News Digest 06.03.2026 — 13.03.2026
Regulators
The Russian Ministry of Health will update the procedure for monitoring the safety of medical devices
The Russian Ministry of Health has developed a new procedure for reporting all adverse events detected by medical device (MD) circulators at all stages of their circulation in the Russian Federation. The draft order is open for public comment until March 31.
This document will replace Russian Ministry of Health Order No. 1113n of October 19, 2020. The draft changes the terminology: instead of "side effects not specified in the instructions," "adverse reactions," "interaction characteristics," and "facts and circumstances creating a risk," it proposes introducing a single term—"adverse event."
It also proposes introducing a requirement for post-registration clinical monitoring—collecting data on the effectiveness and safety of a medical device for the first three years after its market launch.
The Russian Ministry of Health also intends to update the Procedure for Monitoring the Safety of Medical Devices, with the exception of those registered in accordance with international treaties and acts constituting the law of the Eurasian Economic Union (EAEU). The draft order is also open for public comment until March 31.
It is proposed to repeal Order No. 980n of the Russian Ministry of Health dated September 15, 2020, "On Approval of the Procedure for Monitoring the Safety of Medical Devices." The document will now regulate the monitoring of only those medical devices registered in accordance with Russian national regulations, excluding those registered in accordance with EAEU regulations.
Furthermore, the draft includes information automatically transmitted by AI-enabled software that is a medical device.
If approved, the documents will enter into force on September 1 and remain in effect until September 1, 2032.
Market news
Siberian State Medical University (SSMU) Launches AI-Based Screening System for Detecting Eye Pathologies
Siberian State Medical University (SSMU) has received registration approval from Roszdravnadzor (Federal Service for Surveillance in Healthcare) for its medical device—the Oftalmik+ telemedicine medical decision support system (MDSS) for diagnosing diabetic retinopathy. The device has passed safety, quality, and clinical efficacy assessments, according to the university's press service.
Ophthalmik+ is an organizational model for digital screening. Using artificial intelligence (AI)-based algorithms, the system analyzes fundus images, identifies pathological lesions, and provides physicians with an assessment of the likelihood of diabetic retinopathy. This technology allows for the initial examination to be conducted in preventive and primary care settings rather than by an ophthalmologist. This is critical for regions with a shortage of ophthalmologists, according to the statement.
In a pilot project in the Tomsk Region, Oftalmik+ helped preserve the vision of over 700 patients with diabetes by promptly detecting retinal changes. The platform is currently being piloted in the Kostroma and Sakhalin Regions and the Kamchatka Krai, and SSMU is exploring various scaling models—from direct implementation in medical institutions to working through partners and creating a unified digital hub for storing and annotating retinal images.
The university emphasizes that the development was developed through a close collaboration between physicians and engineers: the clinical need was generated by the university's ophthalmology clinic, which recognized the problem of late retinopathy diagnosis, while the Scientific and Technological Center "Digital Medicine and Cyberphysics" designed the software, integration with various fundus cameras, a secure medical portal, and a neural network model supporting the DICOM standard. In the future, the developers plan to train the algorithms to detect other ophthalmic pathologies (age-related macular degeneration, glaucoma) and use retinal vascular analysis to assess the risk of cardiovascular complications, including heart attack and stroke.
NIOPIK to Launch Pharmaceutical Substance Production in Dolgoprudny for 4 Billion Rubles
VEB.RF and the State Research Center NIOPIK have signed a 2 billion ruble loan agreement for the reconstruction of an active pharmaceutical ingredient (API) production facility in Dolgoprudny (Moscow Region). The total investment in the project will exceed 4 billion rubles, with a financing term of 8 years. The facility is planned to produce up to 200 tons of active pharmaceutical ingredients per year, including components for vital and strategically important drugs.
The project envisions the creation of a full-cycle production facility. It will involve the reconstruction of an 11,500 square meter workshop and the installation of eight universal chemical synthesis lines, which will enable the production of over 80% of existing types of pharmaceutical ingredients.
NIOPIK intends to begin production of 15 active pharmaceutical ingredients, eight of which are included in the VED list, and three are considered strategically important drugs. Five of the proposed substances are not currently produced in Russia.
According to VEB.RF, the launch of the production facility will create approximately 200 jobs for highly qualified specialists and will contribute to strengthening the country's drug security. The project has also been supported by the Russian Ministry of Industry and Trade and approved by the Interdepartmental Commission of the Cluster Investment Platform (CIP).
According to SPARK-Interfax, JSC NIOPIK, which is affiliated with the Russian Ministry of Industry and Trade, was registered in 1993 in Dolgoprudny. Antonina Melnichenko is the legal entity's director. In 2021, NIOPIK's revenue amounted to 217.5 million rubles, with a loss of 37 million rubles. Its authorized capital in 2022 was 1.26 billion rubles. No financial information is available for subsequent years. JSC NIOPIK manufactures pharmaceutical ingredients, medicinal products used in human and veterinary medicine, as well as dyes, pigments, and organic surfactants.
