News Digest 08.12.2023 — 11.12.2023

Regulators

The Ministry of Industry and Trade did not support the introduction of an excise tax on ethyl alcohol

The Ministry of Industry and Trade does not support the introduction of an excise tax on medical alcohol in Russia. This was announced at a meeting in the Federation Council by the director of the department for the development of the pharmaceutical and medical industry, Dmitry Galkin.

During the meeting, General Director of the Association of Russian Pharmaceutical Manufacturers Viktor Dmitriev noted that the issue of introducing an excise tax worries the industry. According to him, this could create a new problem, which will then have to be resolved promptly. “I understand that there is a problem of combating illegal alcohol; it must, of course, be closed, but in such a way that it does not harm conscientious producers,” he emphasized.

Source: https://pharmvestnik.ru/content/news/Minpromtorg-ne-podderjal-vvedenie-akciza-na-etilovyi-spirt.html



Market news

Rosstat reported an increase in prices for medicines and medical products in November

Prices for drugs from the Vital and Essential Drugs List increased in November by 0.4%, and the cost of drugs not included in this list increased by 0.9%. Prices for medical products have also increased.

Among medical goods and dressings, prices increased for: standard electronic medical thermometers - by 1.2%; electronic blood pressure measuring devices - by 0.8%; bandages - by 0.7%; corrective glasses and domestic cotton wool - by 0.5%; disposable syringes - by 0.4%.

Source: https://pharmvestnik.ru/content/news/Rosstat-soobshil-o-roste-cen-v-noyabre-na-lekarstva-i-medizdeliya.html



Other

Sobyanin: Moscow scientists have developed pre-standards for the use of AI in medicine

The documents are aimed at safety in the use of AI in medical decision-making systems, educational platforms and algorithms in radiology diagnostics. Preliminary standards can be used in clinical trials, in internal testing, and in the development of technical and operational documentation. If the draft is adopted, it will come into force on January 1, 2024 and will be valid for three years.

Source: https://www.mos.ru/mayor/themes/18299/10470050/



New registered medical devices

We publish a list of new medical devices registered from 01.12.2023 to 08.12.2023

https://asiamc.ru/uploads/blogs/2023-12-15/657c9955483e5.pdf

News

News Digest 24.07.2026 — 31.07.2026
31.07.2026
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
24.07.2026
The Procedure for Maintaining the Register of Clinical Trials of Medical Devices May Be Extended Until the End of 2028; Roszdravnadzor has divided the powers of licensing medical device maintenance with the regions; It has been proposed to extend the rules for labeling medical devices to multi-product sets
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News Digest 10.07.2026 — 17.07.2026
17.07.2026
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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