ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of November 30, 2024 No. 1684

About approval of Rules of state registration of medical products

The government of the Russian Federation decides:

1. Approve the enclosed Rules of state registration of medical products.

2. State registration of medical products, including state registration of medical products with low degree of potential risk of their application concerning which features of state registration are established modification of the documents containing in registration files on medical products, applications for which are submitted in the Federal Service on supervision in the field of health care about day of entry into force of this resolution, are performed according to requirements of rules of state registration of the medical products operating about day of entry into force of this resolution.

The registration certificates issued affect the medical products which underwent state registration based on the application submitted in the Federal Service on supervision in the field of health care about day of entry into force of the Rules approved by this resolution before modification of the data containing in the register entry of the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products.

3. The medical organizations which are conforming to requirements to the medical organizations which are carrying out clinical testing of medical products, approved in accordance with the established procedure, and confirmed such compliance till March 1, 2025 notify the Federal Service on supervision in the field of health care by means of the direction of the letter to the specified Service (on paper directly, or by the registered mail with the assurance of receipt, or in electronic form, signed by the strengthened qualified digital signature or the strengthened unqualified digital signature which certificate of key of check is created and it is used in the infrastructure providing information and technology interaction of information systems, used for provision of the state and municipal services electronically, in the procedure established by the Government of the Russian Federation on the e-mail address of the Federal Service on supervision in the field of health care) till September 1, 2025 about compliance to the requirements established by the subitem "e" of Item 6 and (or) the subitem "d" of Item 7 of the Rules approved by this resolution.

4. Recognize invalid acts of the Government of the Russian Federation according to the list according to appendix.

5. Approve the enclosed changes which are made to acts of the Government of the Russian Federation.

6. Realization of the powers provided by this resolution is performed by the Federal Service on supervision in the field of health care within the number of her workers, and also budgetary appropriations provided to the Federal Service on supervision in the field of health care on management and management in the field of the established functions established by the Government of the limiting Russian Federation.

7. This resolution becomes effective since March 1, 2025, except for the subitem "e" of Item 137 of the Rules approved by this resolution which becomes effective since September 1, 2025.

Items 1, 2 and 6 these resolutions and Rules approved by this resolution are effective till December 31, 2026, except for Items 63, of 87 and 101 specified Rules which are effective till December 31, 2025.

Approved by the Order of the Government of the Russian Federation of November 30, 2024 No. 1684

Rules of state registration of medical products

I. General provisions

1. These rules establish procedure for state registration of the medical products which are subject to the address in the territory of the Russian Federation (further - medical products).

2. Any tools, devices, devices, the equipment, materials and other products applied in the medical purposes separately or in combination among themselves, and also together with other accessories necessary for application of the specified products to destination, including the special software, and intended by the producer (manufacturer) for prevention, diagnostics, treatment and medical rehabilitation of diseases, monitoring of condition of human body, carrying out medical researches, recovery, substitution, change of anatomical structure or physiological functions of organism, prevention or termination of pregnancy which functional purpose is not implemented by pharmacological, immunological, genetic or metabolic impact on human body are subject to state registration.

In the territory of the Russian Federation the medical products specified in part 5 of article 38 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" are not registered.

3. State registration of medical products is performed by the Federal Service on supervision in the field of health care (further - registering body).

4. In these rules the following basic concepts are used:

"safety of medical products" - lack of the unacceptable risk connected with damnification of life, to health of the person and the environment;

"evidential materials of the producer (manufacturer) of medical product" - evidential materials (documents) of the producer (manufacturer) of medical product or other organization containing the results of testing for the purpose of determination of quality and safety of medical product, compliance of its characteristics (properties) to requirements of the regulating documentation, technical and operational documentation of the producer (manufacturer) and (or) researches for the purpose of assessment of biological safety of medical product, and also reasons for the chosen methods, their validity allowing to estimate the applied methods (techniques) and the list of the used test equipment;

