0A4F4F9BD490A749D5437F821CF06DF1

Regulation about Medical Devices (2010)

http://www.almbih.gov.ba/_doc/regulative/pravilnik_ms_bos.pdf

http://leaux.net/URLS/ConvertAPI Text Files/AB0148A79044269C64144A0DFEC221F1.en.txt

Examining the file media/Synopses/AB0148A79044269C64144A0DFEC221F1.html:

This file was generated: 2020-07-14 06:54:32

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 Type	Vulnerability	Indicator	# Matches
Political	political affiliation	party	3
Health	Drug Usage	drug	7
Health	Drug Usage	influence	1
Health	Drug Usage	substance	1
Health	HIV/AIDS	HIV	2
Health	Mentally Disabled	disability	2
Social	Access to Social Goods	socialXwelfare	1
Social	Access to Social Goods	access	3
Social	Linguistic Proficiency	language	2
Social	Marital Status	single	3
Social	Property Ownership	property	3
Social	Religion	conviction	1
Social	Trade Union Membership	union	10
Social	education	education	3
Social	gender	gender	1
Social	philosophical differences/differences of opinion	opinion	3
General/Other	Dependent	dependent	1
General/Other	Relationship to Authority	authority	8

Political / political affiliation

Searching for indicator party:

(return to top)
p.000004: funds.
p.000004: (4) The Medical Devices Commission shall have nine members. The entity ministries propose four members each, and the Department for
p.000004: Brcko District Health one member.
p.000004: PART FIVE - MEDICAL PRODUCTION MANUFACTURING
p.000004: Article 29
p.000004: The manufacturer of the medical device is obliged, in the production process, to ensure the application of the technical regulations regarding
p.000004: product safety in the market, application of codes of good manufacturing practice (GMP), good laboratory practice
p.000004: (GLP), and good storage and transportation practices to protect the safety and health of consumers.
p.000004: Article 30
p.000004: (1) The manufacturer of medical devices must, in addition to the general legal requirements, also meet the special conditions stipulated by the Law and
p.000004: this:
p.000004: a) declare its activity to the Agency before the production of medical devices begins;
p.000004: (b) it must carry out the business of ensuring the quality system and all good practices, for full protection
p.000004: population health, as determined by the Agency's "GMP" inspector;
p.000004: c) it must meet the prescribed requirements in terms of personnel, space and equipment, in the procedure with the competent Entities
p.000004: Of the Ministries of Health, that is, of the Brcko District Department, on the basis of which, according to the procedure, it receives a certificate
p.000004: on the registration in the register of manufacturers of medical devices by the Agency, without which it cannot begin business
p.000004: production of medical devices;
p.000004: d) it must be insured for possible damage caused to the user or third party.
p.000004: (2) Pursuant to the Law, the Entities or District Brcko prescribes special conditions relating to space, equipment and personnel.
p.000004: manufacturers, on the basis of which they make a decision on their fulfillment, as a prerequisite for issuing a certificate of enrollment in
p.000004: register of medical device manufacturers by the Agency.
p.000004: (3) The manufacturer of medical devices must, when designing a medical device, use technical regulations based on which
p.000004: ensuring that the medical device complies with the general and specific requirements.
p.000004: (4) The manufacturer of the medical device must ensure the conditions for testing and quality control of each batch of products
p.000004: in their own or other authorized laboratory, which are eligible for good laboratory practice.
p.000004: Article 31
p.000004: (Registration of medical device manufacturing activity)
p.000004: (1) The manufacturer of a medical device shall submit to the Agency a completed application form (application)
p.000004: of production, with a documented inventory and from which, after supervision by the competent inspector of the Agency,
p.000004: may conclude that the medical device was manufactured while ensuring a quality and protection system
p.000004: public health, and that medical devices are manufactured according to general and specific requirements.
p.000004: (2) Introduced quality assurance in the medical device manufacturing facility shall be demonstrated
p.000004: the relevant "ISO" quality system certification issued by the competent certification bodies
p.000004: in BiH.
p.000004: (3) The manufacturer of the medical device shall also submit to the Agency a description of the manufacturing process, proof that he is a legal entity and
...

p.000003: 3
p.000004: 4
p.000005: 5
p.000006: 6
p.000007: 7
p.000008: 8
p.000009: 9
p.000010: 10
p.000010: Trademark
p.000010: Generic name
p.000010: Purpose
p.000010: Form and packaging (size, dimensions with all variations)
p.000010: Catalog number
p.000010: Agency for Medicines and Medical Devices of Bosnia and Herzegovina
p.000010: Veljka Mlađenovića bb, Banja Luka; telephone +387 51 456040, 456050, 450302; fax + 387 51 450301; email ::
p.000010: opp@alims.gov.ba
p.000010: Annex 4
p.000010: Number: Received by:
p.000010: Date of receipt:
p.000010: Date of request for additional documentation:
p.000010: Date of receipt of additional documentation:
p.000010: Date when the request is formally complete:
p.000010: To be completed by the Agency
p.000010: REQUEST
p.000010: FOR ENTRY IN THE REGISTER OF MEDICAL PRODUCERS MANUFACTURERS
p.000010: APPLICANT for obtaining a certificate of registration in the manufacturer's register Full name of the manufacturer:
p.000010: Place of production: Address:
p.000010: Phone: Fax: Email:
p.000010: DOCUMENTATION CONTENT OF THE MANUFACTURER'S ENTRY INTO THE REGISTER:
p.000010: 1. A certified copy of the Court Register Excerpt with Forms 1 to 4,
p.000010: 2. Certified copy of the decision of the Federal Ministry of Health (if the applicant is from the FBiH) or
p.000010: RS Ministry of Health and Social Welfare (if the applicant is from RS) or the Brčko Department of Health
p.000010: District (if the applicant is from BD) on the eligibility of personnel, space and equipment
p.000010: manufacturers,
p.000010: 3. Description of the manufacturing process - technological design and production design documentation, 4. List of medical devices
p.000010: which are produced,
p.000010: 5. A copy of the insurance policy for the damage caused to the user or to a third party caused by the production activity
p.000010: m.s.,
p.000010: 6. Evidence of the quality system in place (submit the relevant "ISO" certificate of the system provided
p.000010: the quality of the production facility or a copy of the evidence that the "ISO" certification process has been initiated by the competent authorities in
p.000010: BiH. If a copy of the evidence of the instituted proceedings is provided, the applicant shall be obliged subsequently at the latest within 6
p.000010: months, submit the final "ISO" certificate).
p.000010: 7. PROCEDURE COSTS
p.000010: Proof of payment for the certification process:
p.000010: INSTRUCTIONS FOR PAYMENT OF PROCEDURE COSTS:
p.000010: • paid by: The name of your business
p.000010: • Purpose of payment: Payment of costs for the issue of a certificate of registration in the manufacturer's register
p.000010: medical devices in Bosnia and Herzegovina
p.000010: • recipient: JRT Treasury of BiH
p.000010: • Giro account number (payee): 3380002210018390 ("Unicredit bank")
p.000010: • KM (amount): enter KM 1,000.00
p.000010: • type of payment: enter "0"
p.000010: • Income type: 722760
p.000010: • Taxpayer number: Thirteen digit ID. legal entity number, or citizen's JMB (for individuals)
p.000010: • Municipality: the seat of the payer or the municipality of residence
p.000010: • Budget organization: 0717999
p.000010: • call to number: enter all "0"
p.000010: 8. Proof of payment of the administrative fee
p.000010: ADMINISTRATIVE FEES PAYMENT INSTRUCTIONS:
p.000010: • paid by: The name of your business
p.000010: • purpose of payment: Payment of a tax upon request
p.000010: • recipient: JRT Treasury of BiH
p.000010: • Giro account number (payee): 3380002210018390 ("Unicredit bank")
p.000010: • KM (amount): enter KM 20.00
p.000010: • type of payment: enter "0"
p.000010: • Income type: 722903
p.000010: • Taxpayer number: Thirteen digit ID. legal entity number, or citizen's JMB (for individuals)
p.000010: • municipality: the seat of the payer or the municipality of residence
p.000010: • Budget organization: 9999999
p.000010: call to number: enter all "0"
p.000010: Place and date
p.000010: Applicant
p.000010: Agency for Medicines and Medical Devices of Bosnia and Herzegovina
p.000010: Veljka Mlađenovića bb, Banja Luka; telephone +387 51 456040, 456050, 450302; fax + 387 51 450301; email:
p.000010: registration-ms@alims.gov.ba
p.000010: Annex 5
p.000010: Number: Received by:
p.000010: Date of receipt:
p.000010: Date of request for additional documentation:
p.000010: Date of receipt of additional documentation:
p.000010: Date when the request is formally complete:
p.000010: To be completed by the Agency
p.000010: REQUEST
p.000010: (APPLICATION) FOR ENTRY IN THE REGISTER OF WHOLESALE MEDICAL DEVELOPERS IN BiH
p.000010: APPLICANT for obtaining a certificate of entry in the register of wholesalers of medical devices
p.000010: Full company name:
p.000010: Address:
p.000010: Phone:
p.000010: Fax:
p.000010: Email:
p.000010: CONTENT OF THE DOCUMENTATION REQUIRED:
p.000010: 1. Certified copy of extracts from the court register, with forms 1 to 4,
p.000010: 2. A copy of the insurance policy for damage caused to the beneficiary or to a third party caused by the activity
p.000010: wholesale traffic m.s.,
p.000010: 3. Certified copy of the proof of ownership (lease) of the business premises,
p.000010: 4. Certified copy of the occupancy permit for the premises or the corresponding statement; 5.Copy of the layout of the wholesale facility
p.000010: with the indicated vertical cross section,
p.000010: 6. Evidence of the quality system in place (submit the relevant "ISO" certificate of the quality assurance system
p.000010: quality at the wholesale facility or a copy of the proof that the "ISO" certification process has been initiated
p.000010: of competent houses in BiH. If a copy of the evidence of the initiated proceedings is provided, the applicant shall be
p.000010: obliged to submit a final ISO certificate at the latest within 6 months).
p.000010: 7. Certified copy of the professional evidence for 2 responsible persons,
p.000010: 8. Certified copy of the employment contract with the responsible person for wholesale transport,
p.000010: 9. Evidence of payment of expenses for the certification procedure:
p.000010: INSTRUCTIONS FOR PAYMENT OF PROCEDURE COSTS:
p.000010: • paid by: The name of your business
p.000010: • purpose of payment: Payment of costs for issuing a certificate for wholesale trade of medical devices in BiH
p.000010: • recipient: JRT Treasury of BiH
p.000010: • Giro account number (payee): 3380002210018390 ("Unicredit bank")
p.000010: • KM (amount): enter KM 700.00
p.000010: • type of payment: enter "0"
p.000010: • Income type: 722761
p.000010: • Taxpayer number: Thirteen digit ID. legal entity number, or citizen's JMB (for individuals)
p.000010: • municipality: the seat of the payer or the municipality of residence
p.000010: • Budget organization: 0717999
p.000010: • call to number: enter all "0"
p.000010: 10. Proof of payment of the administrative fee
p.000010: ADMINISTRATIVE FEES PAYMENT INSTRUCTIONS:
...

Health / Drug Usage

Searching for indicator drug:

(return to top)
p.000004: (RULE 1 - Medicinal products not in contact with the user or in contact with only intact skin)
p.000004: Non-invasive medical devices, if any of the following apply, are classified into:
p.000004: Class I, such as:
p.000004: 1) medical devices for taking fluid from the body eg: bottles or bags for taking urine, a “stoma” bag,
p.000004: incontinence cartridges and the like;
p.000004: 2) medical devices used to immobilize body parts; eg gypsum, longets, compression
p.000004: socks and the like;
p.000004: 3) medical devices needed for external assistance to the patient; eg: hospital beds, supplies for
p.000004: walking, wheelchairs, stretchers, dental chairs and the like;
p.000004: 4) correction glasses, frames, prescription glasses, stethoscope, surgical covers, contact and conductive
p.000004: gels, non-invasive electrodes, computer image processing equipment and the like.
p.000004: Article 10
p.000004: (RULE 2 - Medical Devices for Guidance and Preservation of Substances)
p.000004: (1) Medical devices used to direct (conduct) and store substances, blood, organs, body parts,
p.000004: body fluids or tissues, fluids and infusion gases are classified in:
p.000004: Class IIa, such as:
p.000004: 1) medical devices for directing (conducting) blood in transfusion;
p.000004: 2) medical devices for temporary storage and transportation of organs for transplantation or processing;
p.000004: 3) medical agents for long-term storage of biological substances such as: cornea, sperm, tissues and the like.
p.000004: (2) If medical devices can be attached to an active medical device of Class IIa or higher class, they may
p.000004: indirectly to be invasive and, according to the degree of risk to the user, be classified in the upper class, such as:
p.000004: a) Medical devices used as a router in active drug delivery systems
p.000004: (systems used with infusion pump);
p.000004: b) medical devices used for guidance in respiratory anesthesia, indicators
p.000004: pressure limiting devices;
p.000004: c) syringe and infusion pump.
p.000004: (3) In all other cases, the medical devices referred to in the preceding paragraph shall be classified in Class I, such as:
p.000004: a) directing means where the force of the fluid transfer originates from gravity (delivery systems;
p.000004: infusions or drugs and the like);
p.000004: b) means for temporary weighing and storage (containers and spoons made especially for the administration of medicines and the like);
p.000004: c) syringes without needles.
p.000004: Article 11
p.000004: (RULE 3 - Non-invasive medical devices that alter the biological or chemical composition of blood, body
p.000004: liquids or other liquids)
p.000004: (1) All non-invasive medical devices intended to change the biological or chemical composition of blood, others
p.000004: body fluids, which are intended for parenteral use and may be indirectly invasive, are classified as:
p.000004: Class IIb, such as:
p.000004: 1) products intended for the removal of undesirable substances from the blood (hemodialysis devices, dialysis systems, for
p.000004: autotransfusion and the like);
p.000004: 2) products intended for cell separation.
p.000004: (2) Medical devices used for filtration, centrifugation or exchange of gases and heat,
p.000004: are classified in:
p.000004: Class IIa, such as:
p.000004: 1) blood filtration agents;
p.000004: 2) blood centrifuging preparations for the preparation of blood for transfusion or autotransfusion;
p.000004: 3) blood circulation heating and cooling agents.
p.000004: Article 12
p.000004: (RULE 4 - Medical Devices in Contact with Damaged Skin)
p.000004: All non-invasive medical devices that come in contact with damaged skin are classified into:
p.000004: a) Class I;
...

p.000004: lancets, disposable scalpels, surgical tampons, tip drills if associated with active
p.000004: medical devices, surgical gloves and the like.
p.000004: c) Class IIB:
p.000004: 1) medical devices intended to supply energy in the form of ionizing radiation;
p.000004: 2) bioactive medical agents that, by biological influence, actively elicit a tissue response to the level
p.000004: molecule;
p.000004: 3) medical devices that are intended to be administered by an application system whose
p.000004: use could be hazardous to the patient, as well as medication self-dosing agents such as
p.000004: are: insulin pens - injectors and the like.
p.000004: d) Class III,
p.000004: If the medical devices are intended to diagnose, monitor heart failure or systemic
p.000004: circulatory system of the central blood system, such as: vascular catheters and associated guidewire wires,
p.000004: circulatory surgical instruments made for single use and the like.
p.000004: Article 15
p.000004: (RULE 7 - Surgical invasive devices intended for short-term use)
p.000004: Invasive surgical devices intended for short-term use in a surgical or in-patient setting
p.000004: postoperative care, are classified in:
p.000004: a) Class IIa,
p.000004: All surgical invasive products intended for short-term use - clutches, infusion cannulas, products for
p.000004: suture of wounds, with the exceptions listed below.
p.000004: b) Class IIb,
p.000004: 1) medical devices that provide energy in the form of ionizing radiation, such as: auxiliary to
p.000004: brachytherapy;
p.000004: 2) medical devices that undergo chemical changes in the body, except those that are embedded in the teeth or used for
p.000004: drug application, such as: adhesives and the like.
p.000004: c) Class III,
p.000004: 1) clamps, infusion cannulas, suture aids and the like;
p.000004: 2) medical devices for determining the diagnosis, for monitoring the damage to the heart or the systemic bloodstream and which are in
p.000004: direct contact with these parts of the body, such as: cardiovascular catheter, cardiac probes
p.000004: minute volume, electrodes for temporary stimulation of the heart;
p.000004: 3) medical devices that are in direct contact with the central nervous system, such as
p.000004: are: a neurological catheter, cortical electrodes; medical devices that are completely or largely resorbed
p.000004: in the body, such as: resorption threads and biological adhesives and the like.
p.000004: Article 16
p.000004: (RULE 8 - Surgical invasive durable and implantable medical devices)
p.000004: (1) These are mainly implantable medical devices, which have been used for a long time (implants in the
p.000004: orthopedics, dentistry, ophthalmology and cardiovascular medicine, and implants for implantation of soft
p.000004: tissues used in plastic surgery).
p.000004: (2) All implantable invasive surgical devices used for long-term use
p.000004: to:
p.000004: a) Class IIa,
p.000004: If intended for implantation into the teeth, such as: dental covers, dental materials, wedges, stoppers,
p.000004: dental alloys, dental porcelain and polymers, fixed prosthetic dentures and the like.
p.000004: b) Class IIb,
p.000004: Invasive surgical invasive medical devices and invasive surgical products used
p.000004: long lasting, eg. joint prostheses, bindings, Santo, stent, screws, tiles, intraocular lenses, attachments for
p.000004: infusions, peripheral blood vessel transplants, nonresorption threads, bone cement, maxillofacial transplants and
p.000004: similarly.
p.000004: c) Class III,
p.000004: 1) medical devices in direct contact with the heart, major bloodstream, central nervous system
p.000004: system; artificial heart valves, aneurysm clamps, blood vessel prostheses, spinal supports, supports
p.000004: for blood vessels, stent, central nervous system electrodes, cardiovascular stent and the like;
p.000004: 2) medical devices intended for the production of biological material for complete or incomplete resorption,
p.000004: such as: resorption threads, adhesives and implantable excipients
p.000004: Bioactive due to additional surface coatings, phosphorylcholine and the like;
p.000004: 3) medical devices that can cause chemical changes in the body, such as inactive systems for
p.000004: refillable drug application.
p.000004: CHAPTER IV - CLASSIFICATION OF ACTIVE MEDICAL RESOURCES
p.000004: Article 17
p.000004: (RULE 9 - Active medical devices intended to supply or modify energy)
p.000004: (1) Active medical devices classified under this rule are:
p.000004: a) electrical equipment used in surgery;
p.000004: b) lasers and generators;
p.000004: c) ancillary to specialist treatment, for example radiation;
p.000004: d) stimulants;
p.000004: e) other similar medical devices intended to supply or modify energy.
p.000004: (2) All active medical devices intended for energy supply or change shall be classified in:
p.000004: a) Class IIa,
p.000004: 1) muscle work stimulants, external bone growth stimulators, painkillers, magnets for
p.000004: removal of foreign particles from the eye acting on the basis of electrical, magnetic, electromagnetic energy;
p.000004: 2) medical devices for phototherapy for the treatment of skin diseases and postpartum care
p.000004: newborns operating on the basis of light energy;
p.000004: 3) heating pad, cryosurgery equipment operating on the basis of thermal energy;
p.000004: 4) motor dermatomes, drills for dentists acting on the basis of mechanical energy;
p.000004: 5) sound-based hearing products.
p.000004: b) Class IIb,
p.000004: Medical devices whose use is at risk for patients and which operate on the basis of:
p.000004: - kinetic energy (pulmonary ventilators);
p.000004: - thermal energy (blood heaters, incubators, non-conscious heating pad);
p.000004: - as well as bandages, bandages for bleeding, bleeding from the nose or from dental protolithic prosthesis;
p.000004: - electricity (high frequency electrical generators in surgical, equipment for
p.000004: electrocautery, external cardiac stimulator, external defibrillator, electroconvulsive equipment
p.000004: electro-shock treatment);
...

