Resolution of the Government of the Russian Federation of 30.11.2024 No. 1684 “On approval of the Rules for state registration of medical devices and recognition of certain acts of the Government of the Russian Federation as invalid” (came into force on March 1, 2025).
This article is not an exhaustive review of the new rules for registration of medical devices. Its purpose is to attract the attention of market participants to study and discuss this document. We have studied the draft in detail with colleagues and identified key points, wording and sections that should be paid attention to. Let’s start with the problems.
New registration rules. What changes should not be ignored
Requirements for medical organizations conducting clinical trials of medical devices
The new rules describe in detail the requirements for clinics that conduct clinical trials of medical devices, and also establish the procedure for confirming compliance with these requirements. In particular, the activity of conducting clinical trials of medical devices (hereinafter – CTMD) must be specified in the Charter of the medical organization. In addition, the clinic must develop and implement SOPs (standard operating procedures) regulating the conduct of CTMD, including:
- qualification requirements and training of personnel;
- interaction with the ethics committee, obtaining informed consent;
- procedure for conducting clinical trials;
- maintenance and accounting of clinical trial documentation;
- procedures related to the creation and verification of a data set for conducting clinical trials of software using artificial intelligence technologies, which is a medical device (in the case of conducting such trials).
- Compliance with the requirements is assessed by Roszdravnadzor, and if the conclusion is positive, the clinic is included in the register of medical organizations that have the right to conduct clinical trials of medical devices. Therefore, medical organizations that plan to continue testing after the new rules come into force need to prepare for inclusion in the register now.
In addition, medical organizations will be required to upload information about the tests conducted to the Roszdravnadzor AIS within 3 days from the date of their completion. The last point raises certain concerns: electronic services often fail, and such a period may not be feasible.
Updating information about the authorized representative of the manufacturer (ARM)
Today, for various reasons, registry entries contain outdated information about the authorized representative: for example, they display an already liquidated organization. According to the new rules, manufacturers are required to update information about the authorized representative before September 1, 2025: otherwise, the Registration Certificate may be cancelled. This aspect should also be paid attention to by both current ARMs, and distributors, and the manufacturers themselves.
Otherwise, the new rules make a rather favorable impression.
The innovations simplify the procedure as a whole:
- The most comfortable registration conditions are created for domestic manufacturers. Thus, they will be able to choose one of the “alternative” procedures, according to which the dossier will undergo an examination in just 10 working days. True, for this it will be necessary to meet a number of conditions: conduct technical and toxicological tests at the Federal State Budgetary Institution “VNIIIMT” (if, of course, the necessary methods are available in the area of accreditation of the organization), and clinical trials – in medical organizations that meet the requirements of the Ministry of Health and are included in the network of national medical research centers. Under this procedure, only an application is submitted for registration: the rest of the dossier, including the conclusion on the results of the examination of quality, efficiency and safety, must already be checked and agreed upon by the expert institution by this time.
- The manufacturer will be able to use its own evidence, reducing the volume of tests carried out in testing laboratories (centers). But this can only be done in the absence of a standardized / certified research method.
- The concept of “other substance” is specified as “active substance”, which significantly limits the requirements for the volume of documentation provided by the manufacturer. With regard to medical devices for in vitro diagnostics, the requirement to provide copies of documents confirming the quality of the drug, pharmaceutical substance, biological material and other active substance has disappeared. The launch of a single electronic registry of Registration Certificates has been announced: this will significantly simplify document flow and eliminate the need to restore paper originals of RCs.
- All stages of registration will be transferred to digital format, which is very pleasing: for example, it will not be necessary to notarize the manufacturer’s signature on the technical and operational files; instead, it is provided for certification by an electronic digital signature of the applicant.
- Before a decision on state registration (or its impossibility), it will be possible to appeal the expert opinion. For an already registered medical device, it will be possible to appeal the notification of the need to change the type.
- The new rules also define the conditions under which several models of a medical device (including different types) can be included in one registry entry, and clarify the grounds for registering new medical devices (these provisions actually duplicate the EAEU Rules).
Of course, the main problem remains the validity period of the new rules. According to the current version of the document, the initial submission is limited to 31.12.2025, registration of changes – until 31.12.2026. In addition, before the new rules come into force, it is necessary to update a number of orders of the Ministry of Health, including 11n and 885n, which our company has previously written to the legislative and executive authorities.
The material was prepared jointly by the Federation of Laboratory Medicine (FLA) and the Association of Participants in the Circulation of Medical Devices (AUSOMI)
Information about AUSOMI: OGRN 1227700848968, registered by the Ministry of Justice on 09.12.2022
https://reg-union.ru/
Information about the Federation of Laboratory Medicine: OGRN 1147799015825, registered by the Ministry of Justice on 07.10. 2014
https://fedlab.ru/o-federatsii/
UPD: On March 21, 2025, at a meeting of the Health Committee of the Chamber of Commerce and Industry of the Russian Federation, representatives of the Federal Service for Surveillance in Healthcare announced a decision to extend the national system of registration of medical devices until at least the end of 2027.
Information on the composition of the network of national medical research centers based on scientific organizations subordinate to the Ministry of Health of the Russian Federation is contained in the order of the Ministry of Health of Russia dated 11.09.2017 No. 622 “On the network of national medical research centers”: https://org.gnicpm.ru/wp-content/uploads/2018/11/Prikaz-Minzdrava-Rossii-ot-11.09.2017-N-622-red.-ot-26.12.2.pdf
