News Digest 30.04.2026 — 15.05.2026
Regulators
The procedure for transferring data on AI-enabled medical devices to the automated information system (AIS) has been updated
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) has approved a new procedure for automatically transferring data on the performance of artificial intelligence (AI)-enabled medical devices to the departmental automated information system (AIS). The order (available on MV) extends the validity of the regulation until December 31, 2027, and simultaneously introduces detailed rules for creating and using an applicant's electronic account in the AIS for each such medical device.
According to the procedure, manufacturers and users of AI-enabled medical devices approved for circulation in Russia are required to automatically transfer information on the performance of these devices to the AIS. To this end, the agency will provide applicants with access to the system through an electronic account, authorization for which is organized through the state identification and authentication system used for electronic government services.
An electronic account is created separately for each AI-enabled device and must contain information on the data processed, the name and registration number of the medical device, its scope of application, the type of solution, the number of studies performed, and error data, including network-related and device-related errors. Furthermore, the mandatory specification of the solution type for a medical device with AI technology has become a new parameter; it was not included in the previous version of the document.
In March 2026, Russia adopted a state standard for artificial intelligence systems in healthcare. This standard aims to ensure patient safety, high standards of medical services, and minimize the risk of errors or misuse of neural networks. According to GOST, all systems in the standard are divided into two main categories: medical devices with AI technologies and services based on artificial intelligence. The first group includes all systems designed by the manufacturer for the prevention, diagnosis, treatment, and medical rehabilitation of diseases, monitoring the human body, conducting medical research, restoring, replacing, or modifying the anatomical structure or physiological functions of the body, preventing or terminating pregnancy, whose functional purpose is not achieved through pharmacological, immunological, genetic, or metabolic effects on the human body. The second group includes voice services, chatbots, and video analytics services.
Source: https://medvestnik.ru/content/news/obnovlen-poryadok-peredachi-dannyh-o-medizdeliyah-s-ii-v-ais.html
Roszdravnadzor (Federal Service for Surveillance in Healthcare) has identified mandatory information for medical device regulatory documentation
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) has prepared a draft order establishing the information required to be included in medical device regulatory documentation. The document applies to the entire range of medical devices, including those for in vitro diagnostics, and aims to fill a regulatory gap—there is currently no separate regulation on the structure of such information.
The order is scheduled to enter into force by December 31, 2028. It was developed in compliance with the new Rules for the State Registration of Medical Devices, approved by Government Resolution No. 1684 of November 30, 2024.
According to the draft, the documentation will be required to include information about the manufacturer (name, legal form, address, and details of the individual entrepreneur), the type of medical device and its intended purpose, the All-Russian Classifier of Products by Type of Economic Activity code, the potential risk class of its use, as well as a description of its design and operating principle. Separate clauses cover product sterility, labeling, packaging, expiration dates, storage and transportation conditions, and conditions of use, specifying the user's level (professional or non-professional).
For products containing medicinal products, pharmaceutical substances, or materials of animal or human origin, relevant information must be provided, along with the frequency of maintenance, if required.
For implantable medical devices, developers will be required to describe the composition, specifying the component percentages and their functional properties, biodegradation parameters, and the procedure for replacing and removing the implant from the body. A separate set of requirements concerns software-based medical devices: the regulatory documentation proposes specifying the presence of artificial intelligence technologies and functions for interpreting the obtained data.
The draft order identifies three groups of requirements: general requirements applicable to all medical devices; requirements applicable to devices for in vitro diagnostics; and requirements applicable to devices without in vitro diagnostics. Among other things, these requirements stipulate that the medical device must be effective for its intended purpose as defined by the manufacturer and designed to achieve its stated intended use during normal use. The need to minimize the risk posed by contaminants and their residues is also emphasized. For in vitro devices intended for self-testing, it is specifically stated that they must be designed to minimize the risk of user error without specialized training.
Roszdravnadzor has cancelled paper forms for registration certificates for medical devices
Roszdravnadzor has cancelled the forms for registration of medical devices. Order No. 310 of April 3, 2026, was published on the legal information portal.
The following Roszdravnadzor orders are deemed no longer effective:
- No. 40-Pr/13 of January 16, 2013;
- No. 3380-Pr/13 of July 23, 2013;
- No. 1636 of March 3, 2017;
- No. 1450 of July 10, 2017.
