News Digest 30.01.2026 — 06.02.2026

Regulators

The Russian Ministry of Health will create a commission to develop a list of intoxicating substances

The Russian Ministry of Health intends to create an interdepartmental commission to develop a list of intoxicating substances and amend it. The draft order is open for public comment until February 14.

The Ministry has developed regulations for this commission, which will include representatives from the Russian Ministry of Health, the Russian Ministry of Internal Affairs, the Russian Ministry of Defense, the Russian Ministry of Industry and Trade, the Russian Ministry of Education, and Roszdravnadzor, as well as senior external specialists from the Russian Ministry of Health. The minimum commission size is ten people.

The document also outlines the responsibilities of the commission chair, deputy chair, executive secretary, and commission members.

The commission will review proposals and make decisions on whether to include a substance or mixture of substances in the list of intoxicating substances or to remove them from the list. Meetings will be held in person or remotely, at the discretion of the commission chair. Minutes of the meetings will be kept at the Russian Ministry of Health.

The Russian government previously approved the rules and deadlines for compiling a list of intoxicating substances.

Source: https://pharmvestnik.ru/content/news/minzdrav-rf-sozdast-komissiu-po-formirovaniu-perechnya-odurmanivaushih-veshestv.html


Market news

Diagnostic reagent production in Russia increased to 126 million packages

From 2023 to 2025, production of diagnostic reagents for medical laboratories in Russia increased by 10%, reaching 126 million packages. This market growth was driven by import substitution programs and government support, which enabled domestic companies to accelerate the development of reagent lines for high-tech areas such as genetics, oncology, and histology, according to BusinesStat data.

In particular, in 2024, in vitro diagnostic medical devices were included in the list of critical medical products, opening access to subsidies for development and research and stimulating further expansion of production capacity.

Market dynamics, however, remained uneven. In 2023, diagnostic reagent production decreased by 8% compared to 2022, which experts attribute to a decline in demand for laboratory diagnostics and stabilization following a surge in overproduction. A year earlier, the market demonstrated unprecedented growth—up 85% compared to 2021 levels, reaching 126 million packages. At that time, a sharp increase in demand for diagnostic tests and the shift toward import substitution prompted manufacturers to expand capacity and launch new plants and production lines, creating a safety net for the industry's further development.

Previously, analysts estimated the Russian market for reagents for pharmaceuticals, medicine, and science at 286 billion rubles in 2024. According to forecasts by the audit and consulting company Kept, demand for these products will grow by an average of 8.6–10.8% annually, reaching 470–530 billion rubles by 2030. The laboratory and analytical equipment market could increase over this period from 154 billion rubles in 2024 to 256 billion rubles.

At the same time, these markets will develop under the influence of a number of general factors affecting demand. Among these, experts cited the ongoing stabilization of macroeconomic indicators, changes in sanctions restrictions, and population decline, as well as rising morbidity, the development of localized pharmaceuticals, the growth of the commercial laboratory diagnostics market, the development of biotechnology clusters, and increased government funding for this area.

Source: https://medvestnik.ru/content/news/proizvodstvo-diagnosticheskih-reagentov-v-rossii-vyroslo-do-126-mln-upakovok.html

Russia plans to create a "roadmap" for import substitution of dialysis equipment

The Russian Ministry of Industry and Trade plans to convene a working group by the end of March to oversee the import substitution of drugs and medical devices used in nephrology. The first meeting is scheduled for June 30, according to the minutes of a meeting on the development of such production in Russia, held on December 9 (MV has a copy).

By the end of February, manufacturers must submit to the ministry information on raw materials, supplies, and components required for the production of dialysis medical devices, specifying specific brands, technical specifications, and annual requirements; information on registered and planned medical devices and medications; the timelines and stages of investment projects; and proposals for necessary support measures.

By the end of March, the Russian Ministry of Industry and Trade must notify manufacturers of the healthcare system's need for medical devices and medications intended for dialysis procedures and available solutions for replacing imported raw materials, supplies, and components with domestically produced equivalents.

Construction of Russia's first plant for the production of dialysis medical devices is currently being completed in Kaluga. Its launch is scheduled for May. The total investment in the project is approximately 2 billion rubles. Pharmasyntez-Medtech is the investor, and Novadial is the distributor. The plant will manufacture blood lines, dialyzers, and other dialysis consumables, as well as the machines themselves. The new facility will cover the needs of over 60% of hemodialysis patients and 100% of peritoneal dialysis patients, the company reported.

Previously, manufacturers of medical devices and laboratory reagents requested financial support and additional guarantees. This includes legislatively enforcing certain minimum quotas for localized products in public procurement for medical organizations and financial guarantees for investors, MV reported.

Source: https://medvestnik.ru/content/news/v-rossii-planiruut-sozdat-dorojnuu-kartu-po-importozamesheniu-oborudovaniya-dlya-dializa.html

Experts summarize the results of the Russian medical equipment market in 2025

Experts estimate the size of the Russian medical equipment market in 2025 at approximately 129.2 billion rubles, with X-ray machines accounting for almost 40%. AnalitikaMed, a service for analyzing the medical device market, shared data for procurement planning and ratings of manufacturers and suppliers with MV.