p.000004: bodies are classified into:
p.000004: a) Class IIa:
p.000004: Drainage and supply pumps,
p.000004: b) Class IIb
p.000004: Medical devices for bringing drugs and other substances into the body or removing them from the body, which
p.000004: apply in ways that could be dangerous to the patient, such as: infusion pumps,
p.000004: anesthesia, dialysis equipment, artificial heart blood pumps, hyperbolic chambers, blood pressure regulators
p.000004: medical gases and the like.
p.000004: Article 20
p.000004: (RULE 12 - Other active medical devices)
p.000004: Additional Rule 12 includes all active medical devices not covered by earlier rules, a
p.000004: are classified in:
p.000004: Class I:
p.000004: 1) active medical devices intended to illuminate the patient's body in the visible light spectrum, such as
p.000004: are: lamps for examination of the patient, or for optical examination of the body, such as surgical microscopes and the like;
p.000004: 2) medical supplies intended for external assistance to patients, such as: patient lifts, wheelchairs
p.000004: and the like;
p.000004: 3) active diagnostic products for thermography;
p.000004: 4) active products for registering, processing or viewing diagnostic images;
p.000004: 5) polymerization lamps in dentistry.
p.000004: CHAPTER V-SPECIFIC CLASSIFICATION RULES
p.000004: Article 21
p.000004: (RULE 13 - Medicinal Products containing the Medicinal Product - Active Substances)
p.000004: This rule covers combination medical devices which, as an integral part, contain a medicine for additional action on
p.000004: organism with the action of the medical devices themselves. Medicinal products which have a medicinal or medicinal composition
p.000004: substances are classified in:
p.000004: a) Class III:
p.000004: Bone cement containing antibiotics, drug-containing ligaments, spermicide condoms, heparin catheter, endodontic
p.000004: materials containing antibiotics and the like.
p.000004: Article 22
p.000004: (RULE 14 - Medical Devices Used for Contraception or Prevention of Sexually Transmitted Diseases)
p.000004: They are classified in:
p.000004: a) Class IIB:
p.000004: Medical means for preventing pregnancy (contraception) or preventing the spread of infectious sexually transmitted diseases, such as
p.000004: are: condoms, vaginal membranes and the like.
p.000004: b) Class III:
p.000004: Implantable medical devices or invasive long-term medical devices, such as intrauterine
p.000004: cartridges and the like.
p.000004: Article 23
p.000004: (RULE 15 - Special Medical Devices for Disinfection, Cleaning and Rinsing
p.000004: (1) All medical devices used for disinfection, cleaning and rinsing. These wetting
p.000004: contact lenses are classified in:
p.000004: a) Class IIa:
p.000004: Medical devices intended for the disinfection of medical products of medical equipment, work surfaces in healthcare
p.000004: facilities or for living tissue disinfection (antiseptics). E.g. endoscopy disinfectants, apparatus for
p.000004: sterilization.
p.000004: b) Class IIB:
p.000004: Medicinal products intended for disinfection, cleaning and rinsing and wetting of contact lenses.
p.000004: (2) This rule shall not apply to products intended for mechanical cleaning of medical devices.
p.000004: Article 24
p.000004: (RULE 16 - Inactive medical devices used to register X-rays)
p.000004: Inactive medical devices used to register X-rays.
p.000004: Class IIa:
p.000004: Marking of X-ray images, such as: X-ray film, photostimulants
p.000004: phosphorus plates and the like; (3) This does not include the means used to reproduce the x-ray image.
p.000004: Article 25
p.000004: (RULE 17 - Medical Devices Containing Inanimate Animal Tissues)
...

p.000004: (4) The manufacturer or distributor shall be obliged to report to the Agency any undesirable and harmful activity observed
p.000004: medical device.
p.000004: (5) It is the obligation of manufacturers, distributors and healthcare institutions to monitor undesirable and harmful actions
p.000004: medical devices and to report them to the Agency.
p.000004: Section B. - Special Requirements
p.000004: Article 44
p.000004: Medical devices must meet specific requirements:
p.000004: a) with respect to the chemical, physical and biological properties of the medical devices;
p.000004: b) in relation to the microbiological quality of the medical devices;
p.000004: c) in relation to the environment;
p.000004: d) medical devices with measuring function;
p.000004: e) with respect to radiation protection;
p.000004: f) medical devices connected to the energy source;
p.000004: g) active medical devices that are incorporated into the body;
p.000004: h) in relation to the labeling of medical devices and the package leaflet.
p.000004: Article 45
p.000004: (Chemical, physical and biological properties of medical devices)
p.000004: Medical devices with regard to chemical, physical and biological properties must be:
p.000004: a) effective and safe for the user and therapist;
p.000004: b) compatible with the biological tissues, cells and body fluids with which they come in contact;
p.000004: c) non-toxic or acceptable toxicity with respect to the purpose and purpose of use;
p.000004: d) non-flammable and usable as intended;
p.000004: e) formulated, manufactured and packaged so that they can be safely used in relation to materials and gases
p.000004: with whom they come in contact during use;
p.000004: f) comply with medicines regulations, if they contain a drug in their composition;
p.000004: g) formulated, manufactured and packaged so that the risk is minimized should the drug evaporate
p.000004: (departed) from a medical device;
p.000004: h) formulated and constructed in such a way that the risk to the user and the environment, which could occur at unintentional entry
p.000004: of matter into a medical device, disappear or be reduced to a minimum.
p.000004: Article 46
p.000004: (Requirements regarding the microbiological quality of medical devices)
p.000004: (1) Medical devices in relation to microbiological quality must be:
p.000004: a) designed and constructed to eliminate or minimize the risk of infection to the user and other persons
p.000004: a possible measure;
p.000004: b) created from healthy tissues of animals that have been subjected to appropriate veterinary examination and surveillance, which
p.000004: documents with appropriate conviction;
p.000004: c) sterile, formulated, created and packaged in disposable packaging, ensuring that, under
p.000004: prescribed storage and transport conditions, remain sterile until their expiry date;
p.000004: d) created and sterilized by an appropriately validated method for sterile conditions;
p.000004: e) packaged in packagings of appropriate quality so that protection against microbiological is assured
p.000004: contamination at all stages, from production to use;
p.000004: f) marked on the packaging or label so as to distinguish between sterile and non-sterile products.
p.000004: (2) The Agency must keep information on the origin of the animals and the certificates of tissue quality contained in the medical
p.000004: funds, or forms a major part of it.
p.000004: (3) Procedures for the processing, storage, testing and treatment of animal tissues, cells and substances
...

p.000004: (4) Functions of switches and indicators on medical devices must be clearly stated, in writing or in form
p.000004: images so that they are understandable to the person administering the medical device as well as to the user.
p.000004: Article 51
p.000004: (Specific requirements for active medical devices for incorporation into the organism-body)
p.000004: (1) Active medical devices for incorporation into the organism (body) must be formulated, manufactured,
p.000004: designed and packaged with due regard for generally recognized scientific and technical development for the sake of efficiency and
p.000004: security for the user and others.
p.000004: (2) Medical devices "referred to in paragraph (1) of this Article" must be created and packaged under special conditions
p.000004: in disposable packaging, which ensures the sterility of the medical device until expiration
p.000004: the validity, opening or damage of protective packaging and traffic, as prescribed, such that u
p.000004: eliminate or reduce as far as possible:
p.000004: a) danger of incorporation into the body in relation to the physical properties of active medical devices;
p.000004: b) energy-related hazards, in particular for active medical devices that are installed in use
p.000004: electricity;
p.000004: c) hazards associated with the use of energy sources such as magnetic fields, external electrical influences,
p.000004: electrostatic discharge, pressure or pressure changes and acceleration;
p.000004: d) treatment-related hazards, especially with defibrillators or high-frequency surgical equipment;
p.000004: e) radiation hazards of radioactive substances possessed by active medical devices;
p.000004: f) the dangers of dispensing or dispensing a drug which is an integral part of a medical device;
p.000004: g) hazards that may arise when maintenance or calibration is not possible, including:
p.000004: reduced insulation from electricity, aging of materials used, excessive heat provided by
p.000004: creates an active implantable medical device, reduced fluid of any measuring or control system and the like.
p.000004: Article 52
p.000004: (1) If a medical device complies with BiH norms that are accepted and comply with European standards, it shall consider
p.000004: that it meets the appropriate special requirements.
p.000004: (2) Reference to standards also includes monographs of the European Pharmacopoeia, which are specifically relevant to surgical
p.000004: threads, as well as the interactions between the drugs and the materials that make up the components of the products in which these drugs are contained.
p.000004: (3) If it is established that a medical device properly placed and used for its intended purpose may
p.000004: endangering the health and safety of patients, users or other persons, the Agency shall withdraw this medical device from
p.000004: traffic, or restrict its use ex officio or at the request of inspectors in the medical field
p.000004: funds.
p.000004: (4) When a medical device that does not meet the specific requirements bears a conformity mark,
p.000004: The Agency will withdraw this medical device from circulation upon notice from the inspector in the medical device field.
p.000004: Article 53
p.000004: (Labeling of medical devices and instructions for use)
p.000004: (1) Every medical device that is on the market in BiH must be marked as such on the outside and
p.000004: inner packaging in one of the languages officially used in BiH and have accompanying instructions for use.
p.000004: (2) The labeling of medical devices means the listing of information about a medical device on the outside,
p.000004: that is, contact packaging.
...

Searching for indicator influence:

(return to top)
p.000004: b) Class IIa:
p.000004: 1) if they are intended for short-term use, such as: contact lenses, urine catheter, tracheal tube,
p.000004: stent and the like.
p.000004: 2) when used in the oral cavity up to the pharynx, in the ear to the eardrum or in the nasal cavity, such as:
p.000004: orthodontic wire, fixed prosthetic dentures and replacements, sealants;
p.000004: 3) invasive medical devices used in body openings other than surgical invasive medical
p.000004: aids intended to be coupled to an active medical device of Class IIa or higher
p.000004: classes such as: tracheal tube, tracheotomy cannula, mechanical nasal washer, nasopharyngeal tube,
p.000004: nasogastric probes, aspiration catheters and the like.
p.000004: c) Class IIb:
p.000004: If they are intended for long-term use, such as: "supports", a stent for a tube or the like.
p.000004: Article 14
p.000004: (RULE 6 - Surgical invasive agents for transient-temporary use)
p.000004: (1) Surgical invasives include three main groups of medical devices:
p.000004: a) medical aids for making skin passages;
p.000004: b) surgical instruments;
p.000004: c) various types of catheters.
p.000004: (2) All surgical instruments are classified into:
p.000004: a) Class I:
p.000004: Reusable or reusable surgical instruments such as: scalpels, saws, refractive forceps and the like;
p.000004: b) Class IIa:
p.000004: Disposable surgical instruments such as: suture needles, injection needles,
p.000004: lancets, disposable scalpels, surgical tampons, tip drills if associated with active
p.000004: medical devices, surgical gloves and the like.
p.000004: c) Class IIB:
p.000004: 1) medical devices intended to supply energy in the form of ionizing radiation;
p.000004: 2) bioactive medical agents that, by biological influence, actively elicit a tissue response to the level
p.000004: molecule;
p.000004: 3) medical devices that are intended to be administered by an application system whose
p.000004: use could be hazardous to the patient, as well as medication self-dosing agents such as
p.000004: are: insulin pens - injectors and the like.
p.000004: d) Class III,
p.000004: If the medical devices are intended to diagnose, monitor heart failure or systemic
p.000004: circulatory system of the central blood system, such as: vascular catheters and associated guidewire wires,
p.000004: circulatory surgical instruments made for single use and the like.
p.000004: Article 15
p.000004: (RULE 7 - Surgical invasive devices intended for short-term use)
p.000004: Invasive surgical devices intended for short-term use in a surgical or in-patient setting
p.000004: postoperative care, are classified in:
p.000004: a) Class IIa,
p.000004: All surgical invasive products intended for short-term use - clutches, infusion cannulas, products for
p.000004: suture of wounds, with the exceptions listed below.
p.000004: b) Class IIb,
p.000004: 1) medical devices that provide energy in the form of ionizing radiation, such as: auxiliary to
p.000004: brachytherapy;
p.000004: 2) medical devices that undergo chemical changes in the body, except those that are embedded in the teeth or used for
p.000004: drug application, such as: adhesives and the like.
p.000004: c) Class III,
p.000004: 1) clamps, infusion cannulas, suture aids and the like;
p.000004: 2) medical devices for determining the diagnosis, for monitoring the damage to the heart or the systemic bloodstream and which are in
p.000004: direct contact with these parts of the body, such as: cardiovascular catheter, cardiac probes
...

Searching for indicator substance:

(return to top)
p.000004: (2) Mechanical and thermal risk protection:
p.000004: a) Medical devices must be formulated and designed to protect patients and users from
p.000004: mechanical risk which, e.g. associated with the base, the stability and the movable parts;
p.000004: b) medical devices must be formulated and created so that the risk arising from the vibrations they cause
p.000004: these products, unless vibrations are part of the special operation of the product, are minimized;
p.000004: c) Power supply terminals and connectors, gas, hydraulic or pneumatic devices
p.000004: the user, must be designed and constructed to eliminate all possible risks;
p.000004: d) accessible parts of medical devices, with the exception of parts intended to supply heat or
p.000004: reaching the given temperatures, as well as their surroundings, must not be warmed to normal under normal use
p.000004: dangerous temperatures.
p.000004: (3) Protection against risks from the supply of energy or matter to the user:
p.000004: a) Medical devices that supply energy or matter must be formulated and designed to flow
p.000004: energy that can be adjusted and maintained accurately enough to guarantee the safety of users;
p.000004: b) medical devices must be equipped with means of preventing errors and / or warning of
p.000004: errors, in the flow of energy that could pose a danger;
p.000004: c) the medical devices must be adapted in such a way as to prevent as far as possible an unpleasant release
p.000004: hazardous energy levels from an energy source or a substance source.
p.000004: (4) Functions of switches and indicators on medical devices must be clearly stated, in writing or in form
p.000004: images so that they are understandable to the person administering the medical device as well as to the user.
p.000004: Article 51
p.000004: (Specific requirements for active medical devices for incorporation into the organism-body)
p.000004: (1) Active medical devices for incorporation into the organism (body) must be formulated, manufactured,
p.000004: designed and packaged with due regard for generally recognized scientific and technical development for the sake of efficiency and
p.000004: security for the user and others.
p.000004: (2) Medical devices "referred to in paragraph (1) of this Article" must be created and packaged under special conditions
p.000004: in disposable packaging, which ensures the sterility of the medical device until expiration
p.000004: the validity, opening or damage of protective packaging and traffic, as prescribed, such that u
p.000004: eliminate or reduce as far as possible:
p.000004: a) danger of incorporation into the body in relation to the physical properties of active medical devices;
p.000004: b) energy-related hazards, in particular for active medical devices that are installed in use
p.000004: electricity;
p.000004: c) hazards associated with the use of energy sources such as magnetic fields, external electrical influences,
p.000004: electrostatic discharge, pressure or pressure changes and acceleration;
p.000004: d) treatment-related hazards, especially with defibrillators or high-frequency surgical equipment;
p.000004: e) radiation hazards of radioactive substances possessed by active medical devices;
p.000004: f) the dangers of dispensing or dispensing a drug which is an integral part of a medical device;
...

Health / HIV/AIDS

Searching for indicator HIV:

(return to top)
p.000004: divide the funds into lists A and B;
p.000004: b) In vitro diagnostic medical devices for self-diagnosis (List C);
p.000004: c) All other In vitro diagnostic medical devices (list D).
p.000004: (5) According to the manner and place of issue, medical devices shall be classified into:
p.000004: a) Prescription / ordered medical supplies only in pharmacies and specialized
p.000004: stores;
p.000004: b) over-the-counter medical supplies only in pharmacies and specialty stores;
p.000004: c) prescription drugs / orders at hospital pharmacies;
p.000004: d) over-the-counter medical supplies.
p.000004: (6) If the medicinal product is presented in combination with a medicinal product or in combination with a free product
p.000004: sales, assets are classified according to the primary purpose declared by the manufacturer.
p.000004: Article 5
p.000004: (1) Medical devices for in vitro diagnostics may only be placed on the market if they do not endanger it
p.000004: the health and safety of patients, users and other persons and, if properly manufactured, placed,
p.000004: maintained and used in accordance with their purpose.
p.000004: (2) Unless otherwise specifically prescribed, medical devices for in vitro diagnostics shall be subject to all the provisions of this
p.000004: Of the Rules.
p.000004: (3) In vitro medicinal products shall be classified by purpose, place and method of use into:
p.000004: a) List A-diagnostic tools used only by professional staff:
p.000004: 1) reagents and reagent products, including control and calibration materials for the determination of blood groups
p.000004: (ABO system), rhesus factor, antibodies (C, c, D, E, e), anticell, etc .;
p.000004: 2) reagents and reagent products, including control and calibration materials, for detection, confirmation and
p.000004: quantification of HIV 1 and 2 HIV infection labels, HTLV 1 and 2, hepatitis B, C, and D in human material.
p.000004: b) List B diagnostic tools used only by qualified personnel:
p.000004: 1) reagents and reagent products, including control and calibration material for the determination of the following blood
p.000004: group: "anti-Duff; and anti-kidd ";
p.000004: 2) reagents and reagent products, as well as control and calibration materials for the determination of illicit substances
p.000004: anti-erythrocyte antibodies;
p.000004: 3) reagents and reagent products as well as control and calibration materials for determination and
p.000004: quantification of similar infections: rubella, toxoplasmosis and more in human material;
p.000004: 4) reagents and reagent products as well as control and calibration materials for diagnosis
p.000004: hereditary diseases (phenylketonuria);
p.000004: 5) reagents and reagent products, as well as control and calibration materials for human determination
p.000004: infection (cytomegalovirus, chlamydia);
p.000004: 6) reagents and reagent products, as well as control and calibration materials for the determination of "HLA"; -
p.000004: tissue groups ("DR, A, B");
p.000004: 7) reagents and reagent products, as well as control and calibration materials for control
p.000004: tumor marker materials ("PSAs");
p.000004: 8) reagents and reagent products, as well as control and calibration materials and software, to determine specificity
p.000004: hereditary risk of trisomy 21.
p.000004: c) List of C-Diagnostics for self-testing, with accessories for
p.000004: self-diagnosis, as well as control and calibration materials (measuring instruments for sugar and the like).
p.000004: d) List D-all other diagnostic tools.
p.000004: Article 6
p.000004: (1) Special-purpose medical devices include:
p.000004: a) custom made medical devices for an individual user;
...

Health / Mentally Disabled

Searching for indicator disability:

(return to top)
p.000004: which energy source, from gravity, and which interact with the change of that energy, ie gravity;
p.000004: g) active therapeutic medical devices are used separately or in combination with other medical devices;
p.000004: h) non-active diagnostic medical devices are used separately or in combination with other medical devices
p.000004: means and provide information for the detection of irregularities, diagnosis, monitoring or treatment of physiological disorders, diseases
p.000004: or congenital anomalies;
p.000004: i) medical device conformity statement is a statement that the manufacturer certifies that the product, process or
p.000004: the service complies with the requirements laid down by the standards and / or technical regulations;
p.000004: j) clinical trial of medical devices is the determination or confirmation of medical safety
p.000004: the means, its effectiveness and its compliance with the general and specific requirements as intended
p.000004: manufacturer.
p.000004: (2) Other terms used in this Ordinance, which are not listed and are defined by the Medicines Act and
p.000004: medical devices ("Official Gazette of BiH", No. 58/08 - hereinafter: the Law), and
p.000004: regulations based on the same, apply mutatis mutandis to medical devices.
p.000004: Article 3
p.000004: (1) Medical devices, within the meaning of this Ordinance, are: instruments, devices, materials and other products which
p.000004: applied to humans and which do not reach their pharmacological primary purpose, specified by the manufacturer,
p.000004: immune or metabolic activities already used alone or in combination, including software, for the purpose of:
p.000004: a) diagnosing, preventing, monitoring, treating or alleviating the disease;
p.000004: b) diagnosing, monitoring, controlling, treating or alleviating injuries or alleviating them
p.000004: disability or replacement of defects or consequences caused by disability;
p.000004: c) testing, replacing or altering anatomical or physiological functions;
p.000004: d) conception controls.
p.000004: (2) In vitro diagnostic medical devices include reagents, reagent kits, reagent products,
p.000004: control and calibration materials, instruments and appliances, equipment or system used
p.000004: alone or in combination with another medicinal product intended for use in vitro,
p.000004: for testing biological samples, including tissue samples obtained from the human body, to obtain data:
p.000004: a) physiological or pathological conditions;
p.000004: b) congenital anomalies;
p.000004: c) the safety and compatibility of potential transplant recipients;
p.000004: d) information required to monitor therapeutic effects.
p.000004: (3) An aid, by definition, not a medical device, which means a product which, in combination with
p.000004: medical device enables the medical device to function in accordance with its purpose.
p.000004: (4) A custom-made medical device for a particular user is that medical device that is made in
p.000004: as instructed by the appropriate expert;
p.000004: (5) A medical device intended for clinical trial is a product and a medical device
p.000004: clinical trial workers.
p.000004: (6) A medical device in or on a human body does not show efficacy based on its own
p.000004: pharmacological, immunobiological, or metabolic properties, but may or may assist in its function
p.000004: backed by products that act this way.
p.000004: (7) The provisions of this Ordinance shall not apply to:
p.000004: a) a) medical devices containing blood products;
p.000004: b) transplant, tissues or cells of human or animal origin (except non-living animal
p.000004: tissue);
p.000004: c) personal protective equipment in accordance with the regulations.
p.000004: PART TWO - CLASSIFICATION AND CLASSIFICATION OF MEDICAL RESOURCES
p.000004: Article 4
...

