LAW OF THE KYRGYZ REPUBLIC

of August 2, 2017 No. 166

About the address of medical products

Accepted by Jogorku Kenesh of the Kyrgyz Republic on June 21, 2017

Chapter 1. General provisions

Article 1. Regulation subject in the sphere of the address of medical products

Subject of regulation of this Law are the relations in the sphere of the address of medical products for the purpose of ensuring efficiency, safety of production, production, storage, realization, utilization of medical products.

Article 2. Legislation on medical products

1. The legislation of the Kyrgyz Republic in the sphere of the address of medical products consists of this Law, other regulatory legal acts of the Kyrgyz Republic and come in the procedure established by the law into force of international treaties which participant is the Kyrgyz Republic.

2. Operation of this Law does not extend on:

1) cosmetic products;

2) individual remedies;

3) human blood and its components, products from human blood;

4) the medical products containing or made using fabrics, cages, blood and its components of human origin;

5) living tissues and cages of animal origin, intended for transplantation, except for the medical products made of impractical fabrics of animal origin or with their use.

Article 3. The basic concepts used in this Law

For the purposes of this Law the following basic concepts are used:

1) release into the stream of commerce of medical products - any paid or voluntary conveyance of medical products which is performed for the first time and makes them available for distribution and (or) application, except for transfers of medical products for carrying out researches (testing) for the purpose of their subsequent realization and application;

2) the State register of medical products of the Kyrgyz Republic (further - the Register) - the official electronic document of accounting of the registered medical products in the Kyrgyz Republic;

3) the instruction on medical application of medical products - the document intended for specialists of health sector, constituted by the producer of medical product about its proper application and the address and containing the description of medical product;

4) medical products - any tools, devices, devices, the equipment, materials and other products which are applied in the medical purposes separately or in combination among themselves, and also with the accessories necessary for application of the specified products to destination (including the special software), intended by the producer for prevention, diagnostics, treatments of diseases, medical rehabilitation and monitoring of condition of organism, carrying out medical researches, recovery, replacement, change of anatomical structure or physiological functions of organism, prevention or termination of pregnancy which functional value is not implemented by pharmacological, immunological, genetic or metabolic impact on human body;

5) medical products for diagnostics of in vitro - any tools, devices, devices, the equipment, materials, reagents, calibrators, control materials and other products applied in the medical purposes separately or in combination among themselves and also together with the accessories necessary for application of the specified products to destination, including the special software, information of rather physiological or pathological condition, congenital pathology, predisposition to certain clinical condition or disease, compatibility of fabrics with the potential recipient intended by the producer for application in case of the researches in vitro of samples of biomaterials of the person for obtaining, forecasting of reactions to therapeutic impacts, the choice of therapeutic means and (or) control of treatment;

5-1) The national list of the vital medical products - the list of the products for medical application providing priority requirements of health care for the purpose of prevention and treatment of diseases;

6) unfavorable event - any defect and (or) deterioration in characteristics or violation of functioning of medical product, either insufficiency or incorrectness of accompanying information (documentation) on medical product, or the side effect which is not specified in the instruction for application or the operation manual on medical product which directly or indirectly led to death or serious deterioration in the state of health of users or the third parties;

7) poor-quality medical product - the medical product which is not conforming to requirements and unsuitable to medical application owing to discrepancy of technical and (or) operational documentation of the producer (manufacturer);

8) the address of medical products - designing, development, creation of prototypes, carrying out technical testing, researches (testing) for the purpose of assessment of biological effect, clinical testing, examinations of safety, quality and efficiency of medical products, toxicological researches (in case of need), registration, quality evaluation and safety, production (production), storage, transportation, realization, installation, adjustment, application (operation), maintenance, repair and utilization of medical products;

9) sample of medical product - the medical product intended for carrying out technical and clinical testing;

10) the producer of medical products - the legal entity, and also the physical person registered as the individual entrepreneur, performing including with participation of the third parties, production, production, packaging, marking of medical products and responsible for their safety, quality and efficiency;

11) registration of medical products - the procedure of confirmation of conformity of medical product to quality requirements, safety and efficiency for the purpose of its address;

12) the registration file - the set of documents and materials of the established structure represented by the applicant in case of registration of medical product or in case of modification of the registration file of medical product, and also the copy of the decisions made by registering body on specific medical item;

13) the registration certificate about state registration of medical product - the document of single form confirming the fact of registration of medical product;

14) registration number - the specification symbol appropriated to medical products in case of their registration under which they are entered in the register of medical products, and kept invariable in case of the address of medical product in the market;

15) subjects of the address of medical products - the physical persons and legal entities performing the address of medical products;

16) counterfeited (counterfeit) medical product - the medical product which is purposely supplied with the marking or packaging which is incorrectly specifying its authenticity and (or) source of origin;

17) efficiency of medical product - compliance of medical product to the appointment determined by the producer.

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