"applicant" - the producer (manufacturer) of medical product or the authorized representative of the producer (manufacturer);

"single personal account of the applicant" - subsystem of single personal account of the applicant in the federal state information system "Single Portal of the State and Municipal Services (Functions)";

"single personal account of the medical organization" - subsystem of single personal account of the medical organization in the federal state information system "Single Portal of the State and Municipal Services (Functions)";

"quality of medical product" - set of the properties and characteristics of medical product influencing its capability to be effective to destination on condition of compliance to requirements of the regulating documentation, technical and operational documentation of the producer (manufacturer). Purpose of medical product is understood as the decision of the producer (manufacturer) concerning target use of medical product based on its specific properties providing goal achievement of medical application, and reflected in technical and operational documentation of the producer (manufacturer);

"clinical testing" - the developed and planned systematic research undertaken including with participation of the person as the subject, for assessment of safety and efficiency of medical product;

"model (brand) of medical product" - the option of execution of medical product which is characterized by certain constructive technology solutions and specific measure values of its target (functional) appointment;

"regulating documentation" - the document regulating safety requirements, qualities, and also expected efficiency of the provided application and control methods of compliance of medical product to these requirements. The scope of information, specified in the regulating documentation, affirms registering body;

"accessory" - the product which is not medical product, determined by his producer for combined use with one or several medical products when using according to their appointment;

"the producer (manufacturer) of medical product" the legal entity or the physical person registered as the individual entrepreneur responsible for the development and production of medical product making it available for use on its own behalf irrespective of is developed and made medical product by this person or from his name other person (persons), and the bearing responsibility for safety, quality and efficiency of medical product;

"production site" - territorially isolated complex intended for accomplishment of all production process of medical product or its certain stages.

Are understood as certain stages of production process:

production of all medical product or its main units, except the main units which are the medical products registered in accordance with the established procedure in the territory of the Russian Federation in territorially isolated complexes entering organizational structure of the producer (manufacturer) of medical product;

production under agreements with the third-party producer (contractor) of all medical product or its main units, except the main units which are the medical products registered in accordance with the established procedure in the territory of the Russian Federation;

sterilization of medical product (for the medical products issued in sterile type);

marking of medical product (when implementing marking of medical product by the producer (manufacturer)).

Main units are understood as products, except spare parts of medical product, released on behalf of the producer (manufacturer) of the registered medical product, mechanically not connected with other main units of medical product by delivery of medical product and providing functioning of medical product according to appointment.

The building, construction, the room with appointment "residential" cannot be the production site of medical products;

"the registration file" - the set of documents represented by the applicant for state registration of medical product, modification of such documents, cancellations of state registration of medical product, and also the copy of the decisions made by the registering body and federal state budgetary institution which is under authority of registering body (further - expert organization), concerning specific medical item;

"registration number of medical product" - the specification symbol appropriated to medical product in case of its state registration under which it is entered in the state register of medical products and the organizations (individual entrepreneurs) performing production and production of medical products (further - the state register), and kept invariable in case of the address of medical product;

"technical documentation of the producer (manufacturer) of medical product" - the document (documents) regulating design of medical product, establishing technical requirements and containing data for its development, production, application, operation, maintenance, repair, utilization or destruction;

"technical testing of medical product" - the testing for the purpose of determination of quality and safety of medical product, compliance of its characteristics (properties) to requirements of the regulating documentation, technical and operational documentation of the producer (manufacturer) and adoption of the subsequent decision on possibility of carrying out clinical testing which are carried out in the test laboratory (center) accredited in national accreditation system taking into account area of its accreditation;

the "toxicological researches of medical product" of research for the purpose of assessment of biological safety of medical product and adoption of the subsequent decision on possibility of carrying out clinical testing conducted in the test laboratory (center) accredited in national accreditation system taking into account area of its accreditation;

