Category Archives: MD regulation

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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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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Funding of Russian manufacturers of medical devices

What kind of activities are the subject of State funding programs The State funding program is regulated by Rules for the Provision of funding from the federal budget for Russia-based organizations as amended by a Government Order dated 30 December, 2022. According to the aforementioned document, funding may be provided for the following types of projects: Various actions and processes,

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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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Authorization of medical devices in Europe in the context of COVID-19

The standard registration procedure* for medical devices, in vitro diagnostic devices (IVD) and personal protective equipment includes a Conformity Assessment.  Depending on the risk class of MD, IVD and the category of personal protective equipment, the manufacturer either registers its product independently through the EUDAMED system (for non-sterile MDs that are not measuring instruments, I risk class), or applies to

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Emergency Use Authorization for medical devices and drugs to fight against COVID-19 in the United States

The COVID-19 pandemic has made adjustments to many areas of society, including the regulatory sector for drugs and medical devices (MD). In this regard, in many countries, legislation regarding the introduction of drugs and MD to the market has been adapted to the emergency situation. For example, in Russia, Government Resolution No. 430 was adopted for MD, allowing to approve

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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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