News Digest 19.01.2024 — 22.01.2024
Regulators
Two medical products were included in the list of purchases by trade name
A list of medical devices (MD) has been published, for the purchase of which a trademark may be indicated if they are purchased for the needs of a specific patient. There are currently two MIs on the list, as follows from the government order.
The list includes “Glucose IVD, reagent,” which is used for in vitro diagnostics for diseases such as diabetes mellitus and visual impairment, and a one-component closed colostomy bag for intestinal stoma.
Market news
Roszdravnadzor commented on the difficulties with licenses for servicing devices
The departure from the market of companies that have not renewed their license to service medical devices according to the new rules will not affect the quality and timeliness of this service, as well as the repair of medical equipment, the head of Roszdravnadzor, Alla Samoilova, said through the press service.
According to her, the licensing system for the medical device maintenance sector has been significantly improved at the request of the business community within the framework of the regulatory guillotine. Thanks to the adoption of new legal acts, licensing for servicing medical devices of low risk classes has been abolished, and the requirements for organizations servicing medical devices of other risk classes have been ranked depending on the complexity of the work. Such changes were positively received by the market, Samoilova added.
According to the new rules, in order to obtain a license, market participants are required to have the entire list of measuring equipment in accordance with the product group, have a certain number of engineers with certain qualifications on staff, and implement a quality management system according to a certain standard.
Source: https://www.interfax.ru/russia/941023
The first interregional offset for medical products was left without participants
The first interregional offset contract for the localization of the production of medical products was left without participants. At the Samarapharmacia auction to create the production of nitrile gloves in the region in exchange for the supply of medical products for ten years to two addresses - for the needs of Samarapharmacia itself and the Moscow City Clinical Hospital No. 15 named after. O.M. Filatov for 75.2 million rubles - not a single company submitted an application. Moscow Mayor Sergei Sobyanin announced plans to conduct a joint offset in April 2023. Then it was assumed that the minimum amount of investment that the winning company should make in production would be 100 million rubles.
The American regulator issued a record number of permits for new medical devices in 2023
The US Food and Drug Administration (FDA) approved 124 new medical devices last year, setting a record. Before the COVID-19 pandemic, the highest figures were recorded in 2018, when the regulator approved 106 medical devices.
Other
Deloitte analysts named the leading trends in healthcare in 2024
Deloitte predicts that in 2024, generative artificial intelligence will drive the digital transformation of healthcare, and consumers will make more informed decisions about their health because they will have more data to analyze. The role of employers in maintaining the health of employees will increase.
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