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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of February 12, 2016 No. 46

About Rules of registration and examination of safety, quality and efficiency of medical products

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, Items 2 and 4 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, Item 92 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, and for the purpose of execution of the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union" Council of the Eurasian economic commission DECIDED: No. 109

1. Approve the enclosed Rules of registration and examination of safety, quality and efficiency of medical products (further - Rules).

2. Determine that:

a) during transition period till December 31, 2021:

registration of medical product at the choice of the producer of medical product (his authorized representative) can be performed according to Rules or according to the legislation of state member of the Eurasian Economic Union (further - state members);

the medical products registered according to the legislation of state member address in the territory of this state member;

b) the documents confirming the fact of registration of medical products and issued by authorized body of state member in the field of health care according to the legislation of this state member are valid before the termination of term of their action, but no later than December 31, 2021.

3. To state members till December 31, 2016:

a) approve the amount of charges (duties) or other obligatory payments provided by Rules, taking into account complexity of procedures and amount of the performed works which are carried out in the reference state and the states of recognition including in case of:

registration of medical product;

to examination of safety, quality and efficiency of medical product;

modification of the registration file of medical product;

to issue of duplicates of registration certificates;

b) determine bodies (organizations) responsible for registration implementation, modification of the registration file and other procedures connected with registration of medical products provided by Rules and to inform on it the Eurasian economic commission.

4. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Members of council of the Eurasian economic commission:

From the Republic of Armenia

V. Gabriyelyan

From the Republic of Belarus

V. Matyushevsky

From the Republic of Kazakhstan

B. Sagintayev

From the Kyrgyz Republic

O. Pankratov

From the Russian Federation

I. Shuvalov

Approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 46

Rules of registration and examination of safety, quality and efficiency of medical products

I. General provisions

1. These rules are developed according to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014 and Item 2 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014 and establish procedure for carrying out registration and examination of safety, quality and efficiency of medical products (further - registration and examination of medical product), modification of the registration file of medical product, issue of duplicates of registration certificates, and also refusal of registration of medical product, suspension and cancellation of action (cancellation) of the registration certificate of medical product within the Eurasian Economic Union (further - the Union).

Requirements of these rules are not applied to medical products, requirement for which arises in emergency situations or for diagnosis of new, natural and focal or especially dangerous infectious diseases which address is regulated by the legislation of state members.

2. During transition period at the choice of the producer of medical products (his authorized representative) examination and registration of medical products are performed according to the legislation of state member of the Union (further - state member) or with these rules.

3. The concepts used in these rules mean the following:

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

"validation" - confirmation by means of submission of the objective certificates of fulfillment of requirements intended for specific use or use;

"validation of the software" - process of confirmation of suitability of the software for the solution of specific applied objectives;

"verification" - confirmation on the basis of submission of objective certificates of accomplishment of the established requirements;

"verification of the software" - process of confirmation of conformity of the software to the established requirements (including to the meeting specification, specifications, to industry standards);

"the state of recognition" - state member, authorized body (the expert organization) of which performs reconciliation procedure of the expert opinion of the reference state;

"the unified register of the medical products registered within the Eurasian Economic Union" - the electronic database of the medical products registered and allowed for medical application in the territory of the Union;

"applicant" - the producer who is resident of state member or his authorized representative;

"identification and marking of operating system" - information analysis about the operating system used in case of development of the software for the purpose of assessment of opportunities of protection of the software against unauthorized access;

"quality of medical product" - degree of compliance of set of properties and characteristics of medical product to the purposes of its intended use;

"classification of medical product depending on potential risk of use" - reference or determination of belonging of medical product to one of classes of potential risk of use in the medical purposes;

"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 use as a part of medical product or together with medical product;

"medical products for diagnosis 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 use of the specified products to destination (including the special software), and information of rather physiological or pathological condition, inborn pathology, predisposition to certain clinical condition or disease, compatibility of fabrics with the potential recipient intended by the producer for use in case of the researches in vitro of samples of biological materials of the person for obtaining, forecasting of reactions to therapeutic impacts, the choice of therapeutic means and (or) control of treatment;

"modification of medical product" - the kind of medical product having general with the main medical product the constructive signs developed based on the main product for the purpose of its enhancement, expansion or specialization of use in the medical purposes;

"multicenter research of the software" - simultaneous testing of the software in the conditions of its planned use on several external experimental platforms (out of the company - developer of such software);

"set (set) of medical products" - set of the medical products having single appointment and marking, with indication of the list of the specified medical products;

"accessory" - the product which is not medical product, intended by the producer for combined use with one or several medical products for use according to their appointment;

"the producer of medical product" - the legal entity or physical person registered as the individual entrepreneur responsible for the development and production of medical product making it available for use on its own behalf irrespective of is developed and made medical product by this person or from his name other person (persons), and the bearing responsibility for safety, quality and efficiency of medical product;

"production site" - territorially isolated complex intended for accomplishment of all production process of medical product or its certain stages;

"consumable material to medical products" - the products and materials spent when using medical products, providing carrying out manipulations according to functional purpose of medical product;

"the registration file" - the set of documents and materials of the established structure represented by the applicant in case of registration of medical product, modification of the registration certificate and also copies of the decisions made by authorized body (the expert organization) on specific medical item;

"registration number" - the specification symbol appropriated to medical products in case of their registration under which they are entered in the unified register of the medical products registered within the Union, and kept invariable in case of the address of medical product within the Union;

"registration certificate" - the document of single form confirming the fact of registration of medical product;

"registration of medical product" - the procedure of issue by authorized body of permission to medical application of medical product within the Union;

"the reference state" - the state member chosen by the applicant which authorized body performs registration of medical product;

"the authorized representative of the producer" - the legal entity or physical person registered as the individual entrepreneur being residents of state member and representatives according to the power of attorney of the producer of medical product to represent its interests and to bear responsibility regarding the address of medical product within the Union and execution of the mandatory requirements imposed to medical products.

4. Registration and examination of medical product are compulsory provisions of its release into the stream of commerce within the Union and are performed by authorized body of the reference state. At the same time identical requirements for the medical products made in the territory of the Union and imported on customs area of the Union from the third states are imposed.

5. Before giving in authorized body of the reference state of the registration application and examination of medical product the applicant performs collection of proofs of safety and efficiency of medical product and preparation of the corresponding registration file.

6. For the purpose of preparation of the registration file the applicant:

a) gets preliminary advice of the expert organization for registration and examination of medical product (if necessary);

b) carries out technical testing, testing (research) for the purpose of assessment of biological effect of medical product, testing for the purpose of approval like measuring instruments (concerning the medical products carried to measuring instruments which list affirms the Commission) for confirmation of conformity to general requirements of safety and efficiency of medical products, requirements to their marking and operational documentation on them in the organizations and the organizations chosen as the applicant having the right to conduct such (testing) researches for the purpose of registration of medical products and the authorized organizations of the Union included in the unified register (further - authorized organizations);

c) carries out clinical testing (researches) according to rules of carrying out clinical testing (researches) of medical products in the authorized organizations chosen as the applicant or includes the available clinical data in the registration file.

7. For the purpose of registration of medical product expertize of medical product by the expert organization determined by authorized body of state member is carried out (further - the expert organization).

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