Government Decree No. 1684 (2025)
Overview
Government Decree No. 1684 was published in November 2024 and entered into force on 1 March 2025, replacing the longstanding Government Decree No. 1416, which had been in force since 2012. Decree No. 1684 is now the primary instrument governing the national medical device registration process in Russia.
Key changes from Decree No. 1416
Decree No. 1684 introduced several important updates:
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Updated documentation requirements — dossier content requirements are more closely aligned with EAEU Decision No. 46 standards, reducing divergence between national and EAEU dossiers
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Revised manufacturing site inspection rules — clearer procedural requirements for the QMS inspection process, reflecting the mandatory inspections that came into force in January 2024
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Fast-track provisions — clearer rules for expedited registration of devices affected by import sanctions, with timelines as short as 5 working days for Class I devices under certain conditions
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Registration maintenance — updated rules for notifying changes and managing amendments to registered devices
What remains unchanged
The fundamental two-phase registration process (Phase 1: dossier and initial expert review; Phase 2: clinical data and final review) continues under Decree No. 1684. The GRLS registration database and Registration Certificate system remain the same.
EAEU transition
Decree No. 1684 governs national registration only. From 1 January 2027, new submissions must be under the EAEU pathway (EEC Decision No. 46). Decree No. 1684 will cease to accept new applications from that date.
Government Decree No. 1684: government.ru