Registered with the Ministry of Justice of Russia on November 2, 2020. No. 60697<\/p>\n
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MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION \u00a0<\/strong><\/p>\n ON APPROVAL OF THE PROCEDURE FOR MONITORING THE SAFETY OF MEDICAL DEVICES<\/strong><\/p>\n Pursuant to Part 5<\/u> of Article 96 of Federal Law No. 323-FL dated November 21, 2011 \u201cOn the Fundamentals of Health Protection of Citizens in the Russian Federation\u201d (Collection of Legislation of the Russian Federation, 2011, No. 48, Art. 6724) and subparagraph 5.2.191<\/u> of the Regulation on the Ministry of Healthcare of the Russian Federation, approved by Decree of the Government of the Russian Federation No. 608 dated June 19, 2012 (Collection of Legislation of the Russian Federation, 2012, No. 20, Art. 2528), I hereby order:<\/p>\n <\/p>\n Minister \u00a0<\/em><\/p>\n by Order of the Ministry of Healthcare <\/p>\n PROCEDURE FOR MONITORING THE SAFETY OF MEDICAL DEVICES<\/strong><\/p>\n ——————–<\/p>\n <1> Decrees of the Government of the Russian Federation No. 1416 dated December 27, 2012<\/u> \u201cOn Approval of the Rules for State Registration of Medical Devices\u201d (Collection of Legislation of the Russian Federation, 2013, No. 1, Art. 14; 2020, No. 12, Art. 1792), and No. 430 dated April 3, 2020 \u201cOn the Specifics of the Circulation of Medical Devices, Including State Registration of a Batch (Lot) of a Medical Device\u201d (Collection of Legislation of the Russian Federation, 2020, No. 15, Art. 2284; Official Internet Portal of Legal Information, http:\/\/www.pravo.gov.ru, June 4, 2020).<\/p>\n <\/p>\n Monitoring of the safety of medical devices registered in accordance with the acts constituting the law of the Eurasian Economic Union and in circulation within the territory of the Russian Federation shall be carried out by the Service in accordance with Decision No. 174 of the Board of the Eurasian Economic Commission dated December 22, 2015 \u201cOn Approval of the Rules for Monitoring the Safety, Quality and Effectiveness of Medical Devices\u201d <2>.<\/p>\n ——————–<\/p>\n <2> Official website of the Eurasian Economic Union, http:\/\/www.eaeunion.org\/, December 30, 2015.<\/p>\n <\/p>\n 1) on adverse events received from entities involved in the circulation of medical devices in the manner established by the federal executive authority authorized by the Government of the Russian Federation <3>;<\/p>\n ——————–<\/p>\n <3> Part 3<\/u> of Article 96 of Federal Law No. 323-FL dated November 21, 2011 \u201cOn the Fundamentals of Health Protection of Citizens in the Russian Federation\u201d (Collection of Legislation of the Russian Federation, 2011, No. 48, Art. 6724), subparagraph 5.2.191<\/u> of the Regulation on the Ministry of Healthcare of the Russian Federation, approved by Decree of the Government of the Russian Federation No. 608 dated June 19, 2012 (Collection of Legislation of the Russian Federation, 2012, No. 20, Art. 2528).<\/p>\n <\/p>\n 2) obtained during the exercise of state control over the circulation of medical devices;<\/p>\n 3) posted on the official websites of foreign regulatory authorities (agencies) in the field of medical device circulation, concerning adverse events that occurred in other states involving medical devices registered within the territory of the Russian Federation;<\/p>\n 4) on the safety and clinical effectiveness of the use of medical devices belonging to potential risk class 3, as well as medical devices belonging to potential risk class 2\u0431 that are implanted in the human body, received from manufacturers of medical devices (their authorized representatives);<\/p>\n 5) on adverse events involving implanted medical devices, obtained from the subsystem for maintaining specialized patient registries for individual nosologies and categories of citizens, monitoring the organization of the provision of high-technology medical care and sanatorium-resort treatment, and other information systems intended for the collection, storage, processing and provision of information relating to the activities of medical organizations and the services they provide <4>, as well as from the federal state information system \u201cUnified Automated Vertically Integrated Information and Analytical System for Conducting Medical and Social Expertise\u201d <5>;<\/p>\n ——————–<\/p>\n <4> Clause 4 of Section III of the Regulation on the Unified State Information System in the Healthcare Sector, approved by Decree of the Government of the Russian Federation No. 555 dated May 5, 2018 (Collection of Legislation of the Russian Federation, 2018, No. 20, Art. 2849).<\/p>\n <5> Clause 51 of Section VIII of the Regulation on the Unified State Information System in the Healthcare Sector, approved by Decree of the Government of the Russian Federation No. 555 dated May 5, 2018 (Collection of Legislation of the Russian Federation, 2018, No. 20, Art. 2849).<\/p>\n <\/p>\n 6) provided by the manufacturer of the medical device (its authorized representative) concerning an adverse event, corrective actions relating to the safety of the medical device, safety notices concerning the medical device, and reports of errors made during the use of medical devices that resulted in the death of the user or a serious deterioration in the user\u2019s health.