{"id":2487,"date":"2026-10-20T11:43:17","date_gmt":"2026-10-20T08:43:17","guid":{"rendered":"https:\/\/grandlocus.com\/?post_type=resources&p=2487"},"modified":"2026-10-20T11:43:37","modified_gmt":"2026-10-20T08:43:37","slug":"resolution-of-the-government-of-the-russian-federation-dated-30-06-2021-n1066-on-federal-state-control-supervision-over-the-circulation-of-medical-devices","status":"publish","type":"resources","link":"https:\/\/grandlocus.com\/en\/resources\/resolution-of-the-government-of-the-russian-federation-dated-30-06-2021-n1066-on-federal-state-control-supervision-over-the-circulation-of-medical-devices\/","title":{"rendered":"Resolution of the Government of the Russian Federation dated 30.06.2021 N1066 On Federal State Control (Supervision) over the circulation of medical devices"},"content":{"rendered":"

GOVERNMENT OF THE RUSSIAN FEDERATION<\/strong><\/p>\n

 <\/p>\n

RESOLUTION
\n<\/strong>dated 30 June 2021 N 1066<\/strong><\/p>\n

 <\/p>\n

ON FEDERAL STATE CONTROL (SUPERVISION) OVER THE CIRCULATION OF MEDICAL DEVICES<\/strong><\/p>\n

(as amended by Resolutions of the Government of the Russian Federation dated 07.12.2021 N 2220<\/a>, dated 19.11.2025 N 1829<\/a>)<\/p>\n

 <\/p>\n

 <\/p>\n

In accordance with part 5<\/a> of Article 95 of the Federal Law “On the Fundamentals of Health Protection of Citizens in the Russian Federation”, the Government of the Russian Federation resolves:<\/p>\n

    \n
  1. To approve the attached:<\/li>\n<\/ol>\n

    Regulations on Federal State Control (Supervision) over the Circulation of Medical Devices;<\/p>\n

    list of acts of the Government of the Russian Federation that are no longer in force.<\/p>\n

      \n
    1. To establish that scheduled inspections included in the annual plan for scheduled inspections of legal entities and individual entrepreneurs for 2021 and unscheduled inspections whose commencement date falls after 30 June 2021 shall be conducted by the Federal Service for Surveillance in Healthcare in accordance with the Regulations approved by this Resolution.<\/li>\n
    2. This Resolution shall enter into force from 1 July 2021.<\/li>\n<\/ol>\n

       <\/p>\n

       <\/p>\n

      Chairman of the Government
      \n<\/em>of the Russian Federation
      \n<\/em>MISHUSTIN<\/em><\/p>\n

      \u00a0<\/em><\/p>\n

      APPROVED
      \n<\/em>by Resolution of the Government
      \n<\/em>of the Russian Federation
      \n<\/em>dated 30 June 2021 N 1066<\/em><\/p>\n

       <\/p>\n

       <\/p>\n

      REGULATIONS<\/strong><\/p>\n

      ON FEDERAL STATE CONTROL (SUPERVISION) OVER THE CIRCULATION OF MEDICAL DEVICES<\/strong><\/p>\n

      (as amended by Resolutions of the Government of the Russian Federation dated 07.12.2021 N 2220<\/a>, dated 19.11.2025 N 1829<\/a>)<\/p>\n

       <\/p>\n

      General provisions<\/strong><\/p>\n

        \n
      1. These Regulations establish the procedure for the organisation and exercise of federal state control (supervision) over the circulation of medical devices (hereinafter – state control).<\/li>\n
      2. The subject matter of state control shall be:<\/li>\n<\/ol>\n

        \u0430) compliance with mandatory requirements for the circulation of medical devices, including:<\/p>\n

        requirements for technical testing, toxicological studies, clinical trials, production, manufacture, import into the territory of the Russian Federation, confirmation of conformity, storage, transportation, sale, installation, adjustment, use, operation, including maintenance, repair, disposal and destruction;<\/p>\n

        requirements for the quality, safety and effectiveness of medical devices in circulation in the territory of the Russian Federation;<\/p>\n

        \u0431) compliance with licensing requirements for activities involving the production and maintenance (except where maintenance is carried out to meet the own needs of a legal entity or an individual entrepreneur) of medical equipment;<\/p>\n

        \u0432) compliance with requirements for the provision by entities involved in the circulation of medical devices of information on medical devices in accordance with the Federal Law<\/a> “On the Fundamentals of Health Protection of Citizens in the Russian Federation”;<\/p>\n

        \u0433) implementation of decisions adopted following control (supervisory) measures.<\/p>\n

          \n
        1. State control shall be exercised by the Federal Service for Surveillance in Healthcare and its territorial bodies (hereinafter – the state control authority).<\/li>\n
        2. The officials of the state control authority authorised to exercise state control shall be:<\/li>\n<\/ol>\n

          \u0430) the head (deputy head);<\/p>\n

          \u0431) officials whose official duties, in accordance with their official regulations or job description, include the exercise of powers to exercise state control, including the conduct of preventive measures and control (supervisory) measures.<\/p>\n

            \n
          1. The officials authorised to adopt decisions on the conduct of control (supervisory) measures shall be the head (deputy head) of the state control authority.<\/li>\n
          2. The provisions of the Federal Law<\/a> “On State Control (Supervision) and Municipal Control in the Russian Federation” shall apply to relations connected with the exercise of state control.<\/li>\n
          3. The rights and duties of inspectors are established by Article 29<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”.<\/li>\n<\/ol>\n

             <\/p>\n

            \u00a0<\/strong><\/p>\n

            Objects of state control<\/strong><\/p>\n

              \n
            1. The state control authority shall exercise state control over the following objects (hereinafter – objects of state control):<\/li>\n<\/ol>\n

              \u0430) the activities of legal entities and individual entrepreneurs (hereinafter – controlled persons) in the field of circulation of medical devices;<\/p>\n

              \u0431) the results of the activities of controlled persons;<\/p>\n

              \u0432) buildings, premises, structures and equipment subject to mandatory requirements and used in activities in the field of circulation of medical devices (hereinafter – production facilities).<\/p>\n

                \n
              1. Objects of state control shall be recorded through the collection, processing, analysis and recording of information on objects of state control submitted to the state control authority in accordance with regulatory legal acts of the Russian Federation, information received through interdepartmental interaction, and publicly accessible information without interaction with controlled persons.<\/li>\n<\/ol>\n

                 <\/p>\n

                 <\/p>\n

                Management of risks of harm (damage) to legally protected values in the exercise of state control<\/strong><\/p>\n

                  \n
                1. State control shall be exercised on the basis of management of risks of harm (damage).<\/li>\n
                2. In the exercise of state control, the Federal Service for Surveillance in Healthcare shall assign objects of state control to one of the following categories of risk of harm (damage) (hereinafter – risk): (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                  \u0430) high risk; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                  \u0431) significant risk; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                  \u0432) medium risk; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                  \u0433) moderate risk; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                  \u0434) low risk. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                   <\/p>\n

                   <\/p>\n

                    \n
                  1. Objects of state control shall be assigned to a specific risk category on the basis of the criteria for assigning objects of the activities of legal entities and individual entrepreneurs carrying out activities in the field of circulation of medical devices, established according to the appendix.<\/li>\n<\/ol>\n

                    The Federal Service for Surveillance in Healthcare shall review the risk category previously assigned to an object of state control within 5 working days from the date of receipt of information that the object of state control meets the risk criteria of another risk category or that the risk criteria have changed in accordance with the criteria for assigning objects of state control to risk categories provided for in the appendix to these Regulations.<\/p>\n

                     <\/p>\n

                     <\/p>\n

                    Taking into account risks of harm (damage) to legally protected values when conducting control (supervisory) measures and mandatory preventive visits (as amended by Resolution of the Government of the Russian Federation <\/strong>dated 19.11.2025 N 1829<\/strong><\/a>)<\/strong><\/p>\n

                      \n
                    1. Scheduled control (supervisory) measures in respect of objects of state control assigned to the high risk category shall be conducted with the following frequency: (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                      inspection visit – once every 2 years; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                      on-site inspection – once every 2 years; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                      test purchase – once every 2 years; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                      documentary inspection – once every 2 years. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                      In accordance with clause 2<\/a> of part 2 of Article 25 of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”, for objects of state control assigned to the high risk category, one scheduled control (supervisory) measure shall be conducted every 2 years or one mandatory preventive visit per year. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                       <\/p>\n

                       <\/p>\n

                        \n
                      1. No scheduled control (supervisory) measures shall be conducted in respect of objects of state control assigned to the significant, medium, moderate and low risk categories. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                         <\/p>\n

                         <\/p>\n

                        Prevention of risks of harm (damage) to legally protected values<\/strong><\/p>\n

                          \n
                        1. The state control authority shall annually approve a programme for the prevention of risks of harm (damage) to legally protected values, which shall be posted on its official website on the information and telecommunications network “Internet” (hereinafter – the “Internet” network).<\/li>\n
                        2. The state control authority may conduct the following preventive measures:<\/li>\n<\/ol>\n

                          \u0430) provision of information;<\/p>\n

                          \u0431) generalisation of law enforcement practice;<\/p>\n

                          \u0432) announcement of a warning;<\/p>\n

                          \u0433) provision of advice;<\/p>\n

                          \u0434) preventive visit.<\/p>\n

                            \n
                          1. The annual report on the results of the generalisation of law enforcement practice shall be prepared no later than 25 February of the year following the year of the generalisation of law enforcement practice.<\/li>\n
                          2. The report on law enforcement practice shall be approved by Order of the head of the Federal Service for Surveillance in Healthcare and posted on its official website on the “Internet” network within a period not exceeding 5 working days from the date of approval of the report.<\/li>\n<\/ol>\n

                             <\/p>\n

                             <\/p>\n

                            Announcement of a warning<\/strong><\/p>\n

                              \n
                            1. Where the state control authority has information on impending violations of mandatory requirements or signs of violations of mandatory requirements and (or) where there are no confirmed data that a violation of mandatory requirements has caused harm (damage) to legally protected values or created a threat of harm (damage) to legally protected values, the state control authority shall announce to the controlled person a warning of the inadmissibility of violation of mandatory requirements (hereinafter – warning) and propose that measures be taken to ensure compliance with mandatory requirements.<\/li>\n
                            2. A controlled person shall be entitled, within 15 days from the date of receipt of a warning, to submit to the state control authority an objection to the warning.<\/li>\n
                            3. In the objection to the warning, the controlled person shall specify:<\/li>\n<\/ol>\n

                              \u0430) the name of the legal entity, surname, first name and patronymic (if any) of the individual entrepreneur;<\/p>\n

                              \u0431) the taxpayer identification number of the legal entity, individual entrepreneur;<\/p>\n

                              \u0432) the date and number of the warning sent to the controlled person;<\/p>\n

                              \u0433) justification of the position regarding the actions (inaction) of the controlled person specified in the warning that lead or may lead to a violation of mandatory requirements.<\/p>\n

                              In this regard, the controlled person shall be entitled to attach to the objection documents confirming the validity of such objections, or certified copies thereof, or to submit them to the state control authority within the period specified in the objections (not exceeding the period for consideration of the objections).<\/p>\n

                                \n
                              1. Objections to a warning shall be sent by the controlled person on paper by post to the state control authority or as an electronic document drawn up in accordance with Article 21<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation” to the email address of the state control authority specified in the warning, or by other means specified in the warning.<\/li>\n
                              2. The state control authority shall consider objections to a warning and, following consideration thereof, shall send a reply to the controlled person within 20 working days from the date of receipt of the objections to the warning in the procedure established by Article 21<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”.<\/li>\n<\/ol>\n