These documents regulated the form of the paper registration certificate.
The order was prepared in accordance with Russian Government Resolution No. 1684 of November 30, 2024, which approved the new Rules for State Registration of Medical Devices and established the transition to a registry-based model for issuing registration certificates.
Now, registration certificates for medical devices, including those for applications submitted prior to the effective date of Resolution No. 1684, will be issued as an entry in the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.
This also applies to medical devices for which state registration applications were submitted to Roszdravnadzor prior to the effective date of Resolution No. 1684.
The Federal Tax Service (FTS) has clarified the specifics of reissuing certificates for alcohol-containing drugs
The Federal Tax Service (FTS) has published a clarification for pharmaceutical companies that hold a pharmaceutical production certificate and are beginning to produce new drugs or medical devices based on ethanol as the active ingredient. According to the FTS's announcement, such manufacturers are only required to notify the tax authority in accordance with the rules of Section 4.5 of Article 179.2 of the Tax Code of the Russian Federation. If this procedure is followed, reissuing the registration certificate of an organization that handles ethyl alcohol is not required.
This applies to medicines, pharmaceuticals, and medical devices registered under the laws of the Eurasian Economic Union (EAEU) and/or Russian law and included in the lists of pharmaceutical products approved by the Russian Ministry of Health that use ethanol as a raw material.
The Federal Tax Service reminds that, in accordance with paragraph 4.5 of Article 179.2 of the Russian Tax Code, an organization holding a pharmaceutical manufacturing certificate must, along with its excise tax declaration, submit copies of documents confirming changes that occurred during the reporting tax period to the tax authority. Such changes include, among other things, the launch of new drugs and medical devices that meet the criteria of the Russian government and the lists of the Russian Ministry of Health.
Therefore, the launch of new alcohol-containing medicines does not entail a separate procedure for changing the certificate, and all updates are recorded through the excise tax declaration and accompanying documents.
The Russian Government has approved new regulations for the removal and disposal of medical waste
Russian Government Resolution No. 506 of April 30, 2026, established the procedure for providing medical waste transportation and disposal services. Only providers included in the official regional list will be allowed to handle such waste, with mandatory recording of the waste class, weight, and volume at all stages.
The document applies to Classes "B" and "C" medical waste, as well as Class "G" waste, with the exception of those classified as extremely hazardous and highly hazardous according to a separate list approved by Russian Government Resolution No. 1354.
These requirements are valid until September 1, 2032, and supplement the provisions of the laws "On the Sanitary and Epidemiological Welfare of the Population" and "On Production and Consumption Waste."
The transportation and disposal of waste is permitted only under an agreement between the client (a medical organization or other entity generating medical waste) and the contractor, details of which are posted on the official website of the authorized body of the constituent entity of the Russian Federation. These contractors may be regional state unitary enterprises, government agencies, or other legal entities and individual entrepreneurs authorized to provide such services.
Before commencing work, the contractor is obligated to provide the client with a list of responsible persons and the vehicles used, indicating their makes and license plates. Before departing for the site, responsible persons are issued transport documents, executed in accordance with the requirements of industry transport legislation, which must specify the class of medical waste and the object to be disposed of. Upon delivery of the waste, the client confirms its disposal, stating its class, weight, and volume. A representative of the contractor visually inspects the packaging, checks the integrity of the containers, and verifies the correctness of the labeling. If any violations are found, a report is drawn up, and removal is permitted only after the violations have been rectified.
Additional requirements have been established for vehicles: mechanisms for the safe loading and unloading of containers, restraint devices, and, if necessary, refrigeration equipment. Waste disposal facilities must be equipped with special storage facilities, emission treatment systems, waste mass and volume measurement devices, areas for washing and disinfecting vehicles, and a system for controlling unauthorized access to the premises and technical equipment.
Previously, as reported by FV, the Russian Ministry of Health developed a list of Class G medical waste. This waste is similar in composition to extremely hazardous and highly hazardous waste. The list includes seven waste groups of hazard classes I and II, in accordance with the codes of the Federal Waste Classification Catalog. The document will come into effect in September 2026.
