News Digest 10.01.2024 — 12.01.2024
Regulators
Vladimir Putin supported simplification of the procedure for testing rehabilitation means for their registration
The President promised to consider the possibility of simplifying the registration of technical means of rehabilitation. Manufacturers of medical devices may have the opportunity to test them and conduct laboratory tests before submitting an application to Roszdravnadzor.
Roszdravnadzor has terminated more than 2.5 thousand licenses for the maintenance of medical devices in the Russian Federation from January 1, 2024.
Order No. 9896 dated December 29, 2023 was published on the RZN website, which contains a complete list of legal entities.
Source: https://t.me/promedizd/107
Changes have been made to the rules for licensing activities for the maintenance of medical devices
The changes affected the technical maintenance of medical devices, if the medical device manufacturer or an authorized representative of a foreign medical device manufacturer, information about which is contained in the registration dossier for a medical device, carries out technical maintenance only of medical devices manufactured by it.
Source: https://promedizd.com/2129new/
Market news
Chelyabinsk OFAS identified a cartel of 17 companies at auctions for the supply of medical equipment
In Chelyabinsk, the antimonopoly service discovered a cartel at auctions for the supply of medical equipment. It included 17 companies from several cities across the country. The total amount of initial contract prices amounted to more than 500 million rubles. The case materials have been transferred to law enforcement agencies.
In France, a device has been developed to measure four health indicators
French health device company Withings has developed the BeamO multiscope to measure four health parameters. The device can measure body temperature, blood oxygen levels, heart and lung sounds. In addition, BeamO detects abnormal heart rates and detects atrial fibrillation. The device sends all information to the user’s phone.
In 2024, Withings plans to clinically validate the device and receive CE (European Conformity) marking and US Food and Drug Administration approval. They plan to sell the multiscope for $250.
Source: https://t.me/vademecum_live/12684
Other
A training manual “Design of medical devices” was published on the Liters platform
The manual provides practical guidance on key issues and processes in the design and development of medical devices that meet regulatory requirements and standards in Russia and the Eurasian Economic Union (EAEU). The textbook includes 22 chapters. Each section provides a list of scientific articles or regulatory documents for a more detailed study of the relevant topic.
Source: https://t.me/vniiimt/417
Moscow Technological School and Sechenov University will open courses on additive technologies
The course “Application of additive technologies: printing a product according to an individual project” for specialists with a specialized engineering higher education will be held in a full-time distance format and is designed for 30 academic hours. The second course, distance learning, “Application of additive technologies in the creation of medical products: theoretical foundations” is designed for specialists with the same level of education and takes 18 academic hours. Both courses are aimed at training students to work with digital 3D technologies for the medical industry. After training, participants will receive a certificate of advanced training in the established form.
Source: https://t.me/vademecum_live/12665
New registered medical devices
We are publishing a list of new medical devices registered from 12/29/2023 to 01/12/2024
Link to the list: [see. table in attachment]
News
