Navigate Up
Sign In
National marketing authorization certificates for medical devices to be used in EAEU until their expiry date

National marketing authorization certificates for medical devices to be used in EAEU until their expiry date

05-04-6.jpg
4/5/2021
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 approbated amendments to be introduced into 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 perform the internal legal procedures required for its signing.

The amendments provide that medical devices registered under national regulations of an EAEU State may be released into circulation in the territory of such State until national marketing authorization certificates expire.
Medical devices for which a national marketing authorization certificate of limited validity has been issued can be re-registered until December 31, 2026, and a national marketing authorization certificate of unlimited validity can be obtained.

The marketing authorization application for medical devices may be amended under national rules until December 31, 2026.