News Digest 13.10.2023-20.10.2023

Regulators

Roszdravnadzor intends to extend the procedure for issuing permits for the export of medical devices

Roszdravnadzor is going to extend the procedure for issuing permits for the export of medical devices, the export of which from the country is temporarily restricted. The draft order on this is posted on the website regulation.gov.ru. According to the document, the procedure will be valid until December 31, 2025, and not until the end of 2023, as stated in the current

Source: https://pharmvestnik.ru/content/news/Roszdravnadzor-nameren-prodlit-poryadok-vydachi-razreshenii-na-vyvoz-medizdelii.html


Market news

The list of medical equipment for re-equipping oncology clinics will increase to 123 items

The Ministry of Health has approved a new list of equipment for the re-equipment of oncology clinics, including specialized dispensaries and hospitals, as well as medical institutions that provide medical care in the profile of “children’s oncology and hematology”, “oncology” and “children’s oncology” in specialized beds in regions with a population of less than 100 thousand people . Compared to the current list for modernizing the clinic fleet, the list has grown quantitatively to 123 units, but the expansion occurred solely due to the inclusion of various modifications of medical equipment of the same range.

The list was approved by order of the Ministry of Health No. 423n dated August 14, 2023, and in October 2023 he received a visa from the Ministry of Justice. The regulation will come into force on January 1, 2024.

Source: https://vademec.ru/news/2023/10/19/perechen-medtekhniki-dlya-pereosnashcheniya-onkoklinik-vyrastet-do-123-pozitsiy/


The Leadlab brand of laboratory analyzers was introduced in Russia

The Russian manufacturer of medical equipment from Yekaterinburg, Lidcor, presented a new brand of domestic laboratory equipment, Lidlab, which currently includes four lines of solutions for various areas of in-vitro diagnostics. One brand brought together the instruments and reagents needed in most laboratories in the country. The presentation of LeadLab took place as part of the Russian Diagnostic Summit in Moscow.

Source: https://medvestnik.ru/content/news/V-Rossii-predstavili-torgovuu-marku-laboratornyh-analizatorov-Lidlab.html?utm_source=TG_post&utm_medium=Group&utm_campaign=V-Rossii-predstavili-torgovuu-marku-laboratornyh-analizatorov


Other

The court recovered 120 million rubles from the supplier of the Perm Ministry of Health

The Arbitration Court of the Perm Territory decided to recover 120 million rubles. with Medtrek LLC, which did not fulfill the terms of the agreement with the local Ministry of Health. X-ray machines not registered in Russia were supplied to medical institutions in the region for this amount.

The regional Ministry of Health entered into a government contract with the company in 2020. Medtrack LLC purchased and supplied 16 X-ray machines worth 7.5 million rubles to the Perm Regional Hospital. each for distribution to medical institutions in the region.

Source: https://medvestnik.ru/content/news/Sud-vzyskal-s-postavshika-permskogo-Minzdrava-120-mln-rublei.html


New registered medical devices

We publish a list of new medical devices registered from 10/13/2023 to 10/20/2023

https://cont.asiamc.ru/uploads/blogs/2023-10-20/6532c70659a70.pdf

News

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The Russian Ministry of Health will introduce additional risk indicators for state oversight of medical device circulation; The registry of permits for clinical trials of medical devices will be extended by two years; The WHO has included the Russian Ministry of Health in its list of 12 authorities to facilitate regulation of the medical device market
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News Digest 17.07.2026 — 24.07.2026
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Amendments to Federal Law No. 44-FZ for the procurement of medicines and medical devices have been submitted to the State Duma of the Russian Federation; The Ministry of Industry and Trade has proposed including drugs and medical devices in the new system for assessing technological leadership; The Russian Ministry of Industry and Trade intends to update the forms for certificates and declarations of conformity
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