000009: 1. design which shall not affect quality in respect of its specifications, indication for use, performance and
p.000009: stability of the medical device;
p.000009: 2. in the manufacturing process, equipment, or testing which shall not affect quality of the device;
p.000009: 3. packaging specifications excluding primary packaging material.
p.000009:
p.000009: Seventh Schedule
p.000009: [See rules 51(1), 51(2), 53(ii), 53(v), 59(3)]
p.000009:
p.000009: Requirements for permission to import or manufacture investigational medical device for conducting clinical
p.000009: investigation
p.000009:
p.000009: 1. Application for permission.-
p.000009: (1) an application in Form MD-22 shall be made to the Central Licensing Authority along with following data in
p.000009: accordance with tables, namely:-
p.000009: (i) Design analysis data as per Table 1.
p.000009: (ii) Biocompatibility and Animal Performance Study as per Table 2.
p.000009: (iii) Information specified in Table 3 shall be submitted along with Investigator’s Brochure as
p.000009: prescribed in Table 4, Clinical Investigational Plan as prescribed in Table 5, Case Report Form as prescribed in Table
p.000009: 6, Serious adverse event reported, if any, as prescribed in Table 7, Informed Consent Form as prescribed in Table 8,
p.000009: investigator’s undertaking as prescribed in Table 9, of this schedule and Ethics Committee approval, if available, as
p.000009: prescribed in Appendix VIII of Schedule Y of the Drugs and Cosmetics Rules, 1945.
p.000009: (iv) Regulatory status in other countries, including information in respect of restrictions imposed, if
p.000009: any, on use of investigational medical device in other countries, prescription based device, exclusion of
p.000009: certain age groups, warning about adverse device effect. Likewise, if the investigational
p.000009: medical device has been withdrawn in any country by the manufacturer or by regulatory authority, such
p.000009: information shall also be furnished along with reasons and its relevance, if any. This information must continue
p.000009: to be submitted by the sponsor to the Central Licensing Authority during the entire duration of marketing of
p.000009: the said medical device in the Country;
p.000009: (v) Proposed Instruction for use or direction for use and labels shall be submitted as part of the
p.000009: application. The drafts of label shall comply with provisions of labeling rules specified in Medical Devices Rules,
p.000009: 2017:
p.000009: Provided that after submission and approval by the Central Licensing Authority, no change in the
p.000009: Instructions for Use shall be effected without such changes having been approved by the Central Licensing Authority;
p.000009: (vi) Report of clinical investigation should be in consonance with the format as prescribed in Table 10, such reports
p.000009: shall be certified by Principal Investigator.
p.000009: (2) For investigational medical device developed in India, clinical investigation is required to be carried out in
p.000009: India right from Pilot clinical investigation or first in human study and data generated should be
p.000009: submitted.
p.000009: (3) For investigational medical devices developed and studied in country other than India, Pilot
p.000009: Clinical Investigation or relevant clinical study data should be submitted along with the application.
p.000009: After submission of such data generated outside India to the Central Licensing Authority, permission may be
p.000009: granted to repeat pilot study or to conduct Pivotal Clinical Investigation. Pivotal Clinical Investigation is required
p.000009: to be conducted in India before permission to market the medical device in India except investigational
p.000009: medical device classified under class A, in exceptional cases, the Central Licensing Authority, may, for
p.000009: reasons to be recorded in writing, if consider it necessary, mandate conduct of clinical investigation, depending on
p.000009: the nature of the medical device.
p.000009: (4) The number of study subjects and sites to be involved in the conduct of clinical investigation shall depend on
p.000009: the nature and objective of the clinical investigation.
p.000009: 2. CLINICAL INVESTIGATION:
p.000009: (1) Approval for clinical investigation
p.000009: (i) Clinical investigation on an investigational medical device shall be initiated only after approval
p.000009: has been obtained from the Ethics Committee(s), registered under rule 122DD of Drugs and Cosmetics Rules, 1945, and
p.000009:
p.000009: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000203: 203
p.000203: permission granted by Central Licensing Authority. The investigation shall be initiated at the respective sites
p.000203: only after obtaining such approval from the Ethics Committee for that site.
p.000203: (ii) All investigators should possess appropriate qualification, training and experience and should have
p.000203: access to such investigational and treatment facilities as are relevant to the proposed clinical investigation. A
p.000203: qualified physician (or dentist, when appropriate), who is an investigator or a
p.000203: sub-investigator for the investigation, shall be responsible for all investigation related decisions
p.000203: concerning medical or dental issues. Laboratories used for generating data for clinical investigation should
p.000203: be compliant with Good Laboratory Practices or should have accreditation certificate issued by National
p.000203: Accreditation Board for Testing and Calibration Laboratories. In all cases, information about laboratory or
p.000203: facility to be used for the investigation, if other than those at the investigation site, should be furnished
p.000203: to the Central Licensing Authority prior to initiation of investigation at such site.
p.000203: (iii) Clinical investigational plan amendments, if it becomes necessary, to so amend it, before initiation or during
p.000203: the course of a clinical investigation, shall be notified to the Central Licensing Authority in writing
p.000203: along with approval of the Ethics Committee, if available, which has granted the approval for the study.
p.000203: No deviations from or changes to clinical investigational plan shall be implemented without prior written
p.000203: approval of the Ethics Committee and the Central Licensing Authority except when it is necessary to eliminate
p.000203: immediate hazards to the study subject or when changes involve only logistic or administrative aspects of
p.000203: investigation. All such exceptions shall be immediately notified to the Ethics Committee as well as to the Central
p.000203: Licensing Authority within 30 days.
p.000203:
p.000203: (2) Responsibilities of Sponsor:
p.000203: (i) The sponsor is responsible for implementing and maintaining quality assurance system to ensure that
p.000203: the clinical investigation is designed, conducted, monitored, and that data is generated, documented, recorded and
p.000203: reported in compliance with clinical investigational plan and Good Clinical Practices (GCP) Guidelines issued by the
p.000203: Central Drugs Standards Control Organization, Directorate General of Health Services, Government of India and
p.000203: applicable rules.
p.000203: (ii) The Sponsor is required to submit a status report on Clinical Investigation to the Central Licensing Authority, at
p.000203: the prescribed periodicity including safety summary and deviations.
p.000203: (iii) Report of any serious adverse event occurring during clinical investigation, after due analysis,
p.000203: shall be forwarded by the sponsor to the Chairman of the Ethics Committee, Central Licensing Authority, and the Head
p.000203: of institution where the clinical investigation has been conducted within 14 calendar days from knowledge of occurrence
p.000203: of the serious adverse event as prescribed in Table 7 of this schedule.
p.000203: (iv) In case of injury or death occurring to the clinical investigation subject, the sponsor or his
p.000203: representative whosoever, had obtained permission from the Central Licensing Authority for conduct of clinical
p.000203: investigation, shall make payment for medical management of the subject and also provide financial
p.000203: compensation for clinical investigation related injury or death in the manner as specified in the Drugs
p.000203: and Cosmetics Rules, 1945.
p.000203: (v) The sponsor or his representative, whosoever, had obtained permission from the Central Licensing Authority for
p.000203: conduct of clinical investigation shall submit details of compensation paid for clinical investigation related injury
p.000203: or death to the Central Licensing Authority within thirty days of the receipt of the order from Central Licensing
p.000203: Authority.
p.000203: (vi) The sponsor shall ensure that the clinical investigation report, whether for a completed or
p.000203: prematurely terminated clinical investigation, is provided to the Ethics Committee, participating
p.000203: investigators and to the Central Licensing Authority.
p.000203: (vii) In case, an investigation need to be discontinued prematurely for any reason including lack of
p.000203: commercial interest, the sponsor shall need to inform to the Central Licensing Authority and also submit summary report
p.000203: within a period of ninety days having a description of the investigation, the number of patients exposed to the
p.000203: investigational medical device, details of adverse device affect or serious adverse event, compensation paid, if
p.000203: any, and the reason for discontinuation of the investigation or non-pursuit of the investigational
p.000203: medical device application.
p.000203:
p.000203: (3) Responsibilities of the Investigator:
p.000203: (i) The investigator shall be responsible for the conduct of the investigation according to clinical
p.000203: investigation plan, GCP guidelines and also for compliance as per the undertaking by the investigator as given in Table
p.000203: 9 of
p.000203:
p.000203: 204 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000203: II—SEC. 3(i)]
p.000203:
p.000203: this schedule. Standard operating procedures are required to be documented by the investigators for the tasks
p.000203: performed by them. During and following a subject’s participation in an investigation, the investigator should ensure
p.000203: that adequate medical care is provided to the participant for any adverse events. Investigator shall report all serious
p.000203: adverse events to the Central Licensing Authority, sponsor or his representative, whosoever had obtained
p.000203: permission from the Central Licensing Authority for conduct of the clinical investigation, and the Ethics
p.000203: Committee that accorded approval to the clinical investigation plan, within forty eight hours of their
p.000203: occurrence. In case the Investigator fails to report any serious adverse event within the stipulated period, he shall
p.000203: have to furnish the reason for the delay to the Central Licensing Authority along with the report of the serious
p.000203: adverse event. The detailed report of the serious adverse event, after due analysis, shall be forwarded by the
p.000203: Investigator to Chairman of the Ethics Committee, Central Licensing Authority and the head of the
p.000203: Institution where investigation has been conducted within fourteen calendar days of occurrence of
p.000203: the serious adverse event.
p.000203: (ii) The Investigator shall provide information to the clinical investigation subject through informed
p.000203: consent process as provided in Table 8 about the essential elements of the clinical investigation and the subject's
p.000203: right to claim compensation in case of investigation related injury or death. He shall also inform the subject or his/
p.000203: her nominee(s) of their rights to contact the Sponsor or his representative whosoever had obtained permission from the
p.000203: Central Licensing Authority for conduct of the clinical investigation for making claims in case of
p.000203: investigation related injury or death.
p.000203:
p.000203: (4) Responsibilities of the Ethics Committee:
p.000203: (i) It is the responsibility of the Ethics Committee that reviews and accords its approval to a Clinical
p.000203: Investigation Plan to safeguard the rights, safety and well-being of all study subjects. The Ethics Committee should
p.000203: exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the
p.000203: study. Explanation.- The vulnerable subject means the members of a group with hierarchical structure (e.g. prisoners,
p.000203: armed forces personnel, staff and students of medical, nursing and pharmacy institutions), patients with
p.000203: incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority
p.000203: groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics
p.000203: committee(s) get documented ‘standard operating procedures’ and should maintain a record of its proceedings.
p.000203: (ii) Ethics Committee(s) shall, at appropriate intervals, undertake an ongoing review of the investigation
p.000203: of the Clinical Investigation Plan. Such review may be based on periodic study progress reports
p.000203: furnished by investigators or monitoring and internal audit reports furnished by the Sponsor.
p.000203: (iii) In case, an Ethics Committee revokes sites approval accorded to a Clinical Investigation Plan, it shall record
p.000203: the reasons for doing so and at once, communicate such a decision to the Investigator as well as to the
p.000203: Central Licensing Authority.
p.000203: (iv) Any report of serious adverse event occurring during clinical investigation, after due analysis,
p.000203: shall be forwarded by the Chairman of Ethics Committee to the Central Licensing Authority and to the
p.000203: Head of institution where the clinical investigation has been conducted within 14 calendar days of the
p.000203: knowledge of occurrence of the serious adverse event.
p.000203: (5) Informed consent:
p.000203: (i) In all investigations, a freely given, informed, written consent is required to be obtained from
p.000203: each study subject. The investigator shall provide information about the study verbally and
p.000203: through the patient information sheet, in a language that is non-technical and is understandable by the study
p.000203: subject. The Subject’s consent must be obtained in writing using an ‘Informed Consent Form’. The patient information
p.000203: sheet as well as the Informed Consent Form shall be approved by the Ethics Committee and furnished to
p.000203: the Central Licensing Authority. Any change in the informed consent documents should be approved by the
p.000203: Ethics Committee and submitted to the Central Licensing Authority before such changes are implemented.
p.000203: (ii) Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering
p.000203: from severe mental illness or disability), the same may be obtained from a legally acceptable representative. If the
p.000203: subject or his legally acceptable representative is unable to read or write, an impartial witness should be present
p.000203: during the entire informed consent process who must append his signatures to the consent form. Explanation: a legally
p.000203: acceptable representative means a person who is able to give consent or authorise an intervention in the
p.000203: patient as provided by the law in India.
p.000203:
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p.000205: 205
p.000205: (iii) A checklist of essential elements to be included in the study subject’s informed consent document as well as a
p.000205: format for the Informed Consent Form for study Subjects is given in Table 8 of this schedule.
p.000205: (iv) The informed consent process, in case of vulnerable subjects in clinical investigations of an innovative medical
p.000205: device which is not approved anywhere in the world, shall be audio-video recorded.
p.000205:
p.000205: (6) Pilot Clinical Investigation
p.000205: (i) Pilot clinical investigation is defined as those clinical investigations which are used to acquire specific
p.000205: essential information about a device before beginning the pivotal clinical investigation. Pilot clinical
p.000205: investigation is exploratory study which may be conducted in a few numbers of patients with the disease or condition
p.000205: being studied before moving to large population and scope that give insight into the performance and safety
p.000205: of a device but cannot provide definitive support for specific mechanistic or therapeutic claims.
p.000205: (ii) The objectives of a pilot clinical investigation typically include assessing feasibility (e.g,
p.000205: preliminary device performance), exploring eligibility criteria and their practical application for pivotal
p.000205: controlled investigation, ascertaining potential harm (preliminary safety evaluations), studying device mechanism,
p.000205: validating a method for determining an outcome measure, using a defined device mechanism to validate a
p.000205: surrogate outcome measure, and evaluating the logistics of pivotal investigation for performance.
p.000205: (iii) If the application is for conduct of clinical investigation as a part of multi-national clinical
p.000205: development of medical device, the number of sites and the patients as well as justification to conduct
p.000205: such clinical investigation in India shall be provided to the Central Licensing Authority.
p.000205: (7) Pivotal Clinical Investigation:
p.000205: (i) The pivotal clinical investigation is a definitive study in which evidence is gathered to support the
p.000205: safety and effectiveness evaluation of the medical device for its intended use. Pivotal clinical investigation is
p.000205: confirmatory study that may be conducted in large number of patients with disease or condition being studied and scope
p.000205: to provide the effectiveness and adverse effects.
p.000205: (ii) For investigational medical device which does not have a predicate medical device but has been approved for sale
p.000205: or distribution in any country other than India, pivotal studies need to be carried out primarily to generate evidence
p.000205: of safety and effectiveness of the medical device in Indian patients when used as recommended in the prescribing
p.000205: information except in cases of investigational medical device classified under class A which shall be governed as per
p.000205: permission of para 6 above. Prior to conduct of pivotal clinical investigation in Indian subjects, the Central
p.000205: Licensing Authority may require making the pilot study data available to assess whether the pilot data is in
p.000205: conformity to the data already generated outside the country.
