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

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalCriminal Convictionsprisoners1
Politicalnomadnomads1
Politicalvulnerablevulnerable5
HealthCognitive Impairmentimpairment2
HealthDrug Usagedrug8
HealthDrug Usageinfluence2
HealthDrug Usagesubstance12
HealthDrug Usageusage2
HealthMentally Disableddisability4
HealthMentally Incapacitatedincapable1
HealthMotherhood/Familyfamily11
HealthPhysically Disabledillness6
HealthPhysically Disabledphysically1
HealthPhysically Illsick1
HealthPregnantpregnant6
HealthUnconscious Peopleunconscious1
Healthinjuredinjured6
Healthpatients in emergency situationsemergencies2
SocialAccess to Social Goodsaccess7
SocialAgeage6
SocialChildchild1
SocialChildchildren6
SocialElderlyelderly2
SocialEthnicityethnic2
SocialFetus/Neonatefetus1
SocialFetus/Neonatefetuses1
SocialFetus/Neonatefoetus3
SocialHomeless Personshomeless1
SocialIn Nursing Homenursing home1
SocialIncarceratedrestricted1
SocialLinguistic Proficiencylanguage2
SocialMarital Statussingle6
SocialOccupationoccupation3
SocialPolice Officerofficer108
SocialProperty Ownershiphome2
SocialProperty Ownershipproperty6
SocialRacial Minorityminority1
SocialRacial Minorityracial1
SocialStudentstudent1
SocialTrade Union Membershipunion3
SocialUnemploymentunemployed1
SocialVictim of Abuseabuse1
SocialWomenwomen7
SocialYouth/Minorsminor6
Socialeducationeducation3
Socialeducationeducational1
Socialembryoembryo1
Socialemployeesemployees7
Socialgendergender4
Socialparentsparent2
Socialparentsparents1
Socialphilosophical differences/differences of opinionopinion9
General/OtherDependentdependent2
General/OtherNatural Hazardshazard3
General/OtherOther Countryother country0
General/OtherPublic Emergencyemergency3
General/OtherRelationship to Authorityauthority317

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:
...

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:
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.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:
...

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
...

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:
p.000159: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
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.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.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:

(return to top)
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.000183: 183
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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: 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
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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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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
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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: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
p.000143: 143
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
...

Health / Physically Disabled

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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:

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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:

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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:

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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:

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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:

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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:

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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:

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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;
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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
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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
...

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:
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: 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: 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:

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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:

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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:

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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:

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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:

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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:

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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
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:
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.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:
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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: (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:
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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: (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:
p.000161: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
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:
p.000163: ¹Hkkx IIµ[k M 3(i)º Hkk r dk kti=k % vlk/k k
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:
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.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:
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.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_