Category Archives: medicaldevices

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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Registration of medical devices in Uzbekistan.

The main legislative act regulating the procedure for state registration of medical devices is Resolution No. 213 dated March 23, 2018 “Regulations on the procedure for state registration of medical devices medicines, medical products and medical equipment and the issuance of a registration certificate.” According to this Resolution, medical devices in Uzbekistan are divided into two groups: medical devices (MD)

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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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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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