The regulator has approved a new procedure for consulting on medical device registration
Roszdravnadzor has updated its procedure for consulting on medical device registration and introduced a preliminary dossier analysis. This should reduce the risk of refusal and simplify the workflow for applicants.
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) has approved an updated procedure for consulting applicants on matters of state registration of medical devices. The document (available on MV) replaces the regulations in effect since 2017. It applies to the service's subordinate expert institutions and introduces a formalized consultation procedure.
These consultations will also cover the preparation and submission of dossiers: experts will be able to assess the completeness and accuracy of the materials, provide clarifications on testing requirements, the evidence base, and the structure of the documentation. The preliminary dossier analysis effectively creates a mechanism for the early identification of regulatory risks, allowing manufacturers to adjust their documentation in advance and reduce the likelihood of registration denial.
The document establishes that consulting services are provided by two institutions: the All-Russian Research and Testing Institute of Medical Equipment (VNIIIMT) and the National Institute of Quality of Roszdravnadzor. This service is voluntary and not mandatory for medical device registration.
Consulting covers a wide range of issues: from product development and registration dossier, planning and conducting necessary tests, to the electronic submission of documents. Consultations are separately provided on classifying a product as a medical device (including software and artificial intelligence solutions, as well as in vitro diagnostic devices), its nomenclature classification by risk types and classes, as well as on reporting adverse events, adverse reactions, and safety hazards associated with the handling of medical devices.
The procedure also extends to clinical evaluation: experts can advise on the need for clinical trials involving human subjects, the preparation of plans for such trials, and clinical monitoring plans for high-risk and implantable devices. Consultations are provided based on an agreement between the applicant and the expert institution; the service is available in oral and written form. The consultation period must not exceed 20 business days from the commencement of services.
The document also establishes restrictions for experts: they are not authorized to evaluate registration dossiers on behalf of Roszdravnadzor, make administrative notes on documents, give instructions to service officials, or provide advice on materials related to appeals of the regulator's decisions and actions. To prevent conflicts of interest, officials of expert institutions who have provided consultations or conducted inspection audits of production facilities cannot subsequently participate in the assessment of the quality, efficacy, and safety of the same medical devices.
In December 2025, Roszdravnadzor presented a draft administrative regulation for the provision of the state service for registration of medical devices, which details the timelines for procedures, grounds for refusal, the specifics of amending dossiers and conducting clinical trials, and also outlines the use of digital services. In March 2026, it was proposed to abolish orders requiring paper registration certificates and transition entirely to electronic documents. In April, the service developed administrative regulations for the state service for registering medical devices in accordance with the rules of the Eurasian Economic Union (EAEU).
Market news
Finland to tighten export regulations for medical supplies to Russia
The Finnish government intends to tighten export regulations for a number of medical devices and pharmaceuticals shipped to Russia. At the request of the Cabinet, the Finnish Ministry of Foreign Affairs has prepared a resolution proposing to ban the issuance of exceptional export licenses for goods already included on EU sanctions lists, but which could previously be exported under individual permits for medical and pharmaceutical purposes.
Finnish authorities explain this initiative by concerns that such products could be used to benefit the Russian military, including during military operations in Ukraine. The document has been posted on the government's public consultation portal and is expected to enter into force in July. Once adopted, the current practice of exempting sanctioned medical and pharmaceutical products should cease. However, some medical and pharmaceutical products are not subject to sanctions at all and can be exported without special permits, according to Elina Rimppi, head of the Finnish Ministry of Foreign Affairs' sanctions department.
According to Yle, the Finnish Ministry of Foreign Affairs receives an average of five to ten applications for exclusive licenses annually, with each company permitted to submit multiple applications. Three companies directly affected by the proposed changes sought permission in 2025. Among them are PaloDEx Group Oy, a Tuusula-based manufacturer of dental equipment under the Dexis brand, and part of the American corporation Envista. Envista stated that it was aware of the upcoming restrictions.
Another company that could be subject to restrictions is Pribori Holding Oy, which produces fetal and newborn screening equipment. Meanwhile, Northern Europe's largest hospital furniture manufacturer, Lojer-Merivaara, continues to supply operating tables and hospital beds to Russia. These products do not fall under EU sanctions categories and are therefore not subject to either the current restrictions or the new initiatives by the Finnish Ministry of Foreign Affairs.