                                 <\/p>\n

                                 <\/p>\n

                                Provision of advice<\/strong><\/p>\n

                                  \n
                                1. Advice shall be provided by an official of the state control authority upon an in-person request, by telephone, email or video conferencing, and, upon receipt of a written request, in writing in the procedure established by the Federal Law<\/a> “On the Procedure for Considering an Appeal of Citizens of the Russian Federation”, as well as during a preventive measure or control (supervisory) measure.<\/li>\n<\/ol>\n

                                  Advice shall be provided free of charge.<\/p>\n

                                  Advice shall be provided in writing in the following cases:<\/p>\n

                                  a controlled person has submitted a written request for a written reply on matters of advice;<\/p>\n

                                  it is impossible to provide a reply to the questions posed within the time of the provision of advice.<\/p>\n

                                  Where the state control authority receives 5 or more appeals of the same type from controlled persons and their representatives, advice on such appeals shall be provided by posting on the official website of the state control authority on the “Internet” network written explanations signed by an authorised official of the state control authority.<\/p>\n

                                  When providing advice, an official of the state control authority shall observe the confidentiality of information access to which is restricted in accordance with the legislation of the Russian Federation.<\/p>\n

                                  During the provision of advice, information containing an assessment of a specific control (supervisory) measure, decisions and (or) actions of officials of the state control authority or other participants in the control (supervisory) measure, as well as the results of an expert examination or test conducted within the framework of a control (supervisory) measure, may not be provided.<\/p>\n

                                  Advice during a preventive measure or control (supervisory) measure shall be provided before completion of the relevant measure where the controlled person expresses such a wish, which shall be noted in the documents drawn up following the relevant measure.<\/p>\n

                                    \n
                                  1. Officials of the state control authority shall provide advice on the following matters:<\/li>\n<\/ol>\n

                                    In the electronic document, the numbering of clauses corresponds to the official source.<\/em><\/strong><\/p>\n

                                    the existence and (or) content of mandatory requirements in the field of circulation of medical devices;<\/p>\n

                                    the frequency and procedure for conducting control (supervisory) measures;<\/p>\n

                                    the procedure for fulfilling mandatory requirements in the field of circulation of medical devices;<\/p>\n

                                    compliance with an order issued following a control (supervisory) measure.<\/p>\n

                                    Officials of the state control authority shall provide written advice on the matters provided for in the fifth paragraph of this clause.<\/p>\n

                                     <\/p>\n

                                     <\/p>\n

                                    Preventive visit<\/strong><\/p>\n

                                      \n
                                    1. A preventive visit shall be conducted by an official of the state control authority in the form of a preventive discussion at the place where the controlled person carries out activities or by using video conferencing or the “Inspector” mobile application. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                      A preventive visit shall be conducted on the initiative of the state control authority (mandatory preventive visit) or on the initiative of the controlled person. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                      If, during a preventive visit, violations of mandatory requirements directly related to the production, manufacture, import into the territory of the Russian Federation, storage, installation, adjustment, use, operation, maintenance or repair of medical devices are identified, the official of the state control authority shall collect samples of medical devices for the purposes provided for in clause 102 of these Regulations, in the procedure provided for in Articles 52.1<\/a> and 52.2<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                        \n
                                      1. Mandatory preventive visits in respect of controlled persons shall be conducted by the state control authority in the procedure provided for in Articles 52<\/a> and 52.1<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                        A visual examination and expert examination conducted within the framework of a mandatory preventive visit may be carried out using means of remote interaction, including by video conferencing, as well as using the “Inspector” mobile application. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                        When conducting a visual examination within the framework of a mandatory preventive visit, photography and video recording shall be carried out using the “Inspector” mobile application in the procedure provided for in clause 37 of these Regulations. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                        Evasion by a controlled person of a mandatory preventive visit shall constitute grounds for organising and conducting an unscheduled control (supervisory) measure in respect of that person. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                          \n
                                        1. Mandatory preventive visits shall be conducted with the following frequency: (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                          \u0430) in respect of controlled persons that have submitted a notification of commencement of activities in the field of circulation of medical devices in the form of technical testing, toxicological studies, manufacture, import into the territory of the Russian Federation, export from the territory of the Russian Federation, storage, transportation, sale, disposal and destruction of medical devices in accordance with Article 8<\/a> of the Federal Law “On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control”. In that case, a mandatory preventive visit shall be conducted no later than 6 months from the date of submission of such notification; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                          \u0431) depending on the assigned risk category: (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                          for the high risk category – once a year (if the relevant objects of state control are not included in the plan of control (supervisory) measures for the calendar year planned for the mandatory preventive visit); (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                          for the significant, medium and moderate risk categories – in accordance with the frequency<\/a> established by Resolution of the Government of the Russian Federation dated 1 October 2025 N 1511 “On the Frequency of Mandatory Preventive Visits within the Framework of State Control (Supervision), Municipal Control”; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                          for the low risk category – no mandatory preventive visits shall be conducted; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                          \u0432) on the instructions of the persons specified in clause 4<\/a> of part 1 of Article 52.1 of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                            \n
                                          1. Upon completion of a mandatory preventive visit, an official of the state control authority shall draw up a report on the conduct of the mandatory preventive visit in the procedure provided for in Article 90<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation” for control (supervisory) measures, in 2 copies. This report shall specify: (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                            \u0430) the name of the state control authority; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                            \u0431) the name of the controlled person; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                            \u0432) the date, time and place of drawing up the report on the conduct of the mandatory preventive visit; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                            \u0433) the surnames, first names, patronymics (if any) and job titles of the officials of the state control authority who conducted the mandatory preventive visit; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                            \u0434) the date, time, duration and place of the mandatory preventive visit; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                            \u0435) a list of actions performed during the mandatory preventive visit; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                            \u0436) information on the results of the mandatory preventive visit; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                            \u0437) a list of attached documents and materials (if any); (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                            \u0438) the signatures of the officials of the state control authority who conducted the mandatory preventive visit. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                              \n
                                            1. A preventive visit on the initiative of a controlled person shall be organised and conducted in accordance with Articles 52<\/a> and 52.2<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                               <\/p>\n

                                               <\/p>\n

                                              32 – 33. Clauses no longer in force. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                               <\/p>\n

                                               <\/p>\n

                                              Exercise of state control<\/strong><\/p>\n

                                                \n
                                              1. Scheduled control (supervisory) measures shall be conducted by the state control authority on the basis of a plan for scheduled control (supervisory) measures for the next calendar year approved by the prosecution authorities.<\/li>\n
                                              2. A decision to conduct a control (supervisory) measure shall specify the information provided for in part 1<\/a> of Article 64 of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”.<\/li>\n
                                              3. Photography, audio and video recording may be used by an official of the state control authority and persons engaged to perform control (supervisory) actions to record evidence of violations of mandatory requirements in the following cases:<\/li>\n<\/ol>\n

                                                \u0430) conduct of a test purchase;<\/p>\n

                                                \u0431) conduct of an on-site inspection;<\/p>\n

                                                \u0432) conduct of an inspection visit;<\/p>\n

                                                \u0433) selective control.<\/p>\n

                                                  \n
                                                1. Photography, audio and video recording and other means of recording evidence shall be carried out using equipment, including using the “Inspector” mobile application when carrying out photography and video recording, which shall be recorded in the control (supervisory) measure report, specifying the type and brand of the equipment used to record violations of mandatory requirements. Materials obtained through photography, audio and video recording shall be attached to the control (supervisory) measure report. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                                  Violations of mandatory requirements shall be recorded by photography with at least 2 photographs of each identified violation of mandatory requirements. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                  Audio and video recording shall be carried out during a control (supervisory) measure with notification at the beginning and end of the recording of the date, place and time of commencement and completion of the recording. During the recording, the place and nature of the identified violation of mandatory requirements shall be recorded and specified in detail. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                   <\/p>\n

                                                   <\/p>\n

                                                    \n
                                                  1. An individual entrepreneur who is a controlled person shall be entitled to submit to the state control authority information on the impossibility of being present during a control (supervisory) measure in the following cases:<\/li>\n<\/ol>\n

                                                    \u0430) temporary incapacity for work of the individual entrepreneur;<\/p>\n

                                                    \u0431) the individual entrepreneur being on an official business trip to another locality.<\/p>\n

                                                      \n
                                                    1. In the exercise of state control, the following types of control (supervisory) measures shall be conducted:<\/li>\n<\/ol>\n

                                                      \u0430) documentary inspection;<\/p>\n

                                                      \u0431) on-site inspection;<\/p>\n

                                                      \u0432) selective control;<\/p>\n

                                                      \u0433) test purchase;<\/p>\n

                                                      \u0434) inspection visit;<\/p>\n

                                                      \u0435) observation of compliance with mandatory requirements (safety monitoring).<\/p>\n

                                                      39.1. A visual examination, questioning and expert examination conducted within the framework of an on-site inspection, as well as a visual examination and questioning conducted within the framework of an inspection visit, may be carried out using means of remote interaction, including by video conferencing, as well as using the “Inspector” mobile application. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                      Photography and video recording during a visual examination within the framework of an on-site inspection and an inspection visit shall be carried out using the “Inspector” mobile application. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                        \n
                                                      1. Following control (supervisory) measures, the Federal Service for Surveillance in Healthcare shall adopt decisions in accordance with Articles 90<\/a> and 90.1<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”, in accordance with parts 18<\/a> and 19<\/a> of Article 38, part 1<\/a> of Article 86, parts 6<\/a> and 7<\/a> of Article 96 of the Federal Law “On the Fundamentals of Health Protection of Citizens in the Russian Federation”, including informing entities involved in the circulation of medical devices by posting information letters on the official website of the Federal Service for Surveillance in Healthcare on the “Internet” network concerning the identification of falsified medical devices, substandard medical devices, counterfeit medical devices and unregistered medical devices. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                                         <\/p>\n

                                                         <\/p>\n

                                                        Documentary inspection<\/strong><\/p>\n

                                                          \n
                                                        1. During a documentary inspection, the following control (supervisory) actions may be performed:<\/li>\n<\/ol>\n

                                                          \u0430) obtaining written explanations;<\/p>\n

                                                          \u0431) requesting documents;<\/p>\n

                                                          \u0432) expert examination.<\/p>\n

                                                            \n
                                                          1. A documentary inspection shall be conducted at the location of the state control authority.<\/li>\n<\/ol>\n

                                                            The controlled person shall be notified of a documentary inspection by sending a copy of the decision to conduct the documentary inspection.<\/p>\n

                                                              \n
                                                            1. The subject matter of a documentary inspection shall be information contained in the documents of the controlled person establishing its organisational and legal form, rights and duties, documents used in carrying out activities in the field of circulation of medical devices and related to its fulfilment of mandatory requirements and compliance with orders.<\/li>\n<\/ol>\n

                                                              In the course of a documentary inspection, officials of the state control authority shall first examine the documents of the controlled person available to the state control authority, including notifications of commencement of certain types of activities, reports on previous inspections, materials on the consideration of cases of administrative offences, and documents received from other state bodies through interdepartmental information exchange, including in electronic form.<\/p>\n

                                                                \n
                                                              1. If the reliability of information contained in documents available to the state control authority raises reasonable doubts or that information does not allow assessment of the controlled person’s fulfilment of mandatory requirements, the state control authority shall send to the controlled person a reasoned request requiring the submission of other documents necessary for consideration during the documentary inspection. A copy of the decision of the state control authority to conduct the documentary inspection certified by a seal shall be attached to the request.<\/li>\n
                                                              2. Within 10 working days from the date of receipt of a reasoned request, the controlled person in respect of whom the documentary inspection is conducted shall send the documents specified in the request to the state control authority.<\/li>\n<\/ol>\n

