Federal Law No. 288-FZ dated 08/04/2026 ratified the Protocol on Amendments to the Agreement on Common Principles and Rules for the Circulation of Medical Devices within the EAEU dated December 23, 2014. The protocol was signed in Moscow on December 29, 2025 and is temporarily applied from January 9, 2026.
The essence of the changes is the extension of the transition period established by Article 11 of the Agreement. Applications for registration of medical devices according to national regulations are accepted until December 31, 2027 instead of the previous deadline. The re-registration of products already registered in one of the Member States is postponed to 2028.
The design of the union market of medical products was based as follows: national registration certificates are gradually being replaced by a single registration according to the rules of the EAEU, recognized in all five countries. The transition turned out to be harder than planned. The unified procedure requires the reissue of the dossier to meet the Union requirements, examination in the reference state and coordination with the other participants — for each product separately.
For the market, this meant the risk of shortages. A product with an expiring national certificate that has not completed the Union procedure falls out of circulation, along with equipment, consumables, and spare parts. The extension removes this risk for a year and a half.
What a business should do. Importers and distributors should raise the register of their registration certificates and sort them out by time: where the national certificate is valid and can be submitted until December 31, 2027, where re-registration falls on 2028, where it is still more profitable to make the transition to the union procedure earlier. Postponement gives time, but the end point of the transition to the unified rules of the EAEU does not disappear from this — the queue for examination will become denser by 2027.
Similar materials on the website
- Pharmaceutical products need 50 points for the "made in Russia" status — the neighboring regulatory circuit for medical products
- The EEC has expanded the use of special customs procedures — fresh changes in the Union regulatory framework
