News Digest 18.09.2026 — 25.09.2026
Regulators
Ministry of Health Proposes Stricter Requirements for Medical Device Evaluators
The Russian Ministry of Health has submitted a draft procedure for organizing and conducting the assessment of the quality, efficacy, and safety of medical devices for public discussion. The document proposes, among other things, significantly expanding the list of requirements for the inspectors engaged in these assessments. Most of the proposed changes stem from the new rules on state registration of medical devices adopted via Russian Government Decree No. 1684 in November 2024. The current Ministry of Health order governing this process was approved in March 2020 and was based on state registration rules dating back to December 2012. The new document is scheduled to come into force in March 2027.
The new draft outlines six types of medical device assessments: review of the registration application and supporting documents; review of the completeness and results of testing for devices that do not require clinical trials; assessment of device quality, efficacy, and safety; assessment of domestic medical devices; and assessment to determine the feasibility of amending the registration dossier.
If the order is approved, assessments will be conducted by a commission of three or more inspectors, either upon the instruction of Roszdravnadzor (the Federal Service for Surveillance in Healthcare) or independently. The document also proposes stricter requirements for evaluators: they must now hold a higher education degree in medicine, engineering, or the natural sciences, possess additional professional training or an academic degree, and have at least one year of work experience at an expert institution. Previously, the only requirements were a higher education degree of any kind and at least one year of experience within the departments of an expert institution.
The Ministry of Health has also proposed banning the inclusion in the commission of representatives from organizations that conducted testing on the device in question, as well as officials who provided consulting services or inspected the manufacturing process. If the order is approved, expert commission findings will be submitted to Roszdravnadzor electronically via an automated information system. Paper-based documentation is stipulated only for findings regarding domestically manufactured products; such documents must be signed by every member of the commission.
If adopted, the new order will enter into force on March 1, 2027, and remain valid until December 31, 2028.
In April 2026, Roszdravnadzor submitted a draft order for public discussion that could approve the administrative regulations for registering medical devices under Eurasian Economic Union (EAEU) rules. The document outlines the procedure for providing the state service of market authorization and establishes Roszdravnadzor’s role as the competent authority of the reference state. The draft is currently at the stage where the results of the public discussion are being summarized.
The Russian Ministry of Health has introduced an emergency notification form for infections and food poisoning
The Russian Ministry of Health has approved record-keeping form No. 058/u: "Emergency notification regarding a case of infectious or parasitic disease, carriage of infectious disease pathogens, food poisoning, or an animal bite or strike." Order No. 740n, dated August 20, 2026 (available on *MV*), will come into effect on March 1, 2027.
The document establishes the notification form and the procedure for its completion by medical professionals. It regulates the reporting of cases involving infectious and parasitic diseases, pathogen carriage, and food poisoning, as well as injuries inflicted by animals—specifically bites, strikes, scratches, and exposure to saliva. Only one diagnosis may be entered into the notification for each identified case.
The new procedure details the steps for providing emergency notification to sanitary authorities. A physician or other medical professional who identifies such a case must notify Rospotrebnadzor by telephone within two hours and submit the formal notification no later than 12 hours after detection. The form may be completed in either paper or electronic format. If the electronic format is used, the data must be uploaded to the Unified State Health Information System (EGISZ).
The document specifies the data elements to be included in the notification. In addition to the date of completion, the diagnosis, and details regarding the patient, medical organization, and healthcare worker, the form includes a dedicated section for the reason for the emergency notification. Specifically, it provides for checkboxes indicating an infectious or parasitic disease, pathogen carriage, food poisoning, or contact with an animal.
The notification will also need to include information regarding the patient's whereabouts during the 30 days prior to the onset of symptoms, as well as any contact with infectious disease patients or with raw materials or products of animal origin.
Market news
Russian AI Company Develops World’s First Wearable Tomography Scanner
Smart Engines, a domestic AI company, has developed the world’s first wearable free-positioning tomography scanner—a 3D X-ray diagnostic solution that operates entirely without mechanical components. Weighing less than 5 kg, the device functions similarly to a standard camera, according to Smart Engines. The company stated that the device is designed for use in field conditions, ambulances, and rural medical stations. Internal investment in the project’s development totaled $5 million. The prototype is currently undergoing testing at medical and veterinary facilities.
Smart Engines explained that the development is based on X-SLAM technology—a suite of algorithms combining computer vision, X-ray tomography, and artificial intelligence. "Thanks to this technology, the system automatically and precisely determines the position of the radiation source as the operator moves it freely around the object, capturing images from various angles," the developers explained.
The system generates a 3D reconstruction from just 10–15 frames—100 times fewer than required in conventional tomography. Consequently, the patient's radiation exposure is hundreds of times lower than in a standard CT scan; the company claims the dose "does not exceed the radiation exposure associated with a single day spent in Moscow."
A report on the wearable free-positioning tomography scanner was presented at the International Conference on Embedded Artificial Intelligence and Sensing Systems (SenSys), held in France from May 11–14, 2026. In June 2026, the project also won the international university award "Gravitation" in the "Breakthrough Scientific Research and Development" category. Furthermore, the system's core technology is protected by a Russian patent, and the company has also filed a patent application in the United States.
The device has already undergone initial testing at medical centers and veterinary clinics. Specialists confirmed that the image quality is sufficient to reliably locate large fragments and determine their position relative to bones and other anatomical structures. The developers noted that the technology's potential extends beyond medicine: "it can be used for art analysis and restoration, forensic examination, customs inspections, and flaw detection."
Other
Study: Consumption of ultra-processed foods increases risk of diabetes by 24% and cancer by 12%
A major meta-analysis of 51 prospective cohort studies involving 8,819,894 adults has shown that a high proportion of ultra-processed foods (UPFs) in a person's diet is associated with an increased risk of several chronic diseases and mortality. The results were published in the journal *Family Medicine and Community Health* (BMJ).
Ultra-processed foods are ready-to-eat or ready-to-heat products that have undergone extensive industrial processing; they typically contain additives, sugar, salt, and fats, while being low in fiber, protein, vitamins, and minerals. This group includes carbonated drinks, chips, candy, fast food, cured meats and sausages, frozen convenience foods, instant soups, and many types of packaged bread and sweetened yogurts.
Compared to minimal consumption, high UPF intake increased the risk of cardiovascular events by 24%, obesity or overweight by 23%, metabolic syndrome and diabetes by 24%, depression and anxiety by 27%, digestive system disorders by 31%, cancer by 12%, and all-cause mortality by 18%. While no significant association with hypertension was found in the categorical analysis, a dose-response analysis revealed an 11% increase in risk for every additional 100g of UPFs consumed daily.
Experts from *The Lancet* note that the share of UPFs in diets is steadily rising worldwide and already exceeds 50% in a number of developed countries. Experts estimate that this trend places an increased burden on the healthcare system and exacerbates socioeconomic inequality by displacing access to high-quality, whole foods. Researchers emphasize that while the specific mechanisms by which ultra-processed foods (UPFs) affect health are still being clarified, the body of accumulated evidence is sufficient to warrant immediate intervention.
Specialists recommend integrating UPFs into national nutrition strategies, updating labeling regulations, tightening advertising restrictions, and revising standards for products high in salt, sugar, and fat. Similar trends have previously been highlighted by researchers from Johns Hopkins University and Yale University. Their data indicates that UPFs account for over 70% of the products available in US stores and more than half of the population's diet, making it impossible to reduce consumption without coordinated government policy.
New registered medical devices
We publish a list of new medical devices registered from 09.18.2026 to 09.25.2026
Link to the list: [see table in the attachment]
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