                                                                The controlled person shall be entitled to submit the documents specified in the request in the form of electronic documents signed with an electronic signature.<\/p>\n

                                                                  \n
                                                                1. It shall not be permitted to require notarisation of copies of documents submitted to the state control authority unless otherwise provided for by the legislation of the Russian Federation.<\/li>\n
                                                                2. If, during a documentary inspection, errors and (or) contradictions in the documents submitted by the controlled person are identified, or a discrepancy is identified between information contained in those documents and information contained in documents available to the state control authority and (or) obtained in the exercise of state control, information thereon shall be sent to the controlled person with a requirement to submit the necessary written explanations within 10 working days. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n
                                                                3. Controlled persons submitting to the state control authority written explanations regarding identified errors and (or) contradictions in the submitted documents or regarding a discrepancy in the information contained in the documents shall be entitled to submit additionally to the state control authority documents confirming the reliability of the previously submitted documents. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n
                                                                4. A documentary inspection whose subject matter is information constituting a state secret shall be conducted in accordance with the provisions of the Law<\/a> of the Russian Federation “On State Secrets”.<\/li>\n<\/ol>\n

                                                                   <\/p>\n

                                                                   <\/p>\n

                                                                  On-site inspection<\/strong><\/p>\n

                                                                    \n
                                                                  1. The duration of an on-site inspection may not exceed 10 working days. In respect of one small business entity, the total duration of interaction during an on-site inspection may not exceed 50 hours for a small enterprise and 15 hours for a microenterprise. The duration of an on-site inspection in respect of an organisation carrying out its activities in the territories of several constituent entities of the Russian Federation shall be established separately for each branch, representative office, separate structural subdivision of the organisation or production facility.<\/li>\n
                                                                  2. An on-site inspection shall be conducted where the grounds specified in clauses 1<\/a> – 5<\/a> and 7<\/a> – 9<\/a> of part 1 of Article 57 of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation” exist. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n
                                                                  3. An on-site inspection shall be conducted at the location (place of activities) of the controlled person (its branches, representative offices, separate structural subdivisions) for the purpose of assessing compliance with mandatory requirements and assessing compliance with an order of the state control authority to remedy identified violations of mandatory requirements.<\/li>\n<\/ol>\n

                                                                    An on-site inspection may be conducted using means of remote interaction, including by video conferencing, as well as using the “Inspector” mobile application. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                      \n
                                                                    1. The controlled person shall be notified of an on-site inspection by sending a copy of the decision to conduct the on-site inspection no later than 24 hours before its commencement in the procedure provided for in Article 21<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”.<\/li>\n
                                                                    2. An on-site inspection shall commence with the presentation of official identification by officials of the state control authority, mandatory familiarisation of the head, another official or an authorised representative of the controlled person with the decision to conduct the on-site inspection of the state control authority on the appointment of the on-site inspection and with the powers of the persons conducting the on-site inspection, as well as with the purposes, objectives and grounds for the on-site inspection, the types and scope of control measures, the composition of experts and representatives of expert organisations engaged in the on-site inspection, and the time limits and conditions of its conduct.<\/li>\n
                                                                    3. If, during an inspection, it is established that the activities of a controlled person carrying out the circulation of medical devices pose a threat of harm to the life and health of citizens and medical workers or such harm has been caused, the state control authority, within its competence, shall immediately take measures to prevent harm or cease its infliction and shall bring to the attention of citizens and other organisations, by any available means, information on the existence of a threat of harm and ways of preventing it.<\/li>\n
                                                                    4. During an on-site inspection, the following control (supervisory) actions may be performed:<\/li>\n<\/ol>\n

                                                                      \u0430) visual examination;<\/p>\n

                                                                      \u0431) questioning;<\/p>\n

                                                                      \u0432) obtaining written explanations;<\/p>\n

                                                                      \u0433) requesting documents;<\/p>\n

                                                                      \u0434) sampling (sample collection);<\/p>\n

                                                                      \u0435) testing;<\/p>\n

                                                                      \u0436) expert examination.<\/p>\n

                                                                        \n
                                                                      1. Samples of medical devices shall be collected by officials of the state control authority in the presence of responsible persons of the controlled person carrying out activities in the field of circulation of medical devices, and a medical device sampling protocol shall be drawn up in the form approved by the Federal Service for Surveillance in Healthcare. Medical devices in circulation in the territory of the Russian Federation shall be subject to sampling.<\/li>\n
                                                                      2. The number of medical device samples necessary for research, testing and expert examinations shall be determined by officials of the state control authority jointly with a federal state budgetary institution under the authority of the Federal Service for Surveillance in Healthcare (hereinafter – expert institution) carrying out the said testing, research and expert examinations, taking into account the norms established by national standards, sampling rules and methods for their research, testing and measurements, technical regulations or other regulatory technical documents, rules and methods of research, testing and measurements in force before the date of their entry into force.<\/li>\n<\/ol>\n

                                                                        Medical device samples may not be collected from products that are in operation and constitute an element of a system if such an action would lead to a change in the technical or technological characteristics of the system and create a threat to its safe operation.<\/p>\n

                                                                          \n
                                                                        1. At all stages of storage, transportation and preparation of samples for testing, as well as during testing, the requirements established by the regulatory, technical and operating documentation for the medical device, violation of which may lead to damage to the samples or their failure, shall be observed.<\/li>\n
                                                                        2. The time for carrying out an expert examination shall depend on the type of expert examination and shall be established individually in each specific case by agreement between the state control authority and the expert or expert organisation.<\/li>\n
                                                                        3. Where it is impossible to transport a research sample to the expert’s place of work, the state control authority shall provide the expert with unhindered access to the sample and the conditions necessary for research.<\/li>\n<\/ol>\n

                                                                           <\/p>\n

                                                                           <\/p>\n

                                                                          Selective control<\/strong><\/p>\n

                                                                            \n
                                                                          1. Selective control shall be carried out on a scheduled and unscheduled basis.<\/li>\n
                                                                          2. During selective control, the following control (supervisory) actions may be performed:<\/li>\n<\/ol>\n

                                                                            \u0430) visual examination;<\/p>\n

                                                                            \u0431) obtaining written explanations;<\/p>\n

                                                                            \u0432) requesting documents;<\/p>\n

                                                                            \u0433) sampling (sample collection);<\/p>\n

                                                                            \u0434) instrumental examination;<\/p>\n

                                                                            \u0435) testing;<\/p>\n

                                                                            \u0436) expert examination.<\/p>\n

                                                                              \n
                                                                            1. Selective control may be carried out at places of use (operation), storage and sale of medical devices.<\/li>\n
                                                                            2. Samples of medical devices may be collected during selective control exclusively where it is impossible to assess compliance with mandatory requirements by other means without collecting samples of medical devices. Samples of medical devices shall be collected in the presence of the controlled person or its representative and (or) with the use of video recording. Video recording shall be mandatory where samples of medical devices are collected at places of their use (operation) in medical organisations.<\/li>\n
                                                                            3. Instrumental examination, testing and expert examination of medical devices following selective control may be carried out in the testing laboratories of expert organisations. The results of instrumental examination, testing or expert examination of medical devices shall be provided to the controlled person within 24 hours after the state control authority receives the instrumental examination, testing or expert examination data.<\/li>\n<\/ol>\n

                                                                              A decision to conduct selective control shall be adopted for the purpose of collecting samples of medical devices for the purpose of confirming their conformity with mandatory safety and (or) quality requirements.<\/p>\n

                                                                                \n
                                                                              1. Instrumental examination shall mean a control (supervisory) action performed by an official of the state control authority or a specialist of an expert organisation at the location (place of activities) of the controlled person (its branches, representative offices, separate structural subdivisions) or at the location of a production facility, using special equipment and (or) technical instruments to determine actual values, indicators and actions (events) relevant to assessment of compliance by the controlled person with mandatory requirements.<\/li>\n
                                                                              2. Controlled persons carrying out the storage and (or) sale of medical devices shall ensure unhindered access for officials of the state control authority to production facilities, as well as to all service and special premises.<\/li>\n
                                                                              3. When planning unscheduled selective control, an official of the state control authority shall submit to the head of the state control authority a reasoned submission on the conduct of unscheduled selective control, justifying the existence of grounds for its conduct.<\/li>\n
                                                                              4. Where the head of the state control authority agrees with the reasoned submission, an official of the state control authority shall prepare a decision to conduct unscheduled selective control. Unscheduled selective control shall be conducted by the officials of the state control authority specified in the decision to conduct unscheduled selective control, without notifying the controlled person.<\/li>\n
                                                                              5. The decision of the state control authority to conduct selective control shall specify:<\/li>\n<\/ol>\n

                                                                                \u0430) the name of the state control authority and the type of state control within the framework of which selective control is conducted;<\/p>\n

                                                                                \u0431) the surnames, first names, patronymics (if any) and position of the person or persons authorised to conduct selective control;<\/p>\n

                                                                                \u0432) the name of the legal entity or surname, first name and patronymic (if any) of the individual entrepreneur in respect of whom selective control is conducted, as well as the location of the legal entity, the place of activities of the individual entrepreneur and (or) the place where the legal entity or individual entrepreneur actually carries out activities, where selective control is directly conducted;<\/p>\n

                                                                                \u0433) the state registration number of the entry on the establishment of the legal entity, the number of the accreditation entry in the state register of accredited branches and representative offices of foreign legal entities, the state registration number of the entry on state registration as an individual entrepreneur and the taxpayer identification number (where the state control authority has the said information);<\/p>\n

                                                                                \u0434) the mandatory requirements, assessment of compliance with which is carried out during selective control;<\/p>\n

                                                                                \u0435) the grounds for conducting selective control;<\/p>\n

                                                                                \u0436) information on the goods (medical devices) subject to sampling during selective control;<\/p>\n

                                                                                \u0437) the date of selective control;<\/p>\n

                                                                                \u0438) information on the use of photography and filming, as well as video recording, during selective control;<\/p>\n

                                                                                \u043a) information on approval of the conduct of selective control by the prosecution authorities or on notification of the prosecution authorities of its conduct (specifying the date and number of the approval letter – in the case of unscheduled selective control).<\/p>\n

                                                                                  \n
                                                                                1. During selective control, officials of the state control authority shall:<\/li>\n<\/ol>\n

                                                                                  \u0430) collect the medical device independently or with the involvement of an employee (representative) of the controlled person;<\/p>\n

                                                                                  \u0431) sign documents and perform other actions necessary for collecting the medical device;<\/p>\n

                                                                                  \u0432) request from the controlled person documents and (or) information relating to the circulation of the medical device.<\/p>\n

                                                                                    \n
                                                                                  1. Information on the organisation of selective control shall be entered by an official of the state control authority in the unified register of control (supervisory) measures no later than 3 working days from the date of selective control.<\/li>\n
                                                                                  2. The results of expert examination (research, testing) of medical devices collected during selective control shall be sent to the controlled person no later than 24 hours after they are drawn up.<\/li>\n
                                                                                  3. Information on the results of expert examination (research, testing) shall be entered by an official of the state control authority in the unified register of control (supervisory) measures no later than 2 working days from the date of completion of research (testing) of medical devices collected during selective control.<\/li>\n<\/ol>\n

