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Ministry of Health Orders

MOH Order No. 11 — Technical & User Documentation Requirements​

MOH Order No. 11 establishes the detailed requirements for the technical and user documentation that must be included in a registration dossier. It is the key reference for structuring the technical file.

Order No. 11 specifies what must be included in:

  • Product description and technical specifications
  • Instructions for use
  • Labelling requirements
  • Pre-clinical and clinical data sections
  • Risk management documentation

All registration dossiers — regardless of class — must comply with MOH Order No. 11.

MOH Order No. 4n — Classification Rules​

MOH Order No. 4n establishes the official classification rules for medical devices in Russia. It specifies which risk class (I, IIa, IIb, III) applies to different device categories and provides the OKPD-2 code list used to identify and classify devices.

Pre-clinical and clinical testing regulations (2022)​

New regulations for pre-clinical and clinical testing came into force in March 2022, updating the requirements for how clinical investigations are designed, conducted, and documented in Russia. These regulations:

  • Clarify when local clinical testing is required vs when overseas data is sufficient
  • Set out the process for obtaining National Ethics Committee approval
  • Specify requirements for clinical investigation protocols in Russia

Where to access​

Ministry of Health Orders are published on the official Minzdrav website and in official legal databases:

Official source

Ministry of Health of Russia: minzdrav.gov.ru