Registration of medical devices in RF and EAEU

The legislation of the Russian Federation establishes the need for mandatory registration of medical devices. This requirement is designed to ensure the circulation of only high-quality, effective and safe medical products. At the same time, the sale of products without a corresponding registration certificate or their use threatens the violator with bringing him to administrative or criminal responsibility.

Registration of a medical device is a complex, time–consuming process that requires the applicant to have specific knowledge. For a person who does not have the proper experience, an attempt to independently undergo this procedure often remains not only fruitless, but also results in a loss of time, money and nerves. Fortunately, the risk of these negative consequences can be avoided if you entrust the task to a team of professionals from our company.

The rules of the state registration of medical products are determined by the Russian Government’s Decree of December 27, 2012 N 1416 «On the Approval of the Rules of State Registration of Medical Products». These rules are periodically revised, which creates additional problems for all market participants, as it is difficult to keep track of changes to manufacturers and distributors of medical products. The latest changes in the registration procedure were made by the Russian Government’s Decree of November 24, 2020 N 1906 «On amending the Rules of State Registration of Medical Products» Certain changes to the procedure are made by adjustments to the documents regulating the activities of Roszdravnadzor and its expert organizations. For example, the Guidelines for the procedure for conducting an examination of the quality, effectiveness and safety of medical products for state registration have recently been published

The rules for the registration of medical devices in accordance with the EAEU law were approved by the Decision of the Council of the Eurasian Economic Commission No. 46 dated February 12, 2016 (hereinafter referred to as the Rules). The rules provide for a transitional period until December 31, 2021, during which the registration of a medical device at the choice of the manufacturer can be carried out either in accordance with the Rules of the Eurasian Economic Union (EAEU), or in accordance with the national legislation of the member states of the union. From 2022, all medical devices will be registered according to the rules of the EAEU

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The list of types of medical devices subject to mandatory registration as medical devices was approved by the Decree of the Government of the Russian Federation No. 552 dated April 1, 2022 "On approval of the specifics of treatment, including the specifics of State registration, of medical devices in case of their defect or the risk of defect due to the introduction of restrictive economic measures against the Russian Federation"

More information about this list can be found at the link

On September 1, 2022, government Resolutions No. 135 and 136 of February 9, 2022 became legally valid, on the basis of which the need for the use of QMS (quality management system) in the production of medical products subject to final sterilization, potential hazard class 2a and other high-risk products, as well as the rules for confirming the use of this system, was fixed.. It is not necessary, but it is recommended to introduce CMK for medical products of class 2a and 1, which are not subject to sterilization.

The production of goods already included in the Unified Register, the documents to which additions are planned to be included in the period from September 1, 2022 to June 1, 2023, are still subject to verification for 2 years after the completion of the registration procedure.

From June 1, 2023, state inspections of production facilities of new high-class products of potential danger and products of risk category 2a, taking into account sterilization, will be carried out without failure. In addition, during this time it is planned to make additions or changes to the registration dossier. Within 2 years after making such additions, it will be necessary to perform a production check, which must confirm the compliance of the CMK with the ISO 13485 standard.

For Russian manufacturers:

• OGRN, manufacturer's INN and SCP;

• extract from the Unified State Register of Legal Entities;

• an international standard document that indicates the presence of a valid CMK at the enterprise;

• power of attorney certifying the right to act in the interests of the applicant (notarized);

• a document establishing technical requirements (technical specifications);

• documentation indicating the presence of production facilities;

• certificate of qualification examination;

• description of the product subject to the registration procedure;

• technical instructions;

• photos of medical products.

For foreign goods:

• manufacturer's registration certificate (in the country of manufacture);

• documentation indicating the conditions for the manufacture of medical devices;

• permits for products subject to registration;

• technical files;

• test reports from the manufacturer;

• power of attorney for the person representing the interests of the manufacturer in Russia;

• instructions for use;

• photos of medical devices subject to registration;

• production control - document;

• ISO Certificate, CE certificate.

The risk class of the medical product, the required amount of research and the registration scheme used may affect the period of the registration procedure. Most often, the process of registering medical-specific products takes the following time:

1st grade – 8 months;

Class 2a and class 2b – about 12 months;

Grade 3 – approximately 12 months.

More information about the period of registration of medical devices in the EAEU can be found at the link

At the time of submitting the Dossier to the expert organization, each applicant must pay a state fee for the state registration of a medical device in the amount of 11,000 rubles.

The cost of the state fee for the examination of the quality, effectiveness and safety of a medical device is determined by the risk category, which includes a particular product.

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We monitor all changes in the regulatory field that we take into account when preparing documents for our clients. In order to help all market participants, we place a registration scheme for medical devices, which we update in a timely manner, taking into account all changes.

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