p.000205: (iii) If the application is for conduct of clinical investigation as part of a Global Clinical Investigation of
p.000205: medical device, the number of sites and patients as well as justification for undertaking such clinical
p.000205: investigation in India shall be provided to the Central Licensing Authority.
p.000205: (8) Post Marketing Clinical Investigation:
p.000205: Post marketing clinical investigation is the study other than surveillance performed after marketing
p.000205: approval has been given to the medical device in relation to the approved indication. This investigation may
p.000205: not be considered necessary at the time of medical device approval but may be required by the Central
p.000205: Licensing Authority for optimizing the intended use of the medical device. Post Marketing Clinical investigation
p.000205: includes additional drug- device interaction, safety studies, investigation designed to support use under the approved
p.000205: indication e.g. mortality or morbidity studies, etc,.
p.000205: (9) Studies in special populations:
p.000205: The clinical investigation data of the medical device is required to be submitted to support the claim sought to be
p.000205: made for use of medical device in children, pregnant women, nursing women, elderly patients with renal or other
p.000205: organ system failure as given below:
p.000205: (i) Geriatrics:
p.000205: Geriatrics patients can be included in pivotal study (and in pilot study at the sponsor’s option) in meaningful
p.000205: numbers, if-
p.000205: (a) the disease intended to be treated is characteristically a disease of aging; or
p.000205: (b) the population to be treated is known to be included in substantial numbers of geriatric patients; or
p.000205: (c) there is specific reason to expect that conditions common in the elderly are likely to be encountered; or
p.000205: (d) the investigational medical device is likely to alter the geriatric patient’s response in regard to
p.000205: safety or performance compared with that of non-geriatric patient.
p.000205: (ii) Paediatrics:
p.000205: (a) The timing of pediatric studies in the medical device development program shall depend on the device, the type of
...
p.000205: who are not pregnant or nursing, would not be suitable.
p.000205: (b) For medical device intended for use during pregnancy, follow-up data pertaining to a period appropriate for that
p.000205: medical device on the pregnancy, foetus and child will be required.
p.000205: 3. Post Marketing Surveillance:
p.000205: (i) Subsequent to approval of an Investigational medical device, it shall be closely monitored for
p.000205: their clinical safety once they are marketed. The applicants shall furnish Periodic Safety Update Reports (PSURs) in
p.000205: order to,-
p.000205: (a) report all the relevant new information from appropriate sources;
p.000205: (b) relate these data to patient exposure;
p.000205: (c) summarise the market authorisation status in different countries and any significant variations related to
p.000205: safety; and
p.000205: (d) indicate whether changes will be made to product information in order to optimize the use of the product.
p.000205:
p.000205: (ii) One medical device should be covered in one PSUR. Within the single PSUR separate presentation of data for
p.000205: different indications or separate population need to be given.
p.000205: (iii) All relevant clinical and non-clinical safety data will cover only the period of the report (interval data).
p.000205: The PSURs shall be submitted every six months for the first two years after marketing approval of the
p.000205: medical device. For subsequent two years, the PSURs need to be submitted annually. The Central Licensing Authority may
p.000205: extend the total duration for submission of PSURs if it is considered necessary in the interest of public health. PSURs
p.000205: due for a period must be submitted within thirty calendar days of the last day of the reporting period. However, all
p.000205: cases involving suspected unexpected serious adverse event shall be reported to the licensing authority
p.000205: within fifteen days of initial receipt of information by the applicant. If marketing of the
p.000205:
p.000205: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000207: 207
p.000207: medical device is delayed by the applicant after obtaining approval to market, such data will have to
p.000207: be provided on the deferred basis beginning from the time the medical device is marketed.
p.000207: (iv) New studies specifically planned or conducted to examine a safety issue should be described in the PSURs.
p.000207: (v) A PSUR should be structured as follows:
p.000207: (a) Title Page:
p.000207: The title page of PSUR shall capture the name of the Medical device; reporting interval; approved
p.000207: indication of Medical devices; date of approval of the medical device; date of marketing of medical device; licence
p.000207: name and address.
p.000207: (b) Introduction:
p.000207: This section of PSUR shall capture the reporting interval; medical device’s intended use, mode of action or principle
p.000207: of operation, risk class and a brief description of the approved indication and population.
p.000207: (c) Current worldwide marketing authorization status:
p.000207: This section of PSUR shall capture the brief narrative overview including details of countries where the
p.000207: device is currently approved along with date of first approval, date of marketing and if the product was
p.000207: withdrawn in any of the countries with reasons thereof.
p.000207: (d) Actions taken in reporting interval for safety reasons:
p.000207: This section of PSUR shall include a description of significant actions related to safety that have
...
p.000211: (f) the provision for an interim analysis, where applicable;
p.000211: (g) criteria for the termination of the clinical investigation on statistical grounds;
p.000211: (h) procedures for reporting any deviation from the original statistical plan;
p.000211: (i) the specification of subgroups for analysis;
p.000211: (j) procedures that take into account all the data;
p.000211: (k) the treatment of missing, unused or spurious data, including drop-outs and withdrawals;
p.000211: (l) the exclusion of particular information from the testing of the hypothesis, if relevant; and
p.000211: (m) in multicenter clinical investigations, the minimum and maximum number of subjects to be included for each center.
p.000211: Special reasoning and sample size(s) may apply for the early clinical investigation(s), e.g. feasibility
p.000211: clinical investigation(s).
p.000211:
p.000211: 1.8 Data management
p.000211: (a) Procedures used for data review, database cleaning, and issuing and resolving data queries.
p.000211: (b) Procedures for verification, validation and securing of electronic clinical data systems, if applicable.
p.000211: (c) Procedures for data retention.
p.000211: (d) Specified retention period.
p.000211: (e) Other aspects of clinical quality assurance, as appropriate.
p.000211:
p.000211: 1.9 Amendments to the Clinical investigation plan
p.000211: Description of the procedures to amend the Clinical investigation plan.
p.000211:
p.000211: 1.10 Deviations from clinical investigation plan
p.000211: (a) Statement specifying that the investigator is not allowed to deviate from the Clinical investigation plan, except
p.000211: without appropriate notifications or approvals from Ethics Committee and Central Licensing authority, as the
p.000211: case may be.
p.000211: (b) Procedures for recording, reporting and analyzing Clinical investigation plan deviations.
p.000211: (c) Notification requirements and time frames.
p.000211: (d) Corrective and preventive actions and principal investigator disqualification criteria.
p.000211:
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p.000213: 213
p.000213: 1.11 Device accountability.
p.000213: Description of the procedures for the accountability of investigational medical devices should be maintained.
p.000213: 1.12 Statements of compliance.
p.000213: (a) Statement specifying that the clinical investigation shall be conducted in accordance with the ethical principles
p.000213: as prescribed in Good Clinical Practices.
p.000213: (b) Statement specifying that the clinical investigation shall not begin until the required approval from the
p.000213: Ethics Committee.
p.000213: (c) Statement specifying that any additional requirements imposed by the Ethics Committee or Central Licensing
p.000213: Authority shall be followed, if appropriate.
p.000213: (d) Statement specifying the type of insurance that shall be provided for subjects, if appropriate.
p.000213: 1.13 Informed consent process.
p.000213: (a) Description of the general process for obtaining informed consent, including the process for providing subjects
p.000213: with new information, as needed.
p.000213: (b) Description of the informed consent process in circumstances where the subject is unable to give it; in the case
p.000213: of emergency treatment, process should be clearly specified.
p.000213: 1.14 Adverse events, adverse device effects and device deficiencies.
p.000213: (a) Definitions of adverse events and adverse device effects.
p.000213: (b) Definition of device deficiencies.
p.000213: (c) Definitions of serious adverse events and serious adverse device effects and, where appropriate, unanticipated
p.000213: serious adverse device effects.
p.000213: (d) Time period in which the principal investigator shall report all adverse events and device deficiencies to the
p.000213: sponsor and, where appropriate, to Ethics Committee and the regulatory authority.
p.000213: (e) Details of the process for reporting adverse events (date of the adverse event, treatment, resolution, assessment
p.000213: of both the seriousness and the relationship to the investigational medical device).
p.000213: (f) Details of the process for reporting device deficiencies.
p.000213: (g) List of foreseeable adverse events and anticipated adverse device effects, together with their likely incidence,
p.000213: mitigation or treatment.
p.000213: (h) Emergency contact details for reporting serious adverse events and serious adverse device effects.
p.000213: 1.15 Vulnerable population.
p.000213: (a) Description of the vulnerable population.
p.000213: (b) Description of the specific informed consent process.
p.000213: (c) Description of the Ethics Committee specific responsibility.
p.000213: (d) Description of what medical care, if any, will be provided for subjects after the clinical investigation has been
p.000213: completed.
p.000213: 1.16 Suspension or premature termination of the clinical investigation.
p.000213: (a) Criteria and arrangements for suspension or premature termination of the whole clinical investigation or of the
p.000213: clinical investigation in one or more investigation sites.
p.000213: (b) Criteria for access to and breaking the blinding or masking code in case of suspension or premature termination of
p.000213: the clinical investigation, if the clinical investigation involves a blinding or masking technique.
p.000213: (c) Requirements for subject follow-up.
p.000213: 1.17 Publication policy.
...
p.000215: (d) Starting date and time of day;
p.000215: (e) Stopping date and time, or duration of treatment;
p.000215: 3. Other treatment(s):
p.000215: Provide the same information for concomitant treatment.
p.000215: 4. Details of suspected adverse device reaction(s)
p.000215: (a) Full description of reaction(s) including body site and severity, as well as the criterion (or
p.000215: criteria) for regarding the report as serious. In addition to a description of the reported signs and
p.000215: symptoms, whenever possible, describe a specific diagnosis for the reaction.
p.000215: (b) Start date (and time) of onset of reaction.
p.000215: (c) Stop date (and time) or duration of reaction.
p.000215: (d) Setting (e.g., hospital, out-patient clinic, home, nursing home).
p.000215: 5. Outcome
p.000215: (a) Information on recovery and any sequel; results of specific tests and/or treatment that may have
p.000215: been conducted.
p.000215: (b) For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; any
p.000215: post-mortem findings.
p.000215: (c) Other information: anything relevant to facilitate assessment of the case, such as medical history including
p.000215: allergy, drug or alcohol abuse; family history; findings from special investigations etc.
p.000215: 6. Details about the Investigator:
p.000215: (a) Name;
p.000215: (b) Address;
p.000215: (c) Telephone number;
p.000215: (d) Profession (specialty);
p.000215: (e) Date of reporting the event to Central Licensing Authority;
p.000215: (f) Date of reporting the event to Ethics Committee overseeing the site;
p.000215: (g) Signature of the Investigator.
p.000215:
p.000215:
p.000215:
p.000215: Table 8 Informed Consent Form
p.000215: Checklist for clinical investigation Subject’s informed consent documents
p.000215: 1.1 Essential elements:
p.000215: 1. Statement that the study involves research and explanation of the purpose of the research
p.000215: 2. Expected duration of the Subject's participation
p.000215: 3. Description of the procedures to be followed, including all invasive procedures
p.000215: 4. Description of any reasonably foreseeable risks or discomforts to the Subject
p.000215:
p.000215: 216 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000215: II—SEC. 3(i)]
p.000215:
p.000215: 5. Description of any benefits to the Subject or others reasonably expected from research. If no benefit is expected,
p.000215: subject should be made aware of this.
p.000215: 6. Disclosure of specific appropriate alternative procedures or therapies available to the Subject.
p.000215: 7. Statement describing the extent to which confidentiality of records identifying the subject will be maintained and
p.000215: who will have access to Subject’s medical records
p.000215: 8. Clinical investigation treatment schedule(s) and the probability for random assignment to each treatment (for
p.000215: randomised clinical investigation)
p.000215: 9. Statement describing the financial compensation and medical management as under:
p.000215: (a) In case of an injury occurring to the subject during the clinical investigation, free medical management shall be
p.000215: given as long as required or till such time it is established that the injury is not related to the clinical
p.000215: investigation, whichever is earlier.
p.000215: (b) In the event of an investigation related injury or death, the Sponsor or his representative, whoever has obtained
p.000215: permission from the Central Licensing Authority for conduct of the clinical investigation, shall provide financial
p.000215: compensation for the injury or death.
p.000215: 10. An explanation about whom to contact for clinical investigation related queries, rights of Subjects and in the
p.000215: event of any injury
p.000215: 11. The anticipated prorated payment, if any, to the Subject for participating in the clinical investigation
p.000215: 12. Subject's responsibilities on participation in the clinical investigation
p.000215: 13. Statement that participation is voluntary, that the Subject can withdraw from the clinical investigation at any
p.000215: time and that refusal to participate will not involve any penalty or loss of benefits to which the Subject is otherwise
p.000215: entitled
p.000215: 14. Statement that there is a possibility of failure of investigational medical device to provide intended
p.000215: therapeutic effect.
p.000215: 15. Any other pertinent information.
p.000215:
p.000215: 1.2 Additional elements, which may be required
p.000215: (a) Statement of foreseeable circumstances under which the Subject's participation may be terminated by the
p.000215: Investigator without the Subject's consent.
p.000215: (b) Additional costs to the Subject that may result from participation in the clinical investigation.
p.000215: (c) The consequences of a Subject’s decision to withdraw from the investigation and procedures for orderly termination
p.000215: of participation by Subject.
p.000215: (d) Statement that the Subject or Subject's representative will be notified in a timely manner if significant
p.000215: new findings are developed during the course of the investigation which may affect the Subject's
p.000215: willingness to continue participation will be provided.
