News Digest 30.05.2025 — 06.06.2025
Regulators
Requirements for technical and operational documentation of medical devices have been updated
The Russian Ministry of Health has updated the requirements for the content of technical and operational documentation of the manufacturer (producer) of medical devices. The document establishes more detailed and updated requirements, including features for software, including those using artificial intelligence (AI) technologies and products for in vitro diagnostics. The new standards will come into force on September 1, 2025. Documentation issued before the entry into force of the new regulation will need to be updated by manufacturers and authorized legal entities and individual entrepreneurs.
The new regulation was approved by Order No. 181 of the Ministry of Health dated April 11, 2025. It establishes uniform standards for technical and operational documentation that regulates the processes of production, storage, transportation, installation, operation, maintenance, repair, disposal or destruction of medical devices. In particular, the technical documentation for medical devices (except software) must contain the name and identification data of the medical device, its purpose, operating principles, indications and contraindications for use, information on potential consumers, technical characteristics, functional elements, components and accessories, interchangeability, the possibility of joint use with other products, labeling, risks and methods of their management, as well as data on verification, validation, and testing. For medical devices for in vitro diagnostics, the technical documentation is supplemented by a description of the target analyte (qualitative, semi-quantitative or quantitative), functional purpose (screening, monitoring, diagnostics), pathology or risk factor, type of sample analyzed, information on user qualifications, operating principles, analytical and diagnostic sensitivity and specificity, information on transportation conditions, measurement procedures, metrological traceability and stability. In the case of software, the documentation must include the name, version, identification data and operating principles, information on interpretation functions, hardware platform, risk classification, information on the availability of AI technologies, components, risks, technical characteristics, system requirements, data exchange protocols, as well as data on verification, validation, installation, cybersecurity measures and clinical recommendations.
The order will enter into force on September 1, 2025 and will be valid until September 1, 2031. Documentation issued before the entry into force of the new regulation will need to be updated by manufacturers and authorized legal entities and individual entrepreneurs; the update deadlines are not specified in the document.
The regulation will replace the order of the Ministry of Health of the Russian Federation No. 11n dated January 19, 2017, which previously approved the requirements for the content of technical and operational documentation for medical devices. Compared to the draft order submitted in February 2025, the approved document excludes the requirement to include in technical documentation a brief description of modifications similar to medical devices in circulation in the countries of the Eurasian Economic Union (EAEU), as well as on international markets.
Some class "G" medical waste is equated to highly and extremely hazardous waste
The Government of the Russian Federation has approved a list of class "G" medical waste, similar in composition to extremely hazardous and highly hazardous waste (hazard class I and II). It includes seven items according to the federal classifier, including personal protective equipment that does not fall into other categories, mercury-containing waste, as well as laboratory waste and chemicals. According to the new regulations and amendments made to the relevant legislative framework in August 2024, such waste must be disposed of in accordance with the requirements for waste of hazard classes I and II: companies and individual entrepreneurs producing them must register in the federal information system for handling and conclude an agreement with the federal environmental operator. The new list includes waste from equipment, machinery and other products that are subject to special control; laboratory waste and chemical residues; waste from personal protective equipment that is not included in other groups; waste from the elimination of mercury pollution and mercury-containing compounds; waste from batteries, including vehicles; waste from battery electrolytes and batteries. According to the current legislation, legal entities and individual entrepreneurs must register in the federal information system for the management of waste of I and II hazard classes (FGIS "OPVK") and conclude an agreement with the federal environmental operator - FSUE "FEO" in order to dispose of waste of these classes.
Regulations in relation to the medical waste of class "G" will come into force on September 1, 2026.
Medical waste is divided into five categories, which are classified from "A" to "D". According to the current sanitary standards, medical waste of class "G" includes toxicologically hazardous waste from the 1st to the 4th hazard class, including mercury-containing items, devices and equipment, medicinal, diagnostic, disinfectants, waste from the operation of equipment, as well as other toxicologically hazardous waste generated in the process of medical, pharmaceutical activities, the production of drugs and medical products.
