News Digest 13.12.2023 — 15.12.2023
Regulators
Roszdravnadzor has again created an interdepartmental commission on defects in medical devices
Roszdravnadzor has created a new interdepartmental commission that will deal with the problem of defects in medical devices. Such order No. 8003 dated November 13, 2023 was published on the legal information portal. The document is valid until January 1, 2025.
The document approves the regulations on the interdepartmental commission, which establishes the procedure for determining defects in medical devices or the risk of their occurrence, as well as the criteria for including medical devices in the list of types of medical devices. It also determines the procedure for organizing the work of the interdepartmental commission and the form of the proposal to include a type of medical device in the list of types of medical devices subject to circulation in accordance with the Peculiarities of Circulation of Medical Devices, approved by Decree of the Government of the Russian Federation No. 552 of 04/01/2022.
Market news
Results of the VIII National Forum of the Rehabilitation Industry and Universal Design “Hope in Technology”
On December 11 and 12, 2023, the VIII National Forum of the Rehabilitation Industry and Universal Design “Hope for Technology” was held in Moscow. Over the course of 2 days, the forum was attended by more than 1,200 people, united by the idea of making the lives of people with disabilities more comfortable and active.
A number of sessions of the business program were devoted to the development of production of rehabilitation products in Russia, the search for tools and optimal solutions for the creation and launch of advanced products on the market. During the discussion, representatives of Russian manufacturers confirmed their readiness to work in close cooperation with the medical community and users of rehabilitation products. “Nothing for us without us” is a principle of the Convention on the Rights of Persons with Disabilities, which reflects the approach of domestic manufacturers.
More than 270 samples of domestically produced rehabilitation products, including the most advanced developments, were presented at 46 exhibition stands. Participants got acquainted with high-tech prosthetics, wheelchairs of various modifications, devices for improving the quality of life of deaf and blind people, specialized play aids, educational kits and orthoses for children.
The event was attended by representatives of the State Duma of the Russian Federation, the Ministry of Industry and Trade, the Ministry of Labor, the Ministry of Health and the Ministry of Defense of Russia, Roszdravnadzor, the Chamber of Commerce and Industry of Russia, the Russian Academy of Sciences, medical centers, development institutes and other organizations.
The manufacturer of nonwoven materials intends to buy out 99.99% in Netkanika
According to SPARK-Interfax, Netkanika LLC was registered in Moscow in 2018. Elena Dudinova and Quark LLC each own 44.7% of the company, another 9.67% belongs to Valery Androsov, and the remaining 0.99% belongs to Invasta Capital. Revenue in 2022 amounted to 3.2 billion rubles, net profit - 102.3 million rubles.
JSC Polimatiz was registered in Tatarstan in 2006. Until April 2023, the company belonged to Nizhnekamskneftekhim (a structure of SIBUR). Then the company was bought by Mikhail Pshennikov’s Business Service Center, which is associated with the Syktyvkar manufacturer of nonwoven materials Komitex.
According to BusinesStat, in 2020, sales of these materials in Russia increased by 23.4% – to 7.02 billion square meters. m, in 2021 the growth was 16.5% - up to 8.17 billion sq. m. Against this background, manufacturers tried to increase capacity. Thus, Netkanika launched a production line in Moscow in January 2023 for personal protective equipment, medical clothing and hygiene products. For these purposes, the company received two loans - from the Industrial Development Fund (400 million rubles) and the Industry and Entrepreneurship Support Fund (300 million rubles).
Vladimir Kotov, President of the Association of Developers, Manufacturers and Suppliers of Personal Protective Equipment, noted that now many manufacturers, including Netkanika, have a surplus of capacity for the production of materials used to create medical devices. Netkanika, Kotov believes, may be of interest to market players as a processor of raw materials for integration into a vertically integrated holding, which will lead to increased profitability of the entire polymer processing chain.
The Sverdlovsk Regional Union of Industrialists and Entrepreneurs collected almost 160 million rubles for six medical projects
The Union at its next “Catherine Assembly” - a charity evening held since 2011 - summed up the results of the auction for the sale of lots from the private collections of businessmen, politicians, athletes, musicians and artists. The collected funds are distributed in the form of grants between various projects, this time the recipients, among others, were six medical organizations. 38 million rubles will be allocated to the Clinical Diagnostic Center for Maternal and Child Health to purchase a set of equipment for non-invasive prenatal testing. The Yekaterinburg Clinical Perinatal Center will purchase medical equipment worth 34.7 million rubles. To equip the Sverdlovsk Regional Clinical Psychoneurological Hospital for War Veterans with the necessary equipment for operations, it will receive 32 million rubles. 27.5 million rubles were sent to the Regional Children's Clinical Hospital for a high-tech operating room. 19.5 million rubles were raised for the repair and technical modernization of the clinical diagnostic laboratory of Children's City Hospital No. 15. For the convenience and rehabilitation of orphans with severe health problems, 7 million rubles were allocated in department No. 1 of the Children's Home in Yekaterinburg.
Source: https://www.sosppea.ru/141223
Other
HHS Finalizes Rule Aimed at Improving Health IT Interoperability and Algorithm Transparency
The U.S. Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), today finalized the Health Data, Technology, and Interoperability: Certification Program Update, Algorithm Transparency, and Information Sharing (HTI-1) Rule. This rule follows the April 2023 release of the HTI-1 proposed rule. The HTI-1 final rule expands patient access, interoperability, and standards, including the following:
Systems based on artificial intelligence (AI) must be transparent: that is, users must know what data the systems were trained on, who trained them, how information is processed in them, and how all these things work. In general, healthcare workers need to be trained in the use of AI - and the more detailed it is, the better.
Adopted new interoperability-focused reporting metrics for certified healthcare IT technologies. Uniform information exchange standards and rules have been established that establish the interoperability of certified IT systems.
Expands information blocking requirements by revising certain information blocking definitions and exceptions to support information sharing, and adding a new exception to encourage secure, efficient, and standards-based exchange of electronic health information.
New registered medical devices
We publish a list of new medical devices registered from 08.12.2023 to 15.12.2023
https://asiamc.ru/uploads/blogs/2023-12-15/657ca49f05c36.pdfNews
