ORDER OF THE GOVERNMENT OF THE KYRGYZ REPUBLIC

of March 5, 2013 No. 113

About approval of the Technical regulation "About Safety of Medical Implants"

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 Medical Implants".

2. This resolution becomes effective after six months from the date of official publication. This resolution is effective before entry into force in the territory of the Kyrgyz Republic of the corresponding technical regulation of the Customs union.

Approved by the Order of the Government of the Kyrgyz Republic of March 5, 2013, No. 113

Technical regulation "About Safety of Medical Implants"

Chapter 1. General provisions

1. This technical regulation "About Safety of Medical Implants" (further - the Technical regulation) is accepted for the purpose of:

protection of life and human health

environmental protections;

preventions of the actions misleading consumers of products.

2. This Technical regulation establishes:

1) essential mandatory requirements to medical implants;

2) classification of medical implants for the purposes of application of this Technical regulation;

3) forms of assessment of conformity of medical implants to requirements of this Technical regulation;

4) requirements to market circulation of implants.

3. Products types falling under action of this Technical regulation, 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 this Technical regulation.

4. Requirements of this Technical regulation do not extend on:

1) products of medical appointment, it is long contacting to the uninjured mucous membranes (obturators, contact lenses, intrauterine contraceptives, etc.);

2) the products of medical appointment contacting to the damaged fabrics (dressing, polymeric coverings, sorbents);

3) the products of medical appointment which are temporarily contacting to blood - vascular catheters, highways of cardiopulmonary bypasses, membranes for hemodialysis;

4) allogenny and ksenogenny transplants;

5) implants and tools for short-term (less than 60 minutes) contact with body tissues;

6) products for orthopedic stomatology, except implanted podnadkostnichno.

5. Subjects to regulation of this Technical regulation are new medical implants, irrespective of the country and the place of origin.

6. In this Technical regulation the following basic concepts are used:

1) active implants - the implanted implants intended for treatment of the patient or simplification of its condition using autonomous or external power sources;

2) active diagnostic implants - the implanted products of medical appointment intended for control of physiological parameters of organism using autonomous or external power sources;

3) safety of implant - set of the normalized properties of implant and conditions of its application providing prevention of harmful effects in case of its use;

4) biological safety of implant - the lack of harmful effects which is most reducing risk of its application for life and health of the person and future generations;

5) harmful effects - causing damage to the patient, personnel or the environment; impact of factors of the habitat, the lives creating threat or to health of the person, or threat of life or to health of future generations;

6) lifecycle of implant - process from the moment of designing of product and its production until its use, operation (for active implants) and removals from organism;

7) danger identification - determination of sources, types, criteria of danger, including possible harmful effects in organism which can be caused by impact of harmful factor and are caused by its integral properties;

8) in vitro is technology of accomplishment of experiments when experiments are made "in test tube" - out of live organism;

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