                                                                                     <\/p>\n

                                                                                     <\/p>\n

                                                                                    Test purchase<\/strong><\/p>\n

                                                                                      \n
                                                                                    1. A test purchase shall be carried out on a scheduled and unscheduled basis.<\/li>\n
                                                                                    2. A visual examination may be performed during a test purchase.<\/li>\n
                                                                                    3. A test purchase shall be conducted for the purpose of verifying compliance by entities involved in the circulation of medical devices with the prohibition on the sale of falsified medical devices, substandard medical devices and counterfeit medical devices.<\/li>\n
                                                                                    4. An unscheduled test purchase may be conducted only with approval by the prosecution authorities, except where it is conducted in accordance with clauses 3<\/a>, 4<\/a>, 6<\/a> and 8<\/a> of part 1 of Article 57, part 12<\/a> of Article 66 and part 7<\/a> of Article 75 of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n
                                                                                    5. Clause no longer in force. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n
                                                                                    6. A decision to conduct a test purchase shall be adopted where assessment of compliance with mandatory requirements in the field of circulation of medical devices established by federal laws and other regulatory legal acts of the Russian Federation adopted in accordance therewith, when selling goods, performing work and providing services to consumers, can be carried out only within the framework of a test purchase.<\/li>\n
                                                                                    7. An official of the state control authority shall submit to the head of the state control authority a reasoned submission on the conduct of a test purchase, justifying the existence of grounds for its conduct.<\/li>\n
                                                                                    8. Where the head of the state control authority agrees with the reasoned submission, the official shall prepare a decision to conduct a test purchase.<\/li>\n
                                                                                    9. The decision of the state control authority to conduct a test purchase shall specify:<\/li>\n<\/ol>\n

                                                                                      \u0430) the name of the state control authority, as well as the type of state control within the framework of which the test purchase is conducted;<\/p>\n

                                                                                      \u0431) the surnames, first names, patronymics (if any) and positions of the official or officials of the state control authority authorised to conduct the test purchase;<\/p>\n

                                                                                      \u0432) the name of the legal entity or surname, first name and patronymic (if any) of the individual entrepreneur in respect of whom the test purchase is conducted, as well as the location of the legal entity, the place of activities of the individual entrepreneur and (or) the place where the legal entity or individual entrepreneur actually carries out activities, where the test purchase is directly conducted. When conducting a remote test purchase, the decision to conduct the test purchase shall include information enabling identification of the place of the test purchase (postal address, telephone number, fax number, website address on the “Internet” network, email address and (or) other information);<\/p>\n

                                                                                      \u0433) the state registration number of the entry on the establishment of the legal entity, the number of the accreditation entry in the state register of accredited branches and representative offices of foreign legal entities, the state registration number of the entry on state registration as an individual entrepreneur and the taxpayer identification number (where the state control authority has the said information);<\/p>\n

                                                                                      \u0434) the mandatory requirements, assessment of compliance with which is carried out during the test purchase;<\/p>\n

                                                                                      \u0435) the grounds for conducting the test purchase;<\/p>\n

                                                                                      \u0436) information on medical devices to be acquired during the test purchase and the methods of their purchase and payment;<\/p>\n

                                                                                      \u0437) the date of the test purchase;<\/p>\n

                                                                                      \u0438) information on the use of photography and filming, as well as video recording, during the test purchase;<\/p>\n

                                                                                      \u043a) information on approval of the conduct of the test purchase by the prosecution authorities or on notification of the prosecution authorities of its conduct (specifying the date and number of the approval letter – in the case of an unscheduled test purchase).<\/p>\n

                                                                                        \n
                                                                                      1. A test purchase shall be conducted by the officials of the state control authority specified in the decision to conduct the test purchase, without prior notification of the controlled person.<\/li>\n
                                                                                      2. A test purchase shall be conducted in the presence of 2 witnesses or with the use of video recording, by the methods used by consumers when acquiring goods (work, services) and entering into the relevant transactions with controlled persons carrying out activities in the field of circulation of medical devices. Where necessary, photography, audio and video recording shall be used during a test purchase to record the test purchase process.<\/li>\n
                                                                                      3. During a test purchase, officials of the state control authority shall:<\/li>\n<\/ol>\n

                                                                                        \u0430) select a medical device independently or with the involvement of an employee (representative) of the controlled person;<\/p>\n

                                                                                        \u0431) sign documents and perform other actions necessary for acquiring goods (work, services);<\/p>\n

                                                                                        \u0432) request documents and (or) information on the medical device, the provision of which to the consumer is required by consumer rights protection legislation.<\/p>\n

                                                                                          \n
                                                                                        1. A test purchase may be conducted by methods that exclude direct contact between employees (representatives) of the controlled person and the consumer when entering into a transaction, including using postal networks, telecommunications networks, including the “Internet” network, as well as communications networks for broadcasting television channels and (or) radio channels.<\/li>\n
                                                                                        2. Information on the organisation of a test purchase shall be entered by an official of the state control authority in the unified register of control (supervisory) measures no later than 3 working days from the date of the test purchase.<\/li>\n
                                                                                        3. After completion of a test purchase (except for a remote test purchase), an official of the state control authority shall announce the conduct of the test purchase, present official identification and the decision to conduct the test purchase, and hand over to the controlled person or its representative a copy of the decision to conduct the test purchase.<\/li>\n
                                                                                        4. After announcement of the conduct of a test purchase (except where, as a result of the test purchase, the goods acquired have lost their consumer properties or the controlled person in respect of whom the test purchase was conducted has incurred expenses in connection with the performance of work or provision of services within the framework of the test purchase), funds shall be returned to the state control authority by:<\/li>\n<\/ol>\n

                                                                                          \u0430) immediate return of cash to the official of the state control authority;<\/p>\n

                                                                                          \u0431) immediate taking by employees (representatives) of the controlled person of the actions necessary to return funds transferred during the test purchase by cashless payment to the account from which payment for the goods (work, service) was made during the test purchase.<\/p>\n

                                                                                            \n
                                                                                          1. Medical devices acquired during a test purchase shall be returned to the employee (representative) of the controlled person.<\/li>\n<\/ol>\n

                                                                                             <\/p>\n

                                                                                             <\/p>\n

                                                                                            Inspection visit<\/strong><\/p>\n

                                                                                              \n
                                                                                            1. During an inspection visit, the following control (supervisory) actions may be performed:<\/li>\n<\/ol>\n

                                                                                              \u0430) visual examination;<\/p>\n

                                                                                              \u0431) questioning;<\/p>\n

                                                                                              \u0432) obtaining written explanations;<\/p>\n

                                                                                              \u0433) requesting documents that, in accordance with mandatory requirements, must be at the location (place of activities) of the controlled person (its branches, representative offices, separate structural subdivisions) or the object of control.<\/p>\n

                                                                                              93.1. An inspection visit may be conducted using means of remote interaction, including by video conferencing, as well as using the “Inspector” mobile application. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                               <\/p>\n

                                                                                               <\/p>\n

                                                                                              Observation of compliance with mandatory requirements (safety monitoring)<\/strong><\/p>\n

                                                                                                \n
                                                                                              1. Observation of compliance with mandatory requirements (safety monitoring) shall be conducted taking into account the provisions of Article 96<\/a> of the Federal Law “On the Fundamentals of Health Protection of Citizens in the Russian Federation” and part 1<\/a> of Article 74 of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation” in the form of analysis of data on objects of state control available to the state control authority, including data that are received: (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                                                                                in the course of interdepartmental information exchange;<\/p>\n

                                                                                                are submitted by controlled persons in the fulfilment of mandatory requirements;<\/p>\n

                                                                                                data contained in state and municipal information systems;<\/p>\n

                                                                                                information submitted by entities involved in the circulation of medical devices in accordance with the Federal Law<\/a> “On the Fundamentals of Health Protection of Citizens in the Russian Federation”.<\/p>\n

                                                                                                  \n
                                                                                                1. If, during observation of compliance with mandatory requirements (safety monitoring), instances of harm (damage) or the emergence of a threat of harm (damage) to legally protected values are identified, information is received on violations of mandatory requirements, impending violations of mandatory requirements or signs of violations of mandatory requirements, the following decisions may be adopted by the state control authority:<\/li>\n<\/ol>\n

                                                                                                  \u0430) a decision to conduct an unscheduled control (supervisory) measure in accordance with Article 60<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”;<\/p>\n

                                                                                                  \u0431) a decision to announce a warning.<\/p>\n

                                                                                                    \n
                                                                                                  1. During observation of compliance with mandatory requirements (safety monitoring), duties not established by mandatory requirements may not be imposed on controlled persons.<\/li>\n<\/ol>\n

                                                                                                     <\/p>\n

                                                                                                     <\/p>\n

                                                                                                    Collection of medical device samples. Conduct of expert examination, testing and (or) instrumental examination<\/strong><\/p>\n

                                                                                                      \n
                                                                                                    1. In the exercise of state control, samples of medical devices may be collected for the purpose of assessing compliance by the controlled person with mandatory requirements.<\/li>\n
                                                                                                    2. Samples of medical devices may be collected during selective control.<\/li>\n
                                                                                                    3. Samples of medical devices shall be collected by officials of the state control authority in the presence of responsible persons of the controlled person.<\/li>\n
                                                                                                    4. The collection of samples of medical devices shall be documented in a medical device sampling protocol in the form approved by the Federal Service for Surveillance in Healthcare.<\/li>\n
                                                                                                    5. In the exercise of state control, the state control authority may carry out expert examination, testing and (or) instrumental examination of medical devices collected during a control (supervisory) measure to verify their quality and safety.<\/li>\n
                                                                                                    6. Expert examination, testing and (or) instrumental examination (where necessary, technical testing, toxicological studies, clinical trials) shall be carried out by expert organisations subordinate to the Federal Service for Surveillance in Healthcare under a state assignment for conformity with the requirements of the regulatory, technical and (or) operating documentation of the manufacturer (producer) or, in its absence, with the requirements of safety standards applicable to specific groups of medical devices.<\/li>\n
                                                                                                    7. Expert examination, testing and (or) instrumental examination may be carried out both at the location (place of activities) of the controlled person (its branches, representative offices, separate structural subdivisions), at the place of use of the medical device directly during a control (supervisory) measure, and at the place of activities of the expert organisation. Where it is impossible to transport a medical device to the place of work of the expert of the expert organisation, the state control authority shall provide the expert with unhindered access to the sample and the conditions necessary for research.<\/li>\n
                                                                                                    8. The time for carrying out expert examination, testing and (or) instrumental examination shall depend on the types of tests necessary to verify quality and safety and shall be established individually in each specific case by agreement between the state control authority and the expert or expert organisation.<\/li>\n
                                                                                                    9. The results of expert examination, testing and (or) instrumental examination shall be documented in an expert opinion specifying (where present) facts and circumstances posing a threat to the life and health of citizens and medical workers and (or) the substandard nature and (or) falsification of the medical device and (or) signs indicating an unregistered medical device.<\/li>\n
                                                                                                    10. Decisions, actions (inaction) of officials of the state control authority and experts engaged where necessary may be appealed in the procedure established by the legislation of the Russian Federation.<\/li>\n
                                                                                                    11. Upon completion of expert examination, testing and (or) instrumental examination, samples of medical devices not used in the process shall be returned to the controlled person carrying out activities in the field of circulation of medical devices under a transfer and acceptance certificate.<\/li>\n
                                                                                                    12. Where samples collected have been consumed or rendered unfit for further use for their intended purpose during testing, instrumental examinations and expert examination, a certificate on their consumption or write-off shall be drawn up. Certificates shall be drawn up by a representative of the controlled person carrying out activities in the field of circulation of medical devices and the head of the expert institution (a person authorised by the head) carrying out the said testing, research and expert examinations.<\/li>\n
                                                                                                    13. At all stages of storage, transportation and preparation of samples for expert examination, testing and (or) instrumental examination, as well as during their conduct, the requirements established in the regulatory, technical and operating documentation for the medical device shall be observed.<\/li>\n
                                                                                                    14. Expert examination, testing and (or) instrumental examination shall be carried out within a period not exceeding 20 working days from the date on which the expert organisation receives the assignment of the Federal Service for Surveillance in Healthcare, as well as samples of medical devices.<\/li>\n
                                                                                                    15. In exceptional cases connected with the need to conduct complex and (or) lengthy tests included in the regulatory, technical and (or) operating documentation of the manufacturer (producer) or, in its absence, in other regulatory documentation, on the basis of reasoned proposals of the expert organisation, the period for conducting expert examination testing and (or) instrumental examination may be extended by the head (deputy heads) of the Federal Service for Surveillance in Healthcare, but by no more than 30 working days.<\/li>\n
                                                                                                    16. Upon receipt of an expert opinion containing conclusions on the identification of substandard medical devices, falsified medical devices, counterfeit medical devices or unregistered medical devices, the Federal Service for Surveillance in Healthcare shall issue an information letter on the identification in circulation of a substandard medical device, falsified medical device, counterfeit medical device or unregistered medical device, and shall also adopt decisions in the form of an Order of the Federal Service for Surveillance in Healthcare on the seizure and destruction of identified falsified medical devices, substandard medical devices and counterfeit medical devices in the procedure established by the Government of the Russian Federation.<\/li>\n
                                                                                                    17. Decisions of the Federal Service for Surveillance in Healthcare on the seizure and destruction of identified falsified medical devices, substandard medical devices, counterfeit medical devices and unregistered medical devices shall be published on the official website of the Federal Service for Surveillance in Healthcare on the “Internet” network.<\/li>\n<\/ol>\n

