News Digest 10.10.2025 — 17.10.2025
Regulators
Roszdravnadzor will tighten oversight of the use of medical artificial intelligence
Roszdravnadzor has approved a procedure for automatically transferring data on the performance of medical devices with artificial intelligence (MDs with AI) to its information system. According to Order No. 4472 of July 21, 2025 (the document is available on MV), manufacturers or their authorized representatives must transfer data on MDs with AI through the applicant's electronic account to the supervisory authority's automated information system.
Manufacturers must provide the name, version, and registration number of the software product, its area of application, the number of studies conducted, the results of the work, as well as error data —including crashes, data quality issues, and operational interruptions. The system will also include the tax identification numbers (TINs) of medical institutions using such technologies. The order is valid until the end of 2025.
This mechanism will enable real-time monitoring of the effectiveness and safety of medical technologies, which is critical for their implementation in clinical practice. According to the regulator, 48 AI-enabled medical devices are currently registered in Russia, 43 of which were developed by domestic companies. These include solutions for automated X-ray analysis and medical decision support systems (MDSS).
The data transfer procedure has been approved in accordance with the requirements of Russian Government Resolution No. 1684 of November 30, 2024, regulating the state registration of medical devices.
GOST for medical electrical devices supplemented with EAEU requirements
GOST IEC 60601-1-2024 entered into force on October 1, 2025, replacing GOST R IEC 60601-1-2022, which was adopted in 2023. Both the old and new documents are identical to the international standard IEC 60601-1:2020. However, the updated GOST contains additional requirements of the Eurasian Economic Union (EAEU) for medical electrical devices and references the new GOST on electromagnetic compatibility.
The appendices to the updated GOST standard state that when assessing the safety of electrical medical devices, Decision No. 299 of the Customs Union Commission dated May 28, 2010, "On the Application of Sanitary Measures in the Eurasian Economic Union" must be taken into account.
The sections on risk management (testing methods for electrical medical devices) and software development have been expanded. The list of normative references used in the standard and information on the compliance of these standards with international standards have also been updated. Specifically, electromagnetic compatibility requirements will be regulated by GOST IEC 60601-1-2—2024, which comes into force on November 1, 2025.
The document was prepared by Medtechstandart LLC and put into effect by Order No. 1304-st of the Federal Agency for Technical Regulation and Metrology dated September 30, 2024.
Previously, the Council of the Eurasian Economic Commission (EEC) decided to amend the Rules for Registration and Expertise of Safety, Quality, and Efficacy of Medical Devices. Now, the authorized body—the expert organization—is required to notify the applicant within 10 business days of the start of the procedure for including a new type of device in the Global Medical Device Nomenclature (GMDN) and the Eurasian Economic Union (EAEU) Medical Device Nomenclature.
Russia plans to centralize procurement of drugs and medical devices for national projects
Russia plans to centralize procurement of important drugs and medical devices for state needs under the national projects "Long and Active Life" and "Family." To this end, it is proposed to transfer authority to determine suppliers of drugs and medical devices to the Federal Center for Planning and Organization of Drug Provision for Citizens (FCPiLO) of the Russian Ministry of Health, according to a draft government resolution developed by the agency.
The FCPiLO is expected to select suppliers for both federal institutions and regional government customers if procurement is financed from the federal budget or interbudget transfers under relevant national projects. For a number of diseases (e.g., cardiovascular diseases (as part of routine medical monitoring) and hepatitis C), special lists of drugs to be procured centrally have been established.
Furthermore, the government has established regulations for customer interaction with the Federal Center for Prophylaxis and Defense of the Russian Federation (FCPD). These include annual and additional requests, specific submission deadlines, and detailed information (e.g., information on needs is due by September 1, and requests are due by October 1). An appendix to the draft resolution provides a list of key medical products for federal and regional clinics, including imaging systems, ventilators, sterilizers, anesthesia machines, and others.