Searching for indicator socialXwelfare:

(return to top)
p.000013: - the application of the medical device and the authenticity of the submitted documentation for the purpose of obtaining it
p.000013: certificates of registration of the medical device;
p.000013: - ensuring the quality of the medical device in accordance with Article 40-44. Of the Medical Regulations
p.000013: by means of.
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Appendix 1
p.000013: Appendix to Annexes 1 - 3
p.000013: Row no.
p.000001: 1
p.000002: 2
p.000003: 3
p.000004: 4
p.000005: 5
p.000006: 6
p.000007: 7
p.000008: 8
p.000009: 9
p.000010: 10
p.000010: Trademark
p.000010: Generic name
p.000010: Purpose
p.000010: Form and packaging (size, dimensions with all variations)
p.000010: Catalog number
p.000010: Agency for Medicines and Medical Devices of Bosnia and Herzegovina
p.000010: Veljka Mlađenovića bb, Banja Luka; telephone +387 51 456040, 456050, 450302; fax + 387 51 450301; email ::
p.000010: opp@alims.gov.ba
p.000010: Annex 4
p.000010: Number: Received by:
p.000010: Date of receipt:
p.000010: Date of request for additional documentation:
p.000010: Date of receipt of additional documentation:
p.000010: Date when the request is formally complete:
p.000010: To be completed by the Agency
p.000010: REQUEST
p.000010: FOR ENTRY IN THE REGISTER OF MEDICAL PRODUCERS MANUFACTURERS
p.000010: APPLICANT for obtaining a certificate of registration in the manufacturer's register Full name of the manufacturer:
p.000010: Place of production: Address:
p.000010: Phone: Fax: Email:
p.000010: DOCUMENTATION CONTENT OF THE MANUFACTURER'S ENTRY INTO THE REGISTER:
p.000010: 1. A certified copy of the Court Register Excerpt with Forms 1 to 4,
p.000010: 2. Certified copy of the decision of the Federal Ministry of Health (if the applicant is from the FBiH) or
p.000010: RS Ministry of Health and Social Welfare (if the applicant is from RS) or the Brčko Department of Health
p.000010: District (if the applicant is from BD) on the eligibility of personnel, space and equipment
p.000010: manufacturers,
p.000010: 3. Description of the manufacturing process - technological design and production design documentation, 4. List of medical devices
p.000010: which are produced,
p.000010: 5. A copy of the insurance policy for the damage caused to the user or to a third party caused by the production activity
p.000010: m.s.,
p.000010: 6. Evidence of the quality system in place (submit the relevant "ISO" certificate of the system provided
p.000010: the quality of the production facility or a copy of the evidence that the "ISO" certification process has been initiated by the competent authorities in
p.000010: BiH. If a copy of the evidence of the instituted proceedings is provided, the applicant shall be obliged subsequently at the latest within 6
p.000010: months, submit the final "ISO" certificate).
p.000010: 7. PROCEDURE COSTS
p.000010: Proof of payment for the certification process:
p.000010: INSTRUCTIONS FOR PAYMENT OF PROCEDURE COSTS:
p.000010: • paid by: The name of your business
p.000010: • Purpose of payment: Payment of costs for the issue of a certificate of registration in the manufacturer's register
p.000010: medical devices in Bosnia and Herzegovina
p.000010: • recipient: JRT Treasury of BiH
p.000010: • Giro account number (payee): 3380002210018390 ("Unicredit bank")
p.000010: • KM (amount): enter KM 1,000.00
p.000010: • type of payment: enter "0"
p.000010: • Income type: 722760
p.000010: • Taxpayer number: Thirteen digit ID. legal entity number, or citizen's JMB (for individuals)
p.000010: • Municipality: the seat of the payer or the municipality of residence
p.000010: • Budget organization: 0717999
p.000010: • call to number: enter all "0"
...

Searching for indicator access:

(return to top)
p.000013: Appendix - 1
p.000013: Medical devices must be classified in only one category. Mark with a cross.
p.000013: IN THE CATEGORY OF MEDICAL RESOURCES
p.000013: 01 Active Surgical Implants
p.000013: 02 Anesthetic and Respiratory Medical Devices 03 Dental Medical Devices
p.000013: 04 Medical electro-mechanical means 05 Hospital equipment
p.000013: 06 "In vitro" diagnostic medical devices 07 Inactive surgical implants
p.000013: 08 Ophthalmic and Optical Medical Devices 09 Reusable Instruments
p.000013: 10 Disposables
p.000013: 11 Technical means for handicapped persons
p.000013: Diagnostic and therapeutic medical devices in radiology
p.000013: 13 Other medical devices
p.000013: CERTIFICATE DATA I
p.000013: TO THE COMPETENT AUTHORITY TO ASSIGN CONFORMITY
p.000013: Provide information on the notified body that issued the certificate of conformity for
p.000013: the procedure of sterilization or the measuring function of a medical device.
p.000013: Number of EC certificates:
p.000013: Name and identification number of the conformity assessment body:
p.000013: The certificate is valid until:
p.000013: DECLARATION OF THE PROPERTY'S RESPONSIBLE PERSON
p.000013: I, the undersigned, declare:
p.000013: - the registration dossier is authentic and that the class 1 medical device,
p.000013: which is covered by the application for entry in the Register of Medical Devices, meets the required regulations.
p.000013: I pledge to inform each Agency of Medicines and Medical Devices of Bosnia and Herzegovina immediately
p.000013: a modification regarding a medical device;
p.000013: - that I will monitor the side effects of medical devices and inform the competent authorities accordingly
p.000013: with regulations;
p.000013: - I have access to the registration documentation, which I submit to the Agency;
p.000013: - that the declared activity is carried out in such a way that public health protection is in accordance with the valid ones
p.000013: regulations;
p.000013: - that I will renew and submit to the Agency all certificates which have expired.
p.000013: Name, Surname and Name of the Responsible Person of the Applicant (Company Director) - printed Company Name:
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Name of responsible person (s) for:
p.000013: - the application for the medical device and the authenticity of the documentation submitted to obtain it
p.000013: certificates of registration of the medical device;
p.000013: - ensuring the quality of the medical device in accordance with Article 40-44. Of the Medical Regulations
p.000013: by means of.
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: REG-MS-KL FORM IIa, IIb, III
p.000013: Agency for Medicines and Medical Devices of Bosnia and Herzegovina
p.000013: Veljka Mlađenović b.b. Banja Luka Telephone: + 387 0 51 456-040, 456-041,456-050; fax: + 387 0 51 450-301; electronic
p.000013: mail: registration-ms@alims.gov.ba
p.000013: Annex 2
p.000013: Number: Received by:
p.000013: Date of receipt:
p.000013: Date of request for additional documentation:
p.000013: Date of receipt of additional documentation:
p.000013: Date from which the request is formally complete:
p.000013: To be completed by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.000013: REQUEST
p.000013: FOR THE ENTRY OF A MEDICAL MEDICINE CLASS LIa, IIb, III IN THE MEDICINAL REGISTER
p.000013: (application is to be filled in separately by each manufacturer, class and category)
p.000013: PROPOSAL BASIC INFORMATION (fill in capital letters) 1
...

p.000006: 06
p.000007: 07
p.000008: 08
p.000009: 09
p.000010: 10
p.000011: 11
p.000012: 12
p.000013: 13
p.000013: CATEGORY OF MEDICAL RESOURCES
p.000013: Active surgical implants
p.000013: Anesthetic and Respiratory Medical Devices Dental Medical Devices
p.000013: Medical Electro-Mechanical Devices Hospital Equipment
p.000013: "In vitro" diagnostic medical devices Inactive surgical implants
p.000013: Ophthalmic and Optical Medical Devices Reusable Instruments Disposables
p.000013: Technical means for handicapped persons
p.000013: Diagnostic and therapeutic medical devices in radiology
p.000013: Other medical devices
p.000013: CERTIFICATE DATA I
p.000013: TO THE COMPETENT AUTHORITY TO ASSIGN CONFORMITY
p.000013: Provide information on the notified body that issued the certificate of conformity for
p.000013: the procedure of sterilization or the measuring function of a medical device.
p.000013: Number of EC certificates:
p.000013: Name and identification number of the conformity assessment body:
p.000013: The certificate is valid until:
p.000013: REG-MS-KL FORM IIa, IIb, III
p.000013: DECLARATION OF THE PROPERTY'S RESPONSIBLE PERSON
p.000013: I, the undersigned, declare:
p.000013: - that the attached registration dossier is authentic and that the class IIa medical device, which
p.000013: is covered by the application for entry in the Register of Medical Devices, meets the required regulations. I pledge to
p.000013: I will immediately notify the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina of any changes to the
p.000013: by medical means;
p.000013: - that I will monitor the side effects of medical devices and inform the competent authorities accordingly
p.000013: with regulations;
p.000013: - I have access to the registration documentation, which I submit to the Agency;
p.000013: - that the declared activity is carried out in such a way that public health protection is in accordance with the valid ones
p.000013: regulations;
p.000013: - that I will renew and submit to the Agency all certificates which have expired.
p.000013: Name, Surname and Name of the Responsible Person of the Applicant (Company Director) - printed Company Name:
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Name of responsible person (s) for:
p.000013: - the application for the medical device and the authenticity of the documentation submitted to obtain it
p.000013: certificates of registration of the medical device;
p.000013: - ensuring the quality of the medical device in accordance with Article 40-44. Of the Medical Regulations
p.000013: by means of.
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: REG-IV-MS FORM
p.000013: Agency for Medicines and Medical Devices of Bosnia and Herzegovina
p.000013: Veljka Mlađenović b.b. Banja Luka Telephone: + 387 0 51 456-040, 456-041,456-050; fax: + 387 0 51 450-301; electronic
p.000013: mail: registration-ms@alims.gov.ba
p.000013: Annex 3
p.000013: Number: Received by:
p.000013: Date of receipt:
p.000013: Date of request for additional documentation:
p.000013: Date of receipt of additional documentation:
p.000013: Date from which the request is formally complete:
p.000013: To be completed by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.000013: REQUEST
p.000013: FOR ENTRY OF “IN VITRO” DIAGNOSTIC MEDICINE TO THE MEDICINAL REGISTER
p.000013: (application is filled in separately by each manufacturer, list and category)
p.000013: PROPOSAL BASIC INFORMATION (fill in capital letters) 1
...

p.000013: IN THE CATEGORY OF MEDICAL RESOURCES
p.000013: 01 Active Surgical Implants
p.000013: 02 Anesthetic and Respiratory Medical Devices 03 Dental Medical Devices
p.000013: 04 Medical electro-mechanical means 05 Hospital equipment
p.000013: 06 "In vitro" diagnostic medical devices 07 Inactive surgical implants
p.000013: 08 Ophthalmic and Optical Medical Devices 09 Reusable Instruments
p.000013: 10 Disposables
p.000013: 11 Technical means for handicapped persons
p.000013: Diagnostic and therapeutic medical devices in radiology
p.000013: 13 Other medical devices
p.000013: CERTIFICATE DATA I
p.000013: TO THE COMPETENT AUTHORITY TO ASSIGN CONFORMITY
p.000013: Provide information on the notified body that issued the certificate of conformity for
p.000013: the procedure of sterilization or the measuring function of a medical device.
p.000013: Number of EC certificates:
p.000013: Name and identification number of the conformity assessment body:
p.000013: The certificate is valid until:
p.000013: FORM REG-IV-MS
p.000013: DECLARATION OF THE PROPERTY'S RESPONSIBLE PERSON
p.000013: I, the undersigned, declare:
p.000013: - that the attached registration dossier is authentic and "in vitro" diagnostic
p.000013: the medical device, which is included in the application for entry in the Register of Medical Devices, corresponds to the required
p.000013: regulations. I pledge to the Agency for Medicines and Medical Devices of Bosnia and Herzegovina immediately
p.000013: communicate any changes to the medical device;
p.000013: - that I will monitor the side effects of medical devices and inform the competent authorities accordingly
p.000013: with regulations;
p.000013: - I have access to the registration documentation, which I submit to the Agency;
p.000013: - that the declared activity is carried out in such a way that public health protection is in accordance with the valid ones
p.000013: regulations;
p.000013: - that I will renew and submit to the Agency all certificates which have expired.
p.000013: Name, Surname and Name of the Responsible Person of the Applicant (Company Director) - printed Company Name:
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Name of responsible person (s) for:
p.000013: - the application of the medical device and the authenticity of the submitted documentation for the purpose of obtaining it
p.000013: certificates of registration of the medical device;
p.000013: - ensuring the quality of the medical device in accordance with Article 40-44. Of the Medical Regulations
p.000013: by means of.
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Appendix 1
p.000013: Appendix to Annexes 1 - 3
p.000013: Row no.
p.000001: 1
p.000002: 2
p.000003: 3
p.000004: 4
p.000005: 5
p.000006: 6
p.000007: 7
p.000008: 8
p.000009: 9
p.000010: 10
p.000010: Trademark
p.000010: Generic name
p.000010: Purpose
p.000010: Form and packaging (size, dimensions with all variations)
p.000010: Catalog number
p.000010: Agency for Medicines and Medical Devices of Bosnia and Herzegovina
p.000010: Veljka Mlađenovića bb, Banja Luka; telephone +387 51 456040, 456050, 450302; fax + 387 51 450301; email ::
p.000010: opp@alims.gov.ba
p.000010: Annex 4
p.000010: Number: Received by:
p.000010: Date of receipt:
p.000010: Date of request for additional documentation:
p.000010: Date of receipt of additional documentation:
p.000010: Date when the request is formally complete:
p.000010: To be completed by the Agency
p.000010: REQUEST
p.000010: FOR ENTRY IN THE REGISTER OF MEDICAL PRODUCERS MANUFACTURERS
...

Searching for indicator language:

(return to top)
p.000013: the Applicant's Parties, together with Form Appendix 1;
p.000013: b) Proof of authorized representation of the manufacturer in the territory of Bosnia and Herzegovina, original or certified copy (contract
p.000013: on representation or authorization letter);
p.000013: c) a certificate of conformity of medical devices with the directives and regulations of the European Union (certificate of
p.000013: EC certificate) or certificate of conformity of medical devices, except for Class I medical devices,
p.000013: the original or a certified copy in the country of origin;
p.000013: d) statement by the manufacturer of compliance with the European Medicines Directive with the exact class to which
p.000013: region of the medical device (Declaration of conformity), which refers to the appropriate class of medical device,
p.000013: the original or a certified copy in the country of origin;
p.000013: e) proof that the medical device is on the market in the manufacturer's country or in one of the countries of the European Union;
p.000013: f) insurance policy as proof of insurance of the beneficiary against the damage caused during the use of the medical device;
p.000013: g) quality system certification, except for Class I medical devices;
p.000013: h) certificate of conformity of sterile products for sterile medical devices;
p.000013: i) a description of sterilization methods and sterility control tests for sterile medical devices;
p.000013: j) information about the medical device (composition, short description of the product, declared purpose);
p.000013: k) information on the proposed shelf life and storage conditions;
p.000013: l) packaging, shape, type of material and composition (specimen or packaging attached);
p.000013: m) a foreign language instruction manual for products of foreign origin and a suggested instruction in one of the languages in
p.000013: official use in BiH;
p.000013: n) a certificate of completion of the measurement compliance for medical devices with a measuring function;
p.000013: o) proof of payment Agency fees for entry in the register of medical devices;
p.000013: p) proof of payment of the administrative fee.
p.000013: (2) The documentation prepared for obtaining a certificate of entry of a medical device in the Register must be in order
p.000013: arranged in the above order in the registrars, and at the request of the Agency, documentation for the
p.000013: members of the committee in accordance with the rules of procedure of the committee.
p.000013: Article 69
p.000013: (1) With the request for entry of in vitro diagnostic medical devices in the Register of Medical Devices, it is necessary
p.000013: submit the following documentation:
p.000013: a) In-vitro Medicinal Products Registry Application Form (REG-IV-MS), signed and certified by
p.000013: of the applicant, together with sample Appendix 1;
p.000013: b) Proof of authorized representation of the manufacturer in the territory of Bosnia and Herzegovina, original or certified copy (contract
p.000013: on representation or authorization letter);
p.000013: c) a certificate of conformity of in vitro medical devices with the directives and regulations of the European Union
p.000013: (EC certificate) or medical certificate of conformity, original
p.000013: or a certified copy in the country of origin, except for in vitro List D medicinal products;
p.000013: d) statement of the manufacturer on the compliance with the European directive for in vitro medicinal products with the exact list
p.000013: which region of the medical device (Declaration of conformity), original or certified copy in the country of origin;
p.000013: e) proof that the medical device is in circulation in the manufacturer's country or in one of the countries of the European Union;
p.000013: f) insurance policy as proof of insurance of the beneficiary against the damage caused during the use of the medical device;
p.000013: g) quality system certificate;
p.000013: h) certificate of conformity of sterile products for sterile in vitro medical devices;
p.000013: i) a description of sterilization methods and sterility control tests for sterile in vitro medical devices;
p.000013: j) information about the in vitro medicinal product (composition, summary of product, intended use);
p.000013: k) information on the proposed shelf life and storage conditions;
p.000013: l) packaging, shape, type of material and composition (specimen or packaging attached);
p.000013: m) a foreign language instruction manual for products of foreign origin and a suggested instruction in one of the languages in
p.000013: official use in BiH;
p.000013: n) proof of payment of expenses for entry in the register of in vitro medical devices;
p.000013: o) proof of payment of the administrative fee.
p.000013: (2) The documentation prepared for obtaining a certificate of entry of an in vitro medical device in the Register must be in order
p.000013: arranged in the above order in the registrars, and at the request of the Agency, documentation for the
p.000013: members of the committee in accordance with the rules of procedure of the committee.
p.000013: (3) The costs related to the registration and registration of medical devices in the Register of Medical Devices shall be borne by him
p.000013: the applicant.
p.000013: Article 70
p.000013: (1) The certificate of the Agency for the Registration of Medical Devices in the Registry gives the applicant the right to be placed in the Registry
p.000013: turnover of the medical device until the expiry of the validation period.
p.000013: (2) The deadline for issuing the certificate of entry in the Register of Medical Devices is five years from the date of issuing the certificate of enrollment in
p.000013: Register of Medical Devices.
p.000013: (3) The holder of entry in the Register is obliged to renew within 30 days the validity of certificates and other documents having a deadline
p.000013: validity.
p.000013: (4) Manufacturers or representatives of manufacturers who provide a certificate with only the date of issue,
p.000013: they shall submit a new certificate to the Agency within five years from the date of issue.
p.000013: (5) In case the validity of the expired documents has not been renewed and they have not been submitted to the Agency within the prescribed period,
p.000013: In conclusion, the Agency deletes the medical device from the Register.
p.000013: Article 71
...

