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Import of medical devices into Russia

Documents for import into Russia of medical devices for the state registration

Documents provided to permit the import of medical products in Russia in order to obtain state registration. The application form you can find on the website roszdravnadzor.ru ("Medical products" - "Importation of medical products for the purpose of state registration", "the regulations").

When applying, you must also provide:

  1.  copies of contracts to conduct the necessary tests (researches), indicating the required number of medical devices. In the case of import of medical products with the purpose of state registration for clinical trials should be accompanied by an agreement to conduct such tests with medical organizations.
  2.  a copy of the document confirming the empowerment of the authorized representative of the manufacturer.

Letter from Roszdravnadzor 03.03.2014 N I-217/14 should be considered invalid.

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