...
p.000217: II—SEC. 3(i)]
p.000217:
p.000217: the amendment, except where necessary to eliminate an immediate hazard(s) to the clinical investigation participant or
p.000217: when the change(s) involved are only logistical or administrative in nature.
p.000217: (iii) I agree to personally conduct and/or supervise the clinical investigation at my site.
p.000217: (iv) I agree to inform all Subjects that the medical devices are being used for investigational purposes and I
p.000217: will ensure that the requirements relating to obtaining informed consent and Ethics Committee review and approval
p.000217: specified in this Schedule are met.
p.000217: (v) I agree to report to the Sponsor all adverse experiences that occur in the course of the investigation(s)
p.000217: in accordance with the regulatory and Good Clinical practice guidelines.
p.000217: (vi) I have read and understood the information in the Investigator's brochure, including the potential risks
p.000217: and side effects of the medical device.
p.000217: (vii) I agree to ensure that all associates, colleagues and employees assisting in the conduct of the
p.000217: clinical investigation are suitably qualified and experienced and they have been informed about their obligations in
p.000217: meeting their commitments in the clinical investigation.
p.000217: (viii) I agree to maintain adequate and accurate records and to make those records available for
p.000217: audit / inspection by the Sponsor, Ethics Committee, Licensing Authority or their authorized representatives, in
p.000217: accordance with regulatory and provisions of these rules. I will fully cooperate with any clinical
p.000217: investigation related audit conducted by regulatory officials or authorized representatives of the
p.000217: Sponsor.
p.000217: (ix) I agree to promptly report to the Ethics Committee all changes in the CIP activities and all unanticipated
p.000217: problems involving risks to human Subjects or others.
p.000217: (x) I agree to inform all serious adverse events to the Sponsor, Central Licensing Authority as well as the
p.000217: Ethics Committee within forty eight hours of their occurrence. In case of failure, I will submit the
p.000217: justification to the satisfaction of the Central Licensing Authority. I also agree to report the serious
p.000217: adverse events, after due analysis, to the Central Licensing Authority, Chairman of the Ethics
p.000217: Committee and head of the institution where the investigation has been conducted within fourteen days of the occurrence
p.000217: of serious adverse events.
p.000217: (xi) I will maintain confidentiality of the identification of all participating clinical investigation patients
p.000217: and assure security and confidentiality of clinical investigation data.
p.000217: (xii) I agree to comply with all other requirements, guidelines and statutory obligations as
p.000217: applicable to clinical Investigators participating in clinical Investigations
p.000217:
p.000217:
p.000217: Date:
p.000217: Signature of Investigator
p.000217:
p.000217: Table 10
p.000217: Clinical Investigation Report
p.000217:
p.000217: 1. General
p.000217: This table specifies the contents of the clinical investigation report that describes the design, execution,
p.000217: statistical analysis and results of a clinical investigation.
p.000217:
p.000217: 2. Cover page
p.000217: The page shall be contain the following information:-
p.000217: (a) title of the clinical investigation;
p.000217: (b) identification of the investigational medical devices, including names, models, etc. as relevant for
p.000217: complete identification;
p.000217: (c) if not clear from the title, a single sentence describing the design, comparison, period, usage method, and
p.000217: subject population;
p.000217: (d) name and contact details of sponsor or sponsor's representative;
p.000217: (e) CIP identification/protocol code;
p.000217: (f) name and department of coordinating investigator and names of other relevant parties,
...
p.000003: patients free of cost by that hospital.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: All provisions of Chapter XI of these rules which requires them to be covered by a sale licence subject to the
p.000003: following conditions:-
p.000003: (a) The dispensing and supply of medical devices shall be carried out by or under the supervision of
p.000003: qualified person;
p.000003: (b) The premises where medical devices are supplied or stocked shall be open to inspection by a medical device officer
p.000003: appointed under this Act who can, if necessary, take samples for test.
p.000003: (c) The medical devices shall be stored under proper storage conditions.
p.000003: (d) The medical devices shall be purchased from a manufacturer or a whole seller or retailer licenced
p.000003: under these rules or received as transferred stocks from hospital stores for distribution. Records of
p.000003: such purchases or receipts shall be maintained.
p.000003: (e) No medical device shall be sold or supplied or dispensed after the date of expiration recorded on its label or
p.000003: in violation of any statement or direction recorded on such label.
p.000003: The provisions of Chapter XI of these rules which require them to be covered by a sale licence subject to the condition
p.000003: that the provisions of condition that no medical device shall be sold or supplied or dispensed after the
p.000003: date of expiration recorded on its label or in violation of any statement or direction recorded on such
p.000003: label.
p.000003: The provisions of Chapter V of these rules which require them to be covered by a licence for import provided that
p.000003: the Central Licensing Authority shall issue a No Objection Certificate for such purpose to the applicant.
p.000003:
p.000003:
p.000003: Appendix Form MD-1
p.000003: [See sub-rule (5) of rule 13]
p.000003: Application for grant of Certificate of Registration of a Notified Body
p.000003:
p.000003: 1. Name of Applicant:
p.000003: 2. Nature and constitution of Body:
p.000003: (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust,
p.000003: other to be specified)
p.000003: 3. Corporate/ registered office address including telephone number, mobile number, fax number and e-mail id:
p.000003: 4. Details of accreditation (self-attested copy of certificate to be attached):
p.000003: 5. Standards (BIS/ISO/Others) for which notified body has been accredited under rule 13:
p.000003: 6. Fee paid on Rs_ receipt/challan/transaction id
p.000003: _.
p.000003: 7. Documents enclosed, as specified in the Part I of the Third Schedule of the Medical Devices Rules, 2017, duly signed
p.000003: by me.
p.000003: 8. I undertake to comply with the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices
p.000003: Rules, 2017 and other terms and conditions for working as a Notified Body as may be specified from time to time.
p.000003: Place: _
p.000003:
p.000003: Date:
p.000003: Signature of designated person in India
p.000003:
p.000003: (Name and designation) [To be signed digitally]
p.000003:
p.000003: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000223: 223
p.000223: Form MD-2
p.000223: [See sub-rule (6) of rule 13]
p.000223:
p.000223: Certificate of Registration for a Notified Body under the Medical Devices Rules, 2017
p.000223:
p.000223:
p.000223: Registration No.:
p.000223:
p.000223: 1. M/s, (Name of the firm) situated at
p.000223: (full address with telephone and e-mail) has been registered as a Notified Body of
p.000223: following Class A and/or Class B medical devices.
p.000223:
p.000223: 2. Details of Medical device(s):
p.000223:
p.000223:
p.000223: S.N.
p.000223: Standards for which it is registered
p.000223: Class of medical devices
p.000223:
p.000223:
p.000223:
p.000223: 3. This Registration is subject to the conditions as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and
p.000223: the Medical Devices Rules, 2017.
p.000223:
p.000223:
p.000223:
p.000223:
p.000223: Place: Date: _
p.000223: Central Licensing Authority [To be signed digitally]
p.000223:
p.000223:
p.000223:
p.000223:
p.000223: Form MD-3
p.000223: [See sub-rule (2) of rule 20]
p.000223: Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device
p.000223:
p.000223: 1. Name of Applicant:
p.000223: 2. Nature and constitution of manufacturer:
p.000223: (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust,
p.000223: other to be specified)
p.000223: 3. (i) Corporate/ registered office address including telephone number, mobile number, fax number and e- mail id:
p.000223: (ii) Manufacturing site address including telephone number, mobile number, fax number and e-mail id:
p.000223: (iii) Address for correspondence:
p.000223: [corporate/ registered office/ manufacturing site]
p.000223: 4. Details of medical device(s) to be manufactured [Annexed]:
p.000223: 5. Whether substantial equivalence to a predicate device is claimed: (Yes/ No)
p.000223: 6. Fee paid on Rs receipt/challan/transaction
p.000223: id_ .
p.000223: 7. I have enclosed the documents as specified in the Fourth Schedule of Medical Devices Rules, 2017.
p.000223: 8. I hereby state and undertake that:
p.000223: (i) the manufacturing site is ready for audit or shall be ready for audit on in
p.000223: accordance with
p.000223: the requirements of Medical Devices Rules, 2017.
p.000223:
p.000223: 224 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000223: II—SEC. 3(i)]
p.000223:
p.000223: (ii) I shall comply with all the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) and
p.000223: the Medical Devices Rules, 2017.
p.000223:
p.000223:
p.000223:
...
p.000225: Medical Devices Rules, 2017.
p.000225:
p.000225:
p.000225:
p.000225:
p.000225: Place: Date:
p.000225: Signature
p.000225: (Name and designation) [To be signed digitally]
p.000225:
p.000225:
p.000225: Annexure:
p.000225:
p.000225:
p.000225: S.N.
p.000225: Generic name
p.000225: Model No.
p.000225: Intended use
p.000225: Class of medical device
p.000225: Material of construction
p.000225: Dimension (if any)
p.000225: Shelf life
p.000225: Sterile or Non sterile
p.000225: Brand
p.000225: Name (if registered under the Trade Marks Act, 1999)
p.000225:
p.000225: 226 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000225: II—SEC. 3(i)]
p.000225:
p.000225: Form MD-5
p.000225: [See sub-rule (4) of rule 20 and sub-rule (6) of rule 20]
p.000225:
p.000225: Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device.
p.000225:
p.000225:
p.000225: Licence Number: ……….
p.000225:
p.000225:
p.000225: 1. M/s (Name and full address of manufacturer with telephone,
p.000225: fax and e-mail) has been licenced to manufacture for sale or for distribution the below listed medical
p.000225: device(s) at the premises situated at
p.000225: (address of manufacturing facility where the
p.000225: manufacturing will be carried out).
p.000225: 2. Details of medical device(s) [Annexed].
p.000225:
p.000225: 3. This licence is subject to the provisions of the Medical Devices Rules, 2017 and conditions prescribed therein.
p.000225:
p.000225:
p.000225:
p.000225:
p.000225:
p.000225: Place: Date: _
p.000225: State Licensing Authority [To be signed digitally]
p.000225:
p.000225:
p.000225:
p.000225:
p.000225:
p.000225:
p.000225: S.N. Generic
p.000225: name
p.000225:
p.000225:
p.000225: Model No.
p.000225:
p.000225:
p.000225: Intended use
p.000225:
p.000225:
p.000225: Class of medical device
p.000225:
p.000225:
p.000225: Material of construction
p.000225:
p.000225:
p.000225: Dimension (if any)
p.000225:
p.000225:
p.000225: Shelf life
p.000225:
p.000225:
p.000225: Sterile or Non sterile
p.000225:
p.000225: Annexure: Brand
p.000225: Name (if
p.000225: registered under the Trade Marks Act, 1999)
p.000225:
p.000225: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000227: 227
p.000227: Form MD-6
p.000227: [See sub-rule (4) of rule 20 and sub-rule (6) of rule 20]
p.000227:
p.000227: Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device
p.000227: Loan Licence Number: ……….
p.000227:
p.000227:
p.000227: 1. M/s _ (Name and full address of manufacturer with
p.000227: telephone, fax and e-mail) has been licenced to manufacture for sale or for distribution the below listed medical
p.000227: device(s) at the premises situated at
p.000227: (address of manufacturing facility where the manufacturing will be carried
p.000227: out along with the licence number) C/o (name of manufacturing site licence
p.000227: holder).
p.000227:
p.000227: 2. Details of medical device(s) [Annexed].
p.000227:
p.000227: 3. This licence is subject to the provisions of the Medical Devices Rules, 2017 and conditions prescribed therein.
p.000227:
p.000227:
p.000227:
p.000227: Place: Date:
p.000227: State Licensing Authority [To be signed digitally]
p.000227:
p.000227:
p.000227:
p.000227:
p.000227:
p.000227:
p.000227:
p.000227:
p.000227: S.N. Generic
p.000227: name
p.000227:
p.000227: Model No.
p.000227:
p.000227: Intended use
p.000227:
p.000227: Class of medical device
p.000227:
p.000227: Material of construction
p.000227:
p.000227: Dimension (if any)
p.000227:
p.000227: Shelf life
p.000227:
p.000227: Sterile or Non sterile
p.000227: Annexure: Brand
p.000227: Name (if
p.000227: registered under the Trade Marks Act, 1999)
p.000227:
p.000227: 228 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000227: II—SEC. 3(i)]
p.000227:
p.000227: Form MD-7
p.000227: [See sub-rule (1) of rule 21 and sub-rule (2) of rule 21]
p.000227:
p.000227: Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D
p.000227: 1. Name of Applicant:
p.000227: 2. Nature and constitution of manufacturer:
p.000227: (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust,
p.000227: other to be specified)
p.000227: 3. (i) Corporate/ registered office address including telephone number, mobile number, fax number and e- mail id:
p.000227: (ii) Manufacturing site address including telephone number, mobile number, fax number and e-mail id:
p.000227: (iii) Address for correspondence:
p.000227: [corporate/ registered office/ manufacturing site]
p.000227: 4. Details of medical device(s) to be manufactured [Annexed]:
p.000227: 5. Whether substantial equivalence to a predicate device is claimed: (Yes/ No)
p.000227: 6. Fee paid on Rs receipt/challan/transaction
p.000227: id_ .
...
p.000229:
p.000229:
p.000229:
p.000229:
p.000229: Place: Date:
p.000229: Signature (Name and designation) [To be signed digitally]
p.000229:
p.000229: Annexure:
p.000229:
p.000229:
p.000229: S.N.
p.000229: Generic name
p.000229: Model No.
p.000229: Intended use
p.000229: Class of medical device
p.000229: Material of construction
p.000229: Dimension (if any)
p.000229: Shelf life
p.000229: Sterile or Non sterile
p.000229: Brand Name (if registered under the Trade Marks Act, 1999)
p.000229:
p.000229: 230 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000229: II—SEC. 3(i)]
p.000229:
p.000229: Form MD-9
p.000229: [See sub-rule (1) rule 25]
p.000229:
p.000229: Licence to Manufacture for Sale or for Distribution of Class C or Class D
p.000229:
p.000229:
p.000229: Licence Number: ……….
p.000229:
p.000229:
p.000229: 1. M/s (Name and full address of manufacturer with telephone,
p.000229: fax and e-mail) has been licenced to manufacture for sale or for distribution the below listed medical
p.000229: device(s) at the premises situated at
p.000229: (address of manufacturing facility where the
p.000229: manufacturing will be carried out).
p.000229: 2. Details of medical device(s) [Annexed].
p.000229:
p.000229: 3. The names, qualifications and experience of the competent technical staff responsible for the manufacture and
p.000229: testing of the above mentioned medical device(s).
p.000229:
p.000229: 4. This licence is subject to the provisions of the Medical Devices Rules, 2017 and conditions prescribed therein.
