DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of July 24, 2018 №116

About Criteria of differentiation of the elements of medical product which are components of medical product for the purpose of its registration

Based on Item 2 of Article 3,Items 2 and 4of 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 Item 11 of Rules of registration and examination of safety, quality and efficiency of the medical products approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 № 46, and also according to Item 23 of the list of acts of the Eurasian economic commission on questions of regulation of the total markets of medicines and medical products within the Eurasian Economic Union for 2017-2019 (№ 15) the Board of the Eurasian economic commission decided appendix to the order of Council of the Eurasian economic commission of May 17, 2017:

1. Approve the enclosed Criteria of differentiation of the elements of medical product which are components of medical product for the purpose of its registration.

2. This Decision becomes effective after 30 calendar days from the date of its official publication.

Approved by the Decision of Board of the Eurasian economic commission of July 24, 2018 №116

Criteria of differentiation of the elements of medical product which are components of medical product for the purpose of its registration

1. This document establishes criteria of differentiation of the elements of medical product which are components of medical product for the purpose of its registration.

2. For the purposes of use of this document concepts which mean the following are used:

"the spare part of medical product" – 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;

"the main unit (part) of medical product" – product, except consumable materials to medical product, the functioning of medical product released on behalf of the producer of medical product, mechanically not connected with other main units (parts) of medical product by delivery of medical product and providing according to appointment. The special software which is medical product belongs to main units (parts) of medical product and also other medical products registered in accordance with the established procedure and allowed to the address within the Eurasian Economic Union, intended according to documentation of the producer of the registered medical product for ensuring its functioning according to appointment can belong;

"component of medical product" – the main unit (part) of medical product, accessory, completing to medical product and consumable material to medical product.

Other concepts are used in the values determined by the Rules of registration and examination of safety, quality and efficiency of medical products approved by the Decision of Council of the Euroasian economic commission of February 12, 2016 № 46.

3. Reference of element of medical product to component of medical product for the purpose of its registration is performed based on the following criteria:

a) if the element is the product or material spent when using medical product, providing carrying out manipulations according to functional purpose of medical product, then such element belongs to consumable materials to medical product. At the same time as consumable material use of other medical product including registered in accordance with the established procedure and allowed to the address within the Eurasian Economic Union is allowed to medical product;

b) if the element is not the product or material spent when using medical product, providing carrying out manipulations according to functional purpose of medical product and is released within the Eurasian Economic Union on behalf of the producer of medical product, at the same time:

is not the spare part of medical product, such element belongs to main units (parts) of medical product;

is the spare part of medical product, such element is the component part to medical product;

c) if the element is not the product or material spent when using medical product, providing carrying out manipulations according to functional purpose of medical product and is released within the Eurasian Economic Union not on behalf of the producer of medical product, and on behalf of the producer of element, at the same time:

is the medical product including registered in accordance with the established procedure, allowed to the address within the Eurasian Economic Union and intended according to documentation of the producer of the registered medical product for ensuring its functioning according to appointment, such element belongs to main units (parts) of medical product;

is not medical product and it is specially intended by his producer for combined use with medical product, such element belongs to accessories of medical product;

is not medical product and specially it is not intended by his producer for combined use with medical product, such element belongs to component parts to medical product.

4. In case of reference of element of medical product the standard algorithm according to the scheme according to appendix is applied to component of medical product. Variations from this algorithm in case of identification of components of medical product shall be proved by the applicant in the represented registration file and prove to be true in case of examination within the procedure of registration of medical product and modification of the registration file.

5. If as consumable material to medical product or the main unit (part) of medical product other medical product is used, then it can be registered separately or in set in accordance with the established procedure and it is allowed to the address within the Eurasian Economic Union.

Appendix

to Criteria of differentiation of the elements of medical product which are components of medical product for the purpose of its registration

The scheme of the standard algorithm applied in case of reference of element of medical product to component of medical product

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