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Importers & Distributors

Importers​

Importers of medical devices into Russia must:

  1. Verify registration — only import devices that hold a valid RZN or EAEU Registration Certificate. Importing unregistered devices (other than in specific exempted circumstances such as research samples) is prohibited.

  2. Report every import within 15 days — under Regulation No. 11020 (March 2022), every unit of any medical device imported into Russia must be reported to Roszdravnadzor within 15 days of importation. This applies to all device classes. The report must include the device name, registration certificate number, quantity, and importer details.

  3. Maintain distribution records — importers must keep records enabling traceability of imported devices through the supply chain.

  4. Support recalls and FSCAs — importers must cooperate with manufacturers and Roszdravnadzor in executing FSCAs, including device recalls.

Distributors​

Distributors operating in Russia must:

  • Only distribute devices with a valid Registration Certificate
  • Maintain records allowing devices to be traced from receipt to distribution
  • Cooperate with Roszdravnadzor market surveillance activities
  • Report adverse events or safety issues to the manufacturer and, where required, to Roszdravnadzor

Import permits and customs​

Medical devices imported into Russia are subject to customs procedures. The customs declaration must reference the Registration Certificate number. Samples imported for registration purposes (pre-market) follow a separate simplified process, which was streamlined by Roszdravnadzor in August 2022.

15-day import reporting

The 15-day import reporting obligation is frequently overlooked by importers new to the Russian market. Non-compliance carries enforcement risk. Ensure your logistics and compliance processes capture this requirement.

Official source

Regulation No. 11020 (2022): roszdravnadzor.gov.ru