Searching for indicator single:

(return to top)
p.000004: nasogastric probes, aspiration catheters and the like.
p.000004: c) Class IIb:
p.000004: If they are intended for long-term use, such as: "supports", a stent for a tube or the like.
p.000004: Article 14
p.000004: (RULE 6 - Surgical invasive agents for transient-temporary use)
p.000004: (1) Surgical invasives include three main groups of medical devices:
p.000004: a) medical aids for making skin passages;
p.000004: b) surgical instruments;
p.000004: c) various types of catheters.
p.000004: (2) All surgical instruments are classified into:
p.000004: a) Class I:
p.000004: Reusable or reusable surgical instruments such as: scalpels, saws, refractive forceps and the like;
p.000004: b) Class IIa:
p.000004: Disposable surgical instruments such as: suture needles, injection needles,
p.000004: lancets, disposable scalpels, surgical tampons, tip drills if associated with active
p.000004: medical devices, surgical gloves and the like.
p.000004: c) Class IIB:
p.000004: 1) medical devices intended to supply energy in the form of ionizing radiation;
p.000004: 2) bioactive medical agents that, by biological influence, actively elicit a tissue response to the level
p.000004: molecule;
p.000004: 3) medical devices that are intended to be administered by an application system whose
p.000004: use could be hazardous to the patient, as well as medication self-dosing agents such as
p.000004: are: insulin pens - injectors and the like.
p.000004: d) Class III,
p.000004: If the medical devices are intended to diagnose, monitor heart failure or systemic
p.000004: circulatory system of the central blood system, such as: vascular catheters and associated guidewire wires,
p.000004: circulatory surgical instruments made for single use and the like.
p.000004: Article 15
p.000004: (RULE 7 - Surgical invasive devices intended for short-term use)
p.000004: Invasive surgical devices intended for short-term use in a surgical or in-patient setting
p.000004: postoperative care, are classified in:
p.000004: a) Class IIa,
p.000004: All surgical invasive products intended for short-term use - clutches, infusion cannulas, products for
p.000004: suture of wounds, with the exceptions listed below.
p.000004: b) Class IIb,
p.000004: 1) medical devices that provide energy in the form of ionizing radiation, such as: auxiliary to
p.000004: brachytherapy;
p.000004: 2) medical devices that undergo chemical changes in the body, except those that are embedded in the teeth or used for
p.000004: drug application, such as: adhesives and the like.
p.000004: c) Class III,
p.000004: 1) clamps, infusion cannulas, suture aids and the like;
p.000004: 2) medical devices for determining the diagnosis, for monitoring the damage to the heart or the systemic bloodstream and which are in
p.000004: direct contact with these parts of the body, such as: cardiovascular catheter, cardiac probes
p.000004: minute volume, electrodes for temporary stimulation of the heart;
p.000004: 3) medical devices that are in direct contact with the central nervous system, such as
p.000004: are: a neurological catheter, cortical electrodes; medical devices that are completely or largely resorbed
p.000004: in the body, such as: resorption threads and biological adhesives and the like.
p.000004: Article 16
p.000004: (RULE 8 - Surgical invasive durable and implantable medical devices)
p.000004: (1) These are mainly implantable medical devices, which have been used for a long time (implants in the
p.000004: orthopedics, dentistry, ophthalmology and cardiovascular medicine, and implants for implantation of soft
...

p.000004: inner packaging in one of the languages officially used in BiH and have accompanying instructions for use.
p.000004: (2) The labeling of medical devices means the listing of information about a medical device on the outside,
p.000004: that is, contact packaging.
p.000004: (3) Information necessary for the safe use of medical devices must be provided on the medical device itself
p.000004: means, or where possible on the packaging for each unit.
p.000004: (4) If not feasible for each package, the particulars must be given in the package leaflet
p.000004: each unit or medical device and included in the package.
p.000004: (5) Exceptionally, the guidance is not required for Class I and IIa medical products, if safe to use
p.000004: without directions. It is also not necessary for medical devices operated by professional staff.
p.000004: (6) Information on medical devices may also be given in the form of symbols or identification colors, in accordance
p.000004: general regulations and accepted standards.
p.000004: (7) Where there are no standards, symbols and identification colors must be described in the documentation that is
p.000004: annexed to the request for conformity assessment of medical devices and to the instructions for use of medical devices.
p.000004: Article 54
p.000004: They must be indicated on the primary packaging (s) of the medical device, ie on the sales packaging
p.000004: the following information:
p.000004: a) name and address of the manufacturer or importer / distributor;
p.000004: b) the name and particulars of the medical device and its purpose;
p.000004: c) batch number and date of manufacture;
p.000004: d) shelf life (year, month);
p.000004: e) for sterile medical devices the words: "sterile", stating the method of sterilization;
p.000004: f) for single use medical devices, the text: "single use";
p.000004: g) for custom-made medical devices, the text: 'made-to-order';
p.000004: h) for medical devices intended for clinical testing, the text: "intended exclusively for clinical use
p.000004: examination ';
p.000004: i) for medical devices intended for scientific research and development text:
p.000004: "Intended solely for scientific research and development";
p.000004: j) conditions for storage, storage and handling of the medical device;
p.000004: k) safety precautions during transport, storage and use;
p.000004: l) the batch number of the medical device for the downloadable parts of that medical device;
p.000004: m) in case the intended use is not obvious to the user, it must be clearly indicated on the packaging and in
p.000004: instructions for use of the medical device.
p.000004: Article 55
p.000004: (1) The instructions for use must be written in one of the official languages in Bosnia and Herzegovina, at
p.000004: an understandable way, to enable the user to use it properly and safely.
p.000004: (2) The instruction for use of the medical device must contain:
p.000004: a) the information specified in "Article 42 of this Ordinance", except for the batch number and expiry date;
p.000004: b) information on the effects of the medical device and any adverse effects;
p.000004: c) information on the properties and behavior of the medicinal product when used in combination with another
p.000004: medical devices or equipment;
p.000004: d) information on the measures necessary for effective and safe operation;
p.000004: e) calibration and maintenance information for safety reasons;
p.000004: f) information required for the effective and safe implantation of the medical device;
p.000004: g) risk information regarding the interaction of medical devices during testing, use or
p.000004: treatment;
...

Searching for indicator property:

(return to top)
p.000013: 12. Modification of the storage conditions of the medical device
p.000013: 13. Modification of the manner and place of dispensing of the medical device
p.000013: 14. Other changes
p.000013: Pre-issued certificate number:
p.000013: MARK THE PROPOSAL STATUS
p.000013: Manufacturer MS, licensed for production in BiH (entered in the manufacturer's register)
p.000013: Foreign manufacturer representative Foreign manufacturer representative
p.000013: Wholesale legal entity (entered in the register of distributors)
p.000013: MEANS
p.000013: And the Class
p.000013: I Class - a sterile product
p.000013: I Class - measuring instrument
p.000013: CATEGORIES OF MEDICAL RESOURCES
p.000013: Appendix - 1
p.000013: Medical devices must be classified in only one category. Mark with a cross.
p.000013: IN THE CATEGORY OF MEDICAL RESOURCES
p.000013: 01 Active Surgical Implants
p.000013: 02 Anesthetic and Respiratory Medical Devices 03 Dental Medical Devices
p.000013: 04 Medical electro-mechanical means 05 Hospital equipment
p.000013: 06 "In vitro" diagnostic medical devices 07 Inactive surgical implants
p.000013: 08 Ophthalmic and Optical Medical Devices 09 Reusable Instruments
p.000013: 10 Disposables
p.000013: 11 Technical means for handicapped persons
p.000013: Diagnostic and therapeutic medical devices in radiology
p.000013: 13 Other medical devices
p.000013: CERTIFICATE DATA I
p.000013: TO THE COMPETENT AUTHORITY TO ASSIGN CONFORMITY
p.000013: Provide information on the notified body that issued the certificate of conformity for
p.000013: the procedure of sterilization or the measuring function of a medical device.
p.000013: Number of EC certificates:
p.000013: Name and identification number of the conformity assessment body:
p.000013: The certificate is valid until:
p.000013: DECLARATION OF THE PROPERTY'S RESPONSIBLE PERSON
p.000013: I, the undersigned, declare:
p.000013: - the registration dossier is authentic and that the class 1 medical device,
p.000013: which is covered by the application for entry in the Register of Medical Devices, meets the required regulations.
p.000013: I pledge to inform each Agency of Medicines and Medical Devices of Bosnia and Herzegovina immediately
p.000013: a modification regarding a medical device;
p.000013: - that I will monitor the side effects of medical devices and inform the competent authorities accordingly
p.000013: with regulations;
p.000013: - I have access to the registration documentation, which I submit to the Agency;
p.000013: - that the declared activity is carried out in such a way that public health protection is in accordance with the valid ones
p.000013: regulations;
p.000013: - that I will renew and submit to the Agency all certificates which have expired.
p.000013: Name, Surname and Name of the Responsible Person of the Applicant (Company Director) - printed Company Name:
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Name of responsible person (s) for:
p.000013: - the application for the medical device and the authenticity of the documentation submitted to obtain it
p.000013: certificates of registration of the medical device;
p.000013: - ensuring the quality of the medical device in accordance with Article 40-44. Of the Medical Regulations
p.000013: by means of.
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: REG-MS-KL FORM IIa, IIb, III
p.000013: Agency for Medicines and Medical Devices of Bosnia and Herzegovina
p.000013: Veljka Mlađenović b.b. Banja Luka Telephone: + 387 0 51 456-040, 456-041,456-050; fax: + 387 0 51 450-301; electronic
p.000013: mail: registration-ms@alims.gov.ba
p.000013: Annex 2
...

p.000013: MARK THE PROPOSAL STATUS
p.000013: Manufacturer MS, licensed for production in BiH (entered in the manufacturer's register)
p.000013: REG-MS-KL FORM IIa, IIb, III
p.000013: Foreign manufacturer representative Foreign manufacturer representative
p.000013: Wholesale legal entity (entered in the register of distributors)
p.000013: MEANS
p.000013: IIa Class
p.000013: IIb Class - sterile product III Class - measuring instrument
p.000013: CATEGORIES OF MEDICAL RESOURCES
p.000013: Appendix - 1
p.000013: Medical devices must be classified in only one category. Mark with a cross.
p.000013: CODE 01
p.000002: 02
p.000003: 03
p.000004: 04
p.000005: 05
p.000006: 06
p.000007: 07
p.000008: 08
p.000009: 09
p.000010: 10
p.000011: 11
p.000012: 12
p.000013: 13
p.000013: CATEGORY OF MEDICAL RESOURCES
p.000013: Active surgical implants
p.000013: Anesthetic and Respiratory Medical Devices Dental Medical Devices
p.000013: Medical Electro-Mechanical Devices Hospital Equipment
p.000013: "In vitro" diagnostic medical devices Inactive surgical implants
p.000013: Ophthalmic and Optical Medical Devices Reusable Instruments Disposables
p.000013: Technical means for handicapped persons
p.000013: Diagnostic and therapeutic medical devices in radiology
p.000013: Other medical devices
p.000013: CERTIFICATE DATA I
p.000013: TO THE COMPETENT AUTHORITY TO ASSIGN CONFORMITY
p.000013: Provide information on the notified body that issued the certificate of conformity for
p.000013: the procedure of sterilization or the measuring function of a medical device.
p.000013: Number of EC certificates:
p.000013: Name and identification number of the conformity assessment body:
p.000013: The certificate is valid until:
p.000013: REG-MS-KL FORM IIa, IIb, III
p.000013: DECLARATION OF THE PROPERTY'S RESPONSIBLE PERSON
p.000013: I, the undersigned, declare:
p.000013: - that the attached registration dossier is authentic and that the class IIa medical device, which
p.000013: is covered by the application for entry in the Register of Medical Devices, meets the required regulations. I pledge to
p.000013: I will immediately notify the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina of any changes to the
p.000013: by medical means;
p.000013: - that I will monitor the side effects of medical devices and inform the competent authorities accordingly
p.000013: with regulations;
p.000013: - I have access to the registration documentation, which I submit to the Agency;
p.000013: - that the declared activity is carried out in such a way that public health protection is in accordance with the valid ones
p.000013: regulations;
p.000013: - that I will renew and submit to the Agency all certificates which have expired.
p.000013: Name, Surname and Name of the Responsible Person of the Applicant (Company Director) - printed Company Name:
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Name of responsible person (s) for:
p.000013: - the application for the medical device and the authenticity of the documentation submitted to obtain it
p.000013: certificates of registration of the medical device;
p.000013: - ensuring the quality of the medical device in accordance with Article 40-44. Of the Medical Regulations
p.000013: by means of.
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: REG-IV-MS FORM
p.000013: Agency for Medicines and Medical Devices of Bosnia and Herzegovina
p.000013: Veljka Mlađenović b.b. Banja Luka Telephone: + 387 0 51 456-040, 456-041,456-050; fax: + 387 0 51 450-301; electronic
p.000013: mail: registration-ms@alims.gov.ba
p.000013: Annex 3
...

p.000013: 13. Modification of the manner and place of dispensing of the medical device
p.000013: 14. Other changes
p.000013: Pre-issued certificate number:
p.000013: FORM REG-IV-MS
p.000013: MARK THE PROPOSAL STATUS
p.000013: Manufacturer MS, licensed for production in BiH (entered in the manufacturer's register) Representative of a foreign manufacturer
p.000013: Representative of a foreign manufacturer
p.000013: Wholesale legal entity (entered in the register of distributors)
p.000013: MEANS
p.000013: List A products
p.000013: List B Products List C Products List D Products
p.000013: CATEGORIES OF MEDICAL RESOURCES
p.000013: Appendix - 1
p.000013: Medical devices must be classified in only one category. Mark with a cross.
p.000013: IN THE CATEGORY OF MEDICAL RESOURCES
p.000013: 01 Active Surgical Implants
p.000013: 02 Anesthetic and Respiratory Medical Devices 03 Dental Medical Devices
p.000013: 04 Medical electro-mechanical means 05 Hospital equipment
p.000013: 06 "In vitro" diagnostic medical devices 07 Inactive surgical implants
p.000013: 08 Ophthalmic and Optical Medical Devices 09 Reusable Instruments
p.000013: 10 Disposables
p.000013: 11 Technical means for handicapped persons
p.000013: Diagnostic and therapeutic medical devices in radiology
p.000013: 13 Other medical devices
p.000013: CERTIFICATE DATA I
p.000013: TO THE COMPETENT AUTHORITY TO ASSIGN CONFORMITY
p.000013: Provide information on the notified body that issued the certificate of conformity for
p.000013: the procedure of sterilization or the measuring function of a medical device.
p.000013: Number of EC certificates:
p.000013: Name and identification number of the conformity assessment body:
p.000013: The certificate is valid until:
p.000013: FORM REG-IV-MS
p.000013: DECLARATION OF THE PROPERTY'S RESPONSIBLE PERSON
p.000013: I, the undersigned, declare:
p.000013: - that the attached registration dossier is authentic and "in vitro" diagnostic
p.000013: the medical device, which is included in the application for entry in the Register of Medical Devices, corresponds to the required
p.000013: regulations. I pledge to the Agency for Medicines and Medical Devices of Bosnia and Herzegovina immediately
p.000013: communicate any changes to the medical device;
p.000013: - that I will monitor the side effects of medical devices and inform the competent authorities accordingly
p.000013: with regulations;
p.000013: - I have access to the registration documentation, which I submit to the Agency;
p.000013: - that the declared activity is carried out in such a way that public health protection is in accordance with the valid ones
p.000013: regulations;
p.000013: - that I will renew and submit to the Agency all certificates which have expired.
p.000013: Name, Surname and Name of the Responsible Person of the Applicant (Company Director) - printed Company Name:
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Name of responsible person (s) for:
p.000013: - the application of the medical device and the authenticity of the submitted documentation for the purpose of obtaining it
p.000013: certificates of registration of the medical device;
p.000013: - ensuring the quality of the medical device in accordance with Article 40-44. Of the Medical Regulations
p.000013: by means of.
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Appendix 1
p.000013: Appendix to Annexes 1 - 3
p.000013: Row no.
p.000001: 1
p.000002: 2
p.000003: 3
p.000004: 4
p.000005: 5
p.000006: 6
p.000007: 7
p.000008: 8
p.000009: 9
p.000010: 10
p.000010: Trademark
p.000010: Generic name
p.000010: Purpose
...

Searching for indicator conviction:

(return to top)
p.000004: Medical devices with regard to chemical, physical and biological properties must be:
p.000004: a) effective and safe for the user and therapist;
p.000004: b) compatible with the biological tissues, cells and body fluids with which they come in contact;
p.000004: c) non-toxic or acceptable toxicity with respect to the purpose and purpose of use;
p.000004: d) non-flammable and usable as intended;
p.000004: e) formulated, manufactured and packaged so that they can be safely used in relation to materials and gases
p.000004: with whom they come in contact during use;
p.000004: f) comply with medicines regulations, if they contain a drug in their composition;
p.000004: g) formulated, manufactured and packaged so that the risk is minimized should the drug evaporate
p.000004: (departed) from a medical device;
p.000004: h) formulated and constructed in such a way that the risk to the user and the environment, which could occur at unintentional entry
p.000004: of matter into a medical device, disappear or be reduced to a minimum.
p.000004: Article 46
p.000004: (Requirements regarding the microbiological quality of medical devices)
p.000004: (1) Medical devices in relation to microbiological quality must be:
p.000004: a) designed and constructed to eliminate or minimize the risk of infection to the user and other persons
p.000004: a possible measure;
p.000004: b) created from healthy tissues of animals that have been subjected to appropriate veterinary examination and surveillance, which
p.000004: documents with appropriate conviction;
p.000004: c) sterile, formulated, created and packaged in disposable packaging, ensuring that, under
p.000004: prescribed storage and transport conditions, remain sterile until their expiry date;
p.000004: d) created and sterilized by an appropriately validated method for sterile conditions;
p.000004: e) packaged in packagings of appropriate quality so that protection against microbiological is assured
p.000004: contamination at all stages, from production to use;
p.000004: f) marked on the packaging or label so as to distinguish between sterile and non-sterile products.
p.000004: (2) The Agency must keep information on the origin of the animals and the certificates of tissue quality contained in the medical
p.000004: funds, or forms a major part of it.
p.000004: (3) Procedures for the processing, storage, testing and treatment of animal tissues, cells and substances
p.000004: origins must be carried out in such a way as to ensure optimal security, especially with regard to virus infection and transmission
p.000004: other causative agents.
p.000004: (4) Production procedures must include viral inactivation methods and other necessary methods.
p.000004: Article 47
p.000004: (Environmental Requirements for Medical Devices)
p.000004: (1) If the medical device is intended to be used in combination with another device or equipment, the system
p.000004: quality must ensure overall efficiency and security.
p.000004: (2) All restrictions on use must be indicated on the packaging or in the instructions for use.
p.000004: (3) Medical devices must be designed to eliminate or minimize:
p.000004: a) the risk of injury related to their physical properties;
...

