News Digest 09.09.2024 — 11.09.2024

Regulators

The government has extended the simplified operating regime for medical and pharmaceutical manufacturers

Russia with the requirements of technical regulations, as well as national and interstate standards, for one year. Amendments have been made to Resolution No. 353 of 12.03.2022, which introduced an anti-sanction regime for manufacturers of goods, including medicines and medical devices.

The document was already extended last year. At that time, Prime Minister Mikhail Mishustin explained this need by the disruption of many supply chains due to external restrictions and promised that simplified procedures would help prevent shortages. Now the government has assured that this measure has proven its effectiveness.

According to the adopted procedure, manufacturers and exporters are allowed to provide declarations of conformity of goods included in the perimeter of the resolution, based on their own evidence, without conducting lengthy laboratory studies. After that, market participants have six months to confirm that their goods comply with the requirements of the technical regulations of the EAEU or Russian legislation in the field of technical regulation.

This procedure has reduced the risks of low-quality products entering the market and reduced the burden on businesses, the Cabinet of Ministers emphasized.

Source: https://medvestnik.ru/content/news/Pravitelstvo-prodlilo-uproshennyi-rejim-deyatelnosti-dlya-med-i-farmproizvoditelei.html


Market news

By 2027, the amount of funds for the prevention of occupational diseases will increase by one and a half times

The amount of funding for the prevention of industrial injuries and occupational diseases in 2027 may increase to 43.83 billion rubles, said Deputy Minister of Labor and Social Protection of the Russian Federation Alexey Vovchenko. This is one and a half times more than planned in the budget of the Social Fund of Russia in 2024 - 28.6 billion rubles. In 2025, it is planned to allocate up to 35.5 billion rubles for specialized measures, in 2026 - 39.99 billion rubles.

According to Vovchenko, in 2023, about 21 billion rubles were allocated for thematic events, of which 7.7 billion rubles were allocated to provide workers with personal protective equipment, 4.6 billion rubles - for mandatory medical examinations of workers.

"Sanatorium and spa treatment also takes up a large share of the volume, especially spa treatment of retirement age workers and those employed in harmful and hazardous industries," Vovchenko explained.

In 2022, the Social Fund's expenses on compulsory insurance against accidents and occupational diseases amounted to 117.3 billion rubles. The amount of payments to employees injured at work or who had occupational diseases amounted to 6.955 billion rubles. Most of the funds were spent on providing technical rehabilitation equipment - 2.6 billion rubles, as well as on spa treatment - 2.1 billion rubles.

In June 2024, the Ministry of Labor updated the Rules for financial support of preventive measures to reduce injuries and occupational diseases of workers employed in harmful and hazardous industries. The adjustments concern the assessment of professional risks in the workplace and documentation related to spa treatment of employees.

Later, the Ministry of Health of the Russian Federation prepared a draft order approving the methodology for assessing the contribution of periods of work in harmful and hazardous working conditions at previous places of work. The draft sets out the criteria for assessing the contribution of such periods at the last and previous places of work to the occurrence of chronic occupational diseases. The innovation has not yet been approved.

Source: https://vademec.ru/news/2024/09/11/k-2027-godu-obem-sredstv-na-preduprezhdenie-profzabolevaniy-uvelichat-v-poltora-raza/


Other

Moscow introduces neural network to detect and evaluate vertebral body displacement

Moscow doctors now have access to a service with artificial intelligence (AI), which helps to detect and evaluate vertebral body displacement on X-rays. This is a new direction in the development of such technologies. In total, neural networks in radiation diagnostics find signs of 38 pathologies in studies, the mos.ru website reports.

Vertebral body displacement is a condition in which the vertebrae move out of their normal position, which often leads to pain in the lower back and other parts of the back. This can be the result of injury, degenerative changes, or diseases such as osteoporosis. Accurate diagnostics are important for prescribing the right and timely treatment, and AI services can play an important role here. Neural networks can automatically analyze spinal X-rays, detect signs of displacement and instantly take measurements, which helps doctors diagnose pathology faster and more accurately. This reduces the time required to prepare a report and allows for treatment to be prescribed more quickly.

Source: https://t.me/medicalksu/5228

Apple headphones to feature a hearing aid mode

Apple has announced a software update for AirPods Pro headphones 2, which will provide users with background hearing protection functions from loud sounds and hearing quality testing using standard clinical approaches. The gadget, according to the company, can be used as an over-the-counter hearing aid, but only after the FDA regulator issues a thematic permit (Apple believes that this will happen before the end of autumn). In general, the production of such devices designed for the mass consumer, but also acceptable for use by people with hearing impairments, in the United States became possible after the decision of the Food and Drug Administration in August 2022.

Source: https://vademec.ru/news/2024/09/10/v-naushnikakh-apple-poyavitsya-rezhim-slukhovogo-apparata/

News

News Digest 03.04.2026 — 10.04.2026
10.04.2026
The Russian Government has expanded the list of medical devices subject to labeling; The Ministry of Labor will update the regulatory framework for the technical rehabilitation equipment (TRE) market; Russia's first telemedicine stethoscope has received a patent in the United States
More
News Digest 27.03.2026 — 03.04.2026
03.04.2026
Roszdravnadzor to Update Consultation Procedures for Medical Device Registration; A Ministry of Health commission rejected all applications for the inclusion of new medical devices in the compulsory medical insurance (CMI) lists; The government intends to reduce the share of illegal medical device trafficking to 21% by 2030
More
News Digest 20.03.2026 — 27.03.2026
27.03.2026
The Federal Center for Planning and Organization of Drug Provision for Citizens (FCDPiLO) may be appointed responsible for purchasing drugs and medical devices for national projects; Continuous glucose monitoring systems will be centralized for procurement; Rostec Registers New Anesthesia and Respiratory Machine with Intelligent Control
More