The goals of this measure are to prevent fragmentation of procurement, increase transparency, specialization in the procurement process, and ensure competition and cost savings. The new requirements are planned to apply to purchases for which funding is approved in the federal budget beginning in 2026. Specific requirements and deadlines for information transfer are also established to optimize procurement procedures in national projects.
Marked goods confiscated due to violations have been authorized for donation to humanitarian aid
The Russian government has approved a mechanism for the gratuitous transfer of unmarked goods confiscated for violations to the state. Government Resolution No. 1563 of October 8, 2025, was published on the legal information portal.
According to the document, goods subject to marking that were confiscated by court order for violating Article 15.12 of the Code of Administrative Offenses of the Russian Federation are sent for examination. If the goods are deemed suitable and safe for their intended use, they can be donated free of charge for humanitarian purposes in accordance with the procedure established by the Russian government. If the product is found to be unsafe or unfit for its intended use after inspection, it is sent for recycling or destruction.
This includes medications, medical devices, and dietary supplements subject to labeling. Exceptions include:
- alcohol-containing products;
- alcohol-containing perfumes and cosmetics;
- alcoholic beverages;
- tobacco and nicotine-containing products;
- consumer goods.
The Ministry of Industry and Trade has proposed limiting the purchase of imported stents and catheters for the public sector
According to the Ministry of Industry and Trade, at least seven manufacturers of balloon catheters and coronary stents are already operating in the Russian market, including R-Vascular, Angioline, Stentonic, NanoMed, EviPro, RK Group, and Stentex. Their production capacity allows them to produce over 700,000 stents and 650,000 catheters annually, fully meeting the needs of the healthcare system.
The Ministry notes that in 2021-2022, the market size was approximately 300,000-330,000 stents and 489,000-537,000 catheters, confirming the ability of Russian companies to fully meet domestic demand. The ministry expects the restrictions to support domestic manufacturers, reduce dependence on imported supplies, create incentives for new production facilities, and lead to lower costs of medical devices through the localization of production chains.
Resolution No. 1875, approved by the government in December 2024, establishes measures to ensure national treatment in the procurement of goods, works, and services for state and municipal needs. The document established the "second odd one out" mechanism, which stipulates that bids for foreign products will be rejected if at least one offer for Russian goods is available. Initially, the document applied to medications on the Vital and Essential Drugs List and the List of Strategically Important Medicines. The "second odd one out" mechanism came into effect on January 1, 2025, and applies to government procurement of foreign medications whose production is not localized in Russia.
Later, in August 2025, Government Resolution No. 1326 added medical devices—prostheses (including microprocessor-controlled bioprostheses), as well as medical furniture, surgical gowns, and gauze products—to the "second odd one out" list. For these products, the ability to confirm the country of origin using the ST-1 certificate has been extended until the end of 2025, allowing the temporary use of the old validation procedure without the localization points system. This measure simplifies manufacturers' participation in public procurement and prevents the risk of supply disruptions during the transition period.
In April 2025, the Ministry of Health clarified the application of Resolution No. 1875. The agency clarified that the first appendix to the resolution includes goods of foreign origin that are completely prohibited from being purchased, the second appendix includes products and medications whose purchase is restricted in the presence of domestic equivalents, and the third appendix establishes a minimum share of Russian-made products.
The Ministry of Industry and Trade's draft was developed as part of the state program "Development of Industry and Increasing its Competitiveness" and is aimed at strengthening technological sovereignty, developing the production potential of the medical industry, and improving national security.
The initiative also aligns with the directive of Russian President Vladimir Putin, who in July 2025 instructed the government to strengthen oversight of the priority of Russian goods in public procurement and improve the effectiveness of national regime measures. By the end of 2025, the Cabinet of Ministers must submit proposals to increase the share of domestic products in procurement and improve the mechanism for recognizing Russian medical devices abroad.
