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The Russian government has extended the deadline for the replacement of old registration certificates of medical devices by another four years. Certificates that previously ran for an indefinite term can now be replaced up to January 21, 2021.
The new decision concerns all registration certificates that run for an indefinite term and were issued before January 1, 2013. According to Russian Regulation 1416 on registration rules, these certificates should have expired initially in 2014 and then in 2017 after a first extension of the deadline, and should then have been replaced with new certificates with a limited period of validity. Given the high demand by industry, this deadline has now been extended by another four years. The relevant Regulation No.160 of the Russian government dated February 10, 2017 (in Russian) has already come into effect.
The application for replacement of the registration certificate (in Russian) can be downloaded from the website of the Ministry of Health and Social Development (Roszdravnadzor). Registration certificates that are valid for a limited period need not be changed.
The documents are only available in Russian. Therefore, TÜV SÜD can provide Russian-speaking medical device experts who will be happy to assist you with any issues related to the registration of medical devices in the Russian Federation and will help you to update your registration certificate.
Bosnia and Herzegovina