EEC approves procedure for use of national RC (registration certificate) for medical products


Council of the Eurasian economic commission approved changes in the Agreement on the uniform principles and rules of medical products (products of medical purpose and medical equipment) circulation within the Eurasian Economic Union of December 23, 2014 which allow to use national registration certificates of medical products until the end of their validity period, EEC reports.

The amendments provide that medical products registered according to the national norms of one of the EAEU states can be issued in the territory of this state before the expiration of national registration certificates. It will be possible to change the registration file of the medical product according to national rules until the end of 2026.

“For medical devices with a national registration certificate with a limited validity period, it is possible to re-register such medical devices until December 31, 2026 with the issuance of indefinite national registration certificates,” the EEC said.

Manufacturers will be able to register medical products according to national standards only until the end of the year. From January 1, 2022, registration will be held in accordance with the requirements of the EAEU.


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