Medical device registration in Russia

The medical device registration certificate, an official document issued by the Russian Federation Health Supervisory Authority, Roszdravnadzor, authorizes the relevant medical device to be suitable for production, import, sale and use in Russia because it has passed a preliminary assessment.

Not only medical devices produced in Russia, but all medical devices imported into Russia from abroad must be registered.

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  Classification of medical devices

  Names and classes for medical devices operating in Russia are listed in [Order N4H “About Conformation of Nomenclature Classification of Medical Devices”], and in vitro diagnostic equipment is not included. In vitro diagnostic equipment is subject to separate class regulations.

  • Class 1 – Low risk
  • Class 2a – Medium risk
  • Class 2b – High risk
  • Class 3 – Top risk

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  Medical device registration progress test type

  Testing according to medical device registration can only be conducted in laboratories registered in accordance with the 06.05.2011 N 352 Act, and for clinical trials, a list of institutions that can perform this function is posted on the Roszdravnadzor website.

  • Toxicity test
  • Functional test
  • Electromagnetic inspection
  • Clinical trial

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  Medical device registration validity period

  Permanent(valid until the product registered in the certificate is discontinued)

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  Medical device registration process

  • 1. The agent of the enterprise must apply for a permit that Rosdravnadzor agrees to send the samples to Russia, which is valid for 6 months. In addition, the agent must provide a description of the applied product, a contract with the laboratory, and a contract with an attorney or manufacturer.
  • 2. The agent must go through the procedures to get the sample through customs. In addition to the samples, the representative must provide contracts, documents to be submitted to customs officials, and invoices.
  • 3. Toxicology tests, technical tests and electromagnetic wave tests of electrical products are conducted at accredited laboratory.
  • 4. (Simultaneous with step 3) The company must prepare all technical documents required for registration.
  • 5. The medical device is graded and, if there is no similar medical device registered in Russia, quality assessment, efficiency and safety tests are carried out as the first step. After that, clinical evaluations are conducted at two different medical institutions. A two-step quality assessment, efficiency and safety assessment are performed on medical devices.
  • 6. The entity submits the entire technical file to Rosdravnadzor. After completing the medical device registration, you must obtain the "GOST-R" certificate based on the registration certificate, the hygiene certificate according to the item, and the measuring instrument certificate according to the characteristics of the product.

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  Medical device registration submission documents

  • Manufacturer's power of attorney according to the registration and certification process (requires notarization)
  • Certificates of company registration in the home country (eg, chamber of commerce, internal FDA registration, company registration certificate, business license) must be notarized and submitted
  • ISO 9001 or ISO 13485 certificate issued by domestic or international organizations applicable to medical devices
  • Certificate of conformity in accordance with the requirements of 93/42/EEC, declaration of conformity, free-selling certificate, FDA certification document, medical device certification document for domestic or other countries. (Must be notarized and submitted)
  • Test report proving safety (IEC 60601-1, IEC 60601-1-2, ISO 10993, etc.)-Accurate test report can help to simplify work during technical inspection at the laboratory.
  • Toxic safety/biocompatibility safety test report
  • Providing samples for technical and toxicity testing
  • Medical device new registration application or renewal registration application. The application must use the letterhead of the applicant (a legal entity authorized to conduct registration in Russia). The application must include a description of all components and parts included in the medical device or device. Applications must be submitted in Russian.
  • Submit a power of attorney for appointment of a legal representative to perform the application. The manufacturing company must issue a power of attorney to a legal entity with registration authority (address to the head of the legal entity), and must be notarized in the country of origin of the manufacturer. It must also be translated into Russian and notarized by the Russian consulate in your country. The power of attorney must state that the manufacturer must entrust the applicant to sign a contract and receive a registration certificate to perform the registration of medical devices/equipment, consultation and professional work.

  The registration process does not require Good Manufacturing Practices (GMP) audits. However, legislation to introduce such audits will be implemented in the near future.

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  Why is it important?

  All medical devices produced abroad and imported into Eurasia, as well as medical devices produced in Eurasia, must be registered with the Federal Health Supervisory Service. Medical devices can be imported and sold in Eurasia only after passing the pre-evaluation and registration.
  
  In order to register medical devices in Russia, even if tests were performed for approval by CE or FDA, a separate test, etc., conducted at an Eurasian authorized laboratory must be performed according to mandatory requirements. Russia does not accept internationally recognized certifications such as EU CE certification or US FDA approval, as Russia has not entered into a certification agreement with the EU or the US.

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  IGC’s Competency

  The IGC certification body cooperates with the RUS-TEST PACIFIC certification body to provide the best competitive value to customers and stakeholders, and is reborn as a global certification body through continuous shared growth.
  
  IGC complies with :

  • Comply with legal requirements
  • Teamwork and solidarity among members
  • Sincerity and fairness
  • Social and environmental responsibility
  • Continuous development and improvement activities through knowledge and learning as a certification and registration service provider

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  Why IGC?

  IGC provides a competitive and satisfactory service to its customers through several strengths.

  • Providing competitive services based on knowledge and technology secured through certification projects in various fields
  • Competitive certification cost
  • Minimum time required through rapid authentication service
  • Provide One Stop Service for certification of various systems and products in fields other than Eurasia through subsidiaries