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Registration of medical devices in Russian Federation

Регистрация медицинских изделий в Росздравнадзоре

Registration of medical devices in Roszdravnadzor

Registration of medical devices – is a procedure that allows the production and circulation of high-quality and safe medical devices on the Russian market.

Registration certificate for medical device – a document issued by the Federal Service for Supervision in the health sector (Roszdravnadzor) and gives the official right to issue or sale of medical devices.

* Russian version

Form of registration certificate of Roszdravnadzor

Federal Law «On the Principles of the protection of health of citizens in the Russian Federation» № 323-FZ, states that in the Russian Federation are allowed to use only those medical products that have a valid registration certificate Roszdravnadzor.

Since the registration procedure for medical devices is mandatory by law, the fines for the sale of such devices without a registration certificate can amount to several million rubles.

For more information on fines, see here.

Varieties of medical devices:

In accordance with GOST 31508-2012 and 38 article 323-FZ, medical devices are devices, devices and equipment that are used for medical purposes individually or in combination with each other.

For the full definition of a medical device, see here.

Hazard classes of medical devices:

Hazard class medical device — a conditional value applied to the simplified classification of medical devices according to the degree of potential risk.

  • Class 1 — medical devices with a low level of risk;
  • Class 2a — medical devices with a medium level of risk;
  • Class 2b — medical devices with a heightened level of risk;
  • Class 3 — medical devices with a high level of risk.

The medical device can have only one class of danger.

If a medical device consists of several components, and each of them has a different hazard class, then the entire (whole) medical device must be assigned a general hazard class according to the highest (maximum) hazard class of the components.

To accurately determine the hazard class of a medical device, you can use our table.

Documents required for registration of a medical device:

  • Documents on the registration of the manufacturer as a legal entity (in the country of production);
  • Manufacturer’s certificates of conformity (if any);
  • Permits for a medical device (if any);
  • Apostilled power of attorney for a representative (applicant) in the Russian Federation;
  • Documents confirming the proper production conditions;
  • Technical file (if available);
  • Operational documentation of a medical device: for example, instruction or operation manual (if any);
  • Photos of a medical device.

In the absence of the necessary documents, our experts will develop them without additional fees.

Stages of registration of medical devices by Goszdravnadzor:

  1. We analyze the provided technical documentation, clarify the purpose and technical characteristics of the medical device, check the analogues of the registered medical devices;
  2. We obtain permission to import into the Russian Federation for a medical device (for a foreign manufacturer);
  3. We modifying (or developing) a technical file for a medical device;
  4. We translate design and operational documentation of a medical device into Russian (if necessary);
  5. We check the completeness of the regulatory and technical documentation and form a package of documents for testing;
  6. We select the optimal testing laboratories (the types and types of tests depend on the registered medical device);
  7. We carry out tests in an accredited testing laboratory (if necessary, we make changes to the test reports);
  8. We form and sew a package of documentation (prepare the initial registration dossier), then agree on it when submitting it to Roszdravnadzor;
  9. We draw up and receive a referral for conducting clinical trials;
  10. We conduct clinical trials in a specialized organization, after which we receive a positive decision on these trials;
  11. We carry out the procedure for state registration of a medical device;
  12. We send the generated documentation to the expert organization under Roszdravnadzor;
  13. We receive the original of the Registration Certificate and the positive decision of Roszdravnadzor (a copy of the registration order);
  14. We transfer a complete set of documentation to the customer along with a registration certificate for a medical device..

Goszdravnadzor Company fulfills its obligations!

We indicate all stages of work on registration of a medical device in the contract:

Please note: most mediators for registration of medical devices hide some of the stages of work, thereby misleading their customers!

There are many cases when unscrupulous «registrars» entered into a contract for the provision of services, and then brought the final cost of work to disproportionately high figures.

In this article, you will learn more about how to choose a medical device registrar.

State duty for registration of medical devices:

  • Hazard class 1 — 45,000 rubles (examination) + 7,000 rubles (form RC);
  • Hazard class 2a — 65,000 rubles (examination) + 7,000 rubles (form RC);
  • Hazard class 2b — 85,000 rubles (examination) + 7,000 rubles (form RC);
  • Hazard class 3 — 115,000 rubles (examination) + 7,000 rubles (form RC).

The size of the state fee established by Article 333.32f.2 Tax Code.

In addition to the registration certificate of Roszdravnadzor, you may need a certificate or declaration of conformity.

The cost and term of registration of medical devices:

  • Medical devices of hazard class 1 – 420,000 rubles ($, , ¥);

The project will be completed within 6 months.

  • Medical devices of hazard class 2a – 510,000 rubles ($, , ¥);

The project will be completed within 7 months.

  • Medical devices of hazard class 2b – 580,000 rubles ($, , ¥);

The project will be completed within 9 months.

  • Medical devices of hazard class 3 – 690,000 rubles ($, , ¥);

The project will be completed within 12 months.

If you have already prepared a part of the documentation and some of the registration stages have already been completed, the terms and cost of the work are reduced.

Full price list for services by our experts here.

The cost of the registration certificate issued by Roszdravnadzor does not include the state duty and the cost of conducting the necessary tests (technical, toxicological and clinical). The tests are paid by the Customer directly against the invoices in the laboratory, and the state fee is paid by the invoice from Roszdravnadzor.

In the process, we select parameters for tests with accredited test laboratories.

Since 2011, the company Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction to the smallest nuances. And today we confidently declare that we are one of the leaders in the design and development of permits for medical devices!

Benefits of cooperation with Goszdravnadzor:

Command with a common goal

The Goszdravnadzor company is an organism united by a common goal — to do the work so that the client is satisfied, turns to us again, and advises colleagues and friends. An optimally selected staff of employees successfully solves any tasks in the implementation of projects, moreover, they do it without involving other performers. Our client will never «lose» his project manager since we do not have a staff turnover.

In words, in a contract and in work

The obvious superiority of the Goszdravnadzor company over its competitors is transparent and honest interaction with the customer. After receiving a commercial offer, you can be sure that the prices and terms for the provision of services in it are final. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages — upon completion of the work.

Successful registration guarantee

By the time the contract is concluded, specialists with specialized education conduct a thorough analysis of the available documentation for a medical device. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and shorten the time it takes to complete the work.

Experience, knowledge and authority.

Since 2011, Goszdravnadzor has been implementing projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, carry out tests the first time, and develop documentation without a headache for the customer.