Registration of foreign medical products

National registration procedure

Registration is required for the legal sale and use of medical devices on the territory of the Russian Federation.

The registration process consists of several stages. Some of them are preparatory. These are the ones that we go through before submitting the registration dossier to the Federal Service for Surveillance in Healthcare (hereinafter — Roszdravnadzor). The remaining stages of registration take place in Roszdravnadzor and an expert organization when checking the documentation.

If the decision is favourable, after reviewing the documentation, Roszdravnadzor issues a Registration Certificate.

We have presented the device registration stages in a simplified scheme.

 

To help you, we will:

  • Advise on the registration of a medical device
  • Carry out complex registration work
  • Correct documents for other responsible parties
  • Formalize an import permit
  • Communicate in English with a foreign manufacturer
  • Be an authorized representative of the manufacturer
  • Pick up the goods, deliver them and perform customs clearing
  • Translate documents from any language
  • Notarize the translation
  • Finalize technical and operational documentation
  • Check and correct labeling
  • Develop technical documentation
  • Develop drawings and 3D models
  • Develop a risk management file
  • Choose the type of medical device
  • Find a similar product to simplify registration
  • Determine the risk class of a device
  • Offer the OKPD2 code (Russian Classification of Products by Economic Activities)
  • Register a trademark
  • Prepare documents for registration
  • Deliver the products to the testing center
  • Conduct toxicological testing
  • Carry out sterility tests
  • Perform an implantation test
  • Test measuring instruments
  • Conduct technical testing
  • Conduct clinical and laboratory testing
  • Verify test reports
  • Conduct clinical investigation
  • Pick up the devices from the laboratory and deliver them to you
  • Create a registration dossier
  • Prepare all forms for signing
  • Submit the registration dossier to Roszdravnadzor
  • Correct comments at the request of an expert organization
  • Obtain a marketing authorisation and put it in your hands
  • Support in the post-marketing period
  • Inform about legal developments

Use Calculator to estimate the cost of our registration services.

Choose the communication method convenient for you

 

Mail                                                     info@medexpert.ru

Telephone                                           toll-free number 8 800 201- 27- 87

+7 812 331-09-44 (office on Rustaveli Street in St. Petersburg)

+7 495 679-84-25 (office on Myasnitskaya street in Moscow)

feedback form in the Contacts section

Request a callback                           active button at the top of the web page

Messengers                                        WatsApp +7 977 503-59-37

       Viber +7 977 503-59-37

Ask a question on the website      active button in the bottom right corner of any page of the website