                                                                                                       <\/p>\n

                                                                                                       <\/p>\n

                                                                                                      Documentation of the results of control (supervisory) measures<\/strong><\/p>\n

                                                                                                        \n
                                                                                                      1. Following a control (supervisory) measure, the officials of the state control authority who conducted the inspection shall draw up a control (supervisory) measure report, which shall be drawn up taking into account the provisions of Article 87<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n
                                                                                                      2. Medical device sampling protocols, protocols or opinions on research, testing and expert examinations conducted, explanations of employees of the controlled person carrying out activities in the field of circulation of medical devices on whom responsibility for violation of mandatory requirements is imposed, orders to remedy identified violations and other documents related to the inspection results or copies thereof shall be attached to the control (supervisory) measure report.<\/li>\n
                                                                                                      3. The control (supervisory) measure report shall be drawn up at the place of the control (supervisory) measure on the date of completion of that measure or no later than the day following the date of completion of that measure, if drawing up the said report at the place of that measure is impossible for reasons established by the Federal Law<\/a> “On State Control (Supervision) and Municipal Control in the Russian Federation”. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                                                                                        The controlled person or its representative shall be familiarised with the content of the control (supervisory) measure report in accordance with the procedure established by Article 88<\/a> of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                          \n
                                                                                                        1. Where approval by the prosecution authorities is required for conducting an unscheduled on-site inspection, a copy of the control (supervisory) measure report shall be sent to the prosecution authority that adopted the decision to approve the conduct of the control (supervisory) measure immediately after the said report is drawn up.” (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                                                                                           <\/p>\n

                                                                                                           <\/p>\n

                                                                                                            \n
                                                                                                          1. Controlled persons shall be entitled to keep an inspection log. Where there is no inspection log, an appropriate entry shall be made in the control (supervisory) measure report.<\/li>\n<\/ol>\n

                                                                                                            In the inspection log, officials of the state control authority shall make an entry on the control (supervisory) measure conducted containing information on the name of the state control authority, the dates of commencement and completion of the control (supervisory) measure, the time of its conduct, the legal grounds, purposes, objectives and subject matter of the control (supervisory) measure, identified violations and orders issued, and shall also specify the surnames, first names, patronymics (if any) and positions of the person or persons conducting the control (supervisory) measure and their signatures.<\/p>\n

                                                                                                              \n
                                                                                                            1. Information on the results of a control (supervisory) measure shall be entered by an official of the state control authority in the unified register of control (supervisory) measures no later than 10 working days from the date of its completion.<\/li>\n<\/ol>\n

                                                                                                               <\/p>\n

                                                                                                               <\/p>\n

                                                                                                              Decisions adopted following control (supervisory) measures<\/strong><\/p>\n

                                                                                                                \n
                                                                                                              1. Where no violations of mandatory requirements are identified during a control (supervisory) measure, information thereon shall be entered in the unified register of control (supervisory) measures. An inspector shall be entitled to issue recommendations on compliance with mandatory requirements and conduct other measures aimed at preventing risks of harm to life and health.<\/li>\n
                                                                                                              2. Based on the results of consideration, analysis and assessment of information, protocols or opinions, research, testing and expert examinations conducted, the Federal Service for Surveillance in Healthcare shall communicate information to entities involved in the circulation of medical devices by posting information letters on the official website of the Federal Service for Surveillance in Healthcare on the “Internet” network concerning:<\/li>\n<\/ol>\n

                                                                                                                \u0430) the identification of a batch, series or version of a substandard medical device;<\/p>\n

                                                                                                                \u0431) the identification of an unregistered medical device;<\/p>\n

                                                                                                                \u0432) the identification of a falsified medical device;<\/p>\n

                                                                                                                \u0433) the withdrawal from circulation of a batch or series of a substandard medical device posing a threat to the life and health of citizens;<\/p>\n

                                                                                                                \u0434) the suspension of use of a medical device in connection with confirmation of facts and circumstances posing a threat to the life and health of citizens and medical workers during the use and operation of medical devices;<\/p>\n

                                                                                                                \u0435) the withdrawal from circulation of a medical device where its quality and safety are not confirmed;<\/p>\n

                                                                                                                \u0436) the resumption of use of a medical device where its quality and safety are confirmed.<\/p>\n

                                                                                                                  \n
                                                                                                                1. The Federal Service for Surveillance in Healthcare shall adopt a decision to resume the use of medical devices where the facts and circumstances posing a threat to the life and health of citizens and medical workers during the use and operation of medical devices are not confirmed by the results of research and testing of medical device samples conducted, with notification of the decision adopted to the controlled person carrying out activities in the field of circulation of medical devices.<\/li>\n<\/ol>\n

                                                                                                                  Notification of the decision adopted shall be sent to the controlled person carrying out the circulation of medical devices in the procedure provided for in part 4<\/a> of Article 21 of the Federal Law “On State Control (Supervision) and Municipal Control in the Russian Federation”. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                    \n
                                                                                                                  1. Where facts and circumstances posing a threat to the life and health of citizens and medical workers during the use and operation of medical devices are confirmed, the Federal Service for Surveillance in Healthcare shall adopt a decision to withdraw such medical device from circulation.<\/li>\n
                                                                                                                  2. Information on measures taken following control (supervisory) measures shall be entered by an official of the state control authority in the unified register of control (supervisory) measures no later than 5 working days from the date on which the measures are taken.<\/li>\n
                                                                                                                  3. The criterion for adopting a decision following control (supervisory) measures shall be the presence or absence of violations of mandatory requirements.<\/li>\n
                                                                                                                  4. The result of taking measures following control (supervisory) measures shall be the issuance of an order and the conduct of measures aimed at preventing harm to the life and health of citizens.<\/li>\n<\/ol>\n

                                                                                                                     <\/p>\n

                                                                                                                     <\/p>\n

                                                                                                                    Key indicator of state control over the circulation of medical devices (as amended by Resolution of the Government of the Russian Federation <\/strong>dated 07.12.2021 N 2220<\/strong><\/a>)<\/strong><\/p>\n

                                                                                                                    126.1. The key indicator of state control over the circulation of medical devices (hereinafter – key indicator) shall be the number of persons who died as a result of adverse events during the use of medical devices in the reporting year, per 1000000 persons.<\/p>\n

                                                                                                                    The value of the key indicator shall be calculated on the basis of reports sent during the reporting year to the Federal Service for Surveillance in Healthcare by entities involved in the circulation of medical devices in accordance with Article 96<\/a> of the Federal Law “On the Fundamentals of Health Protection of Citizens in the Russian Federation” and the Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices approved by Decision of the Board of the Eurasian Economic Commission dated 22 December 2015 N 174.<\/p>\n

                                                                                                                    Target value of the key indicator:<\/p>\n

                                                                                                                    for 2022 – no more than 0,7;<\/p>\n

                                                                                                                    for 2023 – no more than 0,65;<\/p>\n

                                                                                                                    for 2024 – no more than 0,6;<\/p>\n

                                                                                                                    for 2025 – no more than 0,55.<\/p>\n

                                                                                                                     <\/p>\n

                                                                                                                     <\/p>\n

                                                                                                                    Pre-trial procedure for submitting a complaint<\/strong><\/p>\n

                                                                                                                      \n
                                                                                                                    1. A complaint shall be submitted by the controlled person in electronic form using the unified portal of state and municipal services and (or) regional portals of state and municipal services. Where a complaint is submitted by an organisation, the complaint shall be signed with an enhanced qualified electronic signature.<\/li>\n<\/ol>\n

                                                                                                                      A complaint against decisions of a territorial body of the Federal Service for Surveillance in Healthcare or the actions (inaction) of its officials shall be considered by the head (deputy head) of the territorial body or by the Federal Service for Surveillance in Healthcare.<\/p>\n

                                                                                                                      A complaint against the actions (inaction) of the head (deputy head) of a territorial body shall be considered by the head of the Federal Service for Surveillance in Healthcare or a deputy head.<\/p>\n

                                                                                                                      A complaint against decisions adopted by the central office of the Federal Service for Surveillance in Healthcare or the actions (inaction) of officials of the central office of the Federal Service for Surveillance in Healthcare shall be considered by the head of the Federal Service for Surveillance in Healthcare.<\/p>\n

                                                                                                                      A complaint against decisions, actions (inaction) of the head of the Federal Service for Surveillance in Healthcare shall be considered by the head of the Federal Service for Surveillance in Healthcare or by a collegial body established in the Federal Service for Surveillance in Healthcare to consider complaints. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                      127.1. Controlled persons whose rights and legitimate interests, in their opinion, have been directly violated in the exercise of state control shall have the right to a pre-trial appeal against: (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                      \u0430) decisions to conduct control (supervisory) measures and mandatory preventive visits; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                      \u0431) reports on control (supervisory) measures and mandatory preventive visits, orders to remedy identified violations; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                      \u0432) actions (inaction) of officials of the state control authority within the framework of control (supervisory) measures and mandatory preventive visits; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                      \u0433) decisions to assign objects of state control to the relevant risk category; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                      \u0434) decisions refusing to conduct mandatory preventive visits upon applications of controlled persons; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                      \u0435) other decisions adopted by the state control authority following preventive and (or) control (supervisory) measures provided for in the Federal Law<\/a> “On State Control (Supervision) and Municipal Control in the Russian Federation” in respect of controlled persons or objects of state control. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                        \n
                                                                                                                      1. A complaint shall be considered by the authority authorised to consider the complaint within 15 working days from the date of its registration in the information system (subsystem of the state information system) for pre-trial appeals. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                                                                                                        A complaint by a controlled person against a decision to assign objects of state control to the relevant risk category shall be considered within no more than 5 working days. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                        Appendix<\/em><\/p>\n

