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AGREEMENT

of December 23, 2014

About the single principles and rules of the address of medical products (products of medical appointment and medical equipment) within the Eurasian Economic Union

The state members of the Eurasian Economic Union which are hereinafter referred to as with state members

based on the Agreement on the Eurasian Economic Union of May 29, 2014,

recognizing feasibility of carrying out the coordinated policy in the field of the address of medical products (products of medical appointment and medical equipment) (further - medical products),

considering mutual interest in providing security guarantees, quality and efficiency of medical products for life and human health, environmental protection, property of legal entities and physical persons, preventions of the actions misleading consumers (users) of medical products

recognizing that medical products belong to socially important products,

for the purpose of forming of the total market of medical products within the Eurasian Economic Union (further - the Union),

aiming at increase in competitiveness of the medical products made within the Union,

aiming at elimination of restrictions in mutual trade,

agreed as follows:

Article 1. Scope of the Agreement

1. This agreement establishes the single principles and rules of the address of medical products within the Union for the purpose of forming of the total market of medical products.

2. Action of this agreement extends to the legal relationship connected with the address of the medical products intended for the address within the Union and also on the medical products which are in circulation within the Union.

3. Regulation of the address of medical products within the Union is performed according to the Agreement on the Eurasian Economic Union of May 29, 2014, this agreement, other international treaties constituting the right of the Union, decisions of the Commission, and also the legislation of state members.

Article 2. Determinations

For the purposes of this agreement concepts which mean the following are used:

"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;

"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) are intended by the producer for prevention, diagnostics, treatment of diseases, medical rehabilitation and monitoring of condition of human body, carrying out medical researches, recovery, substitution, change of anatomical structure or physiological functions of organism, prevention or termination of pregnancy and which functional purpose is not implemented by pharmacological, immunological, genetic or metabolic impact on human body, however can be supported by medicines;

"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, registration, production (production), storage, transportation, realization, installation, adjustment, application (operation), maintenance, repair and utilization of medical products.

Article 3. Carrying out the coordinated policy in the field of the address of medical products

1. State members create the total market of medical products within the Union according to the principles specified in article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014.

2. State members pursue the coordinated policy in the field of the address of medical products by means of:

a) taking measures, state members, necessary for harmonization of the legislation, in the field of the address of medical products;

b) establishments of general requirements of safety and efficiency of medical products within the Union;

c) establishments of single rules of the address of medical products according to recommendations of the International forum of regulators of medical products (IMDRF);

d) determinations of single approaches to creation of system of quality assurance of medical products;

e) harmonizations of the nomenclature of medical products used in state members with the Global nomenclature of medical products (Global Medical Device Nomenclature);

e) harmonizations of the legislation of state members in the field of control (supervision) in the field of the address of medical products.

3. For the purposes of implementation of this agreement the state member determines body (bodies) of the government (management), the representative (representatives) on implementation and (or) coordination of activities in the field of the address of medical products in the territory of state member (further - authorized body), and informs on it other state members and the Eurasian economic commission (further - the Commission).

4. Coordination of the activities directed to harmonization of the legislation of state members in the field of the address of medical products is performed by the Commission.

5. Harmonization of the legislation of state members in the field of the address of medical products is performed on the basis of the international standards taking into account decisions of the Commission in the field of the address of medical products.

6. Authorized bodies perform cooperation in the field of the address of medical products, including by the organization and coordination of carrying out research works, scientific and practical conferences, seminars and other actions.

Authorized bodies hold event for experience exchange and the organization of coeducation of specialists in the field of the address of medical products.

Authorized bodies or the organizations of state members operating according to their order carry out with participation of representatives of the Commission of consultation, sent for approval of line items of state members concerning the address of medical products.

Article 4. Registration of medical products

1. Provisions of this Article extend to the medical products released within the Union from the effective date of this agreement.

2. The medical products released within the Union are subject to registration according to the procedure, established by the Commission.

Registration of medical products is performed by authorized bodies.

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