Medical Device

In order to register medical devices in Russia, it takes a lot of time and fee to perform separate tests according to compulsory requirements, even if tests are conducted for approval by CE or FDA. Since Russia has not entered into a certification agreement with the EU or the United States, it does not accept internationally recognized certificates such as CE certification from the EU or FDA approval from the United States.

Since 2002, the Russian government has started to change the part of the test to other forms such as product safety assurance, such as production site inspection, quality system check, and post-marketing continuous management. However, such attempts were unsuccessful and, therefore, from January 1, 2013, these procedures were operated in a more robust and realistic form.

The Medical Device Registration Certificate, an official document issued by Roszdravnadzor, the Russian Federation Health Supervisory Service, which provides health and social development services, has passed the preliminary evaluation of the relevant medical device and is therefore suitable for production, import, sale and use in Russia. All medical devices, whether produced in Russia or imported into Russia from abroad, must be registered.

The registration certificate contains the name of the manufacturer, distributor or legal representative. If the medical device for which cancer drug registration is to be registered is composed of modules/blocks manufactured by other manufacturers, but is not a branded product, each module/block must be registered individually. Government Decree Jan. For medical devices listed in 17, 2002 N 19, if there is a registration certificate, VAT is not collected from the manufacturing company.

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  Classification of medical devices

  Nomenclature and classification of 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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  Test type of Medical device registration progress

  Testing according to medical device registration can only be conducted in laboratories registered under the 2011 N 352 Act of 06 May 2011, 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 representative of the company must apply for permission to consent to sending samples to Russia by Rosdravnadzor, which is valid for 6 months. In addition, the representative must provide a description of the applied product, a contract with the laboratory, and a contract with an attorney or manufacturer.
  • 2. The representative must check in to get the sample through customs. In addition, the representative must also provide samples, contracts, documents to be submitted to customs officials, and invoices.
  • 3. Toxicity tests, technical tests, and electromagnetic tests are conducted in the case of electrical products at accredited laboratory.
  • 4. (Simultaneous with step 3) The company must prepare all technical documents required for registration.
  • 5. If the class of medical devices is determined, and there is no similar medical device registered in Russia, quality evaluation, efficiency and safety tests are conducted as the first step, and then clinical evaluation is carried out at two different medical institutions. Quality assessment, efficiency and safety assessments are carried out.
  • 6. The company submits the entire technical file to Rospotrebnadzor. After completing the registration of medical devices, GOST-R certificate, hygiene certificate for each item, and measuring instrument certificate according to the characteristics of the product must be secured based on the registration certificate.

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  Medical device registration submission documents

  • Manufacturer's power of attorney following the registration and certification process (requires notarization)
  • Proof of company registration in the home country (for example, chamber of commerce, internal FDA registration or company registration certificate, business license) must be notarized and submitted.
  • 9001 or ISO 13485 certificate issued by national or international organizations applicable to medical devices
  • Certificate of conformity according to the requirements of 93/42/EEC, declaration of conformity, free-selling certificate, FDA certification document, medical device certification document for national or other countries. (Must be notarized and submitted)
  • Test reports proving safety (IEC 60601-1, IEC 60601-1-2, ISO 10993, etc.)-Accurate reports can help to simplify work during technical inspections in laboratory.
  • Toxic Safety / Biocompatibility Safety Test Report
  • Providing samples for technical and toxicity tests
  • Medical device new registration application or renewal registration application. The application must use the letterhead of the applicant (a legal entity authorized to carry out 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 the 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 stipulate that the manufacturer must entrust the applicant to sign a contract to perform registration of medical devices/equipment, perform consultation and professional work, and obtain a registration certificate.
  • ※ The registration process does not require Good Manufacturing Practices (GMP) audits. However, legislation to introduce these screenings will be implemented in the near future.
  • ※ In general, the fee of registration depends on the scope of testing required.

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  Medical device registration confirmation

  You can check the registration status of medical devices on the website of Rospotrebnadzor in the Russian version.
  
  ☞ Go to Rospotrebnadzor website ☜

  For medical devices of Class 1 and 2a, if the products are similar (same grade, applied in the same way, same efficiency), both products are registered on the basis of equivalent or technical testing, safety.
  
  All other products including Class 2b, 3, 1 and 2a (if no similar product has already been registered) are registered on the basis of technical tests, safety assessments, clinical and medical tests to confirm effectiveness and safety.