                                                                                                                        to the Regulations on Federal<\/em><\/p>\n

                                                                                                                        State Control (Supervision)<\/em><\/p>\n

                                                                                                                        over the Circulation of Medical Devices<\/em><\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                        CRITERIA FOR ASSIGNING OBJECTS OF THE ACTIVITIES OF LEGAL ENTITIES AND INDIVIDUAL ENTREPRENEURS CARRYING OUT ACTIVITIES IN THE FIELD OF CIRCULATION OF MEDICAL DEVICES TO A SPECIFIC RISK CATEGORY<\/strong><\/p>\n

                                                                                                                        (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                         <\/p>\n

                                                                                                                          \n
                                                                                                                        1. General provisions<\/strong><\/li>\n
                                                                                                                        2. In the exercise of federal state control (supervision) over the circulation of medical devices, the assignment of the activities of legal entities and individual entrepreneurs carrying out activities in the field of circulation of medical devices (hereinafter – objects of state control) to a specific risk category shall be carried out in accordance with the criteria for the severity of potential negative consequences of possible non-compliance with mandatory requirements (Section II of this document) and taking into account the criteria for possible non-compliance with mandatory requirements (Section III of this document).<\/li>\n
                                                                                                                        3. Objects of state control shall be assigned to risk categories taking into account information contained in the state register of medical devices and organisations (individual entrepreneurs) carrying out the production and manufacture of medical devices, the list of medical organisations entitled to conduct clinical trials of medical devices, the register of notifications of commencement by legal entities and individual entrepreneurs of activities in the field of circulation of medical devices, and the registers of licences maintained by the Federal Service for Surveillance in Healthcare.<\/li>\n<\/ol>\n

                                                                                                                           <\/p>\n

                                                                                                                           <\/p>\n

                                                                                                                            \n
                                                                                                                          1. Criteria for the severity of potential negative consequences of possible non-compliance with mandatory requirements<\/strong><\/li>\n
                                                                                                                          2. The criteria for the severity of potential negative consequences of possible non-compliance with mandatory requirements shall be applied taking into account the following types of activities carried out by legal entities and individual entrepreneurs:<\/li>\n<\/ol>\n

                                                                                                                            \u0430) production (manufacture) of medical devices;<\/p>\n

                                                                                                                            \u0431) use, operation and clinical trials of medical devices in the course of medical activities;<\/p>\n

                                                                                                                            \u0432) maintenance (installation, adjustment, monitoring of technical condition, periodic and routine maintenance, repair) of medical equipment <1>;<\/p>\n

                                                                                                                            ——————–<\/p>\n

                                                                                                                            <1> In accordance with Resolution of the Government of the Russian Federation dated 30 November 2021 N 2129<\/a> “On Approval of the Regulations on Licensing Activities Involving the Maintenance of Medical Devices (Except Where Maintenance Is Carried Out to Meet the Own Needs of a Legal Entity or an Individual Entrepreneur, as Well as Where Maintenance Is Carried Out on Medical Devices with a Low Degree of Potential Risk Associated with Their Use), Amendments to Resolution of the Government of the Russian Federation dated 15 September 2020 N 1445 and Declaring Certain Acts of the Government of the Russian Federation No Longer in Force”. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                            In connection with Resolution of the Government of the Russian Federation <\/em><\/strong>dated 15.09.2020 N 1445<\/em><\/strong><\/a> ceasing to be in force from 01.03.2022, Resolution of the Government of the Russian Federation <\/em><\/strong>dated 30.11.2021 N 2129<\/em><\/strong><\/a>, adopted in its place, shall be followed.<\/em><\/strong><\/p>\n

                                                                                                                            \u0433) sale of medical devices;<\/p>\n

                                                                                                                            \u0434) import of medical devices into the territory of the Russian Federation, export of medical devices from the territory of the Russian Federation;<\/p>\n

                                                                                                                            \u0435) destruction, disposal of medical devices;<\/p>\n

                                                                                                                            \u0436) transportation of medical devices;<\/p>\n

                                                                                                                            \u0437) storage of medical devices;<\/p>\n

                                                                                                                            \u0438) conduct of testing (research) of medical devices, except for clinical trials.<\/p>\n

                                                                                                                              \n
                                                                                                                            1. An object of state control shall be assigned to the high risk category in connection with: (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/li>\n<\/ol>\n

                                                                                                                              production and (or) manufacture of medical devices for in vitro diagnostics and (or) medical devices implanted in the human body assigned to class 3 of potential risk associated with the use of a medical device; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                              conduct of clinical trials of medical devices assigned to class 2\u0431 and (or) 3 of potential risk associated with the use of a medical device. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                              An object of state control shall be assigned to other risk categories taking into account the value of risk indicator K: (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                              where risk indicator K exceeds 70 points, – significant risk; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                              where risk indicator K is from 53 to 70 points, – medium risk; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                              where risk indicator K is from 36 to 52 points, – moderate risk; (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                              where risk indicator K is less than 36 points, – low risk. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                               <\/p>\n

                                                                                                                               <\/p>\n

                                                                                                                                \n
                                                                                                                              1. Legal entities and individual entrepreneurs carrying out only import into the territory of the Russian Federation and (or) export from the territory of the Russian Federation, and (or) storage, and (or) transportation of medical devices shall be assigned to the low risk category.<\/li>\n
                                                                                                                              2. The value of risk indicator K shall be determined using the formula:<\/li>\n<\/ol>\n

                                                                                                                                 <\/p>\n\n\n\n
                                                                                                                                <\/td>\n,<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                where K – criteria determined in accordance with tables 1 – 9.<\/p>\n

                                                                                                                                The value of criteria \u00a0shall be determined by adding the points specified in tables 1 – 9 respectively for all types of activities carried out by the object of state control (as applicable). Where the said criteria are inapplicable, their value shall be taken as zero.<\/p>\n

                                                                                                                                  \n
                                                                                                                                1. The value of criterion shall be determined using the formula:<\/li>\n<\/ol>\n

                                                                                                                                   <\/p>\n\n\n\n
                                                                                                                                  <\/td>\n,<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                  where \u00a0– a criterion determined in accordance with table 1 (points).<\/p>\n

                                                                                                                                  Where criteria \u00a0are inapplicable, their value shall be taken as zero.<\/p>\n

                                                                                                                                   <\/p>\n

                                                                                                                                   <\/p>\n

                                                                                                                                   <\/p>\n

                                                                                                                                   <\/p>\n

                                                                                                                                  table 1<\/em><\/p>\n

                                                                                                                                   <\/p>\n

                                                                                                                                   <\/p>\n

                                                                                                                                  List of criteria \u00a0for legal entities and individual entrepreneurs carrying out the production (manufacture) of medical devices and (or) acting as authorised representatives of manufacturers (producers) of medical devices<\/p>\n

                                                                                                                                   <\/p>\n

                                                                                                                                   <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
                                                                                                                                  Criterion number<\/td>\nCriterion name<\/td>\nNumber of points<\/td>\n<\/tr>\n<\/thead>\n
                                                                                                                                  Risk class of medical devices whose production (manufacture) and (or) representation of the interests of whose manufacturers (producers) in the territory of the Russian Federation is carried out by the legal entity or individual entrepreneur<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\nclass 1 of potential risk associated with use <2><\/td>\n4 <3><\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\nclass 2\u0430 of potential risk associated with use<\/td>\n6<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\nclass 2\u0431 of potential risk associated with use<\/td>\n8<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\nclass 3 of potential risk associated with use<\/td>\n10<\/td>\n<\/tr>\n
                                                                                                                                  Number of types of medical devices in accordance with the nomenclature classification of medical devices<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\n1 – 10 types<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\n11 – 30 types<\/td>\n6<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\n31 – 50 types<\/td>\n8<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\n51 or more types<\/td>\n10<\/td>\n<\/tr>\n
                                                                                                                                  Availability of information on the manufacture of medical devices in the register of notifications of commencement by legal entities and individual entrepreneurs of activities in the field of circulation of medical devices and (or) changes that have occurred (for the producer of a medical device)<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\ninformation is absent due to commencement of activities before 18 December 2014<\/td>\n0<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\ninformation has been entered<\/td>\n-3<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\ninformation is absent (except for the manufacturer of a medical device) (activities commenced or changes occurred after 18 December 2014)<\/td>\n7<\/td>\n<\/tr>\n
                                                                                                                                  Number of addresses of places of production of medical devices (for the manufacturer of a medical device)<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\n1 address<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\n2 – 3 addresses<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\n4 – 10 addresses<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\n11 or more addresses<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                  Updating information in the registration dossier for a medical device<\/td>\n<\/tr>\n
                                                                                                                                  <\/td>\nthe registration dossier has been updated (amendments have been made) during the last year, within the time limits established by the legislation of the Russian Federation<\/td>\n-3<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                   <\/p>\n

                                                                                                                                  ——————–<\/p>\n

                                                                                                                                  <2> In accordance with the nomenclature classification of medical devices by type approved by the Ministry of Health of the Russian Federation.<\/p>\n

                                                                                                                                  <3> One criterion , or , or , or \u00a0shall be taken into account according to the highest class of potential risk associated with use.<\/p>\n

                                                                                                                                   <\/p>\n

                                                                                                                                   <\/p>\n

                                                                                                                                   <\/p>\n

                                                                                                                                   <\/p>\n

                                                                                                                                    \n
                                                                                                                                  1. The value of criterion shall be determined using the formula:<\/li>\n<\/ol>\n

                                                                                                                                     <\/p>\n

                                                                                                                                     <\/p>\n\n\n\n
                                                                                                                                    <\/td>\n,<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                    where \u00a0– a criterion determined in accordance with table 2 (points).<\/p>\n

                                                                                                                                    Where criteria \u00a0are inapplicable, their value shall be taken as zero.<\/p>\n

                                                                                                                                     <\/p>\n

                                                                                                                                     <\/p>\n

                                                                                                                                     <\/p>\n

                                                                                                                                     <\/p>\n

                                                                                                                                    table 2<\/em><\/p>\n

                                                                                                                                    \u00a0<\/em><\/p>\n

                                                                                                                                     <\/p>\n

                                                                                                                                     <\/p>\n

                                                                                                                                     <\/p>\n

                                                                                                                                    List of criteria \u00a0for legal entities and individual entrepreneurs carrying out the use, operation and conduct of clinical trials of medical devices in the course of medical activities<\/p>\n

                                                                                                                                     <\/p>\n

                                                                                                                                     <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
                                                                                                                                    Criterion number<\/td>\nCriterion name<\/td>\nNumber of points<\/td>\n<\/tr>\n<\/thead>\n
                                                                                                                                    Type of activity<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nmedical activities in the field of circulation of medical devices<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nclinical trials of medical devices<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                    Type of medical activity<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of primary pre-physician healthcare in outpatient settings<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of primary physician healthcare in outpatient settings<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of primary physician healthcare in day hospital settings<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of primary specialised healthcare in outpatient settings<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of primary specialised healthcare in day hospital settings<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of primary specialised healthcare in day hospital settings in the following medical activity specialities:<\/td>\n<\/td>\n<\/tr>\n
                                                                                                                                    midwifery<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                    anaesthesiology and resuscitation medicine<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                    cosmetology<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                    cardiology<\/td>\n5<\/td>\n<\/tr>\n
                                                                                                                                    laboratory diagnostics<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                    general medicine<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                    addiction medicine<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                    urgent medical care<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                    operating theatre practice<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                    general practice<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                    radiology<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                    dentistry<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                    traumatology<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                    physiotherapy<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                    functional diagnostics<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                    surgery<\/td>\n5<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of specialised medical care, including high-technology medical care, in inpatient settings<\/td>\n8<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of emergency medical care, including specialised emergency medical care, outside a medical organisation<\/td>\n9<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of emergency medical care, including specialised emergency medical care, outside a medical organisation, including by mobile emergency consultative ambulance teams<\/td>\n9<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of emergency medical care in outpatient settings<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of specialised emergency medical care in outpatient settings<\/td>\n6<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of emergency medical care, including specialised emergency medical care, in inpatient settings (in an emergency medical care department)<\/td>\n6<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of palliative medical care in outpatient settings<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of palliative medical care in inpatient settings<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nprovision of medical care during sanatorium and resort treatment<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nconduct of medical examinations<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nconduct of medical certification examinations<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nconduct of medical expert examinations<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nactivities in the field of circulation of donated blood and its components (work involving the collection and storage of donated blood and (or) its components)<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                    Number of clinical trials conducted<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\nno trials were conducted<\/td>\n0<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\n1 – 5 trials<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\n6 – 10 trials<\/td>\n5<\/td>\n<\/tr>\n
                                                                                                                                    <\/td>\n11 or more trials<\/td>\n7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                                                                                                                                      \n
                                                                                                                                    1. The value of criterion shall be determined using the formula:<\/li>\n<\/ol>\n

