List of type codes dated June 28, 2022 based on the results of a meeting of the interdepartmental commission on the formation of a list of types of medical devices subject to circulation in accordance with the Peculiarities of circulation, including state registration features of medical devices in the event of their defectiveness or the risk of defectiveness in connection
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Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our comparison below: No. Item National system EAEU 1 Main document Decree of the Government of the Russian Federation No. 135 dated 09.02.2022 “On approval of the Rules for arranging and conducting inspections of the production
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The system of national marketing authorization of medical devices in the Russian Federation uses the Nomenclature Classification of Medical Devices by Type (hereinafter referred to as “NCMD”). In the system of marketing authorization of Medical Devices in the EAEU, there is a very close equivalent in content: the European Medical Device Nomenclature (hereinafter referred to as “EMDN”). According to EAEU regulatory
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Government fees for initial registration process as medical device consists of: Government fee for expertise review (depends on risk class, payment for expert center work reviews technical dossier); Government fee for registration process (for Roszdravnadzor work and actions with registration dossier, certificate): Medical device risk class Before 2021 (RUB) From 1st of Jan 2022 (RUB) 1 (expertise) 45 000 72
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Registration certificate (RC) is a document that confirms that a medical device can be used on the territory of the Russian Federation. The executive authority for monitoring and supervision in the field of organizing and ensuring the protection of public health is the Federal Service for Surveillance in Healthcare (Roszdravnadzor). All information about the registration process for a medical device
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The Federal Service for Surveillance in Healthcare (Roszdravnadzor) belongs to the executive authorities and performs control and supervisory functions in the field of organizing and ensuring the protection of public health. When registering medical devices (MD), Roszdravnadzor relies on the Decree of the Government of the Russian Federation No 1416 “On Approval of the Rulesr State Registration of Medical Devices”
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Introduction The shelf life of a medical device determines the period during which the product retains its functional properties and technical specifications established by the manufacturer. After the state registration of a medical device in the territory of the Russian Federation, the established value of the shelf life can be changed in accordance with the Decree of the Government of
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Since March 20, 2020, due to the need to take measures for the non-proliferation of the Coronavirus infection (2019-nCoV), the Federal Service for Surveillance in the Sphere of Health of the Russian Federation (Roszdravnadzor or RZN) introduces special rules. These rules concern consultations about the registration of medical devices intended for the diagnosis of coronavirus infection (consultations in accordance with
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Note: This article does not apply to in vitro testing of medical devices for diagnostics, as in this case field trials (trials on the spot or so called factory audit for testing) are not applicable. Introduction Tests conducted for the purposes of the state registration of medical devices are regulated by Order No. 2n dated 09 January 2014 “On Approval
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Technical testing and toxicological testing of medical devices should be carried out in a testing laboratory with the appropriate scope of accreditation. Information on the accreditation of the laboratory can be found in the general access on the website of the Federal Service for Accreditation (RusAccreditation). How to check the scope of laboratory accreditation: Visit the RusAccreditation website in the
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