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Inventory shortage or risk of inventory shortage – update of legislation. Part 1.

In the spring of 2022, in connection with the introduction of economic restrictive measures against the Russian Federation, the Government of the Russian Federation issued Resolutions regarding the specifics of the circulation of drugs in the event of a inventory shortage or the risk of a inventory shortage (No. 593), as well as on the specifics of introducing changes to

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New types of drug registration under the requirements of the EAEU.

At the end of March 2022, Decision No. 36 of the EEC Council came into force, which introduced some adjustments to the existing drug registration system (Decision No. 78). For example, the following “types” of marketing authorization became possible: registration of drugs with post-registration obligations, registration of drugs in exceptional cases, conditional registration of drugs, accelerated registration of drugs. In

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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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