Category Archives: MD regulation

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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Registration of medical devices in Tajikistan.

Currently, the pharmaceutical sector is one of the priorities for development in Tajikistan. In 2020, the government of Tajikistan issued a resolution “On the State Program for the Development of the Pharmaceutical Industry in the Republic of Tajikistan for 2021-2025”.  One of the objectives of the Program is to improve the legal framework of the Republic of Tajikistan in the

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State registration of medical devices in the Republic of Belarus.

As you know, in the near future, namely from January 1, 2022, the five countries of the Eurasian Economic Union will be united by one harmonized procedure for registration of medical devices. However, most countries of the Union have their own national registration procedures. How is the state registration of MD organized in these countries? What are its features for

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Registration of medical devices in the Republic of Kyrgyzstan.

The Kyrgyz Republic, along with Kazakhstan, Belarus, Armenia and Russia, is part of the Eurasian Economic Union, which means that from 01.01.2022 on the territory of this country the rules for registration of medical devices defined by the legislation of the EAEU will come into force. However, unlike, for example, Armenia, Kyrgyzstan has a national registration system for medical devices,

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Market of medical devices in Armenia.

Until recently, there was no legal basis for regulating the circulation of medical devices in Armenia. The sale and import of medical equipment and products for medical use, according to the local legislation of the Republic of Armenia, did not require state registration. However, accession to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within

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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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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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