Searching for indicator union:

(return to top)
p.000004: (3) In cases where conformity assessment of certain types of medical devices is not performed by authorized persons
p.000004: institutions within the meaning of the Technical Conditions for Products and Conformity Assessment Act,
p.000004: the conformity assessment will be provided by the Medical Devices Commission on the approval of the Professional
p.000004: Council, and upon the proposal of the Director of the Agency. (4) In accordance with existing regulations, the Minister of Civil Affairs
p.000004: BiH, at the proposal of the Expert Council, establishes requirements for conformity assessment of a particular type of medical device
p.000004: funds with general and special requirements pursuant to the Law and by-laws "referred to in paragraph (1) of this Article", procedure
p.000004: the labeling of the medical device, as well as the contents of the certificate of conformity of the medical device.
p.000004: Article 38
p.000004: (Medical labeling)
p.000004: (1) On the basis of the certificate of conformity, the manufacturer of the medical device is obliged to label his product
p.000004: the prescribed conformity marking.
p.000004: (2) At the proposal of the Agency, the Ministry of Foreign Trade and Economic Relations of BiH shall prescribe the appearance of the conformity marking
p.000004: used in BiH and the content of the certificate of conformity issued in BiH, unless otherwise specified
p.000004: by law.
p.000004: (3) The exception to the provision of "paragraph (2) of this Article" is the manufacturer of a medical device whose compliance with the
p.000004: general and specific requirements are established by the EU-recognized conformity assessment body and such medical
p.000004: the asset must be labeled.
p.000004: (4) A mark or certificate of conformity implies compliance with the requirements and directives of the European Union
p.000004: and the application of good practices in production, quality assurance, packaging, labeling and
p.000004: storage. (Good Manufacturing Practice and Good Laboratory Practice).
p.000004: (5) New Approach directives requiring the affixing of a mark to products, in order to prove that it is a product
p.000004: safe for use by humans, animals and the environment, which have been proposed for adoption by the Ministry of Civil
p.000004: of Bosnia and Herzegovina.
p.000004: (6) It is prohibited to label a medical device with the markings provided for in this Article if it is not
p.000004: in accordance with the provisions of Article 101 of the Law on Medicinal Products and Medical Devices of BiH and the regulations adopted on
p.000004: based on it.
p.000004: Article 39
p.000004: It is unnecessary to indicate medical devices:
p.000004: a) intended for clinical trial;
p.000004: b) custom made for the individual patient or user.
p.000004: CHAPTER II - BASIC REQUIREMENTS FOR MEDICAL RESOURCES-GENERAL AND SPECIFIC REQUIREMENTS FOR MEDICAL RESOURCES
p.000004: Article 40
p.000004: (1) Medical devices must comply with the general rules and technical requirements for products and
p.000004: the assessment of compliance with general product safety regulations as well as the general and specific requirements established by this
p.000004: By the rules:
p.000004: (2) General requirements: medical devices must meet the general requirements as follows:
p.000004: a) that the medical devices are designed, manufactured, installed and maintained so that when used as directed
p.000004: ensure quality, efficiency and safety for the user;
p.000004: b) that a quality system is ensured in the production or part of the production at all stages during manufacture
p.000004: in terms of the design and manufacture of the medical device.
p.000004: (3) Special requirements: are the requirements that medical devices must meet in order to be enabled
p.000004: their action in relation to the purpose for which they were produced.
p.000004: (4) Documentation for pharmaceutical, clinical and other types of testing for non-certified medical devices
p.000004: on compliance with European Union (CE) directives, prepared by manufacturers.
p.000004: Article 41
p.000004: (1) The statement of conformity is the statement by which the manufacturer confirms the implementation of the quality assurance system in the process
p.000004: the design, manufacture or part of the manufacture, manufacture, packaging, labeling, use or
p.000004: use, or statement that the medical device meets the prescribed requirements of this regulation.
p.000004: (2) Quality elements must be identified and documented for each production and marketing phase, and for sterile ones
p.000004: product and for the sterilization phase.
p.000004: Section A. - General requirements
p.000004: Article 42
p.000004: Medical devices must be:
p.000004: a) designed and constructed so that, if used under the conditions specified by the manufacturer, no
p.000004: endangering the clinical condition and safety of users and others;
p.000004: b) an acceptable relationship between benefits and risks;
p.000004: a) c) effective, efficient and safe for the user as stated by the manufacturer;
p.000004: c) designed and packaged so that they are fit for use, with or without risk elimination
p.000004: minimization;
p.000004: d) created with acceptable safeguards, including the introduction of a non-existent risk alarm
p.000004: eliminate.
p.000004: Article 43
p.000004: (1) In the manufacturing process, manufacturers must respect scientific and technical developments in the field of medical
p.000004: means, subject to the following principles:
p.000004: a) that the efficacy of medical devices must not be influenced by other factors that may compromise the clinical
p.000004: the condition and safety of users or other persons within the shelf life under the prescribed conditions of storage, traffic and
p.000004: use;
...

p.000004: intensity and distribution of radiation or energy.
p.000004: Article 56
p.000004: In addition to the information referred to in "Article 43 of this Ordinance", the instructions for use of medical devices must also contain
p.000004: information on contraindications and necessary precautions, as follows:
p.000004: a) precautionary measures in case of modification or weakening of the action of the medical device;
p.000004: b) the safety measures required for the environment, ie exposure to magnetic field,
p.000004: electrical influences, electrostatic discharge, pressure change, acceleration, heat source and the like;
p.000004: c) the precautionary measures for medicines or other devices administered by the designed medical device;
p.000004: d) the precautionary measures necessary for the safe and effective disposal of medical
p.000004: funds;
p.000004: e) the precautionary measures for medicines which are an integral part of the medical devices, their disposal or
p.000004: dismissal in accordance with paragraph (d) of this Article;
p.000004: f) safety measures of the specified degrees of accuracy for products with a measuring function.
p.000004: CHAPTER III - MARKING AND DECLARATION OF CONFORMITY
p.000004: Article 57
p.000004: (1) The manufacturer must ensure that the quality assurance system approved for the design is used,
p.000004: production and final testing of medical devices. A declaration of conformity is the procedure by which the manufacturer ensures that and
p.000004: declare that the medical devices comply with the provisions of this Ordinance.
p.000004: (2) The Agency shall accept all quality certificates of the original or certified translation issued by the body
p.000004: verified to verify compliance of a medical device with European Union directives and regulations ().
p.000004: (3) If the manufacturer does not hold a certificate of conformity of quality with EU directives and regulations, he must to the Agency
p.000004: apply for conformity assessment. The request must include the following information:
p.000004: a) the name and address of the manufacturer and all other manufacturing sites which require the same quality system;
p.000004: b) all relevant information about the medical device or type of medical device being evaluated;
p.000004: c) the quality system documentation that has been applied at all stages of production of the medical device;
p.000004: d) a statement by the manufacturer that it will maintain the condition and efficiency of the approved quality system;
p.000004: e) a statement from the manufacturer that he or she will follow scientific and technical developments and experiences in the field of medical devices
p.000004: and introduce procedures to improve them.
p.000004: (4) The application shall also be accompanied by the preparation of technical documentation, which shall enable the conformity assessment of the medical device
p.000004: means containing the following information:
p.000004: a) a general inventory of medical devices, a specification of the project, including the standards used and
p.000004: result of risk analysis;
p.000004: b) nactre plans, description of manufacturing processes, description of medical components and ancillaries
p.000004: funds;
p.000004: c) the responsibility of the leading staff and their authority during the design of the medical device;
p.000004: d) methods of monitoring the quality system applied;
p.000004: e) a description of the sterilization methods used in the case of sterile products and the results of the tests;
...

p.000004: g) clinical data where necessary in accordance with this Regulation;
p.000004: h) marking and instruction manual.
p.000004: (5) The certificate of conformity must contain the conclusions of the examination of the documentation and the reasoned assessment.
p.000004: (6) The costs of issuing the certificate of conformity shall be borne by the manufacturer of the medical device.
p.000004: Article 58
p.000004: (1) The Agency must, through the competent committee, establish a quality system and review whether the insurance systems are in place
p.000004: quality in accordance with accepted standards.
p.000004: (2) The Compliance Committee must have at least one member with experience in technological process evaluation.
p.000004: The composition of the committee is proposed by the entity Ministers of Health.
p.000004: (3) In the process of issuing a certificate of conformity, a certain type of medical device may also be requested by the Agency
p.000004: opinion of authorized institutions on the territory of BiH.
p.000004: (4) Based on the expert opinion of the competent commission, the Agency shall issue a certificate of conformity containing:
p.000004: a) administrative information on the medical device;
p.000004: b) a statement of compliance of the medical device;
p.000004: c) test report and expert medical opinion on the medical device;
p.000004: d) certificate or other document of conformity.
p.000004: Article 59
p.000004: (1) For Class IIa, IIb and Class III medical devices and products List A and List B "referred to in Article 5 of this Ordinance", which does not
p.000004: hold a certificate of conformity in accordance with European Union directives and regulations (), conformity
p.000004: the products shall be determined under the conditions laid down in this Ordinance and the law.
p.000004: (2) For class I medical devices, the manufacturer himself shall determine the conformity of his medical device with those prescribed
p.000004: conditions and makes a declaration of conformity at its own risk, except for sterile Class I medical devices and medical devices
p.000004: agents having a measuring function, which are treated as upper class medical devices.
p.000004: (3) The declaration of conformity guarantees the full implementation of the quality assurance system of the medical device.
p.000004: (4) The manufacturer must ensure that the quality system is used in the production and control of the finished medical device
p.000004: means, as well as verification thereof, "in accordance with Article 46 of this Ordinance".
p.000004: Article 60
p.000004: The certificate of conformity as regards the purpose, nature of operation and use of the medical device must be based
p.000004: on all data obtained during clinical trials, especially when it comes to implantable medical
p.000004: agents and Class III, as well as data from the scientific literature on the use and use of medical
p.000004: the means, and the techniques used to make them.
p.000004: Article 61
p.000004: (1) Medical devices if they meet the basic requirements of this Ordinance, before being placed on the market
p.000004: must be marked with a conformity mark.
p.000004: (2) Medical devices bearing a certificate of conformity and a mark of conformity given in accordance with directives and regulations
p.000004: European Union recognitions may be placed on the market if they are entered in the Agency's register.
p.000004: (3) No medical devices that are clinically tested or made to order for a specific user
p.000004: are indicated by the prescribed sign.
p.000004: (4) Medical devices which do not have the conformity marking issued by the competent authorities of the European Union may be placed in
p.000004: turnover on the basis of a certificate of conformity issued by the Agency and entry in the Agency Register.
p.000004: Article 62
p.000004: (1) The quality assurance system must cover all phases of manufacturing medical devices, from design to
p.000004: controls of finished medical device, labeling, storage and distribution.
p.000004: (2) With respect to quality system monitoring, methods and procedures must be devised for effective system monitoring
p.000004: quality and its application at all stages of production, in particular for sterile medical devices, sterilization methods and
p.000004: packaging as well as labeling the same.
p.000004: (3) The Agency periodically checks the implementation of the approved quality system to determine whether the manufacturer complies with it
p.000004: approved quality system and to maintain and work to improve it.
p.000004: (4) The Agency may also unannounced the manufacturer's control and conformity assessment and, if necessary, may carry out
p.000004: or request tests, to check that the quality system is working, with which the manufacturer must submit
p.000004: test report conducted with the finding.
p.000004: Article 63
p.000004: (1) Changes to the quality system must be re-approved by the body which approved the quality system, respectively
p.000004: of the conformity assessment body.
p.000004: (2) The manufacturer must inform the body which has approved the quality system or the determining body
p.000004: of the issuing certificate of conformity on any changes and deviations from the approved
p.000004: quality system.
p.000004: (3) The Agency shall take a decision on the acceptance of the approved quality system or its evaluation.
p.000004: PART EIGHT - CATEGORIES OF MEDICAL RESOURCES
p.000004: Article 64
p.000004: (1) Each medical device must be classified in only one category.
...

p.000013: d) whether the user is assured of his efficiency and safety in accordance with the prescribed conditions of use;
p.000013: e) whether security is provided for other persons, ie persons handling the medical device in accordance
p.000013: prescribed or other conditions of use;
p.000013: f) whether the manufacturer applied the approved quality system in the production process, carried out tests
p.000013: required to confirm the implementation of the approved quality system and how often;
p.000013: g) whether the action of the medical device is as follows;
p.000013: h) whether the relationship between benefits and risks is as follows;
p.000013: i) whether sterility is provided with sterility for a specified duration; j) whether they are fulfilled
p.000013: conditions for placing on the market of a medical device.
p.000013: (2) Documentation received at the Agency and all data related to medical devices, except for data entered in the
p.000013: the Agency's registers are a trade secret.
p.000013: (3) The provision of the preceding paragraph shall not apply to the exchange of information or warnings between other States and
p.000013: competent authorities.
p.000013: Article 68
p.000013: (1) An application for entry of Class I, IIa, IIb and III medical devices into the Register shall be submitted
p.000013: the following documentation:
p.000013: a) Application form for entry in the register of medical devices of the appropriate class (REG-MS-KL), signed and certified by
p.000013: the Applicant's Parties, together with Form Appendix 1;
p.000013: b) Proof of authorized representation of the manufacturer in the territory of Bosnia and Herzegovina, original or certified copy (contract
p.000013: on representation or authorization letter);
p.000013: c) a certificate of conformity of medical devices with the directives and regulations of the European Union (certificate of
p.000013: EC certificate) or certificate of conformity of medical devices, except for Class I medical devices,
p.000013: the original or a certified copy in the country of origin;
p.000013: d) statement by the manufacturer of compliance with the European Medicines Directive with the exact class to which
p.000013: region of the medical device (Declaration of conformity), which refers to the appropriate class of medical device,
p.000013: the original or a certified copy in the country of origin;
p.000013: e) proof that the medical device is on the market in the manufacturer's country or in one of the countries of the European Union;
p.000013: f) insurance policy as proof of insurance of the beneficiary against the damage caused during the use of the medical device;
p.000013: g) quality system certification, except for Class I medical devices;
p.000013: h) certificate of conformity of sterile products for sterile medical devices;
p.000013: i) a description of sterilization methods and sterility control tests for sterile medical devices;
p.000013: j) information about the medical device (composition, short description of the product, declared purpose);
p.000013: k) information on the proposed shelf life and storage conditions;
p.000013: l) packaging, shape, type of material and composition (specimen or packaging attached);
p.000013: m) a foreign language instruction manual for products of foreign origin and a suggested instruction in one of the languages in
p.000013: official use in BiH;
p.000013: n) a certificate of completion of the measurement compliance for medical devices with a measuring function;
p.000013: o) proof of payment Agency fees for entry in the register of medical devices;
p.000013: p) proof of payment of the administrative fee.
p.000013: (2) The documentation prepared for obtaining a certificate of entry of a medical device in the Register must be in order
p.000013: arranged in the above order in the registrars, and at the request of the Agency, documentation for the
p.000013: members of the committee in accordance with the rules of procedure of the committee.
p.000013: Article 69
p.000013: (1) With the request for entry of in vitro diagnostic medical devices in the Register of Medical Devices, it is necessary
p.000013: submit the following documentation:
p.000013: a) In-vitro Medicinal Products Registry Application Form (REG-IV-MS), signed and certified by
p.000013: of the applicant, together with sample Appendix 1;
p.000013: b) Proof of authorized representation of the manufacturer in the territory of Bosnia and Herzegovina, original or certified copy (contract
p.000013: on representation or authorization letter);
p.000013: c) a certificate of conformity of in vitro medical devices with the directives and regulations of the European Union
p.000013: (EC certificate) or medical certificate of conformity, original
p.000013: or a certified copy in the country of origin, except for in vitro List D medicinal products;
p.000013: d) statement of the manufacturer on the compliance with the European directive for in vitro medicinal products with the exact list
p.000013: which region of the medical device (Declaration of conformity), original or certified copy in the country of origin;
p.000013: e) proof that the medical device is in circulation in the manufacturer's country or in one of the countries of the European Union;
p.000013: f) insurance policy as proof of insurance of the beneficiary against the damage caused during the use of the medical device;
p.000013: g) quality system certificate;
p.000013: h) certificate of conformity of sterile products for sterile in vitro medical devices;
p.000013: i) a description of sterilization methods and sterility control tests for sterile in vitro medical devices;
p.000013: j) information about the in vitro medicinal product (composition, summary of product, intended use);
p.000013: k) information on the proposed shelf life and storage conditions;
p.000013: l) packaging, shape, type of material and composition (specimen or packaging attached);
p.000013: m) a foreign language instruction manual for products of foreign origin and a suggested instruction in one of the languages in
p.000013: official use in BiH;
p.000013: n) proof of payment of expenses for entry in the register of in vitro medical devices;
p.000013: o) proof of payment of the administrative fee.
p.000013: (2) The documentation prepared for obtaining a certificate of entry of an in vitro medical device in the Register must be in order
p.000013: arranged in the above order in the registrars, and at the request of the Agency, documentation for the
p.000013: members of the committee in accordance with the rules of procedure of the committee.
p.000013: (3) The costs related to the registration and registration of medical devices in the Register of Medical Devices shall be borne by him
p.000013: the applicant.
p.000013: Article 70
p.000013: (1) The certificate of the Agency for the Registration of Medical Devices in the Registry gives the applicant the right to be placed in the Registry
p.000013: turnover of the medical device until the expiry of the validation period.
...

Searching for indicator education:

(return to top)
p.000013: Article 74
p.000013: The Agency, upon request, issues expert opinions and answers to queries limiting its validity to one
p.000013: year from the date of issue.
p.000013: PART TEN - MEDICAL TRAFFIC TRAFFIC
p.000013: Article 75
p.000013: (1) Wholesale trade in medical devices includes the procurement, storage, transportation and sale of medical devices,
p.000013: including import and export.
p.000013: (2) The marketing of medical devices which do not comply with the prescribed general and special ones shall be prohibited
p.000013: requirements of the Technical Requirements for Products and Conformity Assessment Act, of the Act; and
p.000013: regulations made on the basis of the law, that is, the circulation of medical devices not registered in the medical register
p.000013: funds managed by the Agency.
p.000013: Article 76
p.000013: In addition to the general legal requirements, a legal person who markets wholesale medical devices must also meet special requirements
p.000013: the conditions laid down by law, ie it is obliged to:
p.000013: a) Prior to commencement of the wholesale circulation of medical devices, report their activity to the Agency considering the application
p.000013: and maintains a register of legal entities engaged in the wholesale marketing of medical devices;
p.000013: b) carry out the activity in accordance with good practices and protection of public health in accordance with the Regulations on Good
p.000013: distribution-wholesale practice;
p.000013: c) Introduce quality assurance in the wholesale medical facility, which proves appropriate
p.000013: "ISO" quality system certificate issued by the competent certification bodies in BiH;
p.000013: d) Have an employed person responsible for the wholesale marketing of medical devices with at least VI level of education
p.000013: medical, pharmaceutical, dental, or other health care professional, having passed the professional examination
p.000013: and appropriate education in the field of medical devices, or other profession depending on the nature,
p.000013: purposes, uses and classes of medical devices;
p.000013: e) have a responsible person employed with at least a VI medical education course in monitoring and
p.000013: reporting adverse reactions in the administration and response to medical devices;
p.000013: f) must provide adequate space, installations and equipment, ensuring that it is properly maintained
p.000013: storage and marketing of medical devices;
p.000013: g) must keep appropriate documentation, by type and amount of medical devices, as well as classes, and therewith
p.000013: a way to allow the competent authority to keep records of medical devices in accordance with good distribution and wholesalers
p.000013: practice.
p.000013: Article 77
p.000013: (1) Wholesale medical supplies may be performed by:
p.000013: a) legal entities holding a certificate of entry in the register of wholesalers of medical devices issued by the Agency
p.000013: (wholesale of medical supplies);
p.000013: b) medical device manufacturers established in Bosnia and Herzegovina for those medical devices that produce i
p.000013: which are entered in the Register of Medical Devices.
p.000013: (2) Wholesalers may obtain medical supplies directly from medical device manufacturers, importers and
p.000013: other wholesale.
p.000013: (3) In addition to the general legal requirements, wholesalers of medical devices must meet special requirements
p.000013: in terms of space, equipment and staff.
p.000013: (4) The necessary rooms for smooth operation are:
p.000013: a) a room for receiving medical supplies;
p.000013: b) a room for the placement and dispensing of medical devices according to the types and volume of traffic, as well as their storage
p.000013: in accordance with the manufacturer's declared conditions;
p.000013: c) a room for the storage of medical supplies withdrawn from the market and storage of packaging;
p.000013: d) sanitary facilities;
p.000013: e) a dressing room or wardrobe;
p.000013: f) office.
...

