The Council of the Eurasian Economic Commission (EEC) has approved amendments that extend medical devices registration according to national rules until December 31, 2025, the press service of the EEC reports. The Protocol has been sent to the EAEU member states for execution, after which the amendments will enter into force.
“The adoption of the protocol will ensure smooth formation of a common market for medical devices within the EAEU,” the press service of the EEC Council said.
The transition to exclusive registration under EAEU rules had been scheduled for January 1, 2022. After consultations between the relevant associations and market participants, the regulator came out with a proposal to postpone the deadline for the termination of national registration for another year, but the extension of the national registration regime for medical devices was approved by the EEC Council a few days before the beginning of 2022.
As a result, from January 1, 2022 until mid-June, registration of medical devices in Russia was temporarily conducted only according to the rules of the EAEU.