Tag Archives: faq

Changes in Government fees during custom clearance of medical device samples

With reference to the current economic situation, in April two resolutions of the Council of the Eurasian Economic Commission were adopted, namely No. 46 dated 5 April 2022 and No. 63 dated 12 April 2022, which changed the import duty rates for a particular group of goods. Pursuant to the above-mentioned resolutions, upon import of goods from the list an

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List of medical devices for fast track registration – increased by Government

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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QMS inspection of medical device manufacturers

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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Changes in main standard – biocompatibility trials for medical devices

At 1st of March standard GOST ISO 10993-1-2021 was updated, main changes in our review: The scope of application has been extended (previously the standard did not cover materials and/or medical devices which do not come into contact with the patient’s body, either directly or indirectly). The new scope of application: This standard is applicable to medical devices (MD) and establishes

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Practice for the Regulation of Wearable Devices in the Russian Federation

Are Wearable Devices Considered Medical Devices? According to the definition of the Federal Service for Surveillance in Healthcare: Medical devices are any instruments, apparatuses, devices, equipment, materials and other items used for medical purposes individually or in conjunction, or together with other accessories necessary for the operation of the aforementioned items as per indications; this includes also specific software products;

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Changes in Government fees for medical device approvals in Russia

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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Classification of hospital cleaning trolleys as medical devices in the Russian Federation

When classifying devices as medical in the Russian Federation, the Federal Service for Overseeing Healthcare (hereinafter Roszdravnadzor) is guided primarily by the definition of medical devices as specified in Clause 1 of Article 38 of Federal Law No. 323-FZ dated 21 November 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (hereinafter Federal Law No. 323-FZ) and in Clause 2 of Decree No. 1416

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How to find out if a medical device is registered or not?

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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Roszdravnadzor – how to use authority website?

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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What in the composition of a drug can be considered a medical device in national regulation system?

With the development of technologies and the integration of “physics” and “chemistry” a variety of products , which are no longer drugs in the form of classic dosage forms (tablets, ointments, etc.), but the whole systems of delivery of a medicinal substance come into the pharmaceutical market. Such systems involve the use of auxiliary elements that may prove to be

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