News Digest 06.12.2024 — 13.12.2024
Regulators
The work of the commission on simplified registration of potentially defective medical devices will be extended until 2028
Roszdravnadzor presented two draft departmental orders for public discussion. In the first document, the regulator proposes to extend from January 1, 2025 until the same date in 2028 the validity of order No. 8003 of November 13, 2023 on the interdepartmental commission for the formation of a list of types of medical devices subject to simplified registration under RF Government Resolution No. 552 of April 1, 2022. The second draft is provided in case order No. 8003 loses its force. It completely duplicates the document, but if adopted, it will be valid until January 1, 2028.
The interdepartmental commission was established in November 2023. It includes one representative from each of the Ministry of Health, the Ministry of Finance, the Ministry of Economic Development, the Ministry of Industry and Trade, the Federal Tax Service, the Federal Customs Service, the Federal Antimonopoly Service and two representatives of Roszdravnadzor itself, as well as one representative from other bodies and organizations - "if necessary". The composition of the commission is approved by an order of Roszdravnadzor.
The commission forms a list of medical devices that can be registered according to the algorithm set out in RF Government Resolution No. 552. Products are included in the list for three reasons: regulators have identified a risk of defects in a medical device on the Russian market during monitoring; the commission has received an application from an authorized person for the supply of medical devices at a price below the average market price; other reasons are at the discretion of the commission.
The last time Roszdravnadzor reported updating the list of medical devices covered by the simplified registration mechanism was in July 2024. At that time, the list expanded to 2,208 items. The Russian government introduced a simplified procedure for registering medical devices with the option of obtaining an indefinite dossier and a simplified algorithm for replacing raw materials and components in already registered medical equipment in early April 2022. Initially, the document was supposed to be valid until September 1, 2023, but later Resolution No. 552 was extended until January 1, 2025. In early November 2024, the Russian Ministry of Health prepared a draft government resolution that should extend the validity of a number of innovations concerning simplified registration regimes for drugs and medical devices. In particular, Resolution No. 552 is planned to be extended until the end of 2028.
Market news
A plant for the production of medical devices will be built in the Moglino SEZ for 810 million rubles
The Supervisory Board of the Moglino industrial-production special economic zone (SEZ) in the Pskov region supported the investment project for the construction of a plant for the production of medical devices by Deliplast. According to Vitaly Safonov, CEO of Deliplast, the investment volume will reach 810 million rubles. 60 jobs will be created on the site.
The area of the production facilities of the planned enterprise is 3 thousand square meters. m. The project is currently at the design stage, and Deliplast, together with medical scientific, research and rehabilitation centers, is developing a range of products. It is predicted that after reaching its design capacity, the plant will be able to produce more than 16 million medical products per year.
The project was approved by the head of the Moglino SEZ Pavel Sobol and the governor of the region Mikhail Vedernikov. The economic zone can provide the investor with "everything necessary for placing production." The investment project was recommended for consideration at a meeting of the SEZ expert council.
According to SPARK-Interfax, Deliplast LLC was registered in 2014 in the Moglino SEZ in the Pskov Region. The majority owner of the company is Moscow-based IMC Triadem LLC, which specializes in the wholesale of pharmaceutical products. There is no information on Deliplast's revenue. In July 2024, the expert council of the Moglino SEZ also approved the investment project of the BetaMed company for the construction of another plant that will produce medical products. The company plans to allocate 1 billion rubles for the creation of the enterprise. The implementation of the initiative is scheduled for early 2026.
FAS revealed a cartel in the supply of medical products worth 681 million rubles
The Federal Antimonopoly Service (FAS) revealed a cartel in the supply of medical products worth more than 681 million rubles. Signs of violations were found at tenders for the needs of state institutions in St. Petersburg, the Kaliningrad Region and the Republic of Dagestan, the FAS press service reported on December 11.
A case has been opened on violation of antimonopoly legislation against Alma-Med LLC and Makrus LLC. The companies are suspected of collusion in order to maintain prices when participating in tenders. The organizations refused to compete, systematically using a single model of behavior when participating in electronic auctions.
General the sum of the initial (maximum) prices of the contracts was 681,720,040 rubles.
If guilty is established, the organizations face turnover fines, the FAS noted.
A slightly smaller cartel agreement in the medical devices market was uncovered by the Moscow Office of the FAS in the summer of 2024. Signs of violations were found in 253 purchases worth more than 642 million rubles, MV reported.
