News Digest 01.11.2023-03.11.2023

Regulators

Roszdravnadzor has updated the list of alcohol-containing medical products

The Roszdravnadzor Commission on the Formation of Alcohol-Containing Medical Products has added to the list of products that contain alcohol and are not subject to regulation by the Federal Service for Control of Alcohol and Tobacco Markets (Rosalkogoltabakregulirovanie, RATR). There were 110 titles left on the list, three were rejected, and another five were excluded.

Source: https://vademec.ru/news/2023/11/02/roszdravnadzor-obnovil-perechen-spirtosoderzhashchikh-medizdeliy-/


Market news

Governor Alexander Beglov presented in the Legislative Assembly a draft budget for St. Petersburg for the development of the healthcare system for the next 3 years

Over three years, 627 billion rubles will be allocated for the development of the St. Petersburg healthcare system. Governor of St. Petersburg Alexander Beglov presented the draft three-year budget at a meeting of the city Legislative Assembly on October 31. More than 96 billion will be allocated for the construction and reconstruction of 26 healthcare facilities, including the construction of a perinatal center in the Kalininsky district. About 9.6 billion will be allocated for the overhaul and equipping of 98% of primary care medical institutions. Another 19.5 billion rubles will be spent on improving the material and technical base of medical institutions, of which 14.3 billion rubles will be spent on purchasing equipment for 143 clinics (53 will undergo major overhauls worth 5.2 billion rubles).

Source: https://www.gov.spb.ru/press/governor/268895/


Other

The expert predicted that accreditation would become more difficult when using AI to prepare tasks

The Russian Ministry of Health may begin to use artificial intelligence in preparing tasks for the accreditation of medical workers. This can significantly complicate the procedure and will require doctors to spend more time on preparation, predicts medical lawyer Alexey Panov.

The Ministry of Health is assessing the capabilities of artificial intelligence (AI) methods in creating (generating) new test tasks and situational cases for the accreditation of medical and pharmaceutical workers in accordance with the specification of the assessment tool (specialty, discipline, nosology, labor functions), the deputy told RIA Novosti Minister of Health Tatyana Semenova. This can make the procedure more difficult, requiring doctors to spend more time educating themselves.

Source: https://medvestnik.ru/content/news/Ekspert-sprognoziroval-uslojnenie-akkreditacii-pri-ispolzovanii-II-dlya-podgotovki-zadanii.html?utm_source=TG_post&utm_medium=Group&utm_campaign=Ekspert-sprognoziroval-uslojnenie-akkreditacii-pri-ispolzovanii-II-dlya-podgotovki


An artificial lung has been patented in the USA

A new device developed by an Israeli startup and positioned as an artificial lung has been patented in the United States. The developers claim that their compact device can almost instantly increase the patient’s oxygen saturation to 95% or higher.

The startup developed the device to reduce the need for mechanical ventilation systems, which are associated with a 50% mortality rate among patients, can increase the risk of coma and even cause bacterial infections or other lung damage. INSPIRA ART500 is designed to rebalance oxygen saturation levels in minutes in awake and breathing patients.

The device can be used to treat patients both in intensive care units and beyond. In the context of an aging population and an increase in the incidence of COPD and related respiratory diseases, the demand for such technologies will grow, the developers note.

Source: https://medvestnik.ru/content/news/V-SShA-zapatentovali-iskusstvennoe-legkoe.html


New registered medical devices

We publish a list of new medical devices registered from 11/01/2023 to 11/03/2023

https://cont.asiamc.ru/uploads/blogs/2023-11-03/6545276e4dc77.pdf

 


News

News Digest 05.12.2025 — 12.12.2025
12.12.2025
Roszdravnadzor (the Federal Service for Surveillance in Healthcare) regulates the issuance of permits for clinical trials of medical devices in accordance with EAEU rules; The ability to confirm localization of production with the ST-1 certificate may be extended until June 30, 2026; The Ministry of Labor will establish technical specifications for hearing aids
More
News Digest 28.11.2025 — 05.12.2025
05.12.2025
The launch of the scoring system for assessing drug localization will be postponed; The volume of major public medical procurement for the first nine months amounted to almost 1.1 trillion rubles; The UK was the first country to receive a full exemption from US tariffs on pharmaceuticals
More
News Digest 21.11.2025 — 28.11.2025
28.11.2025
EAEU regulations will expand the permissible cases for the circulation of unregistered medical devices; The Government Expanded Risk Categories for Medical Device Inspections; The government has clarified the labeling parameters for disposable technical rehabilitation devices
More