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What's New

2025​

Government Decree No. 1684 — new registration rules (1 March 2025)​

The most significant regulatory change of 2025: Government Decree No. 1684 replaced the longstanding Decree No. 1416 (in force since 2012). The new Decree introduces:

  • Updated documentation requirements aligned more closely with EAEU standards
  • Clearer rules for manufacturing site inspections
  • Fast-track provisions for sanction-impacted devices

See Government Decree No. 1684 for details.

2024​

Mandatory QMS inspections — in force from 1 January 2024​

The requirement for mandatory manufacturing site QMS inspections before submission became fully enforced from 1 January 2024 for:

  • Class IIa sterile devices
  • Class IIb devices
  • Class III devices

This was one of the most significant process changes in recent years, adding both time and cost for higher-class device registrations.

See Manufacturing Site Inspections for details.

2022​

Annual clinical PM monitoring reports (February 2022)​

Regulation No. 1113 introduced mandatory annual clinical post-market monitoring reports for Class III and IIb implantable devices registered after January 2021.

Mandatory import reporting (March 2022)​

Regulation No. 11020 introduced the requirement to report all imported medical device units to Roszdravnadzor within 15 days of importation.

New clinical testing regulations (March 2022)​

Updated regulations for pre-clinical and clinical testing came into force, clarifying when local testing in Russia is required.

Mandatory GOST certification list updated (September 2022)​

Government Decree No. 2425 updated the list of products subject to mandatory GOST certification and declaration.

QMS inspections introduced as voluntary (September 2022)​

Russia introduced QMS inspection requirements with a transition period, initially voluntary, before becoming mandatory from January 2024.

Upcoming changes​

EAEU-only pathway from January 2027​

The national registration pathway (Decree No. 1684) closes to new submissions from 1 January 2027. All new registrations must use the EAEU pathway from this date.

Stay current

Regulatory updates are published by Roszdravnadzor at roszdravnadzor.gov.ru and by the Ministry of Health at minzdrav.gov.ru. This page is community-maintained and may not reflect the very latest changes — always verify against official sources.