Tag Archives: medicaldevices

Control over the circulation of falsified MD — the experience of European countries

The common space of the European Union allows the member states to take a more comprehensive and global approach to solving many issues, including the problem of circulation of falsified medical devices. As a result of the implementation of the global approach, regulations are being created to strengthen international cooperation, including with countries outside the EU (for example, the Convention

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Control over the circulation of the counterfeit medical devices – MEDICRIME Convention.

The circulation of counterfeit medical devices (MD) and other medical products* is a global problem that poses a risk to public health and can cause significant economic damage. In this regard, there was a need to develop a single document aimed at combating counterfeit medical products. This was the MEDICRIME Convention. The MEDICRIME Convention (Council of Europe Convention on the

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Difference in classification rules between national system in Russia and EAEU regulation

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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First online factory audit under EAEU regulation

For the first time, the Federal Service for Surveillance in HealthCare is conducting remote inspection of medical device manufacturing located abroad. The FGBU VNIIIMT of Roszdravnadzor with the participation of Roszdravnadzor specialists began for the first time the remote inspection of medical device manufacturing located abroad (the manufacturing site, Tianjin Huahong Technology Co., Ltd, is located in the People’s Republic

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In vitro diagnostics in medicine and veterinary medicine: basic concepts and difference.

In recent years, clinical laboratory diagnostics have received a big leap in their development, whose is the main task detection or confirmation of pathology that would be impossible refuted or confirmed by organoleptic methods. In vitro diagnostics are carried out using various biological fluids, such as whole blood, plasma, serum, sputum, cerebrospinal fluid, etc. The process of conducting clinical laboratory

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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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Foreign Practise for the Regulation of Wearable Devices

USA In the USA, medical device regulators consider wearable devices to be low-risk devices and therefore do not label them. For example, the U.S. Food and Drug Administration (FDA) considers such products to be “general wellness” products. The FDA believes that wearable devices pose low risks to user safety and therefore refrains from regulating them. Manufacturers either self-regulate the production and

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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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