News Digest 24.07.2026 — 31.07.2026
Regulators
The Russian Ministry of Health will introduce additional risk indicators for state oversight of medical device circulation
The regulator plans to introduce new risk indicators for violations of mandatory requirements used by Roszdravnadzor to monitor the circulation of medical devices (MD). The draft order of the Russian Ministry of Health has been published for anti-corruption review on the regulation.gov.ru portal.
The list of risk indicators approved by Order No. 368n of the Russian Ministry of Health dated July 17, 2023, is proposed to be supplemented with four items:
- the absence in the automated information system (AIS) of Roszdravnadzor of reports of adverse events during the use of MD from medical organizations classified in various risk categories for harm (damage) during medical activities;
- the identification by Roszdravnadzor of information on MDs proposed for sale with potential risk of use of 2b or 3, the registration dossiers of which have not been amended for more than 10 years;
- discrepancies between information about the medical device in the unified procurement information system and its name and intended use in the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices;
- identification on the labeling of a medical device in circulation of information about its place of manufacture or the address(es) of the production site that is not included in the registration certificate or in the registry entry of the state register of medical devices and organizations (individual entrepreneurs) engaged in the production and manufacture of medical devices.
In March of last year, the Russian Ministry of Health expanded the list of risk indicators for state oversight of the circulation of medical devices to five items. Failure to receive a repeat application from the developer or manufacturer of the medical device to amend the documents contained in the registration dossier within 180 business days from the date of Roszdravnadzor's refusal to amend it was added to the list of reasons for inspections of developers or manufacturers, MV reported. However, in April, the list of risk indicators was reduced to two items.
The registry of permits for clinical trials of medical devices will be extended by two years
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) has proposed extending the registry of permits for clinical trials of medical devices by two years. The amendments are being made to Order No. 4484 of July 22, 2025, which expires on December 31, 2026.
The explanatory note states that the purpose of the draft is to ensure the implementation of the requirements of the Rules for State Registration of Medical Devices and to continue the procedure for maintaining the registry of issued permits for clinical trials. The registry is publicly available on the Roszdravnadzor website.
Information must be entered into the registry on the day the decision to grant permission to conduct a clinical trial is made and within three business days of receiving notification of the start of the clinical trial. Manufacturers or authorized representatives will be able to submit information about the start of trials online, through their personal account on the government services portal.
The WHO has included the Russian Ministry of Health in its list of 12 authorities to facilitate regulation of the medical device market
The World Health Organization (WHO) has published the first interim list of regulatory authorities in the field of medical devices, designated tWLA (transitional WHO Listed Authorities). The document is intended to serve as a basis for strengthening international cooperation and implementing regulatory trust mechanisms, which should ultimately accelerate patient access to safe and high-quality medical products. The list of 12 regulators includes the Russian Ministry of Health.
The list also includes specialized regulators from the United States, the European Union, the United Kingdom, China, Canada, Japan, South Korea, Brazil, Singapore, Australia, and Switzerland.
With the rapidly increasing sophistication of technologies in diagnostic equipment, implants, and pacemakers, national regulators are facing an increasing burden of verifying product compliance with safety and efficacy standards. For many countries, especially those with limited resources, conducting a full cycle of independent assessments is becoming a significant administrative and financial challenge. The WHO-proposed regulatory reliance mechanism allows agencies to utilize the results of assessments conducted by other authoritative regulators without abdicating responsibility for the final decision.
Temporary tWLA status is awarded to national and regional authorities that have already demonstrated a high level of competence in overseeing the circulation of medical devices. This initiative is a transitional step in replacing the outdated concept of so-called strict regulatory authorities (SRAs) with the new WLA system. Unlike the previous approach, the new model is based on transparent and objective performance criteria consistent with international standards and WHO-approved indicators.
As Dr. Rogerio Gaspar, Director of the WHO Department of Regulation and Prequalification, emphasized, strengthened cooperation between regulatory authorities will allow for a more efficient allocation of expert resources and reduce duplication of inspections. "This is an important step toward creating a more coherent and effective global system that directly protects public health," he said.
The tWLA list is temporary and will be updated gradually as regulators complete the full assessment process and achieve permanent WLA status. Completing the transition to the new system is expected to allow countries to more quickly bring high-quality medical devices to market, reducing administrative barriers without compromising patient safety.
Market news
A medical device supplier paid a fine for participating in a cartel
Focus paid an administrative fine for participating in an anticompetitive agreement during a tender for the supply of medical instruments and consumables. The amount, 43.1 million rubles, was transferred to the Russian budget, the Federal Antimonopoly Service reported.
As reported by FV, the Antimonopoly Service opened a case for violation of antimonopoly legislation in May 2025. The case concerned the supply of medical materials by Focus, Otrimed, and Extravision. The total initial contract prices exceeded 1.2 billion rubles.
The Federal Antimonopoly Service imposed turnover-based fines on the organizations. The service did not report payments made by other cartel participants.
Other
Russian scientists have developed replaceable copper coatings for hospital surfaces
Scientists from the A.N. Frumkin Institute of Physical Chemistry and Electrochemistry of the Russian Academy of Sciences (RAS), the N.F. Gamaleya Research Center of Epidemiology and Microbiology, and Peoples' Friendship University of Russia (RUDN University) have developed replaceable coatings based on thin copper foil for door handles, elevator buttons, light switches, and other frequently used surfaces in healthcare facilities. The results of the study were published in the Chemical Engineering Journal.
