Tag Archives: Medicaldevices

IVD regulatory approval process in European Union.

Approaches to the regulation of in vitro diagnostic (IVD) medical devices vary by country. For example, in the United States, there is no separate classification for IVD devices, and a general regulatory system developed for medical devices is applied. If we talk about the European Union (EU), then the approach is different. For IVD products, a separate classification and a

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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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The first list of type codes under Decree No. 552 has been published

On the website of the Federal Service Rosddravnadzor, the first list of type codes to the Decree of the Government of the Russian Federation No. 552 dated 01.04.2022 has been published (On approval of the specifics of circulation, including the specifics of the state registration of medical devices in the event of their defectiveness or the risk of defectiveness in connection

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POC testing. Definition

Point-of-care testing devices Point-of-car (POC) diagnostics becomes increasingly popular in nowadays medicine. In Russia, there is no exactly corresponding technical article, however one can’t say that there are no similar devices available on the local market. Let’s have a look on those devices and try to understand how their manufacturing and sales are regulated. Definition Abroad The term concerned consists

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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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