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229: Place: Date: _
p.000229: Central Licensing Authority [To be signed digitally]
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229: S.N. Generic
p.000229: name
p.000229:
p.000229:
p.000229: Model No.
p.000229:
p.000229:
p.000229: Intended use
p.000229:
p.000229:
p.000229: Class of medical device
p.000229:
p.000229:
p.000229: Material of construction
p.000229:
p.000229:
p.000229: Dimension (if any)
p.000229:
p.000229:
p.000229: Shelf life
p.000229:
p.000229:
p.000229: Sterile or Non sterile
p.000229:
p.000229: Annexure: Brand
p.000229: Name (if
p.000229: registered under the Trade Marks Act, 1999)
p.000229:
p.000229: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000231: 231
p.000231: Form MD-10
p.000231: [See sub-rule (1) rule 25]
p.000231:
p.000231: Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device
p.000231: Loan Licence Number: ……….
p.000231:
p.000231:
p.000231: 1. M/s _ (Name and full address of manufacturer with
p.000231: telephone, fax and e-mail) has been licenced to manufacture for sale or for distribution the below listed medical
p.000231: device(s) at the premises situated at
p.000231: (address of manufacturing facility where the manufacturing will be carried
p.000231: out along with the licence number) C/o (name of manufacturing site licence
p.000231: holder).
p.000231:
p.000231: 2. Details of medical device(s) [Annexed].
p.000231:
p.000231: 3. The names, qualifications and experience of competent technical staff responsible for the manufacture and testing of
p.000231: the above mentioned medical device:
p.000231:
p.000231: 4. This licence is subject to the provisions of the Medical Devices Rules, 2017 and conditions prescribed therein.
p.000231:
p.000231:
p.000231:
p.000231: Place: _ Date: _
p.000231: State Licensing Authority [To be signed digitally]
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231: S.N. Generic
p.000231: name
p.000231:
p.000231:
p.000231: Model No.
p.000231:
p.000231:
p.000231: Intended use
p.000231:
p.000231:
p.000231: Class of medical device
p.000231:
p.000231:
p.000231: Material of construction
p.000231:
p.000231:
p.000231: Dimension (if any)
p.000231:
p.000231:
p.000231: Shelf life
p.000231:
p.000231:
p.000231: Sterile or Non sterile
p.000231:
p.000231: Annexure: Brand
p.000231: Name (if
p.000231: registered under the Trade Marks Act, 1999)
p.000231:
p.000231: 232 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000231: II—SEC. 3(i)]
p.000231:
p.000231: Form MD-11
p.000231: [See clause (vii) of rule 26]
p.000231: Form in which the Audit or Inspection Book shall be maintained.
p.000231: (A) The cover of the audit or inspection book shall contain the following particulars, namely:-
p.000231: 1. The name and address of the licencee _
p.000231: 2. Licence Number
p.000231:
p.000231:
p.000231: (B) (i) The pages of the audit or inspection book shall be serially numbered and duly stamped by the
p.000231: Central Licensing Authority*/State Licensing Authority*. The pages, other than the first and the last pages, shall
p.000231: have the following particulars:-
p.000231:
p.000231: Name and designation of the auditor or medical device officer who audited or inspected the premises: Date of audit or
p.000231: inspection _
p.000231: Observations of the auditor or medical device officer
p.000231:
p.000231: Signature of the auditor or medical device officer
p.000231:
p.000231: (ii) The first and last pages of the audit or inspection book shall be endorsed by the Central
p.000231: Licensing Authority*/State Licensing Authority* with the following words, namely:-
p.000231: Audit or inspection book maintained by M/s _ situated at
p.000231: for licence number _ _ in Form under the Medical
p.000231: Devices Rules, 2017.
p.000231:
p.000231: *Central Licensing Authority/
p.000231: *State Licensing Authority [To be signed digitally]
p.000231: *Delete whichever is not applicable.
p.000231:
p.000231: Notes:
p.000231: (i) Printed copy of the Inspection Book may be obtained by the licencee from the Licensing Authority on payment of fee
p.000231: as may be specified by the concerned Licensing Authority from time to time.
p.000231: (ii) The audit or inspection book shall be maintained at the premises of the licencee.
p.000231: (iii) The original copy of observations made by the auditor or medical device officer shall be maintained in the
p.000231: premises of the licencee and duplicate copy shall be sent to the Central Licensing Authority/ State
p.000231: Licensing Authority. The triplicate copy shall be taken as record by the auditor or medical device officer.
p.000231:
p.000231:
p.000231: Form MD-12
p.000231: [See sub-rule (1) of rule 31]
p.000231: Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation,
p.000231: examination, demonstration or training
p.000231:
p.000231: 1. Name of Applicant:
p.000231: 2. Nature and constitution of manufacturer:
p.000231: (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust,
p.000231: other to be specified)
p.000231: 3. (i) Corporate/ registered office address including telephone number, mobile number, fax number and e-mail id:
p.000231: (ii) Testing or evaluation site address including telephone number, mobile number, fax number and e-mail id:
p.000231: (iii) Address for correspondence: [corporate office/ testing site]
p.000231: 4. Details of medical device(s) to be manufactured [Annexed]:
p.000231: 5. Fee paid on Rs receipt/challan/transaction
p.000231: id_ .
p.000231:
p.000231: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000233: 233
p.000233: 6. I hereby state and undertake that, I shall comply with all applicable provisions of the Drugs and Cosmetics Act,
p.000233: 1940 (23 of 1940) and the Medical Devices Rules, 2017.
p.000233:
p.000233:
p.000233:
p.000233:
p.000233:
p.000233:
p.000233: Place: Date: _
p.000233:
p.000233:
p.000233:
p.000233:
p.000233:
p.000233: Signature (Name and designation) [To be signed digitally]
p.000233:
p.000233:
p.000233:
p.000233:
p.000233: S.N. Generic name Class of medical device
p.000233:
p.000233:
p.000233: Quantity proposed to be manufactured
p.000233:
p.000233: Annexure:
p.000233:
p.000233:
p.000233:
p.000233:
p.000233: Form MD-13
p.000233: [See sub-rule (3) of rule 31]
p.000233: Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or
p.000233: Demonstration or Training
p.000233:
p.000233:
p.000233: 1. M/s .................................., of , is hereby licenced to manufacture the medical
p.000233: device(s) specified
p.000233: below for the purposes of clinical investigations or test or evaluation or demonstration or training at
p.000233: ……………………………… (address of the premise).
p.000233:
p.000233:
p.000233: S.N.
p.000233: Generic name
p.000233: Class of medical device
p.000233: Quantity permitted to be manufactured
p.000233:
p.000233:
p.000233: 2. This licence is subject to the provisions of the Medical Devices Rules, 2017 and conditions prescribed therein.
p.000233:
p.000233: 3. This licence shall be in force for a period of three year from the date specified below.
p.000233:
p.000233:
p.000233: Place: Date: _
p.000233: Central Licensing Authority [To be signed digitally]
p.000233:
p.000233:
p.000233:
p.000233: Form MD-14
p.000233: [See sub-rule (1) of rule 34]
p.000233:
p.000233: Application for issue of import licence to import medical device
p.000233:
p.000233: 1. Name of Authorised agent:
p.000233: 2. Nature and constitution of Authorised agent:
p.000233: (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust,
p.000233: other to be specified)
p.000233: 3. (i) Corporate/ registered office address including telephone number, mobile number, fax number and e-mail id:
p.000233:
p.000233: 234 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000233: II—SEC. 3(i)]
p.000233:
p.000233: (ii) Authorised Agent address including telephone number, mobile number, fax number and e-mail id as per wholesale
p.000233: licence or manufacturing licence:
p.000233: (iii) Address for correspondence: [corporate/ registered office/ authorised agent]
p.000233: 4. Particulars of overseas Manufacturer, Manufacturing site(s):
p.000233:
p.000233:
p.000233: Sr.
p.000233: No.
p.000233: Name and address of manufacturer (full address with telephone, fax and e-mail address of the manufacturer)
p.000233: Name and address of manufacturing site (full address with telephone, fax and e-mail address of the manufacturing site)
p.000233:
p.000233:
p.000233: 5. Details of medical device(s) to be imported [Annexed]:
p.000233: 6. Whether substantial equivalence to a predicate device is claimed: (Yes/ No)
p.000233: 7. Fee paid on Rs receipt/challan/transaction
p.000233: id_ .
p.000233: 8. I have enclosed the documents as specified in the Fourth Schedule for grant of licence to import
p.000233: medical device(s).
...
p.000233: Material of construction
p.000233: Dimension (if any)
p.000233: Shelf life
p.000233: Sterile or Non sterile
p.000233: Brand Name (if registered under Trade Marks Act 1999)
p.000233:
p.000233: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000235: 235
p.000235: Form MD-15
p.000235: [See sub-rule (1) of rule 36]
p.000235:
p.000235: Licence to Import Medical Device
p.000235:
p.000235:
p.000235: Licence No.: _
p.000235:
p.000235: 1. M/s _(Name, full address, as per wholesale licence/
p.000235: manufacturing licence, of authorised agent with telephone and e-mail address) is hereby licenced to import
p.000235: the medical device(s) manufactured by overseas manufacturer having manufacturing site as specified below.
p.000235:
p.000235: 2. Details of overseas manufacturer and manufacturing site under this licence.
p.000235:
p.000235:
p.000235: Sr. No.
p.000235: Name & address of overseas manufacturer
p.000235: (full address with telephone and e- mail address of the manufacturer)
p.000235: Name & address of overseas manufacturing site
p.000235: (full address with telephone and e-mail address of the manufacturing site)
p.000235:
p.000235:
p.000235:
p.000235: 3. Details of medical device(s) [Annexed].
p.000235:
p.000235: 4. The authorised agent M/s. _ will be responsible for the
p.000235: business activities of the overseas manufacturer, in India in all respects.
p.000235:
p.000235: 5. This licence is subject to the provisions of the Medical Devices Rules, 2017 and conditions prescribed therein.
p.000235:
p.000235:
p.000235:
p.000235:
p.000235:
p.000235: Place: Date: _
p.000235: Central Licensing Authority
p.000235: Seal or Stamp
p.000235:
p.000235:
p.000235:
p.000235:
p.000235:
p.000235: S.N. Generic
p.000235: name
p.000235:
p.000235:
p.000235: Model No.
p.000235:
p.000235:
p.000235: Intended use
p.000235:
p.000235:
p.000235: Class of medical device
p.000235:
p.000235:
p.000235: Material of construction
p.000235:
p.000235:
p.000235: Dimension (if any)
p.000235:
p.000235:
p.000235: Shelf life
p.000235:
p.000235:
p.000235: Sterile or Non sterile
p.000235:
p.000235: Annexure: Brand
p.000235: Name (if
p.000235: registered under Trade Marks Act 1999)
p.000235:
p.000235:
p.000235:
p.000235: Form MD-16
p.000235: [See sub-rule (2) of rule 40]
p.000235:
p.000235: Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or
p.000235: Demonstration or Training
p.000235:
p.000235: 1. Name of applicant:
p.000235: 2. Address of applicant including telephone number,
p.000235:
p.000235: 236 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000235: II—SEC. 3(i)]
p.000235:
p.000235: mobile number, fax number and e-mail id:
p.000235: 3. Name and Address of device Manufacturer:
p.000235: 4. Name and Address of site(s) where test or evaluation is proposed to be conducted:
p.000235: 5. Details of medical device(s) to be imported [Annexed].
p.000235: 6. Brief description of the medical device
p.000235: 7. Purpose of import
p.000235: 8. Justification for quantity to be imported
p.000235: 9. An undertaking stating that required facilities including equipment, instrument and personnel have been provided to
p.000235: test or evaluate medical device
p.000235: 10. An undertaking stating that the medical device proposed to be imported to be used
...
p.000235: Signature (Name and designation) [To be signed digitally]
p.000235:
p.000235: Annexure:
p.000235:
p.000235:
p.000235:
p.000235: S.N.
p.000235: Name of medical device (Generic and brand )
p.000235: Model No.
p.000235: Intended use
p.000235: Class of medical device
p.000235: Material of construction
p.000235: Dimension (if any)
p.000235: Shelf life
p.000235: Sterile or Non sterile
p.000235: Quantity to be imported
p.000235:
p.000235:
p.000235:
p.000235:
p.000235:
p.000235:
p.000235: Form MD-17
p.000235: [See sub-rule (1) of rule 41]
p.000235:
p.000235: Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or
p.000235: Training
p.000235:
p.000235:
p.000235: 1. M/s............................................. is hereby licenced to import the medical device specified
p.000235: below from M/s
p.000235: .....................(Name and full address of overseas manufacturer) for the purposes of clinical investigations or
p.000235: test or evaluation or demonstration or training at (Name and address, where clinical
p.000235: investigations or
p.000235: test or evaluation or is to be carried out).
p.000235:
p.000235: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000237: 237
p.000237:
p.000237: S.N.
p.000237: Generic name
p.000237: Class of medical device
p.000237: Quantity permitted to be imported
p.000237: 2. This licence is subject to conditions prescribed under the Medical Devices Rules, 2017.
p.000237: 3. This licence shall, unless previously suspended or revoked, be in force for a period of three year
p.000237: from the date specified below:-
p.000237:
p.000237: Place: Date: _
p.000237: Central Licensing Authority [To be signed digitally]
p.000237:
p.000237:
p.000237:
p.000237: Form MD-18
p.000237: [See sub-rule (1) of rule 42]
p.000237:
p.000237: Application for licence to import investigational medical devices for the purposes by a government hospital or
p.000237: statutory medical institution for the treatment of patients
p.000237:
p.000237:
p.000237: 1. I ..................…………… (Name and designation)
p.000237: of
p.000237: ………………………………… (Name of the Government Hospital or Statutory Medical Institution) hereby apply for a licence to
p.000237: import small quantities of investigational medical device specified below manufactured by M/s.
p.000237: …………………………. (Name and full address of overseas manufacturer) for the purpose of treatment of patients for the
p.000237: disease................................................. (Name of the
p.000237: disease)…………………
p.000237: at (name and address of the hospital).
p.000237:
p.000237: 2. Details of medical device to be imported:
p.000237:
p.000237:
p.000237:
p.000237: Name of the investigational Medical device
p.000237:
p.000237: Name and address of the manufacturer
p.000237:
p.000237: Quantities which may be imported
p.000237:
p.000237:
p.000237:
p.000237: 3. I shall comply with the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices Rules,
p.000237: 2017.
p.000237:
p.000237: 4. A fee of Rs. _ has been credited to the Government under the Head through
p.000237: Challan/receipt No._ _ dated_ (copy attached).
p.000237:
p.000237:
p.000237: Place: Date:
p.000237: Signature……………………..
p.000237: Name…………………………
p.000237: Seal or Stamp………………
...
p.000237: the treatment of patients suffering from and that the said medical device is not
p.000237: available in India.
p.000237:
p.000237:
p.000237: Place: Date:
p.000237:
p.000237: Signature……………………..
p.000237: Medical Superintendent of the Government Hospital / Head of
p.000237: Statutory Medical Institution Seal or Stamp
p.000237:
p.000237: 238 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000237: II—SEC. 3(i)]
p.000237:
p.000237: Form MD-19
p.000237: [See sub-rule (2) of rule 42]
p.000237:
p.000237: Licence to import investigational medical device by a government hospital or statutory medical institution for the
p.000237: treatment of patients
p.000237:
p.000237:
p.000237: Licence No.
p.000237:
p.000237: 1. Dr _ (Name and designation) of
p.000237: (Name of Hospital or Statutory Medical Institution) here by grant licence to import from M/s
p.000237: (Name and full
p.000237: address of manufacturer) the medical devices specified below for the purpose of treatment of patients for the disease
p.000237: _ (name of the disease) at ……………………………….(name and address of the hospital).
p.000237:
p.000237: 2. Details of medical device to be imported:
p.000237:
p.000237: Name of medical device Quantities which may be imported
p.000237:
p.000237:
p.000237:
p.000237: 3. This licence shall, unless previously suspended or revoked, be in force for a period of one year from the date of
p.000237: issue specified above.