This development is designed to reduce the microbial load between scheduled cleanings, thereby reducing the potential for cross-contamination. However, the authors note that it does not replace disinfection and hand hygiene.
Antimicrobial surfaces are increasingly being used as additional infection prevention measures in hospitals, but their long-term effectiveness in real-world clinical use is often limited by wear, organic contamination, and changing surface properties. Scientists proposed applying a functional relief to industrial copper foil and securing it to the object with a self-adhesive backing. This option can be cut to the shape of a specific part, installed without dismantling, and then easily replaced at the end of its service life.
These coatings were tested for 15 weeks in the active intensive care unit of a Moscow hospital. Swabs were taken from the surfaces four times a week, and the number of microbial cell walls destroyed by the copper was counted. A total of approximately 1,500 swabs were analyzed. The experiment showed that microbial contamination on the copper surfaces was significantly lower than on control samples made of stainless steel and plastic.
The tests compared three options: smooth copper foil, laser-textured copper, and a composite coating with titanium dioxide nanoparticles. The laser-textured copper foil without the additional photocatalytic layer demonstrated the most stable long-term antimicrobial activity. Researchers note that the effectiveness of coatings in a real hospital depends not only on the original properties of the material but also on the frequency of touch, lighting, cleaning, and wear.
Rospotrebnadzor (Rospotrebnadzor) reported the blocking of websites selling fly agaric supplements
Over 25,000 online resources offering banned supplements have been blocked at the request of Rospotrebnadzor. The period over which this number of resources were identified is not reported.
The blocked sites included those selling products that had not undergone state registration and/or products containing substances exceeding established levels. These include "Biotin 5000 for Hair 120 Capsules Biotin NOW Foods, USA" and "Vitamin B12 B12 Folic Acid."
A hazardous product, "RedMicro Fly Agaric Microdosing," was also identified.
In 2022, Rospotrebnadzor secured a ban on the sale of food products and dietary supplements containing fly agarics on marketplaces. The legal proceedings were prompted by the poisoning of a teenager by fly agaric mushrooms near a pickup point in Krasnoyarsk. According to Technical Regulations of the Customs Union 021/2011 "On Food Safety," higher mushrooms classified as poisonous and inedible are not subject to inclusion in single-component dietary supplements.
J&J to Settle Talc-Containing Baby Powder Lawsuits with $5.5 Billion
American pharmaceutical company Johnson & Johnson announced a sweeping settlement to resolve tens of thousands of lawsuits related to talc-containing baby powder. The company will pay plaintiffs $5.5 billion in the settlement.
According to J&J, the settlement covers approximately 76,000 lawsuits, including those consolidated in federal court in New Jersey. Most of the claims allege that the baby powders contain talc and asbestos and cause various cancers.
Lawyers representing the plaintiffs note that the terms of the settlement proposed by the pharmaceutical company must be approved by 95% of the consumers who filed the lawsuit for it to take effect.
According to the company, Johnson & Johnson will distribute $3 billion in 2027, with the remaining $2.5 billion to plaintiffs in 2028. The pharmaceutical manufacturer clarifies that the final amount could be higher, depending on the number of plaintiffs participating in the settlement.
J&J has repeatedly stated that its baby powder is safe and asbestos-free. In 2020, the company discontinued sales of talc-based baby powder in the US and switched to a cornstarch-based product.
Rospotrebnadzor (Rospotrebnadzor) has updated the composition of its flu vaccines in accordance with WHO recommendations
Rospotrebnadzor (Rospotrebnadzor) has updated the composition of its flu vaccines for the upcoming flu season. In accordance with World Health Organization (WHO) recommendations, the vaccine formula includes virus strains similar to A/Missouri/11/2025 (H1N1)pdm09 (swine flu); A/Darwin/1454/2025 (H3N2) (Hong Kong flu); and B/Tokyo/EIS13-175/2025 (B/Victoria lineage), RIA Novosti reports.
Thus, all three strains in the vaccine have been updated compared to the 2025-2026 season.
In February 2026, the Federal Service warned that the proportion of swine flu A(H1N1)pdm09 and B viruses was growing in Russia, compared to the overall number of acute respiratory viral infections and influenza cases. These strains, even if spreading more slowly, could trigger a new wave of cases, Rospotrebnadzor stated.
Prior to this, during the 2024-2025 epidemic season, swine flu also dominated in Russia, with influenza B virus activity being high. Approximately 43% of circulating strains differed from those present in vaccines due to antigenic drift. Antigenic drift is a change in the influenza virus due to the random accumulation of point mutations in the surface antigens—hemagglutinin and neuraminidase. The new variant differs slightly from the original, but this reduces binding to neutralizing antibodies.
Earlier this year, the Institute of Chemical Biology and Fundamental Medicine of the Siberian Branch of the Russian Academy of Sciences developed a multivalent influenza vaccine. The mRNA-based vaccine can be modified during the epidemic season depending on the virus strain, and it is already being offered to pharmaceutical companies, MV reported.
New registered medical devices
We publish a list of new medical devices registered from 07.24.2026 to 07.31.2026
Link to the list: [see table in the attachment]
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