EAEU Centralised Medical Devices Regulation Enters in Force on 1st January 2022

Brain Nervous System Medical Device

As of 1st January 2022, the Eurasian Economic Union (EAEU), formed by Belarus, Kazakhstan, Russia, Armenia, and Kyrgyzstan, will enforce the new common regulation for Medical Devices that their regulatory body, the Eurasian Economic Commission (EEC), has been developing during the past two years.

The new regulation harmonises the requirements for medical devices along with the EAEU countries and establishes a common registration procedure. This new registration will still be presented to the competent authorities of one of the member states, which will lead the process but will be valid for all the EAEU.

Upcoming registrations should be submitted according to the new procedure as of 1st January 2022. Existing national registrations which expire after that date will still be valid maximum until 31st December 2026. As of 1st January 2027, all Medical Devices placed in the EAEU market should be registered according to the new regulation.

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