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Who Needs to Comply?

Russian manufacturers​

Russian manufacturers placing medical devices on the domestic market must:

  • Register every device with Roszdravnadzor before commercial sale
  • Obtain and maintain the necessary quality management system (QMS) certification where required by device class
  • Report adverse events and safety information to Roszdravnadzor
  • Maintain distribution records and cooperate with post-market surveillance

Foreign manufacturers​

Foreign manufacturers wishing to sell medical devices in Russia must:

  • Appoint a Russian Authorized Representative (RUS REP) before submitting a registration application — this is mandatory and cannot be bypassed
  • Register every device via either the national or EAEU pathway
  • Ensure all technical documentation is translated into Russian by a certified translator
  • Comply with Apostille requirements for documents issued in foreign countries

See Authorized Representative (RUS REP) for full details.

Importers​

Importers of medical devices into Russia must:

  • Ensure the device holds a valid RZN Registration Certificate before importation for commercial sale
  • Report every import of any medical device to Roszdravnadzor within 15 days of importation — this is a mandatory reporting obligation introduced in 2022 under Regulation No. 11020
  • Maintain records of imported quantities and distribution

Distributors​

Distributors operating in Russia must:

  • Only distribute devices that hold a valid Registration Certificate
  • Cooperate with Roszdravnadzor investigations and market surveillance activities
  • Maintain records that allow traceability of devices distributed

Healthcare facilities​

Healthcare facilities (hospitals, clinics) that use medical devices are also subject to specific reporting obligations — they must report adverse events and device malfunctions encountered during clinical use to Roszdravnadzor.

Official source

Federal Law No. 323-FZ, Article 38: base.garant.ru/12180860/