In August 2024, the head of the urban district of Dolgoprudny was appointed head of the city administration. Vladislav Yudin, head of the Dolgoprudny municipal government, announced plans to implement 22 investment projects in the municipality, all at various stages of completion. These include the reconstruction of the NIOPIK plant, which produces materials for medical devices and medications (specifically, the Alasens metabolic fluorescence diagnostic drug). The total investment in the project was estimated at 3.4 billion rubles, and its completion was scheduled for the end of 2025.
Other
The Eurasian Economic Union (EAEU) has ruled on free medical care for migrant families in Russia
The Court of the Eurasian Economic Union (EAEU) has ruled that although Russia is not obligated to provide families of migrant workers with compulsory medical insurance, they still have the right to free emergency medical care. This was announced by Sergei Leonov, Chairman of the State Duma Committee on Health Protection.
In early 2026, Kyrgyzstan requested clarification of the provisions of the EAEU Treaty regarding compulsory medical insurance for family members of migrant workers. The applicant, the Center for Judicial Representation under the Ministry of Justice of Kyrgyzstan, requested an interpretation of paragraphs 3 and 4 of Article 98 of the Treaty, emphasizing that, according to this document, families of Kyrgyz workers in Russia should have equal access to compulsory medical insurance as local citizens.
Migrant workers and their family members have the right to receive free emergency medical care in Russia, and they will not be denied it, emphasized Sergei Leonov, adding that migrant families can also purchase a voluntary health insurance policy (VHI) and receive the necessary medical care. According to him, there are "no restrictions" in this case.
The deputy emphasized that the special provisions of the EAEU Treaty on the provision of medical care do not automatically apply the compulsory health insurance mechanism to family members of migrant workers. "The court ruled that the specific regulation of these mechanisms remains the sovereign right of each EAEU member state," he wrote.
In recent years, migration policy in Russia has been tightening. In 2025, a law was passed stricter regulating the conditions for issuing compulsory health insurance policies to migrants. Now, to receive free medical care in our country, foreign citizens must legally work here for at least five years instead of three.
Exceptions are made in emergency cases.
Scientists reported liver and kidney damage due to rare earth metals in implants
Scientists from the A.A. Baikov Institute of Metallurgy and Materials Science of the Russian Academy of Sciences (Moscow) and the Ilizarov National Medical Research Center of Traumatology and Orthopedics (Kurgan) discovered that adding the rare earth metals lanthanum and cerium to titanium implants causes persistent liver and kidney damage in rats, while yttrium, another element in this group, does not produce such effects. This was reported by the press service of the Russian Science Foundation (RSF) (available to MV), which supported the study.
Most implants used in orthopedics, traumatology, dentistry, and maxillofacial surgery are made of titanium and its alloys, which are not rejected by living tissue and are biocompatible. Additives in titanium alloys are needed, among other things, to prevent wear and tear and increase strength. Rare earth metals such as lanthanum and cerium were previously considered safe options, but a new study shows that the use of such additives can have dangerous consequences.
"We have shown for the first time in laboratory animals that trace amounts of rare earth elements in titanium alloys, previously considered safe, can negatively affect the internal organs of mammals. This means that patients with implants made of such alloys containing cerium or lanthanum are at risk of experiencing side effects after surgery," noted Alexander Anokhin, a senior researcher at the Laboratory of New Technologies of Metallic and Ceramic Materials at the Institute of Metallurgy and Materials Science.
Rosatom MetalTech CEO Andrey Andrianov previously announced that Rosatom is developing a closed-loop production chain for titanium implants and surgical instruments. He stated that starting in 2024, the corporation will develop capacity for the production of domestically produced medical devices—plates, pins, and components. The full cycle is planned to launch in 2026: from titanium sponge mining and rod production to finished implants.
Deputies Propose Increasing Gift Value Limit for Doctors
A group of deputies has introduced a bill to the State Duma of the Russian Federation to increase the permissible gift value for employees of educational, medical, social service, and other organizations from 3,000 to 10,000 rubles. The document has been published in the Legislative Support System database. The proposed amendments are to Article 575, Part 2 of the Civil Code of the Russian Federation.
According to the explanatory note, the rule adopted in 2008 prohibiting gifts, with the exception of ordinary gifts valued at no more than 3,000 rubles, has long been violated due to inflation and the significant decline in the ruble's purchasing power. Today, "the cost of a typical gift consisting of a bouquet of flowers and a box of chocolates, presented, for example, on a professional holiday or New Year's to a teacher, doctor, or social worker as a sign of true respect and appreciation, can significantly exceed the established permissible value limit," the deputies note.
In September 2025, Yaroslav Nilov, one of the bill's authors and head of the State Duma Committee on Labor, Social Policy, and Veterans' Affairs, announced that the price cap on gifts for doctors needed to be revised. Prior to this, deputies discussed an initiative to increase the maximum price of gifts for doctors and civil servants in 2022, and then they also proposed indexing the maximum price of "tokens of gratitude" from 3,000 to 10,000 rubles, but only for gifts "classified as products of folk art and crafts of recognized artistic merit."
However, already in January of this year, the Russian Government Commission on Legislative Activity opposed such concessions only for employees of the aforementioned organizations. They also cited the lack of an analysis of law enforcement practices confirming the appropriateness of the measure and the risk of violating anti-corruption measures, MV reported.
New registered medical devices
We publish a list of new medical devices registered from 03.06.2026 to 03.13.2026
Link to the list: [see table in the attachment]
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