Source: https://medvestnik.ru/content/news/finlyandiya-ujestochit-eksport-medtovarov-v-rossiu.html
Other
A human digital twin has been created in China to assess organ aging
Researchers from the Institute of Zoology of the Chinese Academy of Sciences, the National Center for Bioinformation of China, and several Chinese medical organizations have presented the Digital Aging Twin system—a human digital twin for assessing biological age and the rate of aging of individual organs. The platform uses artificial intelligence and the analysis of over 240 physiological and molecular parameters, including data on proteins, metabolites, the microbiome, gene activity, and brain and retinal images. The work was published in Cell.
To create the system, the researchers collected data from 2,019 healthy volunteers aged 18 to 91 years from several regions of China. The scientists compiled a database of over 1 billion biological and clinical parameters, including laboratory results, cognitive and motor tests, gait analysis, and multilayered molecular data.
The Digital Aging Twin architecture includes three layers of "aging clocks." The first assesses the overall functional state of the body based on physiological parameters. The second, a multimodal AI model, combines various types of molecular data and predicts a person's age with an average error of approximately 3.9 years. The third level consists of specialized models for individual organs, including the brain, liver, lungs, blood vessels, muscles, and skin.
During the study, the scientists found that organs do not age simultaneously. According to the model, the liver begins to age rapidly after approximately 40 years of age, while a significant acceleration in brain aging is observed closer to 50 years of age. Furthermore, the system identified two particularly critical age periods—40–50 and 60–70 years—when dysfunction in several body systems accelerates most rapidly.
Additionally, the researchers analyzed the impact of lifestyle on the rate of aging. Slower biological aging was associated with regular sleep, moderate physical activity, and fruit consumption, while smoking, lack of sleep, and frequent meals were correlated with accelerated aging. The developers believe that the Digital Aging Twin can be used for the early detection of accelerated aging, personalized selection of preventative interventions, and evaluation of the effectiveness of healthy longevity programs. According to the authors, the study is the first major result of China's national X-Age project, which aims to create a system for assessing the aging of the country's population.
A world-class longevity center will be created in Nizhny Novgorod
The Russian government has announced the results of the selection process for world-class research centers, increasing their number to 13. Each will be eligible for up to 320 million rubles annually. Among the winners is the "Healthy Longevity Medicine and Cognitive Technologies" center, which will be established at Lobachevsky State University of Nizhny Novgorod (UNN). The total funding for the project for 2026–2030 will be 1.16 billion rubles.
The center will be located at UNN's Institute of Biology of Aging and will develop medical devices, personalized models, and methods for the early diagnosis of age-related changes, including cognitive impairment. Priority will be given to implementing approaches to assessing biological age and systems for the early detection of risks of accelerated age growth, followed by correction. Mikhail Ivanchenko, Director of the UNN Institute of Biology of Aging, has been appointed head of the center.
The project is being implemented in a consortium with the Russian Center for Neurology and Neuroscience, the B.V. Petrovsky Russian Scientific Center of Surgery, and the Bauman Moscow State Technical University. This collaboration envisions the integration of clinical and engineering expertise to develop technologies for the diagnosis and prevention of age-related diseases.
The infrastructure will be based on a network of approximately 500 longevity medicine centers, scheduled to launch in 2027. It is expected to reach up to 3.5 million people annually and will ensure the implementation of the center's developments in practical healthcare.
In April 2026, Deputy Prime Minister Tatyana Golikova announced the formation of a healthy longevity medicine system in Russia: the first specialized center opened at the B.V. Petrovsky Russian Scientific Center of Surgery, where approximately 800 people have already been examined in pilot mode, and 264 doctors from 50 regions have been trained in the new specialty. The model focuses on working with healthy individuals through biological age assessment and the identification of disease risks, followed by their correction.
Healthy longevity is enshrined as a key element of the Healthcare Development Strategy to 2030. Longevity centers are viewed as entry points into the system, with tools for assessing biological age and developing personalized health management programs.
Source: https://vademec.ru/news/2026/05/04/v-nizhnem-novgorode-sozdadut-tsentr-dolgoletiya-mirovogo-urovnya/
New registered medical devices
We publish a list of new medical devices registered from 04.30.2026 to 05.15.2026
Link to the list: [see table in the attachment]
News
