News Digest 27.02.2026 — 06.03.2026
Regulators
Medical Device Labeling Experiment Extended Until 2027
The Russian Government has extended the labeling experiment for certain types of medical devices by one year. The corresponding Resolution No. 204 of February 28, 2026, was published on the official legal information portal.
The experiment began on September 1, 2024, based on Russian Government Resolution No. 620 of May 17, 2024, and was scheduled to end on February 28, 2026. According to the new document, the deadline has been extended: the pilot will run until February 28, 2027.
Furthermore, the document introduces a division into three stages and sets new deadlines for reporting for each stage. Specifically, the methodological recommendations and schedule for Stage II must be approved by June 15, 2026, and for Stage III, by October 15, 2026. Final reports on the results will be submitted to the Russian government by July 31, 2026 (for Stage II) and January 31, 2027 (for Stage III).
The list of medical devices participating in the experiment has also been updated:
- Stage I (September 1, 2024 to August 31, 2026): syringes, infusion sets, wipes, test tubes, ventilators and breathing equipment, neonatal incubators, plastic surgery implants (fillers and cosmetology threads), and medical masks are subject to labeling;
- Stage II (March 2, 2026 to August 31, 2026): glucometers, glucose test strips, tonometers, and various rapid tests;
- Stage III (April 2, 2026 to February 28, 2027): reagent kits and reagents for in vitro diagnostics (laboratory testing).
It was previously proposed to extend the experiment until August 31, 2026. Also, compared to the draft, the list of medical devices has changed: condoms, suture materials, and endoprostheses have been excluded.
Source: https://pharmvestnik.ru/content/news/eksperiment-po-markirovke-medizdelii-prodlen-do-2027-goda.html
Market news
The share of imported disposable medical linens in Russia has fallen to 10%
Imported disposable medical linens have virtually disappeared from Russia, giving way to domestically produced products: the share of foreign supplies has fallen from 87% in 2020 to 10% in 2024. Analysts attribute this to increased government procurement of Russian products (accounting for approximately 90% of demand) and the focus on import substitution in the healthcare system, according to a study by the Skolkovo School of Management, which surveyed respondents from 13 regions.
Experts note that sanctions and more complex logistics have made foreign supplies less predictable and more expensive. After explosive growth in 2020, the disposable medical linen market stabilized following the COVID-19 pandemic at a level approximately four times higher than 2019 levels, reaching approximately 27 billion rubles in 2024.
Key growth drivers during this period included mass vaccination, the implementation of the Strategy for the Prevention of the Spread of Antimicrobial Resistance in the Russian Federation, the growing proportion of the retirement-age population, and the increased needs of the Russian Ministry of Defense due to the Special Military Operation (SMO). Factors hindering market development include rising prices for polymers used in production, the lack of regulatory requirements for high quality, the established practice of purchasing reusable drapes in the public sector, as well as the high cost of equipment and sanctions. According to experts, disposable medical linens are "more cost-effective" than reusable ones. For example, the incidence of postoperative infectious complications with the former is reduced by 8%.
However, domestic products still lag behind the best European counterparts in a number of characteristics, according to the study. Furthermore, the participants noted the need to introduce new products to the market, including disposable sterile thermal blankets for patients under sedation during surgical procedures, sterile wire covers, and rolled diapers with frequent perforations.
RSF supported three proposals for localizing medical device production
The Russian Science Foundation (RSF) has summarized the results of its competition to select technology proposals for subsequent scientific and technical projects aimed at organizing and scaling up the production of medical devices in Russia. Based on the review by the Scientific and Technological Council, three applications were recommended for support, and separate competitions will be held for them. Financial support is not provided during the selection stage of technology proposals.
The competition was held to implement the roadmap for meeting the needs of the domestic healthcare system for the most in-demand medical devices and establishing their production in the Russian Federation. The selection process was based on a list of topics for developing technology proposals approved by Deputy Prime Minister Tatyana Golikova. The selected projects will form the basis for launching targeted and applied research, as well as experimental design and engineering work.
The winners were Ortho-Innovations Moscow LLC with a project to develop a pulse generator for a deep brain stimulation system; PC Prometey LLC with an initiative to create a urological endoscopic video system consisting of a flexible, reusable video cystoscope and an endoscopic video processor; and the All-Russian Research and Testing Institute of Medical Equipment (VNIIIMT) of Roszdravnadzor with a proposal to develop a system for antiepileptic electrical stimulation of the vagus nerve.
The planned project implementation period must not exceed three years, and co-financing from a qualified client in the amount of at least 10% of the future grant is a mandatory requirement. In addition, extra-budgetary funds and other client assets may be used.
The Federal Antimonopoly Service of Russia (FAS) has uncovered a cartel agreement in the supply of glucose monitoring systems worth 3 billion rubles
The Federal Antimonopoly Service (FAS) of Russia has uncovered a cartel agreement during an open electronic tender to select a counterparty to fulfill offset obligations, the agency's press service reported.
The agency determined that the cartel was organized during the procurement process for the supply of glucose monitoring kits for the Ministry of Health of the Amur Region, Zabaykalsky Krai, Primorsky Krai, and Khabarovsk Krai.
