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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:

  1. Updated documentation requirements — dossier content requirements are more closely aligned with EAEU Decision No. 46 standards, reducing divergence between national and EAEU dossiers

  2. Revised manufacturing site inspection rules — clearer procedural requirements for the QMS inspection process, reflecting the mandatory inspections that came into force in January 2024

  3. 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

  4. 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. New national submissions may be accepted until 31 December 2027 (extended via an EAEU Protocol signed 29 December 2025) — after that date, new submissions must be under the EAEU pathway (EEC Decision No. 46). National registration/re-registration completion under Union rules is permitted until 31 December 2028.

Official source

Government Decree No. 1684: government.ru | EAEU Eurasian Economic Commission: eec.eaeunion.org

Transition from Decree No. 1416: Manufacturers with existing registrations under Decree No. 1416 may continue to maintain and renew those registrations under the national pathway. New national submissions may be accepted until 31 December 2027, and national registration/re-registration completion under Union rules is permitted until 31 December 2028, per the EAEU Protocol signed 29 December 2025.