p.000237:
p.000237:
p.000237: Place: Date: _
p.000237: Central Licensing Authority
p.000237: Seal or Stamp
p.000237:
p.000237:
p.000237: Form MD-20
p.000237: [See sub-rule (2) of rule 43]
p.000237: Application for permission to import small quantity of medical devices for personal use
p.000237:
p.000237: To
p.000237: The Central Licensing Authority,
p.000237:
p.000237:
p.000237:
p.000237: Sir/Madam,
p.000237:
p.000237: 1. I …………………………………… resident of………………….. by occupation hereby apply for a
p.000237: permission to import the medical device specified below for personal use manufactured by
p.000237: (Name
p.000237: and full address of manufacturer) for the treatment of (name of the disease).
p.000237:
p.000237: Name of medical device Quantity which may be imported
p.000237:
p.000237:
p.000237: 2. The prescription from a registered medical practitioner prescribing the need for the said medical device is
p.000237: attached.
p.000237: 3. The particular of the patients is specified below.
p.000237: Name Age Gender Complete Address
p.000237:
p.000237:
p.000237:
p.000237:
p.000237:
p.000237: Place: Date: _
p.000237:
p.000237: Signature of applicant
p.000237:
p.000237: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000239: 239
p.000239:
p.000239:
p.000239: Form MD-21
p.000239: [See sub-rule (3) of rule 43]
p.000239: Permission to import of small quantity of medical devices for personal use
p.000239:
p.000239: Permit No.
p.000239: Date
p.000239:
p.000239: 1. ………………………………is hereby permitted to import the medical device manufactured by
p.000239: (Name and full address of manufacturer) specified below for personal use.
p.000239:
p.000239: Name of the medical device Quantity
p.000239:
p.000239:
p.000239: 2. This licence is subject to conditions prescribed in the Medical Devices Rules, 2017.
p.000239: 3. This licence shall, unless previously suspended or revoked, be in force for a period of one hundred and eighty days
p.000239: from the date of issue specified above.
p.000239:
p.000239:
p.000239: Central Licensing Authority
p.000239: Seal or Stamp
p.000239:
p.000239: Form MD-22
p.000239: [See sub-rule (1) of rule 51]
p.000239: Application for Grant of permission to conduct clinical investigation of an investigational medical device
p.000239:
p.000239: 1. Name of Applicant:
p.000239: 2. Nature and constitution of applicant:
p.000239: (i.e. proprietorship, partnership including Limited Liability Partnership, company, society, trust, other to be
p.000239: specified)
p.000239: 3. (i) Sponsor address including telephone number, mobile number, fax number and e-mail id:
p.000239: (ii) Clinical investigation site address including telephone number, mobile number, fax number and e-mail id:
p.000239: (iii) Address for correspondence:
p.000239: 4. Details of investigational medical device(s) and Clinical investigation site [Annexed].
p.000239: 5. Clinical investigation plan number with date:
p.000239: 6. Fee paid on Rs receipt/challan/transaction
p.000239: id_ .
p.000239: 7. I have enclosed the documents as specified in the Seventh Schedule of Medical Devices Rules, 2017.
p.000239: 8. I hereby state and undertake that:
p.000239: (i) I shall comply with all the provisions of the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017.
p.000239:
p.000239:
p.000239: Place: Date: _
p.000239: Signature (Name and designation) [To be signed digitally]
p.000239:
p.000239: Annexure:
p.000239: S. N. Generic name Intended use Class
p.000239: of medical device
p.000239:
p.000239:
p.000239:
p.000239:
p.000239: S. N.
p.000239: Name and address of site(s)
p.000239: Ethics Committee details
p.000239: Name of Principle Investigator
p.000239:
p.000239: 240 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000239: II—SEC. 3(i)]
p.000239:
p.000239: Form MD-23
p.000239: [See clause (i) of rule 52]
p.000239: Permission to conduct Clinical Investigation
p.000239: Permission No. _
p.000239:
p.000239: 1. M/s. _ (Name and full address) is hereby granted
p.000239: permission to conduct clinical investigation for following investigational medical device as per clinical
p.000239: investigation plan _ dated
p.000239: in the below mentioned clinical investigation sites.
p.000239:
p.000239: 2. Details of investigational medical device(s) and Clinical investigation site [Annexed].
p.000239:
p.000239: 3. This permission is subject to conditions as prescribed under Medical Devices Rules, 2017.
p.000239:
p.000239:
p.000239:
p.000239: Place: Date: _
p.000239:
p.000239: Central Licensing Authority [To be signed digitally]
p.000239:
p.000239:
p.000239:
p.000239: Details of investigational medical device(s):
p.000239: S. N. Generic name Intended use Class
p.000239: of medical device
p.000239: Annexure:
p.000239:
p.000239:
p.000239:
p.000239:
p.000239: Details of Clinical investigation site:
p.000239: S. N. Name and address of site(s)
p.000239:
p.000239: Ethics Committee details Name of Principle Investigator
p.000239:
p.000239:
p.000239: Form MD-24
p.000239: [See sub-rule (2) of rule 59]
p.000239: Application for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical
p.000239: device
p.000239: 1. Name of Applicant:
p.000239: 2. Nature and constitution of applicant:
p.000239: (i.e. proprietorship, partnership including Limited Liability Partnership, company, society, trust, other to be
p.000239: specified)
p.000239: 3. (i) Sponsor address including telephone number, mobile number, fax number and e-mail id:
p.000239: (ii) Laboratory(s) or institution(s) address including telephone number, mobile number, fax number and e-mail id:
p.000239: (iii) Address for correspondence:
p.000239: 4. Details of new in vitro diagnostic medical device and laboratory(s) or institution(s) [Annexed].
p.000239: 5. Clinical performance evaluation plan number with date:
p.000239: 6. Fee paid on Rs receipt/challan/transaction
p.000239: id_ .
p.000239: 7. I have enclosed the documents as specified in sub-rule (3) of rule 59 of Medical Devices Rules, 2017.
p.000239: 8. I hereby state and undertake that:
p.000239: (i) I shall comply with all the provisions of the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017.
p.000239:
p.000239: Place: Date: _
p.000239: Signature (Name and designation) [To be signed digitally]
p.000239:
p.000239: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000241: 241
p.000241: Annexure:
p.000241: Details of new in vitro diagnostic medical device
p.000241: S. N. Generic name Intended use Class
p.000241: of medical device
p.000241: Details of laboratory(s)/institution(s) involved
p.000241:
p.000241: S. N.
p.000241: Name and address of laboratory(s)/ institution(s)
p.000241: Ethics Committee details
p.000241: Name of Principle Investigator
p.000241:
p.000241:
p.000241:
p.000241: Form MD-25
p.000241: [See sub-rule (5) of rule 59]
p.000241: Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device
p.000241: Permission No. _
p.000241:
p.000241: 1. M/s _ (Name and full address of manufacturer with
p.000241: telephone and e-mail) is hereby granted permission to conduct clinical performance evaluation of following new in
p.000241: vitro diagnostic device as per clinical performance evaluation plan _ dated:
p.000241: on the below mentioned laboratory(s) or institution(s) involved.
p.000241:
p.000241: 2. Details of new in vitro diagnostic medical device and laboratory(s) or institution(s) [Annexed].
p.000241:
p.000241: 3. This permission is subject to conditions as prescribed under Medical Devices Rules, 2017.
p.000241:
p.000241:
p.000241:
p.000241: Place: Date: _
p.000241: Central Licensing Authority [To be signed digitally]
p.000241:
p.000241:
p.000241:
p.000241: Details of new in vitro diagnostic medical device:
p.000241: S. N. Generic name Intended use Class
p.000241: of medical device
p.000241: Annexure:
p.000241:
p.000241:
p.000241:
p.000241: Details of laboratory(s)/institution(s) involved.
p.000241:
p.000241: S. N.
p.000241: Name and address of laboratory(s)/ institution(s)
p.000241: Ethics Committee details
p.000241: Name of Principle Investigator
p.000241:
p.000241: 242 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000241: II—SEC. 3(i)]
p.000241:
p.000241: Form MD-26
p.000241: [See sub-rule (1) of rule 63]
p.000241:
p.000241: Application for grant of permission to import / manufacture for sale or for distribution of medical device which does
p.000241: not have predicate medical device
p.000241:
p.000241: 1. Name of applicant:
p.000241: 2. Nature and constitution of applicant:
p.000241: (i.e. proprietorship, partnership including Limited Liability Partnership, company, society, trust, other to be
p.000241: specified)
p.000241: 3. (i) Corporate/ registered office address including telephone number, mobile number, fax number and e- mail id:
p.000241: (ii) Manufacturing site/ Authorised Agent address including telephone number, mobile number, fax number and e-mail id
p.000241: as per wholesale licence or manufacturing licence:
p.000241: (iii) Address for correspondence:
p.000241: [Corporate/ registered office/ Manufacturing site / authorised agent]
p.000241: 4. Particulars of Manufacturer, Manufacturing site(s):
p.000241:
p.000241:
p.000241: Sr.
p.000241: No.
...
p.000241: id_ .
p.000241: 7. I have enclosed the documents as specified in the Part IV of the Fourth Schedule to the Medical Devices Rules, 2017.
p.000241:
p.000241:
p.000241:
p.000241:
p.000241: Place: Date: _
p.000241: Signature (Name and designation) [To be signed digitally]
p.000241:
p.000241: Annexure:
p.000241:
p.000241:
p.000241: S.N.
p.000241: Generic name
p.000241: Model No.
p.000241: Intended use
p.000241: Class of medical device
p.000241: Material of construction
p.000241: Dimension (if any)
p.000241: Shelf life
p.000241: Sterile or Non sterile
p.000241:
p.000241: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000243: 243
p.000243:
p.000243:
p.000243: Form MD-27
p.000243: [See sub-rule (2) of rule 63]
p.000243:
p.000243: Permission to import or manufacture for sale or for distribution of medical device which does not have predicate
p.000243: medical device
p.000243:
p.000243:
p.000243: Permission No. _
p.000243:
p.000243: 1. M/s. _ (Name and full address of manufacturer with telephone, and e-mail) having
p.000243: manufacturing site _ _ (address of manufacturing site), is hereby permitted to import /
p.000243: manufacture for sale or for distribution of following medical devices.
p.000243:
p.000243: 2. Details of medical device(s) to be imported or manufactured [Annexed].
p.000243:
p.000243:
p.000243: 3. This permission is subject to conditions as specified in the Drugs and Cosmetics Act (23 of 1940)
p.000243: and the Medical Devices Rules, 2017.
p.000243:
p.000243:
p.000243:
p.000243:
p.000243:
p.000243:
p.000243: Place: Date: _
p.000243: Central Licensing Authority [To be signed digitally]
p.000243:
p.000243:
p.000243:
p.000243:
p.000243: S.N. Generic
p.000243:
p.000243:
p.000243: Brand
p.000243:
p.000243:
p.000243: Model
p.000243:
p.000243:
p.000243: Dimensi
p.000243:
p.000243:
p.000243: Intended
p.000243:
p.000243:
p.000243: Shelf life Sterile/
p.000243:
p.000243:
p.000243: Class of
p.000243: Annexure:
p.000243:
p.000243: Name
p.000243: name
p.000243: No. on
p.000243: Use
p.000243: Non Sterile
p.000243: medical device
p.000243:
p.000243: 244 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000243: II—SEC. 3(i)]
p.000243:
p.000243: Form MD-28
p.000243: [See sub-rule (1) of rule 64]
p.000243: Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro
p.000243: diagnostic medical device
p.000243:
p.000243: 1. Name of applicant:
p.000243: 2. Nature and constitution of applicant:
p.000243: (i.e. proprietorship, partnership including Limited Liability Partnership, company, society, trust, other to be
p.000243: specified)
p.000243: 3. (i) Corporate/ registered office address including telephone number, mobile number, fax number and e- mail id:
p.000243: (ii) Manufacturing site/ authorised agent address including telephone number, mobile number, fax number and e-mail id
p.000243: as per wholesale licence or manufacturing licence:
p.000243: (iii) Address for correspondence:
p.000243: [Corporate/ registered office/ Manufacturing site / authorised agent]
p.000243: 4. Particulars of Manufacturer, Manufacturing site(s):
p.000243:
p.000243:
p.000243: Sr.
p.000243: No.
p.000243: Name and address of manufacturer (full address with telephone, fax and e-mail address of the manufacturer)
...
p.000243: id_ .
p.000243: 7. I have enclosed the documents as specified in the part IV of the Fourth Schedule Medical Devices Rules, 2017.
p.000243:
p.000243:
p.000243:
p.000243:
p.000243: Place: Date: _
p.000243: Signature (Name and designation) [To be signed digitally]
p.000243:
p.000243: Annexure:
p.000243:
p.000243:
p.000243: S.N.
p.000243: Generic name
p.000243: Model No.
p.000243: Intended use
p.000243: Class of medical device
p.000243: Material of construction
p.000243: Dimension (if any)
p.000243: Shelf life
p.000243: Sterile or Non sterile
p.000243:
p.000243: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000245: 245
p.000245:
p.000245:
p.000245: Form MD-29
p.000245: [See sub-rule (2) of rule 64]
p.000245: Permission to Import or Manufacture New In Vitro Diagnostic Medical Device
p.000245:
p.000245: Permission No. _
p.000245:
p.000245: 1. The new in vitro diagnostic medical device(s) specified below manufactured
p.000245: by M/s.
p.000245: (Name and full address of manufacturer with telephone,
p.000245: and e-mail) having
p.000245:
p.000245: manufacturing site manufacture.
p.000245: (address of manufacturing site), is hereby permitted to import or
p.000245:
p.000245: 2. Details of new in vitro diagnostic medical device to be imported or manufactured [Annexed].
p.000245:
p.000245:
p.000245: 3. This permission is subject to conditions as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the
p.000245: Medical Devices Rules, 2017.
p.000245:
p.000245:
p.000245:
p.000245:
p.000245: Place: Date: _
p.000245: Central Licensing Authority [To be signed digitally]
p.000245:
p.000245:
p.000245:
p.000245: S.N. Generic
p.000245:
p.000245: Brand
p.000245:
p.000245: Model
p.000245:
p.000245: Dimensi
p.000245:
p.000245: Intended
p.000245:
p.000245: Shelf life Sterile/
p.000245:
p.000245: Class of
p.000245: Annexure:
p.000245:
p.000245: Name
p.000245: name
p.000245: No. on
p.000245: Use
p.000245: Non Sterile
p.000245: medical device
p.000245:
p.000245:
p.000245:
p.000245: Form MD-30
p.000245: [See sub-rule (1) of rule 67]
p.000245:
p.000245: Memorandum to the Central Medical Device Testing Laboratory
p.000245:
p.000245: Serial Number ………………………….
p.000245:
p.000245: To
p.000245: The Director,
p.000245: Central Medical Device Testing Laboratory,
p.000245: ………………………………….
p.000245: ………………………………….
p.000245:
p.000245: From……...........................................
p.000245:
p.000245: 1. I send herewith, under the provisions of sub-section (4) of section 25 of the Drugs and Cosmetics Act, 1940 (23 of
p.000245: 1940), sample(s) of a medical device purporting to be for test or
p.000245: evaluation and request
p.000245: that a report of the result of the test or evaluation may be supplied to this Court.
p.000245:
p.000245: 2. The distinguishing number on the packet is ………………………………………………………..
p.000245:
p.000245: 3. Particulars of offence alleged ……………………………………………………………………….
p.000245:
p.000245: 4. Matter on which opinion is required …………………………………………………………………
p.000245:
p.000245: 246 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000245: II—SEC. 3(i)]
p.000245:
p.000245: 5. A fee of Rs has been deposited in Court.
p.000245:
p.000245: Date………………..
p.000245:
p.000245: ……………………..
