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The document ceased to be valid since  May 24, 2019 according to Item 1 of the Order of the Government of the Kyrgyz Republic of  May 2, 2019 No. 200

ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of February 1, 2012 No. 74

About approval of the Technical regulation "About Safety of Products of Medical Appointment"

(as amended on 05-07-2018)

According to the Law of the Kyrgyz Republic "About bases of technical regulation in the Kyrgyz Republic" the Government of the Kyrgyz Republic decides:

1. Approve the enclosed Technical regulation "About Safety of Products of Medical Appointment".

2. To the Ministry of Health of the Kyrgyz Republic in accordance with the established procedure to make offers on reduction of regulatory legal acts of the Government of the Kyrgyz Republic in compliance with the Technical regulation specified in Item 1 of this Resolution.

3. This Resolution becomes effective after six months from the date of official publication.

Prime Minister

O. Babanov

Approved by the Order of the Government of the Kyrgyz Republic of February 1, 2012, No. 74

Technical regulation "About Safety of Products of Medical Appointment"

Introduction

This Technical regulation (further - Regulations) is developed according to the Constitution of the Kyrgyz Republic, the laws of the Kyrgyz Republic "About medicines", "About bases of technical regulation in the Kyrgyz Republic", and also other regulatory legal acts of the Kyrgyz Republic.

These Regulations are accepted for the purpose of:

protection of life and human health when using products of medical appointment;

environmental protections;

on protection of life and health of animals;

preventions of the actions misleading consumers of products.

Chapter 1. General provisions

1. These Regulations establish:

1) the minimum mandatory requirements to products of medical appointment;

2) classification of products of medical appointment for the purposes of application of these Regulations;

3) forms of assessment of conformity of products of medical appointment to requirements of these Regulations.

2. Products types falling under action of these Regulations, and their codes on the qualifier of the Commodity nomenclature of foreign economic activity of the Eurasian Economic Union (further - the CN FEA EEU) are specified in appendix 1 to these Regulations.

3. These Regulations do not mention the relations connected with ensuring economic interests of the Kyrgyz Republic or certain subjects (group of subjects), the sphere of the product circulation of medical appointment with ensuring product availability of medical appointment and with the organization of providing the population with products of medical appointment.

4. These Regulations do not extend on:

1) products of medical appointment for laboratory diagnostics in artificial conditions (in vitro);

2) medicines;

3) cosmetic products;

4) human blood, products from human blood, plasma or blood cages of human origin, the products of medical appointment containing similar products from blood, plasma or cages of human origin;

5) implants;

6) individual remedies, except used in medical practice;

7) the actions connected with ensuring industrial safety, fire safety, explosion safety, chemical safety and safety of other types in case of production of products of medical appointment, requirements to which are provided in the legislation of the Kyrgyz Republic;

8) transplants, fabrics or cages of human origin;

9) the products of medical appointment made using fabrics or cages of human origin;

10) transplants, fabrics or cages of animal origin, except for the products of medical appointment made using the animal cages deprived of viability or impractical products received from animal fabrics.

5. If in products of medical appointment use as component substance which can separately be considered as constituting medicine or as the medicine making impact on human body in addition to action directly of product of medical appointment, then action of these Regulations extends to such products of medical appointment.

6. Subjects to regulation of these Regulations are:

1) new products of medical appointment, irrespective of country of source;

2) the modernized products of medical appointment which are in operation;

3) the products of medical appointment which are in operation;

4) the products of medical appointment arriving through the humanitarian assistance;

5) the products of medical appointment which were in the use, being in working order.

7. For the purposes of these Regulations the following basic concepts are used:

1) active products of medical appointment - the products of medical appointment having physical or electric contact with the patient and transferring energy to the patient or from the patient;

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