Russia Medical Device Regulation — RAPath
Welcome to the RAPath Russia reference site. This guide covers how to register and maintain medical devices on the Russian market under the oversight of Roszdravnadzor (RZN) — the Federal Service for Surveillance in Healthcare.
Roszdravnadzor (RZN) — Federal Service for Surveillance in Healthcare
Website: roszdravnadzor.gov.ru
Under: Ministry of Health of the Russian Federation — minzdrav.gov.ru
What this site covers
Russia operates two parallel registration systems for medical devices: a national route valid only in Russia, and an EAEU route valid across the five Eurasian Economic Union member states (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan). From 1 January 2027, new submissions must use the EAEU pathway only.
This site guides you through:
- Classification — Russia's four-class (I, IIa, IIb, III) risk-based system and OKPD-2 codes
- Registration — national and EAEU dossier requirements, the two-phase review process, and timelines
- Technical documentation — what to prepare and Russian-language requirements
- Clinical evaluation — when local testing in Russia is required
- Post-market — adverse event reporting, FSCAs, annual clinical PM monitoring for Class III
- Quality management — mandatory QMS inspections from January 2024 for Class IIa sterile, IIb, and III
- EAEU and Authorized Representative — the RUS REP requirement for foreign manufacturers
- Legislation — Federal Law 323-FZ, Government Decree No. 1684 (2025), and key MOH Orders
Key facts at a glance
| Regulatory authority | Roszdravnadzor (RZN) |
| Device classes | Class I · IIa · IIb · III |
| Registration routes | National (Russia only) · EAEU (5 countries) |
| State register | GRLS — grls.rosminzdrav.ru |
| Authorized rep required | Yes — RUS REP mandatory for foreign manufacturers |
| QMS inspection (IIa sterile, IIb, III) | Mandatory from 1 January 2024 |
| Language | Russian (all documents must be translated) |
| EAEU-only deadline | 1 January 2027 |
Important notice
This site provides a plain-English overview of Russian medical device regulation for reference purposes. It is not legal advice. Regulations change frequently — always verify requirements against official sources:
Content on this site is community-maintained as part of the RAPath project.
About RAPath
RAPath is an open, community-maintained medical device regulatory reference project covering multiple jurisdictions. Browse other jurisdictions at rapath.github.io.
Questions or corrections? Use the RAPath Hub Discussions on GitHub.