"the authorized representative of the producer (manufacturer) of medical product" - the legal entity or the physical person registered as the individual entrepreneur which are residents of the Russian Federation, authorized by the producer (manufacturer) of medical product to represent its interests concerning the address of medical product in the territory of the Russian Federation, including concerning assessment procedures of compliance and state registration;

"operational documentation of the producer (manufacturer) of medical product" - the document (documents) intended for acquaintance of the consumer with design of medical product, regulating conditions and service regulations (proper use, maintenance, running repair, storage and transportation) guaranteed by the producer (manufacturer) of value of key parameters, characteristics (properties) of medical product, warranty obligations, and also data on its utilization or destruction;

"electronic office of the applicant" - the service in the automated information system of registering body on the Internet (further - Internet network) allowing the applicant to perform after passing of the procedure of identification and authentication interaction with registering body, and also to get access to the data and documents containing in the registration file, in the cases provided by these rules;

"electronic image of the document" - the paper document transformed to electronic form by scanning with preserving its details;

"efficiency of medical product" - capability of medical product to correspond to the appointment established by the producer (manufacturer). Efficiency of medical product is confirmed by practice of clinical application, including clinical testing.

5. State registration of medical products which confirmation of efficiency requires carrying out clinical testing with participation of the person and receipt of permission of registering body to carrying out clinical testing is performed according to Items 63 - 86 these rules.

State registration of medical products which confirmation of efficiency does not require carrying out clinical testing with participation of the person or receipt of permission of registering body to carrying out such clinical testing is performed according to Items 87 - 100 these rules.

Modification of the documents containing in the registration file is performed according to Items 112 - 118 these rules concerning the changes which are not requiring conducting examination of quality, efficiency and safety of medical product and according to Items 120 - 133 these rules concerning the changes requiring conducting examination of quality, efficiency and safety of medical product.

Modification of the documents containing in the registration file for the software using technologies of artificial intelligence which is medical product is performed according to Items 112 - 118, or 120 - 133, or 135 and 136 these rules.

State registration of medical products is carried out based on results of technical testing, toxicological researches, clinical testing representing forms of assessment of conformity of medical products taking into account classification depending on potential risk of their application, inspection of production, the analysis of evidential materials of the producer (manufacturer) of medical product, examination of quality, efficiency and safety of medical products taking into account classification depending on potential risk of their application, and also testing for the purpose of approval like measuring instruments (concerning the medical products relating to measuring instruments in the field of state regulation of ensuring unity of measurements which list affirms the Ministry of Health of the Russian Federation).

6. Clinical testing of medical products (except for medical products for diagnostics of in vitro) are carried out in the medical organizations meeting the following requirements:

a) availability of the license for implementation of medical activities with indication of the list of works (services) constituting medical activities proceeding from appointment and scope of medical products concerning which testing are carried out;

b) availability in the charter of the medical organization of the following types of activity:

scientific (research) activities;

carrying out clinical testing of medical products;

c) availability of department (chamber) of intensive therapy and resuscitation (in case of carrying out clinical testing of the medical products with participation of the person as the subject belonging to the classes 26 and 3 depending on potential risk of application);

d) ensuring protection of confidential information;

e) availability of the standard operational procedures regulating carrying out clinical testing of the medical products covering including:

qualification requirements and personnel training;

interaction with committee on ethics;

receipt of the informed consent;

procedure for carrying out clinical testing;

maintaining and accounting of documentation of clinical testing;

the procedures connected with creation and verification of data set for carrying out clinical testing of the software using technologies of the artificial intelligence which is medical product (in case of carrying out such testing);

e) ensuring introduction of data on the carried-out testing, including data on the issued appraisal report of results of clinical testing, in the automated information system of registering body according to the procedure, established by registering body;

g) availability at the specialists of the medical organization who are directly carrying out the procedures connected with clinical testing, or making the decisions connected with clinical testing, the higher medical education in the specialty according to area of medical application of medical product.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info