LAW OF THE KYRGYZ REPUBLIC

of December 29, 2023 No. 216

About the address of medical products

Accepted by Jogorku Kenesh of the Kyrgyz Republic on November 22, 2023

Chapter 1. General provisions

Article 1. Subject of regulation of this Law

Subject of regulation of this Law are the relations arising in connection with the address of the medical products which are relating to socially important products and being specific goods owing to possible damnification to health and human life, requiring special control of transportation, production, production, storage, realization, application/operation, destruction and utilization.

This Law creates the legal basis of activities of subjects of the address of medical products, establishes single requirements to the address of medical products in the Kyrgyz Republic, and also governs the relations arising in connection with their development, preclinical (not clinical) and clinical trials (testing), production, production, assessment of their quality, efficiency, safety, realization and other actions in the field of the address of medical products.

Article 2. Coverage of this Law

1. This Law determines procedure for the address of medical products for medical application in the territory of the Kyrgyz Republic.

2. Operation of this Law does not extend on:

1) cosmetic products;

2) individual protection equipment, except for means which are specially intended by the producer (manufacturer) for use in the medical purposes;

3) the products containing or made using fabrics, cages, blood and its components of human origin, except for medical products for diagnostics of in vitro;

4) the living tissues and cages of human and animal origin intended for transplantation.

Article 3. The legislation of the Kyrgyz Republic in the field of the address of medical products

The legislation of the Kyrgyz Republic in the field of the address of medical products consists of this Law, other regulatory legal acts of the Kyrgyz Republic and international treaties which became effective according to the legislation of the Kyrgyz Republic.

Article 4. The basic concepts used in this Law

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

1) safety of medical products - lack of the unacceptable risk connected with damnification of life, to health of the person, the environment;

2) the State register of medical products of the Kyrgyz Republic - the official electronic document of accounting of the medical products permitted for medical application in the Kyrgyz Republic;

3) the spare part - the part of medical product intended for replacement to the same part which was in operation for the purpose of maintenance or recovery of operability or operability of medical product;

4) quality of medical product - degree of compliance of set of properties and characteristics of medical product to the appointment established by the producer;

5) the component part to medical products - the product which is not medical product or belonging to medical product including blocks, parts, the product elements, materials, spare parts intended by the producer of medical product for application as a part of medical product or together with medical product;

6) 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 together 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, substitution, 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;

7) 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 jointly, and also together with the accessories and the special software necessary for their application to destination, and information of rather physiological or pathological condition (inborn pathology, predisposition to certain clinical condition or disease) intended by the producer for the researches in vitro of samples of biological materials of the person for obtaining, compatibility of fabrics with the potential recipient, forecasting of reactions to therapeutic impacts, the choice of therapeutic means and/or control of treatment;

8) 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;

9) unfavorable event (incident) - 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 which directly or indirectly brought or could lead to death or serious deterioration in the state of health of users or the third parties (at the same time serious deterioration in the state of health is understood as life-threatening disease, permanent defeat of function of organism or irreversible damage of structure of body, functional violation at fruit, his death, congenital anomaly or patrimonial injury, the condition requiring medical or surgical intervention for the purpose of prevention of life-threatening disease, either permanent defeat of function of organism, or irreversible damage of structure of body, condition requiring hospitalization or significant increase in term of stay in hospital of already hospitalized patient);

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