The market size across five main product lines amounted to approximately 129.2 billion rubles, with the following breakdown:

  • X-ray equipment (X-ray systems, medical imaging systems) — 51.3 billion rubles;
  • Anesthesiology and resuscitation equipment (anesthesia workstations, patient monitors) — 24.4 billion rubles;
  • Surgical equipment — 23.9 billion rubles;
  • Endoscopic equipment (endoscopic systems, electrosurgical units, shaver systems) — 22.8 billion rubles;
  • Laboratory equipment — 6.8 billion rubles.

This data is useful for procurement planning, assessing the main sources of budget burden, and aligning procurement structures with the development goals of regional and federal healthcare systems.

In 2023, the Russian Ministry of Industry and Trade estimated the market share of Russian medical devices (including equipment) at approximately 25.4%, and in public procurement at 28.5%. Several industry reviews, based on Rosstat data and public procurement, estimate the overall medical equipment segment at approximately 29%. According to IMEDA, the association of international manufacturers, the share of imported medical equipment in certain high-tech areas can reach 80%, particularly in the CT, MRI, and specialized surgical equipment sectors.

There are approximately 3,000 companies in Russia involved in the production of medical devices and equipment. These include developers of complex imaging systems, manufacturers of functional equipment, as well as instruments and consumables. In terms of value, foreign supplies continue to account for a significant share of the market. Customers are balancing between domestic solutions and imports: in some segments, access to Western products remains critical.

The government plans to increase the share of Russian-made medical equipment and other medical products to 50% in the coming years, and to reach 80% in key product groups by 2030. In practice, these goals are being implemented amid sanctions and restrictions. These restrictions have changed logistics, increased delivery times and costs, and some Western brands have reduced their direct presence. As a result, the role of parallel imports, a reorientation toward Asian manufacturers, and domestic production localization have increased.

Rostec announced that domestic manufacturers increased import substitution of medical equipment, medical products, and consumables by 14% last year. The most noticeable growth is observed in the laboratory research segment, MV reported. Independence from imported resuscitation equipment has also been achieved, stated Professor I.P. Sechenov of the First Saint Petersburg Medical University (SPbSMU). Vadim Teplov, Pavlova.

Source: https://medvestnik.ru/content/news/eksperty-podveli-itogi-2025-goda-na-rossiiskom-rynke-medoborudovaniya.html


Other

The European Union has called for healthcare to be officially recognized as "hard work"

At a conference in the European Union (EU) Parliament, a call was made for healthcare to be officially recognized as "hard work." Medical organizations and patient safety experts consider this a necessary element in the fight against staffing shortages, Medscape reports.

Doctors in the EU consistently report the worst working conditions. A recent survey found that 30% of healthcare workers work overtime. Specialists in emergency medicine, intensive care, oncology, psychiatry, and surgery experience particularly high workloads. Burnout, chronic fatigue, mental health problems, and disruption of family relationships are common among them. Physical health risks include musculoskeletal disorders due to patient movement and prolonged awkward positions during procedures.

Patient safety is inseparable from working conditions, workload, and staffing, stated Mirka Cikkelova, Secretary General of the European Patient Safety Foundation (EUPSF). Overworked doctors pose a direct threat to the quality of medical care. Healthcare workers avoid making mistakes by compensating for fatigue at the expense of their mental and physical well-being. While the harm caused by fatigue in an air crash is obvious to an individual worker, in medicine it is distributed among doctors, hospitals, and patients. Harmful actions are often accompanied by a search for personal responsibility rather than a discussion of the safety of the system.

Previously, Russian doctors launched a petition to double the time doctors spend with patients. The authors believe this will reduce the risk of burnout among healthcare workers and improve the quality of care. In 2025, almost 90% of surveyed visitors to private clinics said doctors in public hospitals were overworked.

Source: https://medvestnik.ru/content/news/v-evropeiskom-souze-prizvali-oficialno-priznat-medicinu-tyajeloi-rabotoi.html

Deputies Want to Change Sick Leave Rules in Russia

A group of State Duma deputies, led by Yaroslav Nilov, Chairman of the Labor Committee, introduced a bill to the lower house of parliament introducing a new concept to the Labor Code: "temporary adaptive work schedule." The document proposes establishing a special work format for employees with temporary health conditions, allowing them to work in a reduced workload, including remotely, without sick leave, and with retention of their average wage.

The proposed regulation is to be implemented on January 1, 2027. A temporary adaptive work schedule may be implemented for the entire period of temporary disability or for part of it. The terms and duration of such work are specified in a written supplementary agreement to the employment contract. The adaptive work schedule may be implemented upon the employee's written request and with a medical report containing specific recommendations regarding working conditions.