                                                                                                                                       <\/p>\n

                                                                                                                                       <\/p>\n\n\n\n
                                                                                                                                      <\/td>\n,<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                      where \u00a0– a criterion determined in accordance with table 3 (points).<\/p>\n

                                                                                                                                      Where criteria \u00a0are inapplicable, their value shall be taken as zero.<\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                      table 3<\/em><\/p>\n

                                                                                                                                      \u00a0<\/em><\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                      List of criteria \u00a0for legal entities and individual entrepreneurs carrying out the maintenance (installation, adjustment, monitoring of technical condition, periodic and routine maintenance, repair) of medical equipment <4><\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                      ——————–<\/p>\n

                                                                                                                                      <4> In accordance with Resolution of the Government of the Russian Federation dated 30 November 2021 N 2129<\/a> “On Approval of the Regulations on Licensing Activities Involving the Maintenance of Medical Devices (Except Where Maintenance Is Carried Out to Meet the Own Needs of a Legal Entity or an Individual Entrepreneur, as Well as Where Maintenance Is Carried Out on Medical Devices with a Low Degree of Potential Risk Associated with Their Use), Amendments to Resolution of the Government of the Russian Federation dated 15 September 2020 N 1445 and Declaring Certain Acts of the Government of the Russian Federation No Longer in Force”. (as amended by Resolution of the Government of the Russian Federation dated 19.11.2025 N 1829<\/a>)<\/p>\n

                                                                                                                                       <\/p>\n

                                                                                                                                       <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n
                                                                                                                                      Criterion number<\/td>\nCriterion name<\/td>\nNumber of points<\/td>\n<\/tr>\n<\/thead>\n
                                                                                                                                      Type of activity<\/td>\n<\/tr>\n
                                                                                                                                      <\/td>\nmaintenance (installation, adjustment, monitoring of technical condition, periodic and routine maintenance, repair) of medical equipment<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                      <\/td>\nmaintenance (installation, adjustment, monitoring of technical condition, periodic and routine maintenance, repair) of medical equipment carried out by its manufacturer (authorised representative of the manufacturer)<\/td>\n-3<\/td>\n<\/tr>\n
                                                                                                                                      Number of addresses of places of maintenance (installation, adjustment, monitoring of technical condition, periodic and routine maintenance, repair) of medical equipment<\/td>\n<\/tr>\n
                                                                                                                                      <\/td>\n1 address<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                      <\/td>\n2 – 3 addresses<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                      <\/td>\n4 – 10 addresses<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                      <\/td>\n11 or more addresses<\/td>\n4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                                                                                                                                        \n
                                                                                                                                      1. The value of criterion <5> shall be determined using the formula:<\/li>\n<\/ol>\n

                                                                                                                                        ——————–<\/p>\n

                                                                                                                                        <5> Criterion \u00a0shall not be taken into account for legal entities and individual entrepreneurs carrying out the production of medical devices (manufacturers and (or) authorised representatives of manufacturers of medical devices).<\/p>\n

                                                                                                                                         <\/p>\n

                                                                                                                                         <\/p>\n\n\n\n
                                                                                                                                        <\/td>\n,<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                        where \u00a0– a criterion determined in accordance with table 4 (points).<\/p>\n

                                                                                                                                        Where criteria \u00a0are inapplicable, their value shall be taken as zero.<\/p>\n

                                                                                                                                         <\/p>\n

                                                                                                                                         <\/p>\n

                                                                                                                                         <\/p>\n

                                                                                                                                         <\/p>\n

                                                                                                                                        table 4<\/em><\/p>\n

                                                                                                                                        \u00a0<\/em><\/p>\n

                                                                                                                                         <\/p>\n

                                                                                                                                         <\/p>\n

                                                                                                                                         <\/p>\n

                                                                                                                                        List of criteria \u00a0for legal entities and individual entrepreneurs carrying out the sale of medical devices<\/p>\n

                                                                                                                                         <\/p>\n

                                                                                                                                         <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
                                                                                                                                        Criterion number<\/td>\nCriterion name<\/td>\nNumber of points<\/td>\n<\/tr>\n<\/thead>\n
                                                                                                                                        Type of activity<\/td>\n<\/tr>\n
                                                                                                                                        <\/td>\nsale of medical devices<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                        Number of addresses of places of sale of medical devices<\/td>\n<\/tr>\n
                                                                                                                                        <\/td>\n1 address<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                        <\/td>\n2 – 3 addresses<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                        <\/td>\n4 – 10 addresses<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                        <\/td>\n11 or more addresses<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                        Availability of information on the sale of medical devices in the register of notifications of commencement by legal entities and individual entrepreneurs of activities in the field of circulation of medical devices and (or) changes that have occurred<\/td>\n<\/tr>\n
                                                                                                                                        <\/td>\ninformation is absent due to commencement of activities before 18 December 2014<\/td>\n0<\/td>\n<\/tr>\n
                                                                                                                                        <\/td>\ninformation has been entered<\/td>\n-3<\/td>\n<\/tr>\n
                                                                                                                                        <\/td>\ninformation is absent (activities commenced or changes occurred after 18 December 2014)<\/td>\n7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                                                                                                                                          \n
                                                                                                                                        1. The value of criterion shall be determined using the formula:<\/li>\n<\/ol>\n

                                                                                                                                           <\/p>\n

                                                                                                                                           <\/p>\n\n\n\n
                                                                                                                                          <\/td>\n,<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                          where \u00a0– a criterion determined in accordance with table 5 (points).<\/p>\n

                                                                                                                                          Where criteria \u00a0are inapplicable, their value shall be taken as zero.<\/p>\n

                                                                                                                                           <\/p>\n

                                                                                                                                           <\/p>\n

                                                                                                                                           <\/p>\n

                                                                                                                                           <\/p>\n

                                                                                                                                          table 5<\/em><\/p>\n

                                                                                                                                          \u00a0<\/em><\/p>\n

                                                                                                                                           <\/p>\n

                                                                                                                                           <\/p>\n

                                                                                                                                           <\/p>\n

                                                                                                                                          List of criteria \u00a0for legal entities and individual entrepreneurs carrying out the import of medical devices into the territory of the Russian Federation and (or) export of medical devices from the territory of the Russian Federation<\/p>\n

                                                                                                                                           <\/p>\n

                                                                                                                                           <\/p>\n\n\n\n\n\n\n\n\n\n\n
                                                                                                                                          Criterion number<\/td>\nCriterion name<\/td>\nNumber of points<\/td>\n<\/tr>\n<\/thead>\n
                                                                                                                                          Type of activity<\/td>\n<\/tr>\n
                                                                                                                                          <\/td>\nimport of medical devices into the territory of the Russian Federation and (or) export of medical devices from the territory of the Russian Federation<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                          Availability of information on the import of medical devices into the territory of the Russian Federation and (or) export of medical devices from the territory of the Russian Federation in the register of notifications of commencement by legal entities and individual entrepreneurs of activities in the field of circulation of medical devices and (or) changes that have occurred<\/td>\n<\/tr>\n
                                                                                                                                          <\/td>\ninformation is absent due to commencement of activities before 18 December 2014<\/td>\n0<\/td>\n<\/tr>\n
                                                                                                                                          <\/td>\ninformation has been entered<\/td>\n-3<\/td>\n<\/tr>\n
                                                                                                                                          <\/td>\ninformation is absent (activities commenced or changes occurred after 18 December 2014)<\/td>\n7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                                                                                                                                            \n
                                                                                                                                          1. The value of criterion shall be determined using the formula:<\/li>\n<\/ol>\n

                                                                                                                                             <\/p>\n

                                                                                                                                             <\/p>\n\n\n\n
                                                                                                                                            <\/td>\n,<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                            where \u00a0– a criterion determined in accordance with table 6 (points).<\/p>\n

                                                                                                                                            Where criteria \u00a0are inapplicable, their value shall be taken as zero.<\/p>\n

                                                                                                                                             <\/p>\n

                                                                                                                                             <\/p>\n

                                                                                                                                             <\/p>\n

                                                                                                                                             <\/p>\n

                                                                                                                                            table 6<\/em><\/p>\n

                                                                                                                                            \u00a0<\/em><\/p>\n

                                                                                                                                             <\/p>\n

                                                                                                                                             <\/p>\n

                                                                                                                                             <\/p>\n

                                                                                                                                            List of criteria \u00a0for legal entities and individual entrepreneurs carrying out the destruction and (or) disposal of medical devices<\/p>\n

                                                                                                                                             <\/p>\n

                                                                                                                                             <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
                                                                                                                                            Criterion number<\/td>\nCriterion name<\/td>\nNumber of points<\/td>\n<\/tr>\n<\/thead>\n
                                                                                                                                            Type of activity<\/td>\n<\/tr>\n
                                                                                                                                            <\/td>\ndestruction of medical devices and (or) disposal of medical devices<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                            Availability of information on the destruction of medical devices and (or) disposal of medical devices in the register of notifications of commencement by legal entities and individual entrepreneurs of activities in the field of circulation of medical devices and (or) changes that have occurred<\/td>\n<\/tr>\n
                                                                                                                                            <\/td>\ninformation is absent due to commencement of activities before 18 December 2014<\/td>\n0<\/td>\n<\/tr>\n
                                                                                                                                            <\/td>\ninformation has been entered<\/td>\n-3<\/td>\n<\/tr>\n
                                                                                                                                            <\/td>\ninformation is absent (activities commenced or changes occurred after 18 December 2014)<\/td>\n7<\/td>\n<\/tr>\n
                                                                                                                                            Number of addresses of places of destruction of medical devices and (or) disposal of medical devices<\/td>\n<\/tr>\n
                                                                                                                                            <\/td>\n1 address<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                            <\/td>\n2 – 3 addresses<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                            <\/td>\n4 – 10 addresses<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                            <\/td>\n11 or more addresses<\/td>\n4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                                                                                                                                              \n
                                                                                                                                            1. The value of criterion shall be determined using the formula:<\/li>\n<\/ol>\n

                                                                                                                                               <\/p>\n

                                                                                                                                               <\/p>\n\n\n\n
                                                                                                                                              <\/td>\n,<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                              where \u00a0– a criterion determined in accordance with table 7 (points).<\/p>\n

                                                                                                                                              Where criteria \u00a0are inapplicable, their value shall be taken as zero.<\/p>\n

