Author Archives: beawireA

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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Conditional and accelerated registration of drugs

In the previous article, we reviewed new registration procedures specific to certain drugs in accordance with the requirements of the EAEU. Currently, a drug be approved in the frame of approval procedure with post-registration obligations and in exceptional cases. In addition, Decision 36 also introduces conditional and accelerated registration, which will be discussed in this article. 1. Conditional registration (Section

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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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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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