<\/p>\n 1) register the information received in the \u201cAdverse Events Involving Medical Devices\u201d section of the Service\u2019s automated information system (hereinafter referred to as the \u201cService\u2019s AIS\u201d) on the day of its receipt;<\/p>\n 2) within five working days from the date of registration of this information, notify the manufacturer of the medical device (its authorized representative) of the need to submit to the Service, within ten working days from the date of receipt of the notification, a reasoned position on the facts set out in the report, accompanied, where necessary, by reports on adverse events and corrective actions;<\/p>\n 3) forward the information received, through the Service\u2019s AIS, to a federal state budgetary institution under the authority of the Service (hereinafter referred to as the \u201cexpert institution\u201d).<\/p>\n 1) within three working days from the date of receipt of the information, an expert opinion on the existence of a causal relationship between the use of the medical device and the occurrence of the identified adverse events, as well as on whether the instructions for use or operating manual of the medical device contain indications of the risk of occurrence of the identified adverse events;<\/p>\n 2) where necessary, within ten working days from the date of receipt of the information, an expert conclusion containing recommendations on whether or not control and supervisory measures and regulatory decisions concerning the medical device need to be taken.<\/p>\n 1) to conduct control measures in accordance with Federal Law No. 294-FL dated December 26, 2008 <\/u>\u201cOn the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control\u201d <6> and the Regulation<\/u> on State Control over the Circulation of Medical Devices, approved by Decree of the Government of the Russian Federation No. 970 dated September 25, 2012 <7>, or that there are no grounds for conducting control measures;<\/p>\n ——————–<\/p>\n <6> Collection of Legislation of the Russian Federation, 2008, No. 52, Art. 6249; 2020, No. 14, Art. 2028.<\/p>\n <7> Collection of Legislation of the Russian Federation, 2012, No. 40, Art. 5452; 2019, No. 47, Art. 6667.<\/p>\n <\/p>\n 2) on the need to take measures to prevent harm to the life and health of citizens during the use of the medical device for the period necessary to conduct the inspection, by suspending the use of:<\/p>\n the medical device, if information on adverse events has been received in respect of two or more models (versions) of the medical device;<\/p>\n the model (version) of the medical device, if information on adverse events has been received in respect of two or more batches (lots) of a medical device of the same model (version);<\/p>\n the batch or lot of the medical device, if information on adverse events has been received in respect of a batch (lot) of the medical device.<\/p>\n The Program shall include measures to notify entities involved in the circulation of medical devices, including citizens and medical workers, of the existence of a threat of harm to the life and health of citizens during the use of the medical device, an analysis of the causes of the adverse event, taking into account previously identified reports of adverse events, methods of preventing the aforementioned harm, as well as the time limits for implementing such measures.<\/p>\n Throughout the entire period of validity of the Program, the manufacturer (its authorized representative) shall ensure that purchasers, including consumers, have the opportunity to obtain prompt information on the measures specified in the first paragraph of Clause 12 of this Procedure.<\/p>\n ——————–<\/p>\n <8> Federal Law No. 412-FL dated December 28, 2013<\/u> \u201cOn Accreditation in the National Accreditation System\u201d (Collection of Legislation of the Russian Federation, 2013, No. 52, Art. 66977; 2018, No. 31, Art. 4851).<\/p>\n <\/p>\n ——————–<\/p>\n <9> Collection of Legislation of the Russian Federation, 2002, No. 1, Art. 1; 2013, No. 48, Art. 6165.<\/p>\n","protected":false},"excerpt":{"rendered":" Registered with the Ministry of Justice of Russia on November 2, 2020. No. 60697 MINISTRY OF HEALTHCARE OF THE RUSSIAN FEDERATION ORDER dated September 15, 2020 No. 980n \u00a0 ON APPROVAL OF THE PROCEDURE FOR MONITORING THE SAFETY OF MEDICAL DEVICES Pursuant to Part 5 of Article 96 of Federal Law No. 323-FL dated […]<\/p>\n","protected":false},"featured_media":2339,"template":"","categories":[25],"class_list":["post-2572","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\/2572","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=2572"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/categories?post=2572"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\n<\/strong>ORDER
\n<\/strong>dated September 15, 2020 No. 980n<\/strong><\/p>\n\n
\n<\/em>M.A. MURASHKO
\n<\/em>APPROVED<\/em><\/p>\n
\n<\/em>of the Russian Federation
\n<\/em>dated September 15, 2020 No. 980n<\/em><\/p>\n\n
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