According to the agency's preliminary estimate, the total initial maximum contract prices exceed 3 billion rubles.
The agency has opened a case for violation of antimonopoly legislation (No. 135-FZ "On Protection of Competition") against Sainoke Trade LLC and Diatek LLC. If found guilty, the companies face administrative fines under Article 14.32 of the Code of Administrative Offenses of the Russian Federation ("Concluding an agreement restricting competition, implementing concerted actions restricting competition, and coordinating economic activity").
Other
Experts have calculated the cost of alternatives to disposable shoe covers in hospitals
Amid debates about the future of disposable shoe covers in Russian clinics, experts are proposing alternatives to disposable products. Alexander Reshtenko, Commercial Director of Lindaily, a B2B sharing services company (workwear, carpets, and textiles for HoReCa), spoke to MV about possible solutions: special dirt-trapping mats and reusable shoe covers.
In February, media reported that medical facilities had begun to lift the requirement for visitors to wear shoe covers. Notices to this effect were posted, in particular, in hospitals in St. Petersburg. Experts noted that disposable polyethylene covers often tear and are no substitute for mandatory cleaning. Following this, Badma Bashankayev, First Deputy Chairman of the State Duma Committee on Health Protection, stated that the use of shoe covers creates more problems than they are worth, and that hospitals and clinics should instead use dirt-trapping ramps and mats. He noted that using alternative methods of contamination protection is costly, "but it's much more cost-effective than spending money on shoe covers and collecting large amounts of dirt in entrance areas and hospitals themselves."
Currently, the volume of disposable shoe covers in Russia reaches several hundred million, resulting in over 900 million used shoe covers ending up in landfills annually, or approximately 962 tons of waste per year, according to Lindaily calculations. According to Alexander Reshtenko, replacing them with a dirt-trapping mat system for a medical center with full coverage of 372 square meters would cost approximately 16 million rubles per year if choosing designer mats and approximately 8 million rubles for standard solutions.
The budget for reusable shoe covers is approximately 300,000 rubles per year. With an average daily traffic of approximately 50 people, the organization requires approximately 700 pairs of shoe covers to replace used ones with clean ones weekly. Per-visitor costs are approximately 16.5 rubles, which is comparable to disposable products. However, the expert emphasizes that reusable shoe covers are more convenient to use, have a more aesthetically pleasing appearance, and reduce environmental impact.
"Reusable fabric shoe covers can be considered a transitional step toward reducing or completely eliminating disposable solutions. Unlike carpeting, which requires significant annual costs, the shoe cover rental format does not require a one-time capital investment. It allows for a gradual reduction in disposable waste without the need to modify entrance areas or infrastructure," says Alexander Reshtenko.
He cited transparency, scalability depending on the clinic's size and traffic, manageability, and predictability as advantages of this model.
Drivers demand labeling of medications incompatible with driving
The National Automobile Union (NAU) proposed labeling medications that prevent driving after use, as well as conducting clinical trials to determine the extent of their effects on drivers. The organization submitted its initiative to the Russian Ministry of Health, TASS reports. Information about the incompatibility of driving a vehicle and the use of a medication must be displayed on the box, label, and blister pack, the letter states.
Back in May of last year, the State Duma of the Russian Federation passed in the first reading a bill amending the Code of Administrative Offenses of the Russian Federation, prohibiting driving while taking certain medications and establishing penalties for such violations—a fine of 45,000 rubles and suspension of a driver's license for up to two years. It is envisaged that this penalty will only be applied in the presence of clinical signs of intoxication caused by certain medications.
It was proposed that such drugs include those that impair attention and reaction time but are not classified as ethyl alcohol, psychotropic substances or their analogs, or new potentially dangerous psychoactive substances. The list of prohibited substances could include anesthetics, antiepileptic and antiparkinsonian drugs, sedatives, and hypnotics.
The Union of Automobile Drivers noted that if the law is passed, thousands of Russians risk losing their driving licenses because they are unaware of the ban on their medications. Most drivers don't monitor such legislative changes, and few read the instructions for their medications. Furthermore, it is necessary to establish the specific clinical signs of intoxication that a traffic police inspector should identify, clarify the permissible dosage of medications, and the period of the driving ban after taking the medication.
Yaroslav Nilov, Chairman of the Committee on Social Policy and Veterans' Affairs, previously announced plans to introduce a bill to the State Duma of the Russian Federation requiring "clear and easily understandable pictogram labeling" of prohibited medications for drivers. He stated that the list of such medications is informational in nature and often contains confusing wording for the average person, as do instructions from drug manufacturers.
The bill also drew criticism from the Civic Chamber of the Russian Federation. Alexander Kholodov, Deputy Chairman of the Commission on Security and Interaction with the Public Monitoring Commission, expressed concerns that the bill introduces double standards for drivers and pedestrians, which could lead to unfair conclusions and legal ambiguity during medical examinations. Other experts pointed out that the bill opens wide scope for abuse against drivers prescribed medication, for example, if a person took the medication several days ago and it no longer affects their ability to drive, but traces of it are detected in the test results.
New registered medical devices
We publish a list of new medical devices registered from 02.27.2026 to 03.06.2026
Link to the list: [see table in the attachment]
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