...
p.000245:
p.000245: *If opinion is required on any other matter, the paragraph should be suitably amended.
p.000245:
p.000245:
p.000245: Form MD-32
p.000245: [See sub-rule (2) of rule 68]
p.000245:
p.000245: Report of Test or Evaluation of Medical Devices by Medical Device Testing Officer
p.000245:
p.000245:
p.000245: 1. It is certified that the samples having serial number of memorandum or receipt number
p.000245: dated:
p.000245: ……………… purporting to be sample of ……………………. received on …………….. from has
p.000245: been tested or evaluated and the results of tests or evaluation is as stated below.
p.000245:
p.000245: 2. The conditions of seals on the packet or on portion of sample or container were as follows …………….
p.000245:
p.000245: 2. Based upon the test or evaluation and in the opinion of undersigned the sample is of standard quality/ not of
p.000245: standard quality/ adulterated/misbranded/spurious, as defined in the Drugs and Cosmetics Act, 1940 (23 of
p.000245: 1940) for the reasons given below:-
p.000245:
p.000245:
p.000245:
p.000245: Date……………….
p.000245: Medical Device Testing Officer
p.000245: Seal or Stamp
p.000245:
p.000245: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000247: 247
p.000247:
p.000247:
p.000247: Form MD-33
p.000247: [See rule 69]
p.000247: Application from a purchaser for test or evaluation of a Medical Device under section 26 of the Drugs and Cosmetics
p.000247: Act, 1940 (23 of 1940)
p.000247:
p.000247: To
p.000247: The Central Licensing Authority,
p.000247:
p.000247:
p.000247:
p.000247:
p.000247: Sir/Madam,
p.000247:
p.000247:
p.000247: 1. Full name and address of the applicant
p.000247: ....................................................................................
p.000247: 2.
p.000247: Occupation..............................................................................................................
p.000247: .................
p.000247: 3. Name of medical device purporting to be contained in the sample..........................................
p.000247: 4. Name and full address of the pharmacy or concern where the medical device was purchased. 5. Date on which
p.000247: purchased (invoice attached)
p.000247: 6. Reasons why the medical device is being submitted for test or evaluation………………………….
p.000247: 7. A fee of rupees as charged by medical device
p.000247: testing laboratory has been paid
p.000247: under receipt number ………….. dated: ………..
p.000247:
p.000247: I hereby declare that the medical device being submitted for test or evaluation was purchased by or for me. I further
p.000247: declare that the sample of the medical device being sent for test or evaluation is exactly as it was purchased and has
p.000247: not been tampered with in any way to reduce its potency.
p.000247:
p.000247:
p.000247:
p.000247:
p.000247: Date:……………….
p.000247: Signature
p.000247: Seal or Stamp
p.000247:
p.000247:
p.000247:
p.000247: Form MD-34
p.000247: [See rule 72]
p.000247:
p.000247: Order under clause (c) of sub-section (1) of section of the Drugs and Cosmetics Act, 1940, (23 of 1940) requiring a
p.000247: person not to dispose of stock in his possession
p.000247:
...
p.000249: in
p.000249: accordance with the requirements of Medical Devices Rules, 2017.
p.000249:
p.000249: (ii) I shall comply with the applicable provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940),
p.000249: and the Medical Devices Rules, 2017.
p.000249:
p.000249:
p.000249:
p.000249: Place: Date: _
p.000249:
p.000249: Signature (Name and designation) [To be signed digitally]
p.000249:
p.000249:
p.000249: Annexure:
p.000249:
p.000249:
p.000249: S.N.
p.000249: Generic name
p.000249: Class of medical devices
p.000249:
p.000249: 250 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000249: II—SEC. 3(i)]
p.000249:
p.000249: Form MD-40
p.000249: [See sub-rule (3) of rule 83]
p.000249:
p.000249: Certificate of registration to Medical Device Testing Laboratory for carry out Test or Evaluation of a medical device
p.000249: on behalf of manufacturer
p.000249:
p.000249:
p.000249: Registration No.: ……………….
p.000249:
p.000249: 1. M/s, ……………………………………………………………(Name of the firm) situated at
p.000249: ……………………………………………(full address with telephone and e-mail) has been registered as a Medical Device Testing Laboratory
p.000249: for carry out Test or Evaluation of a medical device on behalf of manufacturer under the Medical Devices Rules, 2017.
p.000249:
p.000249: 2. Details of medical device(s) to be tested or evaluated [Annexed].
p.000249:
p.000249: 3. This Registration is subject to the conditions as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and
p.000249: the Medical Devices Rules, 2017.
p.000249:
p.000249:
p.000249:
p.000249: Place: Date: _
p.000249: Central Licensing Authority [To be signed digitally]
p.000249:
p.000249:
p.000249:
p.000249: Annexure:
p.000249:
p.000249:
p.000249: S.N.
p.000249: Generic name
p.000249: Class of medical devices
p.000249:
p.000249:
p.000249:
p.000249:
p.000249: [F. No. X. 11035/374/2016-DFQC]
p.000249:
p.000249: K. L. SHARMA, Jt. Secy.
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249:
p.000249: Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the
p.000249: Controller of Publications, Delhi-110054.
p.000249:
p.000249: SARVESH
p.000249: KUMAR SRIVASTAVA
p.000249: Digitally signed by
p.000249: SARVESH KUMAR SRIVASTAVA Date: 2017.02.02
...
Orphaned Trigger Words
p.000181: manufacturing environment, facilities and controls used for manufacturing, assembly, any final product testing,
p.000181: labelling and packaging and storage of the finished medical device. If the manufacturing process is carried out at
p.000181: multiple sites, the manufacturing activities at each site should be clearly specified.
p.000181: 5. ESSENTIAL PRINCIPLES CHECKLIST:
p.000181: (i) The dossier should contain the following:-
p.000181: (a) the essential principles;
p.000181: (b) whether each essential principle applies to the device and if not, why not;
p.000181: (c) the method used to demonstrate conformity with each essential principle that applies;
p.000181: (d) a reference for the method employed (e.g., standard); and
p.000181: (e) the precise identity of the controlled document that offers evidence of conformity with each method used.
p.000181: (ii) Methods used to demonstrate conformity may include one or more of the following:
p.000181: (a) conformity with standards as referred to in rule 7;
p.000181: (b) conformity with an in-house test method;
p.000181: (c) the evaluation of pre-clinical and clinical evidence;
p.000181: (d) comparison to a similar device already available on the market.
p.000181: (iii) The essential principles checklist should incorporate a cross-reference to the location of such
p.000181: evidence both within the full technical documentation held by the manufacturer and within the dossier. A
p.000181: template for a checklist is shown in as under:
p.000181:
p.000181:
p.000181: Essential Principle
p.000181: Relevant Yes/No
p.000181: Specification/standard Sub-clause/reference
p.000181: Complies Yes/No
p.000181: Document Reference Justification and/or comments
p.000181:
p.000181:
p.000181:
p.000181:
p.000181: 6. Risk analysis and control summary:
p.000181: The dossier should contain a summary of the risks identified during the risk analysis process and how these risks have
p.000181: been controlled to an acceptable level. This risk analysis should be based on prescribed standards and be part of the
p.000181: manufacturer’s risk management plan based on complexity and risk class of the device. The technique used to analyse
p.000181: the risk must be specified, to ensure that it is appropriate for the medical device and risk involved.
p.000181: The risks and benefits associated with the use of the medical device should be described. The risk
p.000181: analysis submitted shall have periodic updation of the risks identified as per risk management plan.
p.000181: 7. Verification and validation of the medical device
p.000181: 7.1 General:
p.000181: (A) The dossier should contain product verification and validation documentation. The dossier should summarize the
p.000181: results of verification and validation studies undertaken to demonstrate conformity of the device with the essential
p.000181: principles that apply to it. Such information would typically cover wherever applicable:
p.000181: (a) engineering tests;
p.000181: (b) laboratory tests;
p.000181: (c) simulated use testing;
p.000181: (d) any animal tests for demonstrating feasibility or proof of concept of the finished device;
p.000181: (e) any published literature regarding the device or substantially similar devices.
p.000181: (B) Such summary information may include:
p.000181: (i) declaration or certificate of conformity to a recognised standard and summary of the data if no
p.000181: acceptance criteria are specified in the standard;
p.000181: (ii) declaration or certificate of conformity to a published standard that has not been recognised,
p.000181: supported by a rationale for its use, and summary of the data if no acceptance criteria is specified in the
p.000181: standard;
p.000181:
p.000181: 182 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000181: II—SEC. 3(i)]
p.000181:
p.000181: (iii) declaration or certificate of conformity to a professional guideline, industry method, or in-house
p.000181: test method, supported by a rationale for its use, a description of the method used, and summary of the data in
p.000181: sufficient detail to allow assessment of its adequacy;
p.000181: (iv) a review of published literature regarding the device or substantially similar devices.
...
p.000183:
p.000183: Adverse event (false diagnosis)
p.000183: Frequency of occurrence during the period (number of report/total units sold)
p.000183:
p.000183:
p.000183:
p.000183:
p.000183: For Field Safety Corrective Action (FSCA)
p.000183:
p.000183:
p.000183: Date of FSCA
p.000183: Reason for FSCA
p.000183: Countries where FSCA was conducted
p.000183: Description of the action taken
p.000183:
p.000183:
p.000183:
p.000183:
p.000183: (b) If the in vitro diagnostic medical device contains any of the following then descriptive information on the
p.000183: following need to be provided.
p.000183: (1) Animal or human fluids or derivatives thereof, rendered non-viable.
p.000183: (2) Cells, tissues and/or derivatives of microbial recombinant origin.
p.000183: 2. Description and specification, including variants and accessories of the in vitro diagnostic medical device
p.000183: 2.1 Description
p.000183: The device master file should include the following device descriptive information:
p.000183: (a) it may include:-
p.000183: (1) what is detected;
p.000183: (2) its function (for example screening, monitoring, diagnostic or aid to diagnosis, staging or aid to staging
p.000183: of disease);
p.000183: (3) the specific disorder, condition or risk factor of interest that it is intended to detect,
p.000183: define or differentiate;
p.000183: (4) whether it is automated or not;
p.000183: (5) whether it is qualitative or quantitative;
p.000183: (6) the type of specimen required (eg. serum, plasma, whole blood, tissue biopsy, urine);
p.000183: (7) testing population;
p.000183: (b) the intended user (lay person or professional);
p.000183: (c) a general description of the principle of the assay method;
p.000183: (d) the risk based Class of the device;
p.000183: (e) a description of the components (e.g. reagents, assay controls and calibrators) and where
p.000183: appropriate, a description of the reactive ingredients of relevant components (such as antibodies,
p.000183: antigens, nucleic acid primers) where applicable;
p.000183: (f) a description of the specimen collection and transport materials provided with the in vitro diagnostic
p.000183: medical device or descriptions of specifications recommended for use;
p.000183: (g) for instruments of automated assays; a description of the appropriate assay characteristics or dedicated assays;
p.000183: (h) for automated assays; a description of the appropriate instrumentation characteristics or
p.000183: dedicated instrumentation;
p.000183:
p.000183: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000185: 185
p.000185: (i) a description of any software to be used with the in vitro diagnostic medical device;
p.000185: (j) a description or complete list of the various configurations/variants of the in vitro diagnostic medical device
p.000185: that will be made available;
p.000185: (k) a description of the accessories, other in vitro diagnostic medical device and other products that are not in
p.000185: vitro diagnostic medical device, which are intended to be used in combination with the in vitro diagnostic
p.000185: medical device.
p.000185: Reference to the manufacturer’s previous device generation(s) or similar devices or device history.
p.000185: 2.2 For a new in vitro diagnostic medical device:
p.000185: Where relevant to demonstrating conformity to the essential principles, and to provide general background
p.000185: information, the device master file may provide a summary of Clinical Performance Evaluation reports.
...
p.000185: medical devices placed on the market.
p.000185: (ii) External certificates and documents which give written evidence of conformity with the essential principles may
p.000185: be annexed to the device master file.
p.000185: (iii) comparative analysis to prove substantial equivalence to the predicate device(s), if claimed in the application.
p.000185: 3. Essential principles checklist:
p.000185: (i) The device master file should include an essential principles checklist that identifies:
p.000185: (a) the essential principles of safety and performance;
p.000185: (b) whether each essential principle applies to the in vitro diagnostic medical device and if not, why not;
p.000185: (c) the method used to demonstrate conformity with each essential principle that applies; and
p.000185: (d) the reference to the actual technical documentation that offers evidence of conformity with each method used.
p.000185: (ii) The method used to demonstrate conformity may include one or more of the following:-
p.000185: (a) conformity with recognized or other standards;
p.000185: (b) conformity with a commonly accepted industry test method (reference method);
p.000185: (c) conformity with appropriate in house test methods that have been validated and verified;
p.000185: (d) comparison to an in vitro diagnostic medical device already available on the market.
p.000185: (iii) The essential principles checklist should include a cross-reference to the location of such evidence both within
p.000185: the full technical documentation held by the manufacturer and within the Device master file (when such
p.000185: documentation is specifically required for inclusion in the Summary Technical Documentation as outlined in
p.000185: this guidance).
p.000185: 4. Risk analysis and control summary:
p.000185: The device master file should contain a summary of the risks identified during the risk analysis process and a
p.000185: description of how these risks have been controlled to an acceptable level. Preferably, this risk analysis should be
p.000185: based on recognised standards and be part of the manufacturer’s risk management plan.
p.000185: The summary should address possible hazards for the in vitro diagnostic medical device such as the risk from false
p.000185: positive or false negative results, indirect risks which may result from in vitro diagnostic medical device- associated
p.000185: hazards, such as instability, which could lead to erroneous results, or from user-related hazards, such as reagents
p.000185: containing infectious agents. The results of the risk analysis should provide a conclusion with evidence
p.000185: that remaining risks are acceptable when compared to the benefits.
p.000185: 5. Design and manufacturing information:
p.000185: 5.1 Device design:
p.000185: The Device master file should contain information to allow a reviewer to obtain a general understanding of the design
p.000185: applied to the in vitro diagnostic medical device.