Market news
Russia has overcome its dependence on imported intensive care equipment
The supply of domestically produced intensive care equipment has made it possible to completely eliminate the dependence on imports in this area, which existed before 2015, Vadim Teplov, professor at the First Saint Petersburg Medical University (SPbSMU), told TASS.
According to the expert, almost all equipment used in intensive care units, operating rooms, and emergency rooms was previously foreign-made, but after the imposition of Western sanctions against Russia, its supply and maintenance ceased. In recent years, domestically produced equivalents have entered the market: automatic defibrillators, ventilators, cardiopulmonary resuscitation systems, and circulatory support devices.
Close cooperation between physicians and industrialists played a key role. Teplov cited the Life Stream Hepar device, a joint development between Rostec and SPbSMU scientists, as an example of practical success. This system maintains the viability of a donor liver before transplantation. The device also allows for the assessment and improvement of organ function prior to surgery.
The development of domestic medical instrumentation has become a key focus of technological sovereignty. According to the Russian Ministry of Industry and Trade and the Moscow government, medical device production volumes increased by 8% in the first months of 2025.
Johnson & Johnson to Spin Off Orthopedic Division
Johnson & Johnson will spin off its orthopedic division into a separate company called DePuy Synthes within 18-24 months. The American corporation's plans were announced in a press release.
The new enterprise will manufacture prostheses for hip, knee, and shoulder joints, as well as surgical instruments. According to Statista, J&J holds a 21% share of the global market for musculoskeletal devices. Last year, sales in this segment generated $9.2 billion, or 10% of total revenue. Among competitors, only Stryker, a medical device company, came close to this figure, with $9.1 billion.
Namal Navana has already been appointed CEO of DePuy Synthes. He has been with J&J for over 15 years and previously headed the British medical equipment company Smith & Nephew.
The restructuring of the orthopedic division began in 2023. Within two years, the company was able to reduce its geographic footprint and eliminate uncompetitive products. At the same time, J&J acquired two manufacturers of high-margin products used in cardiology: Abiomed for $16.6 billion and Shockwave Medical for $13.1 billion.
In 2023, J&J spun off its over-the-counter (OTC) division. It became Kenvue, a company with annual revenue of $15 billion. Its portfolio includes brands such as Band-Aid (bandages), Neutrogena (cosmetics), Tylenol (paracetamol), and Listerine (mouthwash).
Additionally, the pharmaceutical and medical giant published its financial report for the third quarter:
- Total revenue increased by 6.8% year-on-year to $24 billion；
- Medical device and equipment sales reached $8.4 billion (up 7% year-on-year)；
- Pharmaceuticals earned $15.6 billion (up 7% year-on-year). Among the most profitable drugs are Darzalex (daratumumab, used for multiple myeloma), Tremfeya (guselkumab, for psoriasis and ulcerative colitis), and Carvykti (ciltacabtagene autoleucel, a CAR-T therapy for myeloma)；
- J&J projects annual revenue of $93.7 billion.
Lekker sees unfair competition in the deregistration of antiseptic "felt-tip pens"
Felt-tip pens containing antiseptics from Lekker, a company that produces iodine, brilliant green, and hydrogen peroxide in convenient forms, have disappeared from pharmacies and supermarkets. Following the deregistration of these products last year, production ceased, and warehouse stocks ran dry, Fontanka.ru reports.
The company confirmed that an order from Roszdravnadzor (Federal Service for Surveillance in Healthcare) deregistered its products in October 2024, based on a conclusion by the All-Russian Research and Testing Institute of Medical Equipment. This conclusion states that "polymer devices with a solid porous core for storing and applying solutions to the skin UPTS - Lekker" are not medical devices. Roszdravnadzor considers these products to be drugs, not medical devices, as they have a systemic pharmacological effect on the human body. The company disagrees, claiming that the effect is limited to a local antiseptic effect aimed solely at killing microorganisms in the treatment area.
The company stated that the review could have been initiated by either Roszdravnadzor (for inspection purposes) or competitors. Lekker CEO Vladimir Denisov called the incident a corporate raid.