If the employer is unable to provide the conditions specified in the medical report, they are required to notify the employee in writing within one business day of receiving the request. In this case, the employee is issued a standard sick leave certificate. The employee has the right to terminate the adaptive work schedule at any time and either return to work under normal conditions or take a standard sick leave certificate if their health deteriorates.

In the explanatory note, the authors point out that the current regulation effectively limits an employee's status to two options: fully able to work or completely on sick leave. This is inconsistent with modern conditions, where employees with certain minor illnesses can effectively work in a lighter work schedule. It is assumed that the adaptive work schedule will allow employees to retain 100% of their income during periods of temporary health problems, while employers will be able to reduce losses from the absence of key specialists by avoiding the need for temporary replacements and overloading the sick employee's colleagues. The greatest positive impact is expected in industries with a high proportion of intellectual labor—IT, consulting, and finance—where most functions can be performed remotely or on a flexible schedule.

In November, Yaroslav Nilov reported that parliamentarians were seeking a legal mechanism to address the situation where a mother on maternity leave and her child are both sick and both need assistance. "A mother can't simply interrupt her maternity leave, and a father can't simply take sick leave. And if grandmothers and nannies don't come to the rescue, a complex bureaucratic process begins to restore health and maintain benefits," the parliamentarian argued. The initiative was announced that same month.

The Russian government assessed it at the time and pointed out a number of inconsistencies with current legislation. The conclusion states that the existing system relies on electronic or paper sick leave certificates, which simultaneously confirm the employee's legal absence and serve as the basis for calculating benefits. Moreover, the current model assumes that during a period of temporary disability, the employee does not perform work functions either at the workplace or remotely.

Criticism also concerns the proposed mechanism for obtaining a medical opinion on the possibility of an adaptive regime: such a tool is currently not provided for in the healthcare system, and the government assesses that the deadline for the law's entry into force specified in the draft law is inconsistent with the requirements of the Law "On Mandatory Requirements in the Russian Federation," which will also require revision.

Source: https://medvestnik.ru/content/news/deputaty-hotyat-izmenit-pravila-bolnichnyh-v-rossii.html

Almost half of dental clinics in Russia operate in violation of regulations

About half of dental clinics in Russia operate illegally or in violation of regulations, Izvestia reports, citing a study by the Public Consumer Initiative based on data from the Federal Tax Service, Roszdravnadzor, and the drug labeling system. Experts estimate that approximately 45% of dental clinics are unlicensed or not registered in state monitoring systems, primarily in St. Petersburg, Moscow, the Sverdlovsk and Chelyabinsk regions, and Tatarstan.

The activists have appealed to First Deputy Prime Minister Denis Manturov to allow unscheduled inspections of private clinics, equalize fines for individual entrepreneurs and legal entities for violating drug and medical device circulation regulations, and introduce an "automatic fine" mechanism through the labeling system.

Currently, the penalties for individual entrepreneurs for administrative violations are 10-30 times lower than for legal entities. This includes ignoring labeling requirements and operating without a license. Moreover, violations were detected among individual entrepreneurs almost five times more often—56% versus 11.5%. Another proposal from activists is to ban the advertising of clinics with violations on online maps and digital platforms.

They warn that illegal dental practices pose risks to patients' health and harm the budget. The Russian Dental Association acknowledges the problem and attributes it to a lack of government support, forcing patients to seek cheaper treatment options, often at dubious clinics. Experts call for stricter controls and increased access to legitimate dental services.

An earlier survey by Ingate Group showed that over 50% of respondents decided not to visit state hospitals due to difficulties with appointments or long queues, over 30% due to the need to see a specialist or insufficient attention, and 22% due to ineffective treatment. The quality of medical care in public hospitals suffers due to doctors being overworked, according to 88% of Russians surveyed. Dental clinics are the most popular among respondents (64%), according to the survey results.

Source: https://medvestnik.ru/content/news/pochti-polovina-stomatologicheskih-klinik-v-rossii-rabotaut-s-narusheniyami.html


New registered medical devices

We publish a list of new medical devices registered from 01.30.2026 to 02.06.2026

Link to the list: [see table in the attachment]

News

News Digest 03.04.2026 — 10.04.2026
10.04.2026
The Russian Government has expanded the list of medical devices subject to labeling; The Ministry of Labor will update the regulatory framework for the technical rehabilitation equipment (TRE) market; Russia's first telemedicine stethoscope has received a patent in the United States
More
News Digest 27.03.2026 — 03.04.2026
03.04.2026
Roszdravnadzor to Update Consultation Procedures for Medical Device Registration; A Ministry of Health commission rejected all applications for the inclusion of new medical devices in the compulsory medical insurance (CMI) lists; The government intends to reduce the share of illegal medical device trafficking to 21% by 2030
More
News Digest 20.03.2026 — 27.03.2026
27.03.2026
The Federal Center for Planning and Organization of Drug Provision for Citizens (FCDPiLO) may be appointed responsible for purchasing drugs and medical devices for national projects; Continuous glucose monitoring systems will be centralized for procurement; Rostec Registers New Anesthesia and Respiratory Machine with Intelligent Control
More