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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;

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);

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