Registration of Medical Devices in Russia
Registration of medical devices according to the registration rules of the Russian Federation.
According to the general rule of the Federal Law “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation”, medical devices are subject to state registration. The passage of this procedure is necessary for the launch of a medical device in the Russian market. This procedure is regulated by both the legislation of the Russian Federation and the legislation of the EAEU.
In 2022, the Council of the Eurasian Economic Commission (EEC) decided to extend the national registration until December 31, 2022. After this date, registration according to the rules of the EAEU will become mandatory for all applicants. Currently, registration according to the rules of the EAEU is carried out on a voluntary basis. At the same time, the right to register medical devices under the national procedure is retained.
The rules for the registration of medical devices under the national procedure were approved by Decree of the Government of the Russian Federation of December 27, 2012 N 1416. The authority to register medical devices is vested in Federal Service for Surveillance in Healthcare.
The procedural moments of registration of a medical device depend on its hazard class, determined by the Order of the Ministry of Health of Russia dated 06.06.2012 N 4n, which distinguishes the following classes of medical devices:
- class 1 – low-risk medical devices;
- class 2a – medical devices with an average degree of risk;
- class 2b – medical devices with a high degree of risk;
- class 3 – medical products with a high degree of risk.
To register a medical device, you must submit an application containing the following information:
- name of the medical device;
- full and abbreviated name of the developer of the medical device and / or manufacturer and / or their authorized representative or person in whose name a registration certificate can be issued, its organizational and legal form, address of the location of the legal entity or surname, name and patronymic, details identity document, address of the place of residence of an individual entrepreneur, as well as telephone numbers, e-mail address;
- place of manufacture of the medical product;
- the purpose of the medical device, established by the manufacturer (manufacturer);
- type of medical device in accordance with the nomenclature classification of medical devices;
- class of potential risk of using a medical device in accordance with the nomenclature classification of medical devices;
- code of the All-Russian classifier of products by type of economic activity;
- details about the method of obtaining a registration certificate, as well as information related to the procedure for state registration of a medical device.
The following documents are attached to this application:
- a copy of the document confirming the authority of the applicant;
- information about regulatory documentation for a medical device;
- technical documentation of the manufacturer (manufacturer) for the medical device;
- operational documentation of the manufacturer (manufacturer) for the medical device, including instructions for use or operating instructions for the medical device;
- photographic images of the general view of the medical device, together with accessories, and a photographic image of the electronic media and interface of the software, which is a medical device;
- documents confirming the results of technical testing of a medical device;
- documents confirming the results of toxicological studies of a medical product, the use of which involves contact with the human body;
- documents confirming the results of tests of a medical device in order to approve the type of measuring instruments (for medical devices related to measuring instruments);
- list of documents;
- for medical devices of the 1st class of potential risk of use, software that is a medical device, including software using artificial intelligence technologies, and medical devices for in vitro diagnostics – information confirming the clinical efficacy and safety of medical devices;
- draft plan for clinical trials of a medical device with supporting materials;
- information on the permits issued by the registration authority for the import of medical devices for the purpose of their state registration (for foreign-made medical devices);
- copies of documents confirming the quality of the medicinal product, pharmaceutical substance, biological material and other substance, with the use of which the medical device was manufactured or included in its composition.
When submitting documents, the Federal Service for Surveillance in Healthcare performs an initial check and, if the application or submitted documents do not comply with the above requirements, Federal Service for Surveillance in Healthcare sends the applicant a notification about the need to eliminate the deficiencies within 30 days. And only after the expiration of this period, the documents are returned if the violations have not been eliminated. such notification by registered mail with a return receipt or in the form of an electronic document signed with an electronic signature, or in electronic form via telecommunication channels. When deciding on the state registration of a medical device, an examination of its quality, efficiency and safety is appointed. Also, the state registration of a medical device is suspended for the period of clinical trials, which are subsequently sent to an expert institution for the 2nd stage of the examination. After the examination is completed, a decision is made on the state registration of the medical device or on the refusal of state registration.
It is important to note that the rules for the registration of medical devices in the EAEU, in comparison with the national registration procedure, impose higher requirements for the state registration of medical devices. In this regard, many applicants profiling on the Russian market strive to register a medical device in accordance with national rules.
Due to the limitations of the validity of the rules for registration of medical devices under the national procedure, it is important, when deciding on the choice of registration method, to assess the need to apply for registration according to the rules of the EAEU or according to the rules approved by the Government of the Russian Federation.
Also, the preparation of relevant documents for both procedures requires an individual approach to the assessment of each medical device and a detailed study of all the documentation required for submission.
- Accompanying the issuance of a permit for the import of a medical product into the territory of the Russian Federation for the purpose of its registration
- Preparation of an application for state registration of a medical device
- Legal assistance in the preparation and / or verification of technical and operational documentation in accordance with legal requirements
- Legal support for testing medical devices (if necessary)
- Legal support in the preparation of a package of documents for submission to Federal Service for Surveillance in Healthcare for the purpose of registering a medical device
- Assistance in accompanying clinical trials
- Advising on all issues related to the registration of medical devices