Registration of medical devices in 2026 takes place in the context of the completion of the transition to a unified regulatory system within the framework of the Eurasian Economic Union. The key changes are related to the extension of the transition period, the choice of registration procedure and the limitation of the validity period of national registration certificates.
The transition period for registration of medical devices has been extended until 2026
One of the main innovations was the extension of the transition period until January 31, 2026.
This means that manufacturers of medical devices and authorized representatives can still choose which procedure to register products under.:
- according to the national legislation of the Russian Federation
- according to the rules of the Eurasian Economic Union (EEC Decision No. 46)
Thus, registration of medical devices in Russia in 2026 remains flexible, allowing companies to adapt their strategy to specific tasks.
Choice of registration procedure: Russia or the EAEU
In 2026, it remains possible to choose between two registration models.:
Registration according to national rules is applied if the products are planned for circulation only on the territory of the Russian Federation.
Registration according to the rules of the EAEU allows you to bring a medical device immediately to the markets of all countries of the union, including Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan.
It is important to take into account that medical devices registered under the national procedure can only be applied in the country where registration was carried out.
Mandatory re-registration according to the rules of the EAEU
After the end of the transition period, registration of medical devices will be possible only according to the rules of the Eurasian Economic Union.
This means that all products registered under national legislation must go through the registration procedure again, according to the requirements of the EEC. EAEU registration is characterized by stricter requirements for the dossier structure, evidence base, clinical assessment, and manufacturer's quality system.