"The product has been manufactured for 25 years as a medical device (not licensed). Now it's been banned, and future production is possible, from a regulatory perspective, only at a licensed pharmaceutical manufacturing facility. This is in violation of Article 2 of the Licensing Law. The product doesn't even pose a potential health risk, and Roszdravnadzor hasn't provided any examples of its effects on the human body. So, this is corporate raiding. Everything is as it was in 2005," he said.
The company's products were patented and registered in the early 2000s. The history of complaints against the manufacturing facility began in 2005. The company claims this is the third attempt to challenge the product's status. They note that previous court cases were resolved in their favor. Production has now been suspended following the revocation of the registration.
The company is being asked to obtain a license to manufacture medicinal products. This will require a complete overhaul of production processes and documentation in accordance with drug product requirements. As a result, the final price of the product will increase significantly, according to the company itself. The company is not considering outsourcing production to large pharmaceutical companies.
According to AlphaRM, 1.7 million packages of the company's total product were sold in 2024, valued at 243.9 million rubles, and 154,600 packages were sold in the first eight months of 2025, valued at 29.4 million rubles.
FV sent a request to Roszdravnadzor for comment.
Other
A robot to assist nurses will be created in Nizhny Novgorod
Scientists from the Nizhny Novgorod AIDS Center and the Alekseev Nizhny Novgorod State Technical University's Robotics Development Center plan to develop a robotic assistant arm to assist nurses, said Solomon Apoyan, the center's chief physician. He described this as "a revolution in global medicine."
The robot assistant is expected to take over routine tasks, freeing up nurses to work with patients. According to Kommersant, the device will be able to register patients, draw blood samples, and label test tubes.
Solomon Apoyan noted that similar developments have already begun to emerge in China.
In March, MV reported on the development of a robotic device for cardiopulmonary resuscitation by Medplant, in collaboration with the team at the A.S. Puchkov Emergency and Urgent Medical Care Station of the Moscow Department of Health. The device replaces the needs of a doctor or rescuer during chest compressions and frees up hands for other necessary procedures. It can operate continuously for 92 minutes and can be used by ambulance crews, emergency medical teams, and hospitals.
In 2023, Infinity Business Insights prepared a report predicting that the global market for medical assistive robots will reach $37.2 billion by 2030. From 2023 onward, it is expected to grow at a compound annual growth rate (CAGR) of 17.3%, the report stated. This growth is driven by the continuing aging of the population and the emergence of new technologies.
Source: https://medvestnik.ru/content/news/V-Nijnem-Novgorode-sozdadut-robota-dlya-pomoshi-medsestram.html
Suppliers of counterfeit X-ray machines to Perm hospitals receive six-year prison sentences
A Perm court sentenced two businessmen who supplied counterfeit X-ray machines worth 120 million rubles to hospitals in the region, the regional prosecutor's office press service reported. The convicted individuals (their names have not been released) received six and six-and-a-half-year prison sentences, respectively, to be served in a general regime penal colony. The court also upheld the Perm Krai Ministry of Health's claim for damages against the perpetrators, for which their property worth the contract amount was seized. They will also be fined 500,000 rubles each.
According to investigative documents, in 2020, the defendants supplied X-ray machines of unknown manufacture to medical facilities in the Perm Krai, passing them off as certified products, even though they were not registered in Russia. The equipment was seized from the hospitals.
Earlier in September, MV reported that the Russian Ministry of Health plans to amend the Regulation on Federal State Control (Supervision) over the Circulation of Medical Devices. Several manufacturers face increased scrutiny from regulatory authorities. Roszdravnadzor, the Federal Service for Surveillance in Healthcare, will also subject companies conducting clinical trials of such products to more frequent inspections.
New registered medical devices
We publish a list of new medical devices registered from 10.10.2025 to 10.17.2025
Link to the list: [see table in the attachment]
News
