The Government of the Russian Federation has issued Government Resolution No. 974, amending the Rules for State Registration of Medical Devices. Two key compliance deadlines have been pushed back from September 2026 to September 2027. This transitional adjustment follows Russia’s shift to an electronic‑registry‑based medical‑device registration system and affects all foreign medical‑device manufacturers and clinical‑trial sponsors operating in Russia.
https://pharmvestnik.ru/content/news/pravitelstvo-rf-sdvinulo-sroki-obnovleniya-dannyh-ob-upolnomochennyh-predstavitelyah-medizdelii.html
Institutions intending to conduct medical‑device clinical trials on Russian territory must complete self‑assessment against the updated registration rules and submit notifications to Roszdravnadzor (Federal Service for Surveillance in Healthcare).
This extension is part of Russia’s broader overhaul of medical‑device registration. Under Government Resolution No. 1684 dated 30 November 2024, new Rules for State Registration of Medical Devices entered into force, replacing paper‑based registration certificates with a fully electronic state registry system.
Roszdravnadzor has formally abolished formats for traditional paper medical‑device registration certificates and repealed related administrative documents. The one‑year grace period eases implementation pressure for market participants and prevents administrative bottlenecks and compliance risks from mass simultaneous submissions.