Searching for indicator gender:

(return to top)
p.000013: Article 86 (Materiovigilance)
p.000013: (1) The provisions of Art. 72 (1) of the Law relating to pharmacovigilance shall also apply mutatis mutandis
p.000013: medical means, or maternity care.
p.000013: (2) Adverse reactions of medical devices shall be regulated by the Ordinance on the method of collecting and monitoring unwanted ones
p.000013: the effects of drugs and medical devices.
p.000013: Article 87
p.000013: (Waste management)
p.000013: (1) The circulation of medical devices that are no longer in use or that are defective is not allowed.
p.000013: (2) Medical devices that are no longer in use shall be taken care of at the expense of the owner or legal or natural person at
p.000013: what medical device was found.
p.000013: (3) The disposal of medical devices "referred to in paragraph (1) of this Article" shall be consistently applied
p.000013: "The provisions of Articles 93, 94 and 95" of the Law and the Regulations adopted in this field, resulting from the said Articles
p.000013: of the law.
p.000013: (4) Medical waste shall be disposed of in a way that will not endanger the life and health of humans and the environment.
p.000013: PART TWO - TRANSITIONAL AND FINAL PROVISIONS
p.000013: Article 88
p.000013: (1) Legal entities engaged in the production and marketing of medical devices shall be obliged to conduct their business and organization
p.000013: to comply with the provisions of this Ordinance within 60 days from the date of entry into force of this Ordinance.
p.000013: (2) Requests for the issuance of all types of entries in the Register of Medical Devices, submitted by the entry into
p.000013: The force of this Ordinance shall be settled in accordance with the provisions of this Ordinance.
p.000013: Article 89
p.000013: The grammatical terminology of the use of masculine gender in this Regulation implies the inclusion of both sexes.
p.000013: Article 90
p.000013: Amendments to this Ordinance shall be made in the manner and by the procedure for its adoption.
p.000013: Article 91
p.000013: Contributions 1 to 5 shall also form an integral part of this Ordinance.
p.000013: Article 92
p.000013: This Rulebook shall enter into force on the eighth day after its publication in the Official Gazette of BiH and shall apply until
p.000013: adopting regulations to transpose the relevant EU directives.
p.000013: No: 08-02-2-1172-1-JD / 09 MINISTER
p.000013: Date: December 10, 2009
p.000013: Sredoje Novic, M.Sc.
p.000013: Agency for Medicines and Medical Devices of Bosnia and Herzegovina
p.000013: Veljka Mlađenović b.b. Banja Luka Telephone: + 387 0 51 456-040, 456-041,456-050; fax: + 387 0 51 450-301; electronic
p.000013: mail: registration-ms@alims.gov.ba
p.000013: Annex 1
p.000013: Number: Received by:
p.000013: Date of receipt:
p.000013: Date of request for additional documentation:
p.000013: Date of receipt of additional documentation:
p.000013: Date from which the request is formally complete:
p.000013: To be completed by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina
p.000013: REQUEST
p.000013: FOR ENTRY OF MEDICAL CLASS L IN THE MEDICINAL REGISTRY
p.000013: (application is to be filled in separately by each manufacturer, class and category)
p.000013: PROPOSAL BASIC INFORMATION (fill in capital letters) 1
p.000013: APPLICANT for obtaining a certificate for registration of a medical device in the register Full company name:
p.000013: Address:
p.000013: Phone, Fax: Email:
p.000013: Name and Surname of Responsible Person
p.000013: INFORMATION ABOUT THE MEDICAL MANUFACTURER
p.000013: 1. Manufacturer in Bosnia and Herzegovina Full company name:
p.000013: Address:
p.000013: Phone, fax:
p.000013: E-mail:
...

Searching for indicator opinion:

(return to top)
p.000004: a) a general inventory of medical devices, a specification of the project, including the standards used and
p.000004: result of risk analysis;
p.000004: b) nactre plans, description of manufacturing processes, description of medical components and ancillaries
p.000004: funds;
p.000004: c) the responsibility of the leading staff and their authority during the design of the medical device;
p.000004: d) methods of monitoring the quality system applied;
p.000004: e) a description of the sterilization methods used in the case of sterile products and the results of the tests;
p.000004: f) the proof for the medical device fulfills the essential requirements in case it is connected to another medical device s
p.000004: characteristics specified by the manufacturer;
p.000004: g) clinical data where necessary in accordance with this Regulation;
p.000004: h) marking and instruction manual.
p.000004: (5) The certificate of conformity must contain the conclusions of the examination of the documentation and the reasoned assessment.
p.000004: (6) The costs of issuing the certificate of conformity shall be borne by the manufacturer of the medical device.
p.000004: Article 58
p.000004: (1) The Agency must, through the competent committee, establish a quality system and review whether the insurance systems are in place
p.000004: quality in accordance with accepted standards.
p.000004: (2) The Compliance Committee must have at least one member with experience in technological process evaluation.
p.000004: The composition of the committee is proposed by the entity Ministers of Health.
p.000004: (3) In the process of issuing a certificate of conformity, a certain type of medical device may also be requested by the Agency
p.000004: opinion of authorized institutions on the territory of BiH.
p.000004: (4) Based on the expert opinion of the competent commission, the Agency shall issue a certificate of conformity containing:
p.000004: a) administrative information on the medical device;
p.000004: b) a statement of compliance of the medical device;
p.000004: c) test report and expert medical opinion on the medical device;
p.000004: d) certificate or other document of conformity.
p.000004: Article 59
p.000004: (1) For Class IIa, IIb and Class III medical devices and products List A and List B "referred to in Article 5 of this Ordinance", which does not
p.000004: hold a certificate of conformity in accordance with European Union directives and regulations (), conformity
p.000004: the products shall be determined under the conditions laid down in this Ordinance and the law.
p.000004: (2) For class I medical devices, the manufacturer himself shall determine the conformity of his medical device with those prescribed
p.000004: conditions and makes a declaration of conformity at its own risk, except for sterile Class I medical devices and medical devices
p.000004: agents having a measuring function, which are treated as upper class medical devices.
p.000004: (3) The declaration of conformity guarantees the full implementation of the quality assurance system of the medical device.
p.000004: (4) The manufacturer must ensure that the quality system is used in the production and control of the finished medical device
p.000004: means, as well as verification thereof, "in accordance with Article 46 of this Ordinance".
p.000004: Article 60
p.000004: The certificate of conformity as regards the purpose, nature of operation and use of the medical device must be based
p.000004: on all data obtained during clinical trials, especially when it comes to implantable medical
p.000004: agents and Class III, as well as data from the scientific literature on the use and use of medical
p.000004: the means, and the techniques used to make them.
p.000004: Article 61
p.000004: (1) Medical devices if they meet the basic requirements of this Ordinance, before being placed on the market
...

General/Other / Dependent

Searching for indicator dependent:

(return to top)
p.000004: 2) means for protection of users and other persons;
p.000004: 3) ways to prevent misuse of the product due to radiation;
p.000004: 4) ways to eliminate risk when using the product.
p.000004: (5) In addition to the requirements of paragraph (2) and (3) of this Article, medical devices emitting ionizing rays,
p.000004: according to their purpose must be:
p.000004: a) formulated and created to ensure control of the quantity, direction and quality of radiation;
p.000004: b) intended for diagnostic radiology, formulated and designed to achieve
p.000004: corresponding to the quality of the image or text while minimizing the exposure of users and others;
p.000004: c) intended for therapeutic radiology, formulated and designed to allow safe monitoring and
p.000004: monitoring of received radiation dose, type of air and energy, and in some cases quality
p.000004: radiation.
p.000004: Article 50
p.000004: (Requirements for medical devices related to energy source)
p.000004: (1) Medical devices that are associated with an energy source must also meet specific requirements with respect to theirs
p.000004: application, namely:
p.000004: a) Medical devices incorporating programmable electronic systems must
p.000004: be designed to ensure the reproducibility, safety and efficiency of these systems in use;
p.000004: b) in the event of a system error, means must be available to eliminate or reduce the risk of
p.000004: the smallest possible measure;
p.000004: c) medical devices where the safety of the user depends on the internal power supply must be
p.000004: equipped with means for determining the state of electrical supply;
p.000004: d) medical devices where the safety of the user is dependent on external power supply,
p.000004: must have alarm systems that notify of power outages;
p.000004: e) medical devices intended to monitor one or more clinical parameters of the patient must be
p.000004: equipped with an appropriate alarm system to alert the user to events that could cause deterioration
p.000004: patient's health status or death;
p.000004: f) medical devices must be formulated and designed to be electromagnetic
p.000004: the fields should be minimized to avoid interfering with other medical devices or
p.000004: equipment wide;
p.000004: g) medical devices must be formulated and created in such a way that, when declared by the manufacturer, as well as
p.000004: conditions of use error, to the extent possible avoid the risk of electric shock.
p.000004: (2) Mechanical and thermal risk protection:
p.000004: a) Medical devices must be formulated and designed to protect patients and users from
p.000004: mechanical risk which, e.g. associated with the base, the stability and the movable parts;
p.000004: b) medical devices must be formulated and created so that the risk arising from the vibrations they cause
p.000004: these products, unless vibrations are part of the special operation of the product, are minimized;
p.000004: c) Power supply terminals and connectors, gas, hydraulic or pneumatic devices
p.000004: the user, must be designed and constructed to eliminate all possible risks;
p.000004: d) accessible parts of medical devices, with the exception of parts intended to supply heat or
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.000004: complete request.
p.000004: (6) The certificate of entry in the register of manufacturers of medical devices shall be issued for a period of 5 years and issued
p.000004: only for manufacturers established in the territory of BiH.
p.000004: (7) The certificate “referred to in paragraph (5) of this Article” is final and no appeal can be lodged against it, but an administrative action may be instituted.
p.000004: a dispute with the competent court within 60 days from the date of its receipt.
p.000004: (8) The manufacturer acquires the right to manufacture medical devices in Bosnia and
p.000004: Herzegovina.
p.000004: (9) Costs of issuing a certificate of entry in the Register, changes and deletion from the Register of Manufacturers
p.000004: medical supplies, be borne by the applicant.
p.000004: Article 33
p.000004: (1) The production of medical devices shall not be carried out until the entry in the Register of Medical Manufacturers has been approved
p.000004: funds.
p.000004: (2) The manufacturer shall be responsible for the production, placing on the market and any possible consequences in the application of medical
p.000004: funds.
p.000004: (3) The manufacturer shall, without delay, inform the Agency of any change or error in the
p.000004: production process, quality control, as well as other situations that might cast doubt on quality,
p.000004: safety and efficacy of medical devices.
p.000004: (4) In cases "referred to in paragraph (3) of this Article", the Agency may prohibit the production and marketing of medical devices,
p.000004: that is, order the withdrawal of medical devices from the market.
p.000004: (5) The Agency shall delete the legal persons from the Register of Manufacturers in the cases of:
p.000004: a) the decision of the competent authority that the legal person no longer fulfills the conditions for carrying out the activity in accordance with the regulations;
p.000004: b) the applicant's written request;
p.000004: c) the termination of the legal person in the cases provided for by a special law.
p.000004: PART Six - MEDICAL TESTING
p.000004: Article 34
p.000004: Testing of medical devices is performed to determine or confirm the efficacy, safety and quality, in agreement
p.000004: declared use specified by the manufacturer.
p.000004: Article 35
p.000004: (1) A clinical trial of medical devices is to determine or confirm the safety of a medical device
p.000004: assets, its effectiveness and compliance with the general and specific requirements as intended
p.000004: manufacturer.
p.000004: (2) Adverse reactions and clinical trials of medical devices are governed by the Ordinance on adverse reactions and
p.000004: Clinical Trials Regulations.
p.000004: Article 36
p.000004: (1) The control of the quality of medical devices implies the determination of the prescribed quality of such devices in accordance with these
p.000004: Rulebook and Law.
p.000004: (2) The quality of a medical device shall be determined by regular, special, systematic and extraordinary control
p.000004: in accordance with the provisions of this Ordinance and the Act.
p.000004: (3) The control "referred to in paragraph (2) of this Article" may be ordered by an authorized person in accordance with the Law.
p.000004: PART SEVEN - CONFIRMATION OF CONFORMITY AND LABELING OF MEDICAL RESOURCES
p.000004: CHAPTER I - GENERAL ABOUT CONSISTENCY
p.000004: Article 37
p.000004: (1) The procedure for determining the conformity of a medical device with the general and special requirements of the Act is the procedure by which
p.000004: it is directly or indirectly determined whether the medical device meets the requirements prescribed by the General Law
...

p.000004: (2) The Agency shall accept all quality certificates of the original or certified translation issued by the body
p.000004: verified to verify compliance of a medical device with European Union directives and regulations ().
p.000004: (3) If the manufacturer does not hold a certificate of conformity of quality with EU directives and regulations, he must to the Agency
p.000004: apply for conformity assessment. The request must include the following information:
p.000004: a) the name and address of the manufacturer and all other manufacturing sites which require the same quality system;
p.000004: b) all relevant information about the medical device or type of medical device being evaluated;
p.000004: c) the quality system documentation that has been applied at all stages of production of the medical device;
p.000004: d) a statement by the manufacturer that it will maintain the condition and efficiency of the approved quality system;
p.000004: e) a statement from the manufacturer that he or she will follow scientific and technical developments and experiences in the field of medical devices
p.000004: and introduce procedures to improve them.
p.000004: (4) The application shall also be accompanied by the preparation of technical documentation, which shall enable the conformity assessment of the medical device
p.000004: means containing the following information:
p.000004: a) a general inventory of medical devices, a specification of the project, including the standards used and
p.000004: result of risk analysis;
p.000004: b) nactre plans, description of manufacturing processes, description of medical components and ancillaries
p.000004: funds;
p.000004: c) the responsibility of the leading staff and their authority during the design of the medical device;
p.000004: d) methods of monitoring the quality system applied;
p.000004: e) a description of the sterilization methods used in the case of sterile products and the results of the tests;
p.000004: f) the proof for the medical device fulfills the essential requirements in case it is connected to another medical device s
p.000004: characteristics specified by the manufacturer;
p.000004: g) clinical data where necessary in accordance with this Regulation;
p.000004: h) marking and instruction manual.
p.000004: (5) The certificate of conformity must contain the conclusions of the examination of the documentation and the reasoned assessment.
p.000004: (6) The costs of issuing the certificate of conformity shall be borne by the manufacturer of the medical device.
p.000004: Article 58
p.000004: (1) The Agency must, through the competent committee, establish a quality system and review whether the insurance systems are in place
p.000004: quality in accordance with accepted standards.
p.000004: (2) The Compliance Committee must have at least one member with experience in technological process evaluation.
p.000004: The composition of the committee is proposed by the entity Ministers of Health.
p.000004: (3) In the process of issuing a certificate of conformity, a certain type of medical device may also be requested by the Agency
p.000004: opinion of authorized institutions on the territory of BiH.
p.000004: (4) Based on the expert opinion of the competent commission, the Agency shall issue a certificate of conformity containing:
p.000004: a) administrative information on the medical device;
p.000004: b) a statement of compliance of the medical device;
...

p.000013: the conditions laid down by law, ie it is obliged to:
p.000013: a) Prior to commencement of the wholesale circulation of medical devices, report their activity to the Agency considering the application
p.000013: and maintains a register of legal entities engaged in the wholesale marketing of medical devices;
p.000013: b) carry out the activity in accordance with good practices and protection of public health in accordance with the Regulations on Good
p.000013: distribution-wholesale practice;
p.000013: c) Introduce quality assurance in the wholesale medical facility, which proves appropriate
p.000013: "ISO" quality system certificate issued by the competent certification bodies in BiH;
p.000013: d) Have an employed person responsible for the wholesale marketing of medical devices with at least VI level of education
p.000013: medical, pharmaceutical, dental, or other health care professional, having passed the professional examination
p.000013: and appropriate education in the field of medical devices, or other profession depending on the nature,
p.000013: purposes, uses and classes of medical devices;
p.000013: e) have a responsible person employed with at least a VI medical education course in monitoring and
p.000013: reporting adverse reactions in the administration and response to medical devices;
p.000013: f) must provide adequate space, installations and equipment, ensuring that it is properly maintained
p.000013: storage and marketing of medical devices;
p.000013: g) must keep appropriate documentation, by type and amount of medical devices, as well as classes, and therewith
p.000013: a way to allow the competent authority to keep records of medical devices in accordance with good distribution and wholesalers
p.000013: practice.
p.000013: Article 77
p.000013: (1) Wholesale medical supplies may be performed by:
p.000013: a) legal entities holding a certificate of entry in the register of wholesalers of medical devices issued by the Agency
p.000013: (wholesale of medical supplies);
p.000013: b) medical device manufacturers established in Bosnia and Herzegovina for those medical devices that produce i
p.000013: which are entered in the Register of Medical Devices.
p.000013: (2) Wholesalers may obtain medical supplies directly from medical device manufacturers, importers and
p.000013: other wholesale.
p.000013: (3) In addition to the general legal requirements, wholesalers of medical devices must meet special requirements
p.000013: in terms of space, equipment and staff.
p.000013: (4) The necessary rooms for smooth operation are:
p.000013: a) a room for receiving medical supplies;
p.000013: b) a room for the placement and dispensing of medical devices according to the types and volume of traffic, as well as their storage
p.000013: in accordance with the manufacturer's declared conditions;
p.000013: c) a room for the storage of medical supplies withdrawn from the market and storage of packaging;
p.000013: d) sanitary facilities;
p.000013: e) a dressing room or wardrobe;
p.000013: f) office.
p.000013: (5) The premises referred to in the preceding paragraph must satisfy the following conditions:
p.000013: a) they are housed in a solid material facility that is connected to the utility infrastructure (water supply,
p.000013: sewage, electricity and telephone network, etc.);
p.000013: b) are functionally integrated as a whole for the smooth running of the work process;
p.000013: c) that the walls, floors and ceilings are constructed in such a way as to enable efficient cleaning, hygienic maintenance and
...

p.000013: (4) The Agency shall consider only complete requests. A request is complete if it is made in accordance with the provisions of paragraph 1 of this
p.000013: ".
p.000013: (5) For incomplete applications, the Agency shall provide the applicant with an adequate deadline for supplementing, and in the event that
p.000013: the applicant does not complete the request within the deadline, the Agency will reject the request as formally incomplete.
p.000013: (6) Upon formally complete request of "GMP", the Agency's inspector shall supervise the fulfillment of the conditions related to personnel,
p.000013: premises and equipment and good wholesale practice in the wholesale facility, after which it shall attach a record of the established
p.000013: conditions, on the basis of which the certificate of entry in the register of the wholesaler of medical devices is issued or refuses the request.
p.000013: (7) The Agency shall, no later than 30 days after the receipt of the complete request, issue a certificate of entry in the Register
p.000013: majoring in medical devices and registering the applicant in the Register.
p.000013: (8) A certificate for entry in the Register of Medical Devices Wholesale, shall be issued for a period of 5 years.
p.000013: (9) The certificate referred to in the preceding paragraph shall be final in administrative proceedings and administrative proceedings may be instituted against it
p.000013: litigation with the competent court.
p.000013: (10) The applicant shall notify the Agency of any change in the data related to the entry in the Register, respectively
p.000013: changes in the documentation "referred to in paragraph (1) of this Article".
p.000013: (11) The Agency deletes legal entities from the Register of Major Medical Officers in the following cases:
p.000013: a) the decision of the competent authority that the legal person does not fulfill the conditions for performing the activity in accordance with the regulations;
p.000013: b) the applicant's written request;
p.000013: c) the termination of the legal person in the cases provided for by a special law.
p.000013: (12) A medical major transporter, by entry in the Register of Medical Major Transporters, acquires the right
p.000013: wholesale trade of medical devices.
p.000013: (13) The applicant shall bear the costs of issuing a certificate of entry in the Register of Medical Devices
p.000013: requests.
p.000013: Article 79
p.000013: (1) Major transporters and manufacturers of medical devices may sell medical devices:
p.000013: a) end users (health institutions, institutes, etc.);
p.000013: b) pharmacies and pharmacy depots;
p.000013: c) specialized retail stores for medical devices.
p.000013: (2) The Agency may, by a special act, specify individual medical devices or categories of medical devices
p.000013: assets, which may be found in free sale, except in the cases specified in
p.000013: "Paragraph 1 of this Article".
p.000013: (3) Only specialized medical devices may be sold in specialized stores and pharmacies
p.000013: Agencies entered in the register of medical devices.
p.000013: (4) Depending on the conditions specified in the certificate of entry in the Register of Medical Devices, medical devices shall be issued,
p.000013: that is, they are sold in pharmacies and specialty prescription stores or without prescriptions.
p.000013: (5) A person entitled to prescribe medicines and medical devices may not own or co-own a pharmacy or
p.000013: specialized stores "referred to in paragraph (1) of this Article".
p.000013: Article 80
p.000013: It is prohibited to market and market medicinal products:
p.000013: a) if they do not have a certificate of entry in the Register of Medical Devices issued by the Agency;
...

