Russia Medical Device Regulation
Regulatory authority: Roszdravnadzor (RZN) | Register: GRLS | Legislation: Federal Law 323-FZ · Decree No. 1684 | Last reviewed: May 2026 | For reference only — not legal advice.
Russia regulates medical devices through Roszdravnadzor (RZN) — the Federal Service for Surveillance in Healthcare, operating under the Ministry of Health. Russia operates two parallel registration systems: a national route valid only in Russia, and an EAEU route valid across all five Eurasian Economic Union member states. New national submissions may be accepted until 31 December 2027 (extended via an EAEU Protocol signed 29 December 2025), after which new device registrations must use the EAEU pathway only; national registration/re-registration completion under Union rules is permitted until 31 December 2028. Source: EAEU Eurasian Economic Commission (eec.eaeunion.org).
Regulatory Pathway Map
Click a phase to expand — each card links to the relevant section of this guide.
Key Facts
| Regulatory authority | Roszdravnadzor (RZN) |
| Legislation | Federal Law No. 323-FZ · Government Decree No. 1684 (March 2025) |
| Device classes | Class I · IIa · IIb · III |
| Registration routes | National (Russia only) · EAEU (5 countries) |
| State register | GRLS — grls.rosminzdrav.ru |
| RUS REP required | Yes — mandatory for all foreign manufacturers |
| QMS inspection | Mandatory from January 2024 for Class IIa (sterile), IIb, and III |
| Language | Russian — all documents, labelling and IFU must be in Russian Cyrillic |
| Digital marking | Chestny ZNAK mandatory for specified device categories (from September 2023) |
| EAEU-only deadline | 31 December 2027 — national-only new registrations will no longer be accepted (extended via EAEU Protocol signed 29 December 2025); national registration/re-registration completion under Union rules permitted until 31 December 2028 |
What This Site Covers
- Getting Started — regulatory framework, definitions, who must comply
- Device Classification — four-class system, OKPD-2 codes, IVD classification, SaMD
- Registration Routes — national vs EAEU pathway, dossier requirements, timelines
- Technical Documentation — dossier requirements, labelling (Russian/Cyrillic), risk management
- Clinical Evaluation — when local Russian clinical testing is required
- Quality Management — ISO 13485, GOST standards, manufacturing site inspections
- EAEU & Authorized Representative — RUS REP role, EAEU framework, importer and distributor obligations
- Digital Marking (Chestny ZNAK) — mandatory Data Matrix marking for