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The EEC generally completed formation of the regulatory framework of the EAEU for launching the common market of medical products

The EEC generally completed formation of the regulatory framework of the EAEU for launching the common market of medical products

7/14/2016

In general, the Eurasian Economic Commission (EEC) has completed formation of regulatory framework of the Eurasian Economic Union (EAEU) for launching the common market of medical products. On the legal portal of the EAEU, Rules for registration and examination of safety, quality and efficacy of medical products approved by Decision of the EEC Council No. 46 of February 12, 2016.

The document establishes legal regulation of relations in the field of applying mandatory requirements for medical products and conducting by the EAEU countries the examination for compliance with these requirements.

Regulatory framework for launching the common market of medical products is formed in accordance with the Treaty on the EAEU and the Agreement on common principles and rules for circulation of medical products (medical devices and equipment) within the Eurasian Economic Union.

A unified regulation of the market of medical products circulated in the Union countries requires the use of best practices. This will improve the quality of medical products. At the same time, a unified regulation of this market will reduce the barriers associated with the peculiarities of national markets of medical products.

The procedure for registration of medical products involves the mutual recognition by the authorised authorities of the Union of research and expertise (testing) results acquired during execution of medical product registration procedures, and the possibility of simultaneous release of products to the markets of all the Member States.

This procedure will reduce the costs of manufacturers for medical product registration by eliminating the duplication of evaluation of safety and efficiency of medical products, reducing registration period. It will also increase the availability of medical products for the EAEU citizens.

It is expected that operation of the common market of medical products in full will begin before the end of this year. Its launch will not be a challenge for manufacturers of medical products. Until December 31, 2021 within the EAEU two procedures for releasing medical products in circulation will coexist - under uniform requirements of the Union and in accordance with the legislation of the EAEU countries. During the six-year transitional period, manufacturers will not only be able to bring manufacture of medical products in compliance with the new requirements, but also to critically look at the portfolio of manufactured medical products, which they own.