p.000185: It should include a description of the critical ingredients of an assay such as antibodies, antigens, enzymes and
p.000185: nucleic acid primers provided or recommended for use with the in vitro diagnostic medical device,
p.000185: This section is not intended to take the place of the more detailed information required for a QMS audit or other
p.000185: conformity assessment activity. If design takes place at multiple sites, a controlling site must be identified.
p.000185: 5.2 Manufacturing processes:
p.000185: The device master file should contain information to allow a reviewer to obtain a general understanding of the
p.000185: manufacturing processes. It is not intended to take the place of the more detailed information required for
p.000185: a QMS audit or other conformity assessment activity. The information may take the form of a process flow chart
p.000185:
p.000185: 186 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000185: II—SEC. 3(i)]
p.000185:
p.000185: showing, for example, an overview of production including the technologies used, assembly, any in-process and final
p.000185: product testing, and packaging of the finished in vitro medical device.
p.000185: 5.3 Manufacturing sites:
p.000185: The device master file should identify the sites where these activities are performed (this does not include the sites
...
p.000189: in vitro diagnostic medical device.
p.000189: (9) Specific processing like safe handling, material control, area control, process control, and
p.000189: stability studies, storage at quarantine stage and finished stage, packaging should be highlighted in the product
p.000189: dossier.
p.000189: NOTE:
p.000189: 1. All the test reports submitted as a part of the dossier should be signed and dated by the responsible person.
p.000189: 2. Batch Release Certificates and Certificate of Analysis of finished product for minimum 3 consecutive batches
p.000189: should be submitted.
p.000189: 3. All certificates submitted must be within the validity period.
p.000189: 4. Any information which is not relevant for the subject in vitro diagnostic medical device may be stated as ‘Not
p.000189: Applicable’ in the relevant sections/columns of the above format, and reasons for non-applicability should be provided.
p.000189:
p.000189: Part IV
p.000189: Information required to be submitted with the Application Form for import or manufacture of medical devices
p.000189: which does not have predicate device.
p.000189:
p.000189: (a) Data to be submitted along with the application (for medical devices other than new in vitro
p.000189: diagnostic):-
p.000189: 1. Design Analysis data including, (whichever applicable)-
p.000189: (a) design input and design output documents;
p.000189: (b) mechanical and electrical tests;
p.000189: (c) reliability tests;
p.000189: (d) validation of software relating to the function of the device;
p.000189: (e) any performance tests;
p.000189: (f) in vitro tests.
p.000189: 2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationale for selecting these
p.000189: tests. Summary report of the biocompatibility study including the conclusion of the study.
p.000189: 3. Risk Management data;
p.000189: 4. Animal Performance study data;
p.000189: 5. Pilot or Pivotal Clinical Investigation data, including that carried out in other countries if any;
p.000189: 6. In case, if waiver from clinical investigation is claimed in accordance with the provisions of Medical
p.000189: Device Rules, 2017, the information or supporting data shall be submitted.
p.000189: 7. Regulatory status and Restriction on use in other countries (if any) where marketed or approved;
p.000189: 8. Proposed Instruction for use and labels.
p.000189:
p.000189: 190 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000189: II—SEC. 3(i)]
p.000189:
p.000189: (b) Data to be submitted along with the application (for new in vitro diagnostic medical devices):-
p.000189: 1. Device data including, (whichever applicable)-
p.000189: (i) design input, design output documents, stability data;
p.000189: (ii) device specification including specificity, sensitivity, reproducibility and reputability;
p.000189: (iii) product validation and software validation relating to the function of the device (if any);
p.000189: (iv) performance evaluation report from a laboratory designated under sub-rule (1) of rule 19.
p.000189: 2. Risk Management data.
p.000189: 3. Clinical Performance Evaluation data carried out in India and in other countries (if any).
p.000189: 4. Regulatory status and Restriction on use in other countries (if any) where marketed or approved.
p.000189: 5. Proposed Instruction for use and labels.
p.000189:
p.000189:
p.000189: Fifth Schedule
p.000189: [See rule 20(3), 20(5), 20(8), 22(i)]
p.000189: Quality Management System for medical devices and in vitro diagnostic medical devices
p.000189:
p.000189: 1. General Requirements:
p.000189: 1.1. This schedule specifies requirements for a quality management system that shall be used by the manufacturer for
p.000189: the design and development, manufacture, packaging, labelling, testing, installation and servicing of
p.000189: medical devices and in vitro diagnostic medical devices. If the manufacturer does not carry out design and development
p.000189: activity, the same shall be recorded in the quality management system. The manufacturer shall maintain
p.000189: conformity with this Schedule to reflect the exclusions.
p.000189: 1.2. If any requirement in paragraph 7 (product realisation) of this Schedule is not applicable due to the nature of
p.000189: the medical device and in vitro diagnostic medical devices for which the quality management system is applied, the
p.000189: manufacturer does not need to include such a requirement in its quality management system.
p.000189: 1.3. The processes required by this Schedule, which are applicable to the medical device and in-vitro
p.000189: diagnostic medical device, but which are not performed by the manufacturer are the responsibility of the manufacturer
p.000189: and are accounted for in the manufacturer’s quality management system.
p.000189: 1.4. If a manufacturer engages in only some operations subject to the requirements of this part, and not in others,
...
p.000193: (c) the manufacturer shall ensure that all personnel who are required to work temporarily
p.000193: under special environmental conditions within the work environment are appropriately trained and supervised
p.000193: by a trained person;
p.000193: (d) if appropriate, special arrangements shall be established and documented for the control of
p.000193: contaminated or potentially contaminated product in order to prevent contamination of other product, the work
p.000193: environment or personnel;
p.000193: (e) all personnel shall bear clean body covering appropriate to their duties. Smoking, eating, drinking, chewing or
p.000193: keeping food and drink shall not be permitted in production, laboratory and storage areas.
p.000193: 7 Product realisation,-
p.000193: 7.1 Planning of product realization:
p.000193: The manufacturer shall plan and develop the processes needed for product realization. Planning of product
p.000193: realization shall be consistent with the requirements of the other processes of the quality management system.
p.000193: In planning product realisation, the manufacturer shall determine the following, as appropriate:-
p.000193: (a) quality objectives and requirements for the product;
p.000193: (b) the need to establish processes, documents, and provide resources specific to the product;
p.000193: (c) required verification, validation, monitoring, inspection and test activities specific to the product and the
p.000193: criteria for product acceptance;
p.000193: (d) records needed to provide evidence that the realisation processes and resulting product meet requirements. The
p.000193: output of this planning shall be in a form suitable for the manufacturer’s method of operations.
p.000193: The manufacturer organisation shall establish documented requirements for risk management (as per the IS
p.000193: or ISO 14971) throughout product realisation. Records arising from risk management shall be maintained.
p.000193:
p.000193: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000195: 195
p.000195: 7.2 Customer-related processes.-
p.000195: 7.2.1 Determination of requirements related to the product:
p.000195: The manufacturer shall determine:-
p.000195: (a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;
p.000195: (b) requirements not stated by the customer but necessary for specified or intended use, where known;
p.000195: (c) statutory requirements related to the product, and
p.000195: (d) any additional requirements determined by the manufacturer.
p.000195:
p.000195: 7.2.2 Review of requirements related to the product:
p.000195: The manufacturer shall review the requirements related to the product. This review shall be conducted
p.000195: prior to the manufacturer's commitment to supply a product to the customer and shall ensure that:-
p.000195: (a) product requirements are defined and documented;
p.000195: (b) contract or order requirements differing from those previously expressed are resolved; and
p.000195: (c) the manufacturer has the ability to meet the defined requirements.
p.000195: Records of the results of the review and actions arising from the review shall be maintained.
p.000195: Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the
p.000195: manufacturer before acceptance.
p.000195: Where product requirements are changed, the manufacturer shall ensure that relevant documents are amended and that
p.000195: relevant personnel are made aware of the changed requirements.
p.000195: 7.2.3 Customer communication:
p.000195: The manufacturer shall determine and implement effective arrangements for communicating with customers in relation to:-
p.000195: (a) product information;
...
p.000195: 7.3 Design and development.-
p.000195: 7.3.1 Design and development planning:
p.000195: The manufacturer shall establish documented procedures for design and development. The manufacturer shall plan and
p.000195: control the design and development of product. During the design and development planning, the
p.000195: manufacturer shall determine :-
p.000195: (a) the design and development stages;
p.000195: (b) the review, verification, validation and design transfer activities that are appropriate at each
p.000195: design and development stage; and
p.000195: (c) the responsibilities and authorities for design and development.
p.000195: The manufacturer shall manage the interfaces between different groups involved in design and development to
p.000195: ensure effective communication and clear assignment of responsibility.
p.000195: Planning output shall be documented, and updated as appropriate, as the design and development progresses.
p.000195: NOTE: Design transfer activities during the design and development process ensure that design and development outputs
p.000195: are verified as suitable for manufacturing before becoming final production specifications.
p.000195: 7.3.2 Design and development inputs:
p.000195: Inputs relating to product requirements shall be determined and records maintained. The design requirements relating to
p.000195: a device are appropriate and address the intended use of the device, including the needs of the user and patients.
p.000195: These inputs shall include:-
p.000195: (a) functional, performance and safety requirements, according to the intended use;
p.000195: (b) applicable statutory and regulatory requirements;
p.000195: (c) where applicable, information derived from previous similar designs;
p.000195: (d) other requirements essential for design and development; and
p.000195: (e) output(s) of risk management.
p.000195: These inputs shall be reviewed for adequacy and approved by designated individual. Requirements shall be complete,
p.000195: unambiguous and not in conflict with each other.
p.000195: 7.3.3 Design and development outputs:
p.000195: The outputs of design and development shall be provided in a form that enables verification against the
p.000195: design and development input and shall be documented, reviewed, and approved prior to release.
p.000195: Design and development outputs shall:-
p.000195: (a) meet the input requirements for design and development;
p.000195: (b) provide appropriate information for purchasing, production and for service provision;
p.000195: (c) contain or reference product acceptance criteria; and
p.000195: (d) specify the characteristics of the product that are essential for its safe and proper use. Records of the design
p.000195: and development outputs shall be maintained.
p.000195: Records of design and development outputs can include specifications, manufacturing procedures, engineering drawings,
p.000195: and engineering or research logbooks.
p.000195:
p.000195: 196 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000195: II—SEC. 3(i)]
p.000195:
p.000195: 7.3.4 Design and development review:
p.000195: At suitable stages, systematic reviews of design and development shall be performed in accordance with
p.000195: planned arrangements:-
p.000195: (a) to evaluate the ability of the results of design and development to meet requirements; and
p.000195: (b) to identify any problems and propose necessary actions.
p.000195: Participants in such reviews shall include representatives of functions concerned with the design and development stage
p.000195: being reviewed, as well as other specialist personnel. Records of the results of the reviews and any
p.000195: necessary actions shall be maintained.
p.000195: 7.3.5 Design and development verification:
p.000195: Verification shall be performed in accordance with planned arrangements to ensure that the design and
p.000195: development outputs have met the design and development input requirements. Records of the results of the
p.000195: verification and any necessary actions shall be maintained.
p.000195: 7.3.6 Design and development validation:
p.000195: Design and development validation shall be performed in accordance with planned arrangements to ensure
p.000195: that the resulting product is capable of meeting the requirements for the specified application or intended use.
p.000195: Design validation shall be performed under defined operating conditions on initial production units, lots, or batches
p.000195: or their equivalence. Design validation shall include software validation and risk analysis, where
p.000195: appropriate validation shall be completed prior to the delivery or implementation of the product.
p.000195: Records of the results of validation and any necessary actions shall be maintained.
p.000195: As part of design and development validation, the manufacturer shall perform clinical evaluations and/or evaluation of
p.000195: performance of the medical device or in vitro diagnostic medical devices.
p.000195: NOTE 1.-If a medical device or in vitro diagnostic medical devices can only be validated following
p.000195: assembly and installation at point of use, delivery is not considered to be complete until the product has been
p.000195: formally transferred to the customer.
p.000195: NOTE 2.-Provision of the medical device for purposes of clinical evaluations and/or evaluation of performance is
p.000195: not considered to be delivery.
p.000195: 7.3.7 Control of design and development changes:
p.000195: Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and
p.000195: validated, as appropriate, and approved before implementation. The review of design and development
p.000195: changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
p.000195: Records of the results of the review of changes and any necessary actions shall be maintained.
p.000195: Note.-Each manufacturer shall establish and maintain a Design History File for each type of device. The Design History
p.000195: File shall contain or reference the records necessary to demonstrate that the design was developed in accordance with
p.000195: the approved design plan and the requirements of design and development.
p.000195: 7.4 Purchasing,-
p.000195: 7.4.1 Purchasing process:
...
p.000207: 207
p.000207: medical device is delayed by the applicant after obtaining approval to market, such data will have to
p.000207: be provided on the deferred basis beginning from the time the medical device is marketed.
p.000207: (iv) New studies specifically planned or conducted to examine a safety issue should be described in the PSURs.
p.000207: (v) A PSUR should be structured as follows:
p.000207: (a) Title Page:
p.000207: The title page of PSUR shall capture the name of the Medical device; reporting interval; approved
p.000207: indication of Medical devices; date of approval of the medical device; date of marketing of medical device; licence
p.000207: name and address.
p.000207: (b) Introduction:
p.000207: This section of PSUR shall capture the reporting interval; medical device’s intended use, mode of action or principle
p.000207: of operation, risk class and a brief description of the approved indication and population.
p.000207: (c) Current worldwide marketing authorization status:
p.000207: This section of PSUR shall capture the brief narrative overview including details of countries where the
p.000207: device is currently approved along with date of first approval, date of marketing and if the product was
p.000207: withdrawn in any of the countries with reasons thereof.
p.000207: (d) Actions taken in reporting interval for safety reasons:
p.000207: This section of PSUR shall include a description of significant actions related to safety that have
p.000207: been taken during the reporting interval, related to either investigational uses or marketing experience by
p.000207: the licence holder, sponsor of a clinical investigation, regulatory authorities, data monitoring committee,
p.000207: or Ethics Committee.
p.000207: (e) Changes to reference safety information:
p.000207: This section of PSUR shall capture any significant changes to the reference safety information within the reporting
p.000207: interval. Such changes will include information relating to contraindications, warnings, precautions,
p.000207: adverse events, and important findings from ongoing and completed clinical investigations and significant
p.000207: non-clinical findings.
p.000207: (f) Estimated patient exposure:
p.000207: This section of PSUR shall provide the estimates of the size and nature of the population exposed to the medical
p.000207: device. Brief descriptions of the method used to estimate the subject exposure shall be provided in terms of,-
p.000207: (i) Cumulative and interval subject exposure in Clinical investigation;
p.000207: (ii) Cumulative and interval patient exposure from Marketing Experience in India;
p.000207: (iii) Cumulative and interval patient exposure from Marketing Experience from the rest of the world.
