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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/

Healthcare facilities must also report serious adverse events involving medical devices within specified timeframes. Facility personnel should establish internal procedures for capturing device malfunctions and adverse events encountered during clinical use and ensure timely reporting to Roszdravnadzor or to the manufacturer through their RUS REP.