News Digest 01.11.2024 — 08.11.2024
Regulators
The Ministry of Health has proposed introducing a new risk indicator for the circulation of medical devices
Draft order of the Ministry of Health of Russia "On Amending the List of Risk Indicators for Violation of Mandatory Requirements Used by Roszdravnadzor in the Implementation of Federal State Control (Supervision) over the Circulation of Medical Devices"
The Ministry of Health has proposed adding a new risk indicator to the list for state control over the circulation of medical devices, which was approved by Order of the Ministry of Health No. 368n of July 17, 2023. The draft is currently at the stage of summing up the results of public discussion.
It is planned to add an item concerning deviations in the functioning of medical devices to the list of risk indicators. The basis for an unscheduled inspection will be the availability of information that a medical organization has recorded two or more deviations in the operation of a medical device over a period of six months that did not lead to a threat to the health or life of citizens.
Market news
Moscow will allocate 1 billion rubles for the purchase of sensors for glucose monitoring systems
The Moscow Department of Competition Policy has published a tender for the supply of sensors for the transcutaneous glucose monitoring system. For these purposes, the purchase of systems for 1.054 billion rubles is planned for 2025-2026 - at the rate of 4.44 thousand rubles per piece.
According to the technical specifications, it is planned to purchase a needle electrode for the transcutaneous glucose monitoring system in interstitial fluid for use in the FreeStyle Libre 2 system. Moreover, the minimum remaining shelf life on the delivery date must be at least 12 months.
The delivery period for the products is from January 9, 2025 to December 4, 2026 in two stages. The first stage of the procurement is planned to be carried out in 2025, 502.2 million rubles will be allocated from the city budget for these purposes. The second stage will take place in 2026 - 552.3 million rubles will be allocated.
The contractor must supply monitoring system sensors no later than 15 calendar days from the date of receipt of the application throughout the entire term of the contract. The purchase is carried out in order to continuously and uninterruptedly meet the needs of citizens entitled to receive state social assistance in Moscow. The exact number of sensors is not specified.
According to Headway Company, in 2022, government customers purchased Abbott Freestyle Libre for 4.48 billion rubles, and Medtronic sensors and systems for 611.4 million rubles. However, in 2023, not a single government contract was concluded for the supply of Medtronic sensors due to the lack of applications from suppliers.
Intruline to launch production of cardiology products for 100 million rubles
The Intruline company will invest 100 million rubles in the creation of an enterprise for the production of cardiology products developed by the E.N. Meshalkin National Medical Research Center. Production is planned to begin in 2025. The NMIC, using a grant from the Ministry of Industry and Trade of the Russian Federation, is developing products for pulmonary artery replacement in children, transcatheter aortic and mitral valves, and a prosthesis for hybrid aortic surgery.
Intruline, as an industrial partner of the NMIC, will launch the production of medical products after registration certificates are received. According to the terms of the grant, the NMIC must do this before July 1, 2025. The plant's capacity and other details have not yet been disclosed.
According to the Director General of the NMIC, Alexander Chernyavsky, the tests of the children's prosthesis for pulmonary artery replacement have been completed, the medical device is currently undergoing registration with Roszdravnadzor. For other developments, the tests are nearing completion. Before receiving the registration certificate, the NMIC plans to conduct clinical trials in several medical centers.
The grant from the Ministry of Industry and Trade of the Russian Federation, which was sent to the NMIC at the end of 2021, is being implemented on a co-financing basis. The department allocated 50 million rubles, the NMIC invested 13.5 million rubles, and the industrial partner invested 8 million rubles.
In 2021, Irina Zhuravleva, Director of the Institute of Experimental Biology and Medicine of the NMIC, noted that domestic analogues of these consumables were not available on the Russian medical market, and imported products are expensive. At that time, the cost of one product was estimated at 1.5 million rubles. Zhuravleva specified that the products developed by the NMIC would cost several times less.
According to SPARK-Interfax, Intruline LLC was registered in the Novosibirsk Region in 2016. The company's main activity is the production of medical instruments and equipment. The company is 57.6% owned by Artem Lipov, another 31.2% by Dmitry Plekhanov, 7.2% by Artem Grigoriev and 4% by Alina Zhuravleva. The legal entity's revenue in 2023 amounted to 2.57 million rubles, the loss was 437 thousand rubles.
Other
Israeli Evogene and Google Cloud to Develop AI Model for Drug Development
Evogene has entered into a collaboration agreement with Google Cloud to develop an advanced artificial intelligence (AI) model capable of creating small molecules. This was reported by the press service of the Israeli company specializing in computational biology.
According to the statement, Evogene will be able to use Google Compute Engine graphics processors, Google Cloud Storage data storage service and Vertex AI - a single platform that unites the entire Google Cloud cloud infrastructure for creating and managing AI models. As noted, specialists will train the neural network on a data array of 40 billion different molecular structures.
Newly registered medical devices
We publish a list of new medical devices registered from 11.01.2024 to 11.08.2024
Link to the list: [see table in the attachment]
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