National medical device registation certificates to be valid until their expiry date

Since January 1, 2022, medical devices will be registered only under the rules of the Eurasian Economic Union. They may be registered under national regulations until December 31, 2021. This decision was adopted by the Council of the Eurasian Economic Commission on April 5.

 

The EEC Council has approved amendments to the Agreement on common principles and rules for the circulation of medical devices (medical accessories and medical equipment) within the Eurasian Economic Union dated December 23, 2014. The document was sent to the EAEU countries to be signed. 

 

The amendments stipulate that medical devices registered under national regulations of an EAEU State may enter the market of this State until national registration certificate expires.

Medical devices with a certificate of limited validity can be re-registered until December 31, 2026, and a national registration certificate of unlimited validity can be obtained.

 

Amendments can be introduced to the registration records of a medical device under the national rules – until December 31, 2026.