Regulators have been adjusting the regulatory framework for the medical waste market with varying activity over the past several years. The result of the work was a package of amendments that were introduced in August 2024 to Federal Law No. 89 "On Production and Consumption Waste", Federal Law No. 52 "On the Sanitary and Epidemiological Welfare of the Population" and Federal Law No. 323 "On the Fundamentals of Protecting Citizens' Health", and immersed the medical waste sphere in the current legislation on waste management. According to the new regulations, class "A" medical waste (epidemiologically safe) generated during the activities of legal entities and individual entrepreneurs is transferred by them to regional operators for the handling of municipal solid waste. Class "B" (epidemiologically hazardous) and "B" (extremely epidemiologically hazardous) medical waste is subject to mandatory disinfection, class "G" (toxicologically hazardous) is disinfected in cases stipulated by sanitary rules. Disinfection is carried out by persons whose activities generated the waste, or authorized to carry out this procedure.
Market news
"Circle of Goodness" will begin purchasing domestic sliding endoprostheses
The Board of Trustees of the state fund "Circle of Goodness" approved the expansion of the list of purchases for children with orphan diseases, including domestic endoprostheses for patients who have lost part of the bone as a result of, for example, Ewing's sarcoma. The list of purchases will also include the antitumor drug Venclexta (venetoclax) from the American AbbVie for the treatment of oncological diseases.
An orthosis that accelerates the recovery of fine motor skills after a stroke has been created in the Russian Federation
A fourth-year student at the Institute of Artificial Intelligence of the Russian Technical University MIREA, Daria Maslennikova, has developed an orthosis that allows for the acceleration of the rehabilitation of patients with strokes due to more active restoration of hand motor skills. This was reported to TASS by the university's press service.
Motor impairments develop in 80% of patients who have suffered a stroke. At the same time, existing orthoses often simply fix the hand, without providing active rehabilitation. According to the author of the project, the new solution not only supports the hand, but also stimulates recovery. "The development of a student of RTU MIREA helps patients with radial nerve damage and stroke consequences to regain hand mobility. The orthosis is a system of 10 adjustable elements that are put on the hand and act as tendons. Each element can be individually adjusted to the patient's characteristics. The device not only fixes the hand in the correct position, but also helps to gradually restore motor functions, allowing a person to perform everyday activities again," the university clarified.
As Alexey Kirichenko, the scientific director of the project, senior lecturer of the Department of Biocybernetic Systems and Technologies of RTU MIREA, explained, an important difference of the development is also the ability to bend and unbend each finger separately.
"This is a new technology, which has no analogues on the market yet. Another key feature is the location of the orthosis exclusively on the back of the hand, which provides comfort and preserves the natural mobility of the palm. This is especially important for patients who need to gradually restore fine motor skills without unnecessary discomfort," he added.
Source: https://nauka.tass.ru/nauka/24066507
FAS uncovers 621 million ruble cartel in medical equipment supply in Kaliningrad Oblast
The Federal Antimonopoly Service (FAS) found two St. Petersburg distributors, Alma-Med and Makrus, guilty of a cartel conspiracy in nine tenders for the supply of medical equipment for clinics in the Kaliningrad Oblast and St. Petersburg for a total of 621 million rubles. According to the agency, the cartel existed from 2022 to 2024.
Other
Development of Samara State Medical University ReviStabix is included in the register of domestic software
Software developed at the Samara State Medical University of the Ministry of Health of the Russian Federation (Samara State Medical University) for diagnostics and restoration of balance in dynamic and static modes for diseases and injuries of the musculoskeletal system ReviStabix is included in the Unified Register of Russian computer programs and databases. This indicates that ReviStabix complies with the standards of the Ministry of Digital Development.
The ReviStabix simulator, developed by specialists from the Institute of Innovative Development of the Samara State Medical University, helps in the diagnosis and rehabilitation of patients. It allows you to build individual rehabilitation programs with a game component through the use of biofeedback.
In a stationary state, the simulator is used to assess and treat the balance function due to the patient's transfer of the center of gravity. And the moving state of the device is necessary to restore motor activity and coordination of movements. The simulator has a unique mode when the device automatically changes the angle of inclination to unbalance the patient for his adaptation to urban conditions, as well as training the ability to hold the body with unexpected changes in the angle of inclination of the surface.
Source: https://samsmu.ru/news/2025/20054/
New registered medical devices
We publish a list of new medical devices registered from 05.30.2025 to 06.06.2025
Link to the list: [see table in the attachment]
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