p.000013: (2) They authorize the importation of medical devices for humanitarian aid and for the purpose of clinical trial
p.000013: competent entity ministries of health and the Brcko District Health Department.
p.000013: Article 83
p.000013: Documentation for the importation of a medical device not entered in the Register of Medical Devices must
p.000013: contain:
p.000013: a) a completed application form for the importation of medical devices not registered in the medical register
p.000013: resources, compiled by the Agency and placed on its website;
p.000013: b) an invoice from the manufacturer or supplier with all the necessary information on the medical device, packaging,
p.000013: serial number, price and quantity;
p.000013: c) a statement of justification for the importation of the medical device and the purpose of importation on the end-user memorandum,
p.000013: signed by the director of the health or scientific institution for which the medical device is imported;
p.000013: d) Certificate of quality of the medical device imported by the manufacturer's authorized body
p.000013: ("EC certificate and / or Declaration of conformity");
p.000013: e) evidence of the agency fee paid for processing the submission and issuing consent for the importation of medical devices which
p.000013: not registered in the Register;
p.000013: f) proof of payment of the administrative fee.
p.000013: Article 84
p.000013: The customs authorities at the border crossing point through which imports of unregistered medical devices were carried out are obliged
p.000013: immediately upon importation inform the Agency, ie .. submit a copy of the consent certified by
p.000013: of the customs authority, and for the registered medical devices a copy of the proof of realized import.
p.000013: PART ELEVEN - ADVERTISING MEDICAL RESOURCES, MATERIOVIGILANCES AND DISPOSAL
p.000013: OUTSIDE OF MEDICINAL PRODUCTS
p.000013: Article 85
p.000013: (Advertising)
p.000013: (1) Reporting and advertising of medical devices shall be carried out in accordance with the Rules on Advertising of Medicines and
p.000013: medical devices.
p.000013: (2) The Agency shall inform the expert public about the medical devices that have been entered in the register:
p.000013: a) publication in the official gazettes of BiH, FBiH, RS and Brcko District at least once every three months;
p.000013: b) publication of the BiH Medical Device Registry, which ensures that the registry is accessible to the professional public;
p.000013: c) publication in the medical device database.
p.000013: (3) Agency and Entity Ministries of Health and the Brcko District Health Department through the public media
p.000013: may report to the general public on medical devices or activities carried out in connection with them, if so
p.000013: requires protection of public health.
p.000013: Article 86 (Materiovigilance)
p.000013: (1) The provisions of Art. 72 (1) of the Law relating to pharmacovigilance shall also apply mutatis mutandis
p.000013: medical means, or maternity care.
p.000013: (2) Adverse reactions of medical devices shall be regulated by the Ordinance on the method of collecting and monitoring unwanted ones
p.000013: the effects of drugs and medical devices.
p.000013: Article 87
p.000013: (Waste management)
p.000013: (1) The circulation of medical devices that are no longer in use or that are defective is not allowed.
p.000013: (2) Medical devices that are no longer in use shall be taken care of at the expense of the owner or legal or natural person at
p.000013: what medical device was found.
...

p.000013: 7. Modification of the finished product test procedure (modification of standards and methods)
p.000013: 8. Modification of the appearance and manner of marking the outer and / or inner packaging
p.000013: 9. Modification or supplementation of the shape, packaging or dimensions of the medical device
p.000013: 10. Modifying the class of medical device
p.000013: 11. Modification of the expiry date of the medical device
p.000013: 12. Modification of the storage conditions of the medical device
p.000013: 13. Modification of the manner and place of dispensing of the medical device
p.000013: 14. Other changes
p.000013: Pre-issued certificate number:
p.000013: MARK THE PROPOSAL STATUS
p.000013: Manufacturer MS, licensed for production in BiH (entered in the manufacturer's register)
p.000013: Foreign manufacturer representative Foreign manufacturer representative
p.000013: Wholesale legal entity (entered in the register of distributors)
p.000013: MEANS
p.000013: And the Class
p.000013: I Class - a sterile product
p.000013: I Class - measuring instrument
p.000013: CATEGORIES OF MEDICAL RESOURCES
p.000013: Appendix - 1
p.000013: Medical devices must be classified in only one category. Mark with a cross.
p.000013: IN THE CATEGORY OF MEDICAL RESOURCES
p.000013: 01 Active Surgical Implants
p.000013: 02 Anesthetic and Respiratory Medical Devices 03 Dental Medical Devices
p.000013: 04 Medical electro-mechanical means 05 Hospital equipment
p.000013: 06 "In vitro" diagnostic medical devices 07 Inactive surgical implants
p.000013: 08 Ophthalmic and Optical Medical Devices 09 Reusable Instruments
p.000013: 10 Disposables
p.000013: 11 Technical means for handicapped persons
p.000013: Diagnostic and therapeutic medical devices in radiology
p.000013: 13 Other medical devices
p.000013: CERTIFICATE DATA I
p.000013: TO THE COMPETENT AUTHORITY TO ASSIGN CONFORMITY
p.000013: Provide information on the notified body that issued the certificate of conformity for
p.000013: the procedure of sterilization or the measuring function of a medical device.
p.000013: Number of EC certificates:
p.000013: Name and identification number of the conformity assessment body:
p.000013: The certificate is valid until:
p.000013: DECLARATION OF THE PROPERTY'S RESPONSIBLE PERSON
p.000013: I, the undersigned, declare:
p.000013: - the registration dossier is authentic and that the class 1 medical device,
p.000013: which is covered by the application for entry in the Register of Medical Devices, meets the required regulations.
p.000013: I pledge to inform each Agency of Medicines and Medical Devices of Bosnia and Herzegovina immediately
p.000013: a modification regarding a medical device;
p.000013: - that I will monitor the side effects of medical devices and inform the competent authorities accordingly
p.000013: with regulations;
p.000013: - I have access to the registration documentation, which I submit to the Agency;
p.000013: - that the declared activity is carried out in such a way that public health protection is in accordance with the valid ones
p.000013: regulations;
p.000013: - that I will renew and submit to the Agency all certificates which have expired.
p.000013: Name, Surname and Name of the Responsible Person of the Applicant (Company Director) - printed Company Name:
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Name of responsible person (s) for:
p.000013: - the application for the medical device and the authenticity of the documentation submitted to obtain it
p.000013: certificates of registration of the medical device;
...

p.000013: 9. Modification or supplementation of the shape, packaging or dimensions of the medical device
p.000013: 10. Modifying the class of medical device
p.000013: 11. Modification of the expiry date of the medical device
p.000013: 12. Modification of the storage conditions of the medical device
p.000013: 13. Modification of the manner and place of dispensing of the medical device
p.000013: 14. Other changes
p.000013: Pre-issued certificate number:
p.000013: MARK THE PROPOSAL STATUS
p.000013: Manufacturer MS, licensed for production in BiH (entered in the manufacturer's register)
p.000013: REG-MS-KL FORM IIa, IIb, III
p.000013: Foreign manufacturer representative Foreign manufacturer representative
p.000013: Wholesale legal entity (entered in the register of distributors)
p.000013: MEANS
p.000013: IIa Class
p.000013: IIb Class - sterile product III Class - measuring instrument
p.000013: CATEGORIES OF MEDICAL RESOURCES
p.000013: Appendix - 1
p.000013: Medical devices must be classified in only one category. Mark with a cross.
p.000013: CODE 01
p.000002: 02
p.000003: 03
p.000004: 04
p.000005: 05
p.000006: 06
p.000007: 07
p.000008: 08
p.000009: 09
p.000010: 10
p.000011: 11
p.000012: 12
p.000013: 13
p.000013: CATEGORY OF MEDICAL RESOURCES
p.000013: Active surgical implants
p.000013: Anesthetic and Respiratory Medical Devices Dental Medical Devices
p.000013: Medical Electro-Mechanical Devices Hospital Equipment
p.000013: "In vitro" diagnostic medical devices Inactive surgical implants
p.000013: Ophthalmic and Optical Medical Devices Reusable Instruments Disposables
p.000013: Technical means for handicapped persons
p.000013: Diagnostic and therapeutic medical devices in radiology
p.000013: Other medical devices
p.000013: CERTIFICATE DATA I
p.000013: TO THE COMPETENT AUTHORITY TO ASSIGN CONFORMITY
p.000013: Provide information on the notified body that issued the certificate of conformity for
p.000013: the procedure of sterilization or the measuring function of a medical device.
p.000013: Number of EC certificates:
p.000013: Name and identification number of the conformity assessment body:
p.000013: The certificate is valid until:
p.000013: REG-MS-KL FORM IIa, IIb, III
p.000013: DECLARATION OF THE PROPERTY'S RESPONSIBLE PERSON
p.000013: I, the undersigned, declare:
p.000013: - that the attached registration dossier is authentic and that the class IIa medical device, which
p.000013: is covered by the application for entry in the Register of Medical Devices, meets the required regulations. I pledge to
p.000013: I will immediately notify the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina of any changes to the
p.000013: by medical means;
p.000013: - that I will monitor the side effects of medical devices and inform the competent authorities accordingly
p.000013: with regulations;
p.000013: - I have access to the registration documentation, which I submit to the Agency;
p.000013: - that the declared activity is carried out in such a way that public health protection is in accordance with the valid ones
p.000013: regulations;
p.000013: - that I will renew and submit to the Agency all certificates which have expired.
p.000013: Name, Surname and Name of the Responsible Person of the Applicant (Company Director) - printed Company Name:
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Name of responsible person (s) for:
p.000013: - the application for the medical device and the authenticity of the documentation submitted to obtain it
...

p.000013: 7. Modification of the finished product test procedure (modification of standards and methods)
p.000013: 8. Modification of the appearance and manner of marking the outer and / or inner packaging
p.000013: 9. Modification or supplementation of the shape, packaging or dimensions of the medical device
p.000013: 10. Modifying the class of medical device
p.000013: 11. Modification of the expiry date of the medical device
p.000013: 12. Modification of the storage conditions of the medical device
p.000013: 13. Modification of the manner and place of dispensing of the medical device
p.000013: 14. Other changes
p.000013: Pre-issued certificate number:
p.000013: FORM REG-IV-MS
p.000013: MARK THE PROPOSAL STATUS
p.000013: Manufacturer MS, licensed for production in BiH (entered in the manufacturer's register) Representative of a foreign manufacturer
p.000013: Representative of a foreign manufacturer
p.000013: Wholesale legal entity (entered in the register of distributors)
p.000013: MEANS
p.000013: List A products
p.000013: List B Products List C Products List D Products
p.000013: CATEGORIES OF MEDICAL RESOURCES
p.000013: Appendix - 1
p.000013: Medical devices must be classified in only one category. Mark with a cross.
p.000013: IN THE CATEGORY OF MEDICAL RESOURCES
p.000013: 01 Active Surgical Implants
p.000013: 02 Anesthetic and Respiratory Medical Devices 03 Dental Medical Devices
p.000013: 04 Medical electro-mechanical means 05 Hospital equipment
p.000013: 06 "In vitro" diagnostic medical devices 07 Inactive surgical implants
p.000013: 08 Ophthalmic and Optical Medical Devices 09 Reusable Instruments
p.000013: 10 Disposables
p.000013: 11 Technical means for handicapped persons
p.000013: Diagnostic and therapeutic medical devices in radiology
p.000013: 13 Other medical devices
p.000013: CERTIFICATE DATA I
p.000013: TO THE COMPETENT AUTHORITY TO ASSIGN CONFORMITY
p.000013: Provide information on the notified body that issued the certificate of conformity for
p.000013: the procedure of sterilization or the measuring function of a medical device.
p.000013: Number of EC certificates:
p.000013: Name and identification number of the conformity assessment body:
p.000013: The certificate is valid until:
p.000013: FORM REG-IV-MS
p.000013: DECLARATION OF THE PROPERTY'S RESPONSIBLE PERSON
p.000013: I, the undersigned, declare:
p.000013: - that the attached registration dossier is authentic and "in vitro" diagnostic
p.000013: the medical device, which is included in the application for entry in the Register of Medical Devices, corresponds to the required
p.000013: regulations. I pledge to the Agency for Medicines and Medical Devices of Bosnia and Herzegovina immediately
p.000013: communicate any changes to the medical device;
p.000013: - that I will monitor the side effects of medical devices and inform the competent authorities accordingly
p.000013: with regulations;
p.000013: - I have access to the registration documentation, which I submit to the Agency;
p.000013: - that the declared activity is carried out in such a way that public health protection is in accordance with the valid ones
p.000013: regulations;
p.000013: - that I will renew and submit to the Agency all certificates which have expired.
p.000013: Name, Surname and Name of the Responsible Person of the Applicant (Company Director) - printed Company Name:
p.000013: Signature: Date:
p.000013: Company seal:
p.000013: Name of responsible person (s) for:
p.000013: - the application of the medical device and the authenticity of the submitted documentation for the purpose of obtaining it
...

Orphaned Trigger Words

p.000004: d) conception controls.
p.000004: (2) In vitro diagnostic medical devices include reagents, reagent kits, reagent products,
p.000004: control and calibration materials, instruments and appliances, equipment or system used
p.000004: alone or in combination with another medicinal product intended for use in vitro,
p.000004: for testing biological samples, including tissue samples obtained from the human body, to obtain data:
p.000004: a) physiological or pathological conditions;
p.000004: b) congenital anomalies;
p.000004: c) the safety and compatibility of potential transplant recipients;
p.000004: d) information required to monitor therapeutic effects.
p.000004: (3) An aid, by definition, not a medical device, which means a product which, in combination with
p.000004: medical device enables the medical device to function in accordance with its purpose.
p.000004: (4) A custom-made medical device for a particular user is that medical device that is made in
p.000004: as instructed by the appropriate expert;
p.000004: (5) A medical device intended for clinical trial is a product and a medical device
p.000004: clinical trial workers.
p.000004: (6) A medical device in or on a human body does not show efficacy based on its own
p.000004: pharmacological, immunobiological, or metabolic properties, but may or may assist in its function
p.000004: backed by products that act this way.
p.000004: (7) The provisions of this Ordinance shall not apply to:
p.000004: a) a) medical devices containing blood products;
p.000004: b) transplant, tissues or cells of human or animal origin (except non-living animal
p.000004: tissue);
p.000004: c) personal protective equipment in accordance with the regulations.
p.000004: PART TWO - CLASSIFICATION AND CLASSIFICATION OF MEDICAL RESOURCES
p.000004: Article 4
p.000004: (1) Medical devices shall be classified according to the degree of risk for the user to:
p.000004: a) Class I - low-risk medical devices;
p.000004: b) Class IIa - higher risk medical devices;
p.000004: c) Class IIb - high risk medical devices;
p.000004: d) Class III - highest risk medical devices.
p.000004: (2) Medical devices, by their nature, are related to the source of energy, and to other properties
p.000004: classified into:
p.000004: a) non - invasive medical devices (which are not in contact with the user or are only in contact with
p.000004: intact skin);
p.000004: b) invasive medical devices (penetrating the body through skin, natural or artificial openings);
p.000004: c) active medical devices (used separately or in combination with other medical devices)
p.000004: means and provide information for the detection of irregularities, diagnosis, monitoring or treatment of physiological disorders, diseases
p.000004: or congenital anomalies).
p.000004: (3) Medical devices shall be classified according to the length of their application in or on the human body:
p.000004: a) transitory / transient - continuous applications for a period of less than 60 minutes;
p.000004: b) short-term - continuously applied for up to 30 days;
p.000004: c) long-lasting - continuously applied for more than 30 days.
p.000004: (4) In vitro diagnostic medical devices shall be classified into:
p.000004: a) In vitro diagnostic medical devices that are used only by skilled personnel and which are by type
p.000004: divide the funds into lists A and B;
p.000004: b) In vitro diagnostic medical devices for self-diagnosis (List C);
p.000004: c) All other In vitro diagnostic medical devices (list D).
p.000004: (5) According to the manner and place of issue, medical devices shall be classified into:
p.000004: a) Prescription / ordered medical supplies only in pharmacies and specialized
p.000004: stores;
p.000004: b) over-the-counter medical supplies only in pharmacies and specialty stores;
p.000004: c) prescription drugs / orders at hospital pharmacies;
p.000004: d) over-the-counter medical supplies. ...

p.000004: hereditary diseases (phenylketonuria);
p.000004: 5) reagents and reagent products, as well as control and calibration materials for human determination
p.000004: infection (cytomegalovirus, chlamydia);
p.000004: 6) reagents and reagent products, as well as control and calibration materials for the determination of "HLA"; -
p.000004: tissue groups ("DR, A, B");
p.000004: 7) reagents and reagent products, as well as control and calibration materials for control
p.000004: tumor marker materials ("PSAs");
p.000004: 8) reagents and reagent products, as well as control and calibration materials and software, to determine specificity
p.000004: hereditary risk of trisomy 21.
p.000004: c) List of C-Diagnostics for self-testing, with accessories for
p.000004: self-diagnosis, as well as control and calibration materials (measuring instruments for sugar and the like).
p.000004: d) List D-all other diagnostic tools.
p.000004: Article 6
p.000004: (1) Special-purpose medical devices include:
p.000004: a) custom made medical devices for an individual user;
p.000004: b) medical devices intended for clinical trials;
p.000004: c) medical devices intended for scientific research and development.
p.000004: (2) The documentation for special purpose medical devices shall be submitted in the same manner as the documentation for all
p.000004: medical devices, with the addition of a special purpose statement according to the type of purpose.
p.000004: PART THREE - RULES FOR THE CLASSIFICATION OF MEDICAL RESOURCES CHAPTER I - GENERAL RULES
p.000004: Article 7
p.000004: Rules for the classification of medical devices are based on the conditions set out in Art. 2, 4, i
p.000004: 5 of this Ordinance, according to which medical devices are classified in relation to:
p.000004: a) the duration of contact with the user;
p.000004: b) the degree of risk to the user;
p.000004: c) degree of invasiveness;
p.000004: d) the purpose of the medical device;
p.000004: e) place of application;
p.000004: f) the manner of use of the medical device.
p.000004: Article 8
p.000004: (1) The application of the rules for the classification of medical devices depends on the purpose of the medical device.
p.000004: (2) In the case of a medical device intended for use in combination with another medical device,
p.000004: the classification rules apply to each product separately.
p.000004: (3) Software that enables or interferes with the operation of a medical device shall automatically fall into the same
p.000004: class.
p.000004: (4) Where the medical device is not intended for use solely or principally on a particular part
p.000004: bodies, are categorized as those at highest risk, that is, using the strictest rules
p.000004: sorting.
p.000004: (5) In the event that the same medical devices are subject to several rules, with regard to the purpose and the mode of action it states
p.000004: the manufacturer applies the strictest rules that result in classification into a higher class of medical devices.
p.000004: CHAPTER II - CLASSIFICATION OF NON-INVASIVE MEDICINAL PRODUCTS
p.000004: Article 9
p.000004: (RULE 1 - Medicinal products not in contact with the user or in contact with only intact skin)
p.000004: Non-invasive medical devices, if any of the following apply, are classified into:
p.000004: Class I, such as:
p.000004: 1) medical devices for taking fluid from the body eg: bottles or bags for taking urine, a “stoma” bag,
p.000004: incontinence cartridges and the like;
p.000004: 2) medical devices used to immobilize body parts; eg gypsum, longets, compression
p.000004: socks and the like;
p.000004: 3) medical devices needed for external assistance to the patient; eg: hospital beds, supplies for
p.000004: walking, wheelchairs, stretchers, dental chairs and the like;
p.000004: 4) correction glasses, frames, prescription glasses, stethoscope, surgical covers, contact and conductive
p.000004: gels, non-invasive electrodes, computer image processing equipment and the like.
p.000004: Article 10
p.000004: (RULE 2 - Medical Devices for Guidance and Preservation of Substances)
p.000004: (1) Medical devices used to direct (conduct) and store substances, blood, organs, body parts,
p.000004: body fluids or tissues, fluids and infusion gases are classified in:
p.000004: Class IIa, such as:
p.000004: 1) medical devices for directing (conducting) blood in transfusion;
p.000004: 2) medical devices for temporary storage and transportation of organs for transplantation or processing;
p.000004: 3) medical agents for long-term storage of biological substances such as: cornea, sperm, tissues and the like. ...

