Federal Law No. 323-FZ
Federal Law No. 323-FZ "On the Fundamentals of Health Protection" — the primary legal basis for medical device regulation in Russia, with focus on Article 38.
Government Decree No. 1684 (2025)
Government Decree No. 1684 — Russia's current medical device registration rules, which replaced Decree No. 1416 from 1 March 2025.
Ministry of Health Orders
Key Ministry of Health orders governing medical device regulation in Russia — documentation requirements, classification, and clinical testing.
EAEU Legal Instruments
The key EAEU legal instruments governing medical device registration across Eurasian Economic Union member states — EEC Decision No. 46 and related instruments.