Important changes in the medical device registration system have come into effect in Russia. The company "Elibrium" announces the completion of the transition period and the new operating rules in the industry.
December 30, 2025, will be the final date for accepting documents for the registration of medical devices under national regulations. Documents submitted before February 28, 2025, were reviewed according to the rules established by Government Decree No. 1416. Starting from March 1, 2025, all applications must comply with the new requirements set by Decree No. 1684.
Registration certificates issued earlier under national rules remain valid indefinitely. However, the ability to make changes to such certificates will be significantly limited. The last day for submitting documents for changes is December 31, 2026.
Clinical trials have also undergone changes. Until August 31, 2025, results were provided in paper form. Starting from September 1, 2025, clinics are required to upload data into the automated information system of Roszdravnadzor in electronic format.
Medical organizations authorized to conduct clinical trials had to submit notifications of compliance with the new requirements to Roszdravnadzor by September 1, 2025. Those institutions that failed to meet this requirement were removed from the corresponding registry.
Foreign manufacturers were also required to designate an authorized representative or update their information in the Roszdravnadzor registry by September 1, 2025. Failure to comply with this requirement resulted in the cancellation of registration certificates.
Elibrium continues to monitor changes in the industry and is ready to support its clients in adapting to the new operating conditions.
