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Federal Law No. 323-FZ

Overview​

Federal Law No. 323-FZ — "On the Fundamentals of Health Protection of Citizens in the Russian Federation" — is the foundational statute governing the healthcare system in Russia, including the regulation of medical devices. It was signed into law in November 2011 and has been amended numerous times since.

Article 38 — Medical devices​

Article 38 of Federal Law 323-FZ is the specific provision establishing the regulatory framework for medical devices. Key elements of Article 38 include:

  • The definition of a medical device — instruments, apparatus, appliances, devices, equipment, materials, or other items (including software) used for medical purposes
  • The requirement that all medical devices be registered with the authorised federal body before they can be placed in circulation
  • The basis for the registration procedure, delegated to the Government to establish by decree
  • The requirement for post-market surveillance and reporting of adverse events
  • The authority of Roszdravnadzor to suspend or cancel registrations

Regulatory delegation​

Federal Law 323-FZ delegates the detailed regulatory framework to subordinate instruments:

  • The Government (via Decrees such as Decree No. 1684) establishes registration rules
  • The Ministry of Health (via Orders such as Order No. 11 and Order No. 4n) establishes documentation and classification requirements
  • Roszdravnadzor implements the regulatory framework through administrative procedures

Where to access​

The full text of Federal Law No. 323-FZ is publicly available (in Russian) via:

Official source

Federal Law No. 323-FZ (Russian text): base.garant.ru/12180860/