Russian Railways Medicine to receive 121 million rubles from the Federal Compulsory Medical Insurance Fund for the operation of the medical train "Saint Panteleimon"
The private healthcare institution "Khabarovsk Clinical Hospital "Russian Railways Medicine" will receive funds from the standardized insurance reserve of the Federal Compulsory Medical Insurance Fund (FOMS) in 2025 to reimburse expenses related to the provision of medical care by the mobile consultative and diagnostic center (MCDC) based on the train "Saint Panteleimon" this year. The draft government resolution was submitted for anti-corruption expertise by the Ministry of Health on December 11. The document was developed on the instructions of the president following the results of the Eastern Economic Forum.
MCDC "Saint Panteleimon" is the first train registered by Roszdravnadzor as a medical device. It consists of 14 carriages, eight of which are equipped with medical equipment for radiation and functional diagnostics, therapeutic and surgical care. The presentation of the mobile medical center with the participation of Health Minister Mikhail Murashko and General Director of Russian Railways Oleg Belozerov took place on August 2, 2024, at the Yaroslavsky railway station in Moscow, MV reported.
According to calculations, the maintenance of the mobile medical center costs over 24 million rubles per month. As follows from the draft resolution, during the five months of the train's operation in 2024, medical specialists carried out medical examinations and professional medical examinations of at least 20.8 thousand people living in settlements with a population of up to 50 thousand. For this, Russian Railways should receive almost 121 million rubles from the Mandatory Medical Insurance Fund.
Regions spent 200 million rubles on free Moscow AI services for doctors
Total spending on medical IT solutions based on artificial intelligence (AI) remained almost unchanged in 2024 (514.3 million rubles) compared to 2023 (530.5 million rubles). But the structure of government procurement has changed: Russian medical institutions have spent almost 200 million rubles this year on integration with the Moscow MosMedII system, Vedomosti reports, citing a study by Tenderplan. The MosMedII platform, using 17 AI services, allows analyzing the results of radiation studies: CT, chest X-ray, fluorography, mammography. Since February 15, 2024, Moscow has opened free access to it to the regions, MV wrote. As a result, the subjects spent 197.3 million rubles on integration with the system over 11 months - 40% of the total volume of state purchases of software with AI (514.3 million rubles).
The median cost of the service for integration with MosMedII is 4 million rubles, most often Rostelecom won tenders. As of November 18, 2024, 24 subjects of the Russian Federation connected to the platform.
In Russia, 38 medical devices with AI have already been registered, which are used as systems for supporting medical decision-making based on the results of radiological images, video streams during endoscopic procedures and other studies. In October, it became known about the Ministry of Health’s plans to launch a new federal incident related to the introduction of medical devices with AI by the end of the year. Its details were not disclosed. This year, each region must introduce at least three medical devices with AI. Not all regions successfully cope with this task.
The Ministry of Health has prepared ethical guidelines for developers of AI systems. The provisions of the document will be applied at all stages of development in order to create safe, competitive products and increase Russians’ trust in the new technology. Rosstandart has developed requirements for AI-based systems to optimize patient flows when choosing a medical facility for hospitalization.
Other
Sberbank and AIRI Institute create a center for the development of drugs with AI
Sberbank and AIRI Institute are creating a center for the development of drugs using artificial intelligence in Russia. This was announced by Andrey Belevtsev, Senior Vice President and Head of the Technological Development Block at Sberbank, at the international conference AI Journey.
"Sber and the AIRI Institute are creating the AIDD center, which will focus on searching for medicinal molecules using AI. The main goal of creating the center is to ensure productive longevity and improve the quality of life of people by transforming the process of developing drugs using artificial intelligence. To do this, it is necessary to increase the number of original drugs in the Russian Federation, as well as create platform solutions for developing them. new drugs that will reduce the cost of development and accelerate research through the implementation of AI," he said.
According to Belevtsev, the center's strategy includes searching for biological targets with the involvement of pharmaceutical partner companies, generating new molecules, validating and conducting preclinical studies.
"The starting areas of the AIDD center will be work on finding drug molecules for the treatment of oncology and Alzheimer's disease, as well as therapy to combat diabetes and obesity," he noted.
Source: https://tass.ru/ekonomika/22649019
Newly registered medical devices
We publish a list of new medical devices registered from 12/06/2024 to 12/13/2024
Link to the list: [see table in the attachment]
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