p.000004: declared use specified by the manufacturer.
p.000004: Article 35
p.000004: (1) A clinical trial of medical devices is to determine or confirm the safety of a medical device
p.000004: assets, its effectiveness and compliance with the general and specific requirements as intended
p.000004: manufacturer.
p.000004: (2) Adverse reactions and clinical trials of medical devices are governed by the Ordinance on adverse reactions and
p.000004: Clinical Trials Regulations.
p.000004: Article 36
p.000004: (1) The control of the quality of medical devices implies the determination of the prescribed quality of such devices in accordance with these
p.000004: Rulebook and Law.
p.000004: (2) The quality of a medical device shall be determined by regular, special, systematic and extraordinary control
p.000004: in accordance with the provisions of this Ordinance and the Act.
p.000004: (3) The control "referred to in paragraph (2) of this Article" may be ordered by an authorized person in accordance with the Law.
p.000004: PART SEVEN - CONFIRMATION OF CONFORMITY AND LABELING OF MEDICAL RESOURCES
p.000004: CHAPTER I - GENERAL ABOUT CONSISTENCY
p.000004: Article 37
p.000004: (1) The procedure for determining the conformity of a medical device with the general and special requirements of the Act is the procedure by which
p.000004: it is directly or indirectly determined whether the medical device meets the requirements prescribed by the General Law
p.000004: product safety, the Product Technical Requirements and Conformity Assessment Act, and
p.000004: regulations made on the basis of the aforementioned laws.
p.000004: (2) The procedure for determining the conformity of a medical device with general and specific requirements depends on the classification
p.000004: medical device according to the degree of risk, as follows:
p.000004: a) for Class I medical devices - the manufacturer himself assesses the conformity of the product with the general and specific ones
p.000004: makes a statement or certificate on its own responsibility. The exception is class medical devices
p.000004: And which are used for measuring and sterile matching products, which means treated as s
p.000004: Class IIa, Ilb and III medical devices for measuring their sterility;
p.000004: b) for Class IIa, IIb and III medical devices - the approved institutions shall determine the compliance of the medical device with
p.000004: prescribed general and specific requirements, as well as oversight of the quality assurance system.
p.000004: (3) In cases where conformity assessment of certain types of medical devices is not performed by authorized persons
p.000004: institutions within the meaning of the Technical Conditions for Products and Conformity Assessment Act,
p.000004: the conformity assessment will be provided by the Medical Devices Commission on the approval of the Professional
p.000004: Council, and upon the proposal of the Director of the Agency. (4) In accordance with existing regulations, the Minister of Civil Affairs
p.000004: BiH, at the proposal of the Expert Council, establishes requirements for conformity assessment of a particular type of medical device
p.000004: funds with general and special requirements pursuant to the Law and by-laws "referred to in paragraph (1) of this Article", procedure
p.000004: the labeling of the medical device, as well as the contents of the certificate of conformity of the medical device.
p.000004: Article 38
p.000004: (Medical labeling)
p.000004: (1) On the basis of the certificate of conformity, the manufacturer of the medical device is obliged to label his product
p.000004: the prescribed conformity marking. ...

p.000004: (1) The statement of conformity is the statement by which the manufacturer confirms the implementation of the quality assurance system in the process
p.000004: the design, manufacture or part of the manufacture, manufacture, packaging, labeling, use or
p.000004: use, or statement that the medical device meets the prescribed requirements of this regulation.
p.000004: (2) Quality elements must be identified and documented for each production and marketing phase, and for sterile ones
p.000004: product and for the sterilization phase.
p.000004: Section A. - General requirements
p.000004: Article 42
p.000004: Medical devices must be:
p.000004: a) designed and constructed so that, if used under the conditions specified by the manufacturer, no
p.000004: endangering the clinical condition and safety of users and others;
p.000004: b) an acceptable relationship between benefits and risks;
p.000004: a) c) effective, efficient and safe for the user as stated by the manufacturer;
p.000004: c) designed and packaged so that they are fit for use, with or without risk elimination
p.000004: minimization;
p.000004: d) created with acceptable safeguards, including the introduction of a non-existent risk alarm
p.000004: eliminate.
p.000004: Article 43
p.000004: (1) In the manufacturing process, manufacturers must respect scientific and technical developments in the field of medical
p.000004: means, subject to the following principles:
p.000004: a) that the efficacy of medical devices must not be influenced by other factors that may compromise the clinical
p.000004: the condition and safety of users or other persons within the shelf life under the prescribed conditions of storage, traffic and
p.000004: use;
p.000004: b) safeguards are acceptable, including the introduction of a non-eliminable risk alarm;
p.000004: c) informing users and other persons of possible risks that cannot be eliminated as protective
p.000004: measures.
p.000004: (2) Medical devices must be formulated, designed, created and packaged in accordance with the provisions of “paragraph
p.000004: 1 of this Article ", so that their properties and effectiveness are fully preserved until the indicated shelf life, and
p.000004: that they are not adversely affected by other means with which they come into contact in the process of transport, storage, transport
p.000004: or use.
p.000004: (3) The degree of risk of all undesirable and harmful effects of medical devices must be acceptable in relation
p.000004: to the intended purpose and purpose of use specified by the manufacturer.
p.000004: (4) The manufacturer or distributor shall be obliged to report to the Agency any undesirable and harmful activity observed
p.000004: medical device.
p.000004: (5) It is the obligation of manufacturers, distributors and healthcare institutions to monitor undesirable and harmful actions
p.000004: medical devices and to report them to the Agency.
p.000004: Section B. - Special Requirements
p.000004: Article 44
p.000004: Medical devices must meet specific requirements:
p.000004: a) with respect to the chemical, physical and biological properties of the medical devices;
p.000004: b) in relation to the microbiological quality of the medical devices;
p.000004: c) in relation to the environment;
p.000004: d) medical devices with measuring function;
p.000004: e) with respect to radiation protection;
p.000004: f) medical devices connected to the energy source;
p.000004: g) active medical devices that are incorporated into the body;
p.000004: h) in relation to the labeling of medical devices and the package leaflet.
p.000004: Article 45
p.000004: (Chemical, physical and biological properties of medical devices)
p.000004: Medical devices with regard to chemical, physical and biological properties must be:
p.000004: a) effective and safe for the user and therapist;
p.000004: b) compatible with the biological tissues, cells and body fluids with which they come in contact;
p.000004: c) non-toxic or acceptable toxicity with respect to the purpose and purpose of use;
p.000004: d) non-flammable and usable as intended;
p.000004: e) formulated, manufactured and packaged so that they can be safely used in relation to materials and gases
p.000004: with whom they come in contact during use; ...

p.000004: d) created and sterilized by an appropriately validated method for sterile conditions;
p.000004: e) packaged in packagings of appropriate quality so that protection against microbiological is assured
p.000004: contamination at all stages, from production to use;
p.000004: f) marked on the packaging or label so as to distinguish between sterile and non-sterile products.
p.000004: (2) The Agency must keep information on the origin of the animals and the certificates of tissue quality contained in the medical
p.000004: funds, or forms a major part of it.
p.000004: (3) Procedures for the processing, storage, testing and treatment of animal tissues, cells and substances
p.000004: origins must be carried out in such a way as to ensure optimal security, especially with regard to virus infection and transmission
p.000004: other causative agents.
p.000004: (4) Production procedures must include viral inactivation methods and other necessary methods.
p.000004: Article 47
p.000004: (Environmental Requirements for Medical Devices)
p.000004: (1) If the medical device is intended to be used in combination with another device or equipment, the system
p.000004: quality must ensure overall efficiency and security.
p.000004: (2) All restrictions on use must be indicated on the packaging or in the instructions for use.
p.000004: (3) Medical devices must be designed to eliminate or minimize:
p.000004: a) the risk of injury related to their physical properties;
p.000004: b) the risk associated with foreseeable environmental conditions, such as magnetic field, external electrical influences,
p.000004: electrostatic discharge, pressure, temperature or changes in pressure or acceleration;
p.000004: c) the risk of interaction with other medical devices commonly used in the code
p.000004: testing or performing treatment;
p.000004: d) the risk arising from the inability to maintain or calibrate medical devices.
p.000004: (4) Medical devices must be designed so that there is a risk of fire or explosion, under conditions
p.000004: their use in accordance with the declared use of the manufacturer, as well as in the conditions of error made
p.000004: when used, minimized.
p.000004: (5) Particular attention should be paid to medical devices that are exposed to combustibles during use
p.000004: substances or materials that can cause burns.
p.000004: Article 48
p.000004: (Measuring Instruments)
p.000004: (1) Medical devices with a measuring function must be designed to ensure satisfactory accuracy
p.000004: and stability within the limits specified by the manufacturer.
p.000004: (2) The manufacturer must specify the limits of accuracy of the measuring functions.
p.000004: (3) The measurement, monitoring on the monitor and the scale on the screen shall be designed in accordance with the function, purpose
p.000004: and use of a medical device.
p.000004: (4) Measurements performed by a medical device with a measuring function must be expressed in units of measure which are
p.000004: adopted in Bosnia and Herzegovina.
p.000004: Article 49
p.000004: (Radiation protection)
p.000004: (1) Medical devices must be designed so that the exposure of users and other persons to radiation is reduced to
p.000004: to a minimum, without limitation for therapeutic and diagnostic purposes.
p.000004: (2) From the aspect of medical device application, radiation exposure may be intentional or unintentional.
p.000004: (3) Protection against intentional radiation exposure:
p.000004: a) where medical devices are formulated to emit the dangerous amounts of radiation required
p.000004: for treatment or diagnosis (where there are greater risks than risks), the user must be allowed to control
p.000004: the amount of radiation;
p.000004: b) the design and manufacture of these medical devices must ensure the reproducibility and tolerability of significant variables
p.000004: constants;
p.000004: c) where the medical devices are intended to radiate a potentially dangerous visible or
p.000004: invisible radiation, they must be provided with shelter or warning systems for that radiation, if possible.
p.000004: (4) Inadvertent radiation protection:
p.000004: a) Medical devices must be formulated and created in such a way that the exposure of users and other persons is unintentional
p.000004: or scattered radiation to a minimum;
p.000004: b) the instructions for use of the medical device which radiates (ionizing rays) must have accurate and verified information on:
p.000004: 1) the nature of the radiation;
p.000004: 2) means for protection of users and other persons;
p.000004: 3) ways to prevent misuse of the product due to radiation;
p.000004: 4) ways to eliminate risk when using the product.
p.000004: (5) In addition to the requirements of paragraph (2) and (3) of this Article, medical devices emitting ionizing rays,
p.000004: according to their purpose must be:
p.000004: a) formulated and created to ensure control of the quantity, direction and quality of radiation;
p.000004: b) intended for diagnostic radiology, formulated and designed to achieve
p.000004: corresponding to the quality of the image or text while minimizing the exposure of users and others;
p.000004: c) intended for therapeutic radiology, formulated and designed to allow safe monitoring and
p.000004: monitoring of received radiation dose, type of air and energy, and in some cases quality
p.000004: radiation.
p.000004: Article 50
p.000004: (Requirements for medical devices related to energy source)
p.000004: (1) Medical devices that are associated with an energy source must also meet specific requirements with respect to theirs
p.000004: application, namely:
p.000004: a) Medical devices incorporating programmable electronic systems must
p.000004: be designed to ensure the reproducibility, safety and efficiency of these systems in use; ...

p.000004: (2) With respect to quality system monitoring, methods and procedures must be devised for effective system monitoring
p.000004: quality and its application at all stages of production, in particular for sterile medical devices, sterilization methods and
p.000004: packaging as well as labeling the same.
p.000004: (3) The Agency periodically checks the implementation of the approved quality system to determine whether the manufacturer complies with it
p.000004: approved quality system and to maintain and work to improve it.
p.000004: (4) The Agency may also unannounced the manufacturer's control and conformity assessment and, if necessary, may carry out
p.000004: or request tests, to check that the quality system is working, with which the manufacturer must submit
p.000004: test report conducted with the finding.
p.000004: Article 63
p.000004: (1) Changes to the quality system must be re-approved by the body which approved the quality system, respectively
p.000004: of the conformity assessment body.
p.000004: (2) The manufacturer must inform the body which has approved the quality system or the determining body
p.000004: of the issuing certificate of conformity on any changes and deviations from the approved
p.000004: quality system.
p.000004: (3) The Agency shall take a decision on the acceptance of the approved quality system or its evaluation.
p.000004: PART EIGHT - CATEGORIES OF MEDICAL RESOURCES
p.000004: Article 64
p.000004: (1) Each medical device must be classified in only one category.
p.000004: (2) The classification of a medical device into a category shall be done by starting with the above category and continuing
p.000004: down as indicated on the table.
p.000004: (3) The categories of medical devices, code-marked, are presented in the table below with an orderly series of
p.000004: 01 to 13 according to the degree of risk and method of administration.
p.000004: CODE
p.000001: 01
p.000002: 02
p.000003: 03
p.000004: 04
p.000005: 05
p.000006: 06
p.000007: 07
p.000008: 08
p.000009: 09
p.000010: 10
p.000011: 11
p.000012: 12
p.000013: 13
p.000013: Description of categories of medical devices
p.000013: Active surgical implants
p.000013: Anesthetic and Respiratory Medical Devices Dental Medical Devices
p.000013: Medical Electromechanical Equipment Hospital Apparatus
p.000013: In vitro diagnostic medical devices Inactive surgical implants
p.000013: Ophthalmic and Optical Medical Devices Reusable Instruments
p.000013: Disposable means Technical means for handicapped persons
p.000013: Diagnostic and therapeutic medical devices in radiology Other medical devices
p.000013: PART NINE - CONDITIONS FOR ENTRY OF MEDICAL FACILITIES IN THE REGISTER
p.000013: Article 65
p.000013: (1) The Agency shall keep a register of manufacturers and legal entities engaged in wholesale marketing of medical devices
p.000013: as well as a register of medical devices on the market in BiH.
p.000013: (2) At the proposal of the Director of the Agency, the Expert Council shall prescribe the contents of the register of manufacturers and legal entities
p.000013: who trade wholesale medical supplies, as well as the registry of medical supplies that are
p.000013: in BiH, and the availability of the registry.
p.000013: (3) Upon the proposal of the Expert Council, the Minister of Civil Affairs of BiH shall prescribe the contents of the documentation and
p.000013: the procedure for reporting the wholesale and distribution of medical devices and the process of verifying them.
p.000013: The amount of costs of entry in the register of legal entities that
p.000013: carry out the activity of production and wholesale trade, that is, the entry of a medical device in the register, the Council prescribes
p.000013: Ministers of BiH at the proposal of the Director of the Agency.
p.000013: (4) Registration of a medical device in the Register is an administrative procedure carried out by the Agency for the purpose of records
p.000013: medical devices on the market in BiH for the protection of public health.
p.000013: (5) The application for entry in the Register of Medical Devices shall be submitted by the medical device manufacturer established in
p.000013: BiH or a legal entity representing a foreign manufacturer and having its seat in BiH
p.000013: (6) The manufacturer's representative is obliged to have the manufacturer's authorization or a registered contract of representation
p.000013: Ministry of Foreign Trade and Economic Relations of BiH.
p.000013: (7) The manufacturer or his authorized representative must provide complete information on liability insurance
p.000013: manufacturer for possible damage to the user of a medical device that is valid in the territory of BiH.
p.000013: (8) By entering medical devices in the Register, the applicant acquires the right to place them on the market
p.000013: Of Bosnia and Herzegovina.
p.000013: (9) The Agency shall decide on the entry of a medical device in the register of medical devices by a certificate of entry in
p.000013: The registry, which is required to issue within 90 days of receipt of a complete request. Against this one
p.000013: confirmation is not allowed, but an administrative dispute can be initiated.
p.000013: (10) Manufacturers, distributors and healthcare institutions are obliged to report to the Agency any undesirable findings
p.000013: or the adverse effect of medical devices in accordance with the conditions prescribed by this Ordinance and the Act.
p.000013: Article 66
p.000013: (1) The Agency shall only consider formally complete requests.
p.000013: (2) A formally complete request implies:
p.000013: a) completed a special application form for entry in the Register of Medical Devices of the appropriate class
p.000013: together with Form Appendix 1;
p.000013: b) complete documentation required for obtaining a certificate of entry in the Register of Medical Devices. ...

p.000013: (5) A person entitled to prescribe medicines and medical devices may not own or co-own a pharmacy or
p.000013: specialized stores "referred to in paragraph (1) of this Article".
p.000013: Article 80
p.000013: It is prohibited to market and market medicinal products:
p.000013: a) if they do not have a certificate of entry in the Register of Medical Devices issued by the Agency;
p.000013: b) if they are manufactured by a legal entity that is not registered with the Agency in the Register of Medical Manufacturers
p.000013: funds;
p.000013: c) they do not have adequate quality documentation;
p.000013: d) if they are not marked in accordance with the provisions of this Ordinance;
p.000013: e) if their expiry date stated on the packaging has expired or if their defect is found
p.000013: prescribed quality.
p.000013: Article 81
p.000013: (Import & Export)
p.000013: (1) Medical devices for which a certificate of entry in the Register of Medical Devices in BiH has been issued may be imported without
p.000013: the Agency's specific approvals.
p.000013: (2) Imports of medical devices not entered in the Register shall be made on the basis of the Agency's approval for
p.000013: import.
p.000013: (3) Applicants for the import of medical devices referred to in the previous paragraph may be:
p.000013: a) legal entities registered in the Registry of a wholesaler of medical devices kept by the Agency;
p.000013: b) health facilities;
p.000013: c) natural persons, if they import medical devices at the proposal of a healthcare institution, for the needs of an individual
p.000013: treatment.
p.000013: (4) The Agency may require control of the sample of any imported medical device, if it is in the interest of health or
p.000013: ensuring the required quality of the medical device.
p.000013: (5) The applicant shall bear the costs of issuing the consent for import of medical devices "referred to in paragraph (2) of this Article".
p.000013: (6) The export of medical devices shall be made only with the verification of the submitted application for export, without a special issuing procedure
p.000013: approval of the Agency for the purpose of collecting statistics on realized exports from Bosnia and Herzegovina.
p.000013: Article 82
p.000013: (1) The Agency shall issue approvals for the importation of medical devices not registered in the following cases:
p.000013: a) if it is urgently necessary to import the medical devices necessary for the operation of the hospital, clinic, clinical center
p.000013: or institute;
p.000013: b) if it is urgently necessary to import medical devices necessary for individual treatment, at the suggestion of a healthcare provider
p.000013: institutions;
p.000013: c) if intended for scientific research work, except for clinical trials.
p.000013: (2) They authorize the importation of medical devices for humanitarian aid and for the purpose of clinical trial
p.000013: competent entity ministries of health and the Brcko District Health Department.
p.000013: Article 83
p.000013: Documentation for the importation of a medical device not entered in the Register of Medical Devices must
p.000013: contain:
p.000013: a) a completed application form for the importation of medical devices not registered in the medical register
p.000013: resources, compiled by the Agency and placed on its website;
p.000013: b) an invoice from the manufacturer or supplier with all the necessary information on the medical device, packaging,
p.000013: serial number, price and quantity;
p.000013: c) a statement of justification for the importation of the medical device and the purpose of importation on the end-user memorandum,
p.000013: signed by the director of the health or scientific institution for which the medical device is imported; ...

Appendix

Indicator List

Indicator	Vulnerability
HIV	HIV/AIDS
access	Access to Social Goods
authority	Relationship to Authority
conviction	Religion
dependent	Dependent
disability	Mentally Disabled
drug	Drug Usage
education	education
gender	gender
influence	Drug Usage
language	Linguistic Proficiency
opinion	philosophical differences/differences of opinion
party	political affiliation
property	Property Ownership
single	Marital Status
socialXwelfare	Access to Social Goods
substance	Drug Usage
union	Trade Union Membership

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
access	['socialXwelfare']
drug	['influence', 'substance']
influence	['drug', 'substance']
socialXwelfare	['access']
substance	['drug', 'influence']

Trigger Words

consent

protect

protection

risk

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	political affiliation	party	3
Health	Drug Usage	drug	7
Health	Drug Usage	influence	1
Health	Drug Usage	substance	1
Health	HIV/AIDS	HIV	2
Health	Mentally Disabled	disability	2
Social	Access to Social Goods	socialXwelfare	1
Social	Access to Social Goods	access	3
Social	Linguistic Proficiency	language	2
Social	Marital Status	single	3
Social	Property Ownership	property	3
Social	Religion	conviction	1
Social	Trade Union Membership	union	10
Social	education	education	3
Social	gender	gender	1
Social	philosophical differences/differences of opinion	opinion	3
General/Other	Dependent	dependent	1
General/Other	Relationship to Authority	authority	8

Regulation about Medical Devices (2010)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / political affiliation

Health / Drug Usage

Health / HIV/AIDS

Health / Mentally Disabled

Social / Access to Social Goods

Social / Linguistic Proficiency

Social / Marital Status

Social / Property Ownership

Social / Religion

Social / Trade Union Membership

Social / education

Social / gender

Social / philosophical differences/differences of opinion

General/Other / Dependent

General/Other / Relationship to Authority

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input