On February the 13th, the protocol was published on the EAEU portal on the extension of the registration of medical devices according to national rules until December the 31st, 2025. To date, this protocol has been signed by all the countries that are parts of the EAEU. The agreement on common principles for the trade of medical goods within the Eurasian Economic Union dated December the 23rd, 2014, was amended accordingly.
Previously, it was planned to completely switch to registration in accordance with the general rules and criteria of the EAEU by January the 1st, 2023, but back in December 2022, the heads of ministries revised their decision. This will contribute to a smoother transition from national procedures to a single one and unify the capabilities of each country, including preparing and equipping the relevant centers for testing in accordance with general requirements.
EEC Minister for Technical Regulation Mikhail Nazarenko noted that the measures taken will contribute to the fact that by the beginning of 2026 all participating countries will be fully prepared for the transition to a single system.
The extension of the registration procedure for three years has been considered since August 2022, when the relevant protocol was drawn up at the EEC and sent to the participating parties for consideration and signing. Now we can talk about making a decision at the official level and wait for gradual changes in the rules of national registration to bring it closer to the criteria of uniform principles.
The Protocol is provisionally valid from the date of signing, February the 13th, 2023, but will fully enter into force when all the EAEU countries confirm the implementation of the domestic procedures necessary for this.