Russia medical device regulations
Official sources linkedRoszdravnadzor rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| Government Decree No. 1684 | Rules for State Registration of Medical Devices Current Russian rules for state registration of medical devices under Roszdravnadzor, including electronic submissions, review procedures, and registration-record requirements. | Registration | March 1, 2025 | Official |
| Federal Law No. 323-FZ, Article 38 | Legal Basis for Medical Device Circulation and Registration Establishes that medical devices may circulate in Russia only after state registration and provides the legal basis for registry, licensing, and market-control functions. | General | — | Official |
| Federal Law No. 323-FZ, Article 96 | Medical Device Safety Monitoring Requirements Requires safety monitoring for medical devices in circulation to identify adverse reactions, unexpected interactions, and circumstances that may threaten patients or healthcare workers. | Vigilance | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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