News Digest 29.05.2024 — 31.05.2024

Regulators

Counterfeit medical products

The circulation of counterfeit medical products in the Russian Federation poses a real threat to the life and health of citizens.

According to experts, in Russia there is about 40% of the “gray” market for injection cosmetology. In addition, during the COVID-19 pandemic, the number of unqualified cosmetologists without medical education and licenses has increased almost 2.5 times. The activities of such “specialists” and the counterfeit products they sell can lead to serious health problems and even death.

In 2021, the exclusive distributor of the Ghana R&D Co. plant. Ltd." (Republic of Korea) work has been initiated to combat counterfeit medical (cosmetic, cosmetic) products.

Source: https://t.me/vniiimt/610


Market news

A neuropsychiatry laboratory will be opened at Siberian State Medical University for 13.5 million rubles

Scientists plan to develop a brain implant to be implanted into the brains of patients with depression. It is also planned to develop recommendations for conducting psychotherapeutic consultations in metaverses, as well as methods of VR neurorehabilitation using exoskeletons.

More seriously, Vademecum writes that laboratory scientists will conduct clinical and neurophysiological examinations of patients and final statistical analysis. Based on the data obtained, experts plan to develop new medical technologies, personalized rehabilitation programs and educational programs for training students and residents. Also, together with partners, it is planned to create virtual 3D scenarios for conducting personalized cognitive-behavioral and exposure therapy.

Source: https://vademec.ru/news/2024/05/29/v-sibgmu-za-13-5-mln-rubley-otkroyut-laboratoriyu-neyropsikhiatrii/


Other

The Moscow Department of Health will pay another 66.5 million rubles for research using AI

In April-May, the Moscow Department of Health (DZM) issued three orders to pay for research on the use of innovative technologies in the field of computer vision for the analysis of medical images. In total, 19 companies that participated in the DZM experiment received grants in January–March 2024, the total amount of payments amounted to 66.5 million rubles.

The largest grants totaling 63.8 million rubles were received by the companies “Medical Screening Systems”, “Ira Labs”, “Third Opinion Platform”, “CVisionLab”, “Intel Diagnostics”, “Innopolis University”, “Oxygen Technologies Rus” , Airim, Vision, ArtVision and Airway AI.

The leader in funds received (21.8 million rubles) among them was Ira Labs - it was engaged in the study of computed tomography and low-dose computed tomography of the chest and abdominal organs. According to SPARK-Interfax, this company was registered in May 2020 in Moscow and is owned by Mikhail Belyaev. The net profit of Aira Labs LLC in 2023 amounted to 23 million rubles, revenue – 6 million rubles.

Source: https://vademec.ru/news/2024/05/30/depzdrav-moskvy-vyplatit-eshche-66-5-mln-rubley-za-issledovaniya-s-primeneniem-ii/


New registered medical devices

We publish a list of new medical devices registered from 05/24/2024 to 05/31/2024

Link to the list: [see. table in attachment]

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
More
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
More
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
More