The member states of the Eurasian Economic Union (EAEU) have decided to extend the transition period for the unified registration of medical devices by two years. The transition period will now end on December 31, 2027, whereas it was previously planned to complete this stage by the end of 2025. The deadlines for re-registration of already issued national registration certificates have also been moved to December 31, 2028.
The relevant protocol was signed by the EAEU countries, and this information was published on the union’s legal portal on December 29, 2025.
For companies working with medical devices, the extension of the transition period means the need to revise their market entry strategy and registration approach. The possibility to register products under national rules remains available until the end of 2027. This allows for faster product market introduction, maintaining access to government procurement, and participating in tenders without waiting for the completion of the more complex EAEU procedure.
At the same time, preparation for registration under the Union’s rules can proceed without strict time pressure, providing time for documentation refinement and building a more robust evidence base.
If a company plans a systematic entry into several EAEU markets in the future, registration under unified rules remains the most advantageous long-term solution. However, in the current conditions, it is important to evaluate costs, timelines, and regulatory requirements in advance to ensure that the chosen strategy aligns with the business’s real goals and project capabilities.
At the same time, the extension of the transition period does not cancel the mandatory state registration of medical devices. Both EAEU legislation and national regulations require that products be registered and have a valid registration certificate before being marketed. Unregistered products cannot be legally manufactured, imported, sold, or used in medical practice.