                                                                                                                                               <\/p>\n

                                                                                                                                               <\/p>\n

                                                                                                                                               <\/p>\n

                                                                                                                                               <\/p>\n

                                                                                                                                              table 7<\/em><\/p>\n

                                                                                                                                              \u00a0<\/em><\/p>\n

                                                                                                                                               <\/p>\n

                                                                                                                                               <\/p>\n

                                                                                                                                               <\/p>\n

                                                                                                                                              List of criteria \u00a0for legal entities and individual entrepreneurs carrying out the transportation of medical devices<\/p>\n

                                                                                                                                               <\/p>\n

                                                                                                                                               <\/p>\n\n\n\n\n\n\n\n\n\n\n
                                                                                                                                              Criterion number<\/td>\nCriterion name<\/td>\nNumber of points<\/td>\n<\/tr>\n<\/thead>\n
                                                                                                                                              Type of activity<\/td>\n<\/tr>\n
                                                                                                                                              <\/td>\ntransportation of medical devices<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                              Availability of information on activities involving the transportation of medical devices in the register of notifications of commencement by legal entities and individual entrepreneurs of activities in the field of circulation of medical devices and (or) changes that have occurred<\/td>\n<\/tr>\n
                                                                                                                                              <\/td>\ninformation is absent due to commencement of activities before 18 December 2014<\/td>\n0<\/td>\n<\/tr>\n
                                                                                                                                              <\/td>\ninformation has been entered<\/td>\n-3<\/td>\n<\/tr>\n
                                                                                                                                              <\/td>\ninformation is absent (activities commenced or changes occurred after 18 December 2014)<\/td>\n7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                                                                                                                                                \n
                                                                                                                                              1. The value of criterion shall be determined using the formula:<\/li>\n<\/ol>\n

                                                                                                                                                 <\/p>\n

                                                                                                                                                 <\/p>\n\n\n\n
                                                                                                                                                <\/td>\n,<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                                where \u00a0– a criterion determined in accordance with table 8 (points).<\/p>\n

                                                                                                                                                Where criteria \u00a0are inapplicable, their value shall be taken as zero.<\/p>\n

                                                                                                                                                 <\/p>\n

                                                                                                                                                 <\/p>\n

                                                                                                                                                 <\/p>\n

                                                                                                                                                 <\/p>\n

                                                                                                                                                table 8<\/em><\/p>\n

                                                                                                                                                \u00a0<\/em><\/p>\n

                                                                                                                                                 <\/p>\n

                                                                                                                                                 <\/p>\n

                                                                                                                                                 <\/p>\n

                                                                                                                                                List of criteria \u00a0for legal entities and individual entrepreneurs carrying out the storage of medical devices<\/p>\n

                                                                                                                                                 <\/p>\n

                                                                                                                                                 <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
                                                                                                                                                Criterion number<\/td>\nCriterion name<\/td>\nNumber of points<\/td>\n<\/tr>\n<\/thead>\n
                                                                                                                                                Type of activity<\/td>\n<\/tr>\n
                                                                                                                                                <\/td>\nstorage of medical devices<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                                Availability of information on the storage of medical devices in the register of notifications of commencement by legal entities and individual entrepreneurs of activities in the field of circulation of medical devices and (or) changes that have occurred<\/td>\n<\/tr>\n
                                                                                                                                                <\/td>\ninformation is absent due to commencement of activities before 18 December 2014<\/td>\n0<\/td>\n<\/tr>\n
                                                                                                                                                <\/td>\ninformation has been entered<\/td>\n-3<\/td>\n<\/tr>\n
                                                                                                                                                <\/td>\ninformation is absent (activities commenced or changes occurred after 18 December 2014)<\/td>\n7<\/td>\n<\/tr>\n
                                                                                                                                                Number of addresses of places of activities involving the storage of medical devices<\/td>\n<\/tr>\n
                                                                                                                                                <\/td>\n1 address<\/td>\n1<\/td>\n<\/tr>\n
                                                                                                                                                <\/td>\n2 – 3 addresses<\/td>\n2<\/td>\n<\/tr>\n
                                                                                                                                                <\/td>\n4 – 10 addresses<\/td>\n3<\/td>\n<\/tr>\n
                                                                                                                                                <\/td>\n11 or more addresses<\/td>\n4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
                                                                                                                                                  \n
                                                                                                                                                1. The value of criterion shall be determined using the formula:<\/li>\n<\/ol>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                   <\/p>\n\n\n\n
                                                                                                                                                  <\/td>\n,<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                                  where \u00a0– a criterion determined in accordance with table 9 (points).<\/p>\n

                                                                                                                                                  Where criteria \u00a0are inapplicable, their value shall be taken as zero.<\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                  table 9<\/em><\/p>\n

                                                                                                                                                  \u00a0<\/em><\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                  List of criteria \u00a0for legal entities and individual entrepreneurs conducting testing (research) of medical devices, except for clinical trials<\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                   <\/p>\n\n\n\n\n\n\n\n\n\n\n
                                                                                                                                                  Criterion number<\/td>\nCriterion name<\/td>\nNumber of points<\/td>\n<\/tr>\n<\/thead>\n
                                                                                                                                                  Type of activity<\/td>\n<\/tr>\n
                                                                                                                                                  <\/td>\nconduct of testing (research) of medical devices, except for clinical trials<\/td>\n4<\/td>\n<\/tr>\n
                                                                                                                                                  Availability of information on the conduct of testing (research) of medical devices, except for clinical trials, in the register of notifications of commencement by legal entities and individual entrepreneurs of activities in the field of circulation of medical devices and (or) changes that have occurred<\/td>\n<\/tr>\n
                                                                                                                                                  <\/td>\ninformation is absent due to commencement of activities before 18 December 2014<\/td>\n0<\/td>\n<\/tr>\n
                                                                                                                                                  <\/td>\ninformation has been entered<\/td>\n-3<\/td>\n<\/tr>\n
                                                                                                                                                  <\/td>\ninformation is absent (activities commenced or changes occurred after 18 December 2014)<\/td>\n7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                   <\/p>\n

                                                                                                                                                  III. Criteria for possible non-compliance with mandatory requirements<\/strong><\/p>\n

                                                                                                                                                    \n
                                                                                                                                                  1. Objects of state control assigned in accordance with Section II of this document to the medium, moderate and low risk categories shall be assigned to the significant, medium and moderate risk categories respectively where decisions imposing administrative liability on the legal entity, its officials or the individual entrepreneur for the commission of an administrative offence provided for by the following have entered into legal force within the 2 years preceding the date of adoption of the decision to assign the object of state control to a specific risk category:<\/li>\n<\/ol>\n

                                                                                                                                                    Article 6.28<\/a> of the Code of Administrative Offences of the Russian Federation with regard to the sale of unregistered medical devices;<\/p>\n

                                                                                                                                                    parts 1<\/a> and 2<\/a> of Article 6.33 of the Code of Administrative Offences of the Russian Federation with regard to the production, sale or import into the territory of the Russian Federation of falsified medical devices, the sale or import into the territory of the Russian Federation of counterfeit medical devices, the sale or import into the territory of the Russian Federation of substandard medical devices;<\/p>\n

                                                                                                                                                    part 21<\/a> of Article 19.5 of the Code of Administrative Offences of the Russian Federation with regard to failure to comply with lawful orders of the state control authority to remedy identified violations of mandatory requirements in the field of circulation of medical devices;<\/p>\n

                                                                                                                                                    Article 19.7.8<\/a> of the Code of Administrative Offences of the Russian Federation with regard to failure to submit information or submission of knowingly unreliable information to the federal executive authority exercising control and supervision functions in the field of healthcare during the circulation of medical devices.<\/p>\n

                                                                                                                                                      \n
                                                                                                                                                    1. Objects of state control assigned in accordance with Section II of this document to the significant, medium and moderate risk categories shall be assigned to the medium, moderate and low risk categories respectively where, within the 2 years preceding the date of adoption of the decision to assign the object of state control to a specific risk category, there have been no decisions that have entered into legal force imposing administrative liability on the legal entity, its officials or the individual entrepreneur for the commission of the administrative offences specified in clause 16 of this document.<\/li>\n<\/ol>\n

                                                                                                                                                       <\/p>\n

                                                                                                                                                       <\/p>\n

                                                                                                                                                      APPROVED
                                                                                                                                                      \n<\/em>by Resolution of the Government
                                                                                                                                                      \n<\/em>of the Russian Federation
                                                                                                                                                      \n<\/em>dated 30 June 2021 N 1066<\/em><\/p>\n

                                                                                                                                                       <\/p>\n

                                                                                                                                                       <\/p>\n

                                                                                                                                                      LIST<\/strong><\/p>\n

                                                                                                                                                      OF ACTS OF THE GOVERNMENT OF THE RUSSIAN FEDERATION THAT ARE NO LONGER IN FORCE<\/strong><\/p>\n

                                                                                                                                                        \n
                                                                                                                                                      1. Resolution of the Government of the Russian Federation dated 25 September 2012 N 970<\/a> “On Approval of the Regulations on State Control over the Circulation of Medical Devices” (Collection of Legislation of the Russian Federation, 2012, N 40, Art. 5452).<\/li>\n
                                                                                                                                                      2. Clause 1<\/a> of the amendments to acts of the Government of the Russian Federation approved by Resolution of the Government of the Russian Federation dated 14 September 2016 N 923 “On Amendments to Certain Acts of the Government of the Russian Federation” (Collection of Legislation of the Russian Federation, 2016, N 38, Art. 5567).<\/li>\n
                                                                                                                                                      3. Clause 1 of the amendments to acts of the Government of the Russian Federation with regard to establishing the obligation to use checklists (lists of control questions) when conducting scheduled inspections, approved by Resolution of the Government of the Russian Federation dated 14 July 2017 N 840 “On Amendments to Certain Acts of the Government of the Russian Federation with Regard to Establishing the Obligation to Use Checklists (Lists of Control Questions) When Conducting Scheduled Inspections” (Collection of Legislation of the Russian Federation, 2017, N 30, Art. 4673).<\/li>\n
                                                                                                                                                      4. Resolution of the Government of the Russian Federation dated 22 July 2017 N 868<\/a> “On Amendments to the Regulations on State Control over the Circulation of Medical Devices” (Official Internet Portal of Legal Information (www.pravo.gov.ru), 2017, 27 July, N 0001201707270005).<\/li>\n
                                                                                                                                                      5. Clause 1<\/a> of the amendments to acts of the Government of the Russian Federation approved by Resolution of the Government of the Russian Federation dated 9 November 2019 N 1433 “On Amendments to Certain Acts of the Government of the Russian Federation” (Collection of Legislation of the Russian Federation, 2019, N 46, Art. 6499).<\/li>\n
                                                                                                                                                      6. Clause 2<\/a> of the amendments to acts of the Government of the Russian Federation approved by Resolution of the Government of the Russian Federation dated 15 November 2019 N 1459 “On Amendments to Certain Acts of the Government of the Russian Federation” (Collection of Legislation of the Russian Federation, 2019, N 47, Art. 6667).<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

                                                                                                                                                        GOVERNMENT OF THE RUSSIAN FEDERATION   RESOLUTION dated 30 June 2021 N 1066   ON FEDERAL STATE CONTROL (SUPERVISION) OVER THE CIRCULATION OF MEDICAL DEVICES (as amended by Resolutions of the Government of the Russian Federation dated 07.12.2021 N 2220, dated 19.11.2025 N 1829)     In accordance with part 5 of Article 95 of […]<\/p>\n","protected":false},"featured_media":2339,"template":"","categories":[25],"class_list":["post-2487","resources","type-resources","status-publish","has-post-thumbnail","hentry","category-regulatory-framework-en"],"_links":{"self":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources\/2487","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/types\/resources"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media\/2339"}],"wp:attachment":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media?parent=2487"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/categories?post=2487"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}