p.000207: (g) Presentation of individual case histories:
p.000207: This section of PSUR shall include the individual case information available to a licence holder and
p.000207: provide brief case narrative, medical history indication treated with suspect medical device, causality
p.000207: assessment and provide following information:
p.000207: (i) Reference prescribing information
p.000207: (ii) Individual cases received from India
p.000207: (iii) Individual cases received from rest of the world
p.000207: (iv) Cumulative and interval summary tabulations of serious adverse events from clinical investigations.
p.000207: (v) Cumulative and interval summary tabulations from post-marketing data sources
p.000207: (h) Studies:
p.000207: This section of PSUR shall capture the brief summary of clinically important emerging efficacy or
p.000207: effectiveness and safety findings obtained from the licence holder sponsored clinical investigation and
p.000207: published safety studies that became available during the reporting interval which has the potential impact the product
p.000207: safety information.
p.000207: (i) Summaries of Significant Safety Findings from Clinical investigation during the reporting period
p.000207: (ii) Findings from Non-interventional Studies
p.000207: (iii) Findings from Non-Clinical Studies
p.000207: (iv) Findings from Literature
p.000207: (i) Other information:
p.000207: This section of PSUR shall include details about signals and Risk Management Plan, if any, put in place by the licence
p.000207: holder.
p.000207: (a) Signal and risk evaluation: In this section the licence holder shall provide details of signal and
p.000207: risk identified during the reporting period and evaluation of signals identified during the same period.
p.000207:
p.000207: 208 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000207: II—SEC. 3(i)]
p.000207:
p.000207: (b) Risk Management Plan: In this section the licence holder shall provide brief details of safety concerns and
p.000207: necessary action taken by him to mitigate such safety concerns.
p.000207: (j) Overall Safety Evaluation:
p.000207: This section of PSUR shall capture the overall safety evaluation of medical device based on its risk benefit evaluation
p.000207: for approved indication.
p.000207: (i) Summary of Safety Concerns
p.000207: (ii) Benefit Evaluation
p.000207: (iii) Benefit Risk Analysis Evaluation
p.000207: (k) Conclusion:
p.000207: This section of PSUR shall provide details on the safety profile of medical device and necessary action
p.000207: taken by the licence holder in this regards.
p.000207: (l) Appendix:
p.000207: The appendix includes the copy of marketing authorization in India, copy of prescribing information, line listings with
p.000207: narrative of Individual Case Safety Reports (ICSR).
p.000207:
p.000207: Note: Table means “Table” given below this Schedule.
p.000207:
p.000207: Table 1 Design Analysis Data
p.000207: Design Analysis Data for a medical device shall include the following:
p.000207: (i) Physical and Metrological Standardisation.
p.000207: (ii) Design control documents and a predefined procedure of the medical device at the time of
p.000207: manufacturing.
p.000207: The Design Analysis should be carried out in accordance with the Standards as detailed in the Medical Devices Rules,
p.000207: 2017.
p.000207:
p.000207: A comprehensive report of design analysis including the basic design features of the device, drawings, and tests
p.000207: adapted for design analysis (with specifications) and rationale for selecting those tests and design
p.000207: control procedures shall be prepared.
p.000207:
p.000207: Table 2
p.000207: Biocompatibility and Animal Performance Study for investigational medical device
p.000207:
p.000207: 1. Recent version of ISO-10993, Biological Evaluation of Medical Devices shall be followed
p.000207: for conducting bio-compatibility study for invasive medical devices. A report of biocompatibility study
p.000207: along with rationale for selecting specific tests carried out should be prepared including conclusion of the study.
p.000207:
...
p.000209: (e) Description of the mechanism of action of investigational medical device, along with supporting
p.000209: scientific literature.
p.000209: (f) Manufacturer's instructions for installation and use of investigational medical device, including any necessary
p.000209: storage and handling requirements, preparation for use and any intended re-use (e.g. sterilization), any pre-use safety
p.000209: or performance checks and any precautions to be taken after use (e.g. disposal), if relevant.
p.000209: (g) Description of the intended clinical performance.
p.000209: 3. Preclinical testing
p.000209: Summary of preclinical testing that has been performed on the investigational medical device, together
p.000209: with an evaluation of results of such testing justifying its use in human subjects.
p.000209: The summary shall include or, where applicable, refer to the results of:
p.000209: (a) design input and design output documents,
p.000209: (b) in vitro tests,
p.000209: (c) mechanical and electrical tests,
p.000209: (d) reliability tests,
p.000209: (e) validation of software relating to the function of the device,
p.000209: (f) any performance tests,
p.000209: (g) ex vivo tests, and
p.000209: (h) biological safety evaluation.
p.000209:
p.000209: 210 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000209: II—SEC. 3(i)]
p.000209:
p.000209: 4. Existing clinical data
p.000209: (a) Summary of relevant previous clinical experience with the investigational medical device and with
p.000209: medical devices that have similar characteristics, including such characteristics that relate to other indications for
p.000209: use of the investigational medical device.
p.000209: (b) Analysis of adverse device effects and any history of modification or recall.
p.000209: 5. Risk management
p.000209: (a) Summary of the risk analysis, including identification of residual risks.
p.000209: (b) Result of the risk assessment.
p.000209: (c) Anticipated risks, contra-indications, warnings, etc. for the investigational medical device.
p.000209: 6. Regulatory and other references
p.000209: (a) List of International Standards, if any, complied with in full or in part.
p.000209: (b) Statement of conformity with national regulations, where appropriate.
p.000209: (c) List of references, if relevant.
p.000209: Table 5
p.000209: Clinical Investigation Plan
p.000209:
p.000209: 1.1 General
p.000209:
p.000209: 1.1.1 Introduction
p.000209: This document specifies the content of a clinical investigation plan (herein after to be referred as CIP). If the
p.000209: required information is written in other documentation, for example the IB, such documentation shall be referenced
p.000209: in the CIP. The content of a CIP and any subsequent amendments shall include all the topics listed in this document,
p.000209: together with a justification for each topic if this is not self-explanatory.
p.000209:
p.000209: 1.1.2 Identification of the clinical investigation plan
p.000209: (a) Title of the clinical investigation.
p.000209: (b) Reference number identifying the specific clinical investigation, if any.
p.000209: (c) Version or date of the CIP.
p.000209: (d) Summary of the revision history in the case of amendments.
p.000209: (e) Version or issue number and reference number, if any, with the page number and the total number of pages on each
p.000209: page of the CIP.
p.000209:
p.000209: 1.1.3 Sponsor
p.000209: Name, address and contact details (email id, phone number, etc.) of the sponsor of the clinical investigation.
p.000209:
p.000209: 1.1.4 Principal investigator, coordinating investigator and investigation site
p.000209: (a) Name, address, and professional position of
p.000209: (i) Principal Investigator,
p.000209: (ii) Coordinating investigator, if appointed
...
p.000209: (e) Intended purpose of the investigational medical device in the proposed clinical investigation.
p.000209:
p.000209: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000211: 211
p.000211: (f) The populations and indications for which the investigational medical device is intended.
p.000211: (g) Description of investigational medical device including any materials that will be in contact with tissues or
p.000211: body fluids. (This shall include details of any medicinal products, human or animal tissues or their
p.000211: derivatives, or other biologically active substances.)
p.000211: (h) Summary of the necessary training and experience needed to use the investigational medical device.
p.000211: (i) Description of the specific medical or surgical procedures involved in the use of investigational medical
p.000211: device.
p.000211:
p.000211: 1.3 Justification for the design of the clinical investigation
p.000211: Justification for the design of clinical investigation, which shall be based on conclusions of the
p.000211: evaluation, and shall comprise a section on justification for the design of the clinical investigation and include
p.000211: (a) an evaluation of the results of the relevant pre-clinical testing or assessment carried out to
p.000211: justify the use of investigational medical device in human subjects; and
p.000211: (b) an evaluation of clinical data that are relevant to the proposed clinical investigation.
p.000211:
p.000211: 1.4 Risks and benefits of the investigational medical device and clinical investigation
p.000211: (a) Anticipated clinical benefits.
p.000211: (b) Anticipated adverse device effects.
p.000211: (c) Residual risks associated with investigational medical device, as identified in the risk analysis report.
p.000211: (d) Risks associated with participation in the clinical investigation.
p.000211: (e) Possible interactions with concomitant medical treatments.
p.000211: (f) Steps that will be taken to control or mitigate the risks.
p.000211: (g) Risk-to-benefit rationale.
p.000211:
p.000211: 1.5 Objectives and hypotheses of the clinical investigation
p.000211: (a) Objectives, primary and secondary.
p.000211: (b) Hypotheses, primary and secondary, to be accepted or rejected by statistical data from the clinical investigation.
p.000211: (c) Claims and intended performance of investigational medical device that are to be verified.
p.000211: (d) Risks and anticipated adverse device effects that are to be assessed.
p.000211:
p.000211: 1.6 Design of the clinical investigation
p.000211:
p.000211: 1.6.1 General
p.000211: (a) Description of the type of clinical investigation to be performed (e.g. comparative double-blind, parallel
p.000211: design, with or without a comparator group) with rationale for the choice.
p.000211: (b) Description of the measures to be taken to minimize or avoid bias, including randomization and
p.000211: blinding or masking.
p.000211: (c) Primary and secondary endpoints, with rationale for their selection and measurement.
p.000211: (d) Methods and timing for assessing, recording, and analyzing variables.
p.000211: (e) Equipment to be used for assessing the clinical investigation variables and arrangements for
p.000211: monitoring maintenance and calibration.
p.000211: (f) Any procedures for replacement of subjects.
p.000211:
p.000211: 1.6.2 Investigational medical device and comparator
p.000211: (a) Description of the exposure to the investigational medical device or comparator, if used.
p.000211: (b) Justification of the choice of comparator.
p.000211: (c) List of any other medical device or medication to be used during clinical investigation.
p.000211: (d) Number of investigational medical devices to be used, together with a justification.
p.000211:
p.000211: 1.6.3 Subjects
p.000211: (a) Inclusion criteria for subject selection.
...
p.000219: (iii) components;
p.000219: (iv) shelf-life;
p.000219: (v) storage conditions;
p.000219: (vi) instructions for use; and
p.000219: (vii) other changes.
p.000219: 6.2 Clinical investigation plan (CIP)
p.000219: A summary of the CIP, including any subsequent amendment(s) with a rational for each amendment, should be provided. The
p.000219: summary will include a brief description of the following points:-
p.000219: (a) the clinical investigation objectives;
p.000219: (b) the clinical investigation design including,-
p.000219: (i) the type of clinical investigation;
p.000219: (ii) the clinical investigation endpoints;
p.000219: (iii) the ethical considerations;
p.000219: (iv) the data quality assurance;
p.000219: (v) the subject population for the clinical investigation, with the,-
p.000219: (A) inclusion or exclusion criteria; and
p.000219: (B) sample size; a clear accounting of all participant who entered the clinical investigation shall be
p.000219: mentioned. Mention should also be made of all cases that were dropouts or protocol deviations.
p.000219: Enumerate the patients screened, randomized, and prematurely discontinued. State reasons for premature
p.000219: discontinuation of therapy in each applicable case.
p.000219:
p.000219: 220 THE GAZETTE OF INDIA : EXTRAORDINARY [PART
p.000219: II—SEC. 3(i)]
p.000219:
p.000219: (vi) the treatment and treatment allocation schedule;
p.000219: (vii) any concomitant medications/treatments;
p.000219: (viii) the duration of follow-up;
p.000219: (ix) the statistical analysis including:-
p.000219: (A) the clinical investigation hypothesis or pass or fail criteria;
p.000219: (B) a sample size calculation; and
p.000219: (C) statistical analysis methods.
p.000219:
p.000219: 6.3 Ethics Committee
p.000219:
p.000219: This section shall document that the clinical investigation was conducted in accordance with the ethical
p.000219: principles of Declaration of Helsinki. A detailed description of the Ethics Committee constitution and
p.000219: date(s) of approvals of investigation documents for each of the participating sites should be provided. A
p.000219: declaration shall state that EC notifications as per Good Clinical Practice Guidelines issued by Central
p.000219: Drugs Standard Control Organization and Ethical Guidelines for Biomedical Research on Human Subjects,
p.000219: issued by Indian Council of Medical Research have been followed. The ethics report shall include the following
p.000219: points:
p.000219: (a) a confirmation that the CIP and any amendments to it were reviewed by the EC;
p.000219: (b) a list of all ECs consulted.
p.000219:
p.000219: 6.4 Clinical investigation team
p.000219:
p.000219: Briefly describe the administrative structure of the clinical investigation (Investigators, site staff, Sponsor/
p.000219: designates, Central laboratory etc.).
p.000219:
p.000219: 7. Results
p.000219: The results should include the following points:
p.000219: (a) the clinical investigation initiation date;
p.000219: (b) the clinical investigation completion/suspension date;
p.000219: (c) the disposal of subjects and investigational medical devices;
p.000219: (d) the subject demographics;
p.000219: (e) Clinical investigation Plan compliance;
p.000219: (f) an analysis, which includes,-
p.000219: (i) a performance analysis as provided in the clinical investigation plan;
p.000219: (ii) a summary of all adverse events and adverse device effects, including a discussion of the
p.000219: severity, treatment needed, resolution and relevant principal investigator's judgment concerning the causal
p.000219: relationship with the investigational medical devices or procedure;
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| dependent | Dependent |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| elderly | Elderly |
| embryo | embryo |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| foetus | Fetus/Neonate |
| gender | gender |
| hazard | Natural Hazards |
| home | Property Ownership |
| homeless | Homeless Persons |
| illness | Physically Disabled |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| influence | Drug Usage |
| injured | injured |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| minority | Racial Minority |
| nomads | nomad |
| nursing home | In Nursing Home |
| occupation | Occupation |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| other country | Other Country |
| parent | parents |
| parents | parents |
| physically | Physically Disabled |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| racial | Racial Minority |
| restricted | Incarcerated |
| sick | Physically Ill |
| single | Marital Status |
| student | Student |
| substance | Drug Usage |
| unconscious | Unconscious People |
| unemployed | Unemployment |
| union | Trade Union Membership |
| usage | Drug Usage |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| drug | ['influence', 'substance', 'usage'] |
| education | ['educational'] |
| educational | ['education'] |
| fetus | ['fetuses', 'foetus'] |
| fetuses | ['fetus', 'foetus'] |
| foetus | ['fetus', 'fetuses'] |
| home | ['property'] |
| illness | ['physically'] |
| influence | ['drug', 'substance', 'usage'] |
| minority | ['racial'] |
| parent | ['parents'] |
| parents | ['parent'] |
| physically | ['illness'] |
| property | ['home'] |
| racial | ['minority'] |
| substance | ['drug', 'influence', 'usage'] |
| usage | ['drug', 'influence', 'substance'] |
Trigger Words
consent
cultural
ethics
harm
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input