News Digest 19.09.2025 — 26.09.2025
Regulators
Roszdravnadzor to Tighten Oversight of Medical Device Manufacturers
The Ministry of Health plans to amend the Regulation on Federal State Control (Supervision) of the Circulation of Medical Devices. The draft government resolution has been published on regulation.gov.ru.
The amendments are being made to Russian Government Resolution No. 1066 of June 30, 2021. It is proposed to expand the risk categories for Roszdravnadzor-inspected state control facilities related to medical device production. A fifth risk category—high risk—will be added to the existing categories of significant, medium, moderate, and low.
High-risk control facilities are planned to include: the production and/or manufacture of medical devices, medical devices for in vitro diagnostics, and/or medical devices implanted in the human body, classified as Class 3 potential risk for medical device use; Conducting clinical trials of medical devices classified as potential risk class 2b and/or 3.
For such controlled items, it is proposed to conduct more inspections. These may take the form of:
- an inspection visit – once every two years;
- an on-site inspection – once every two years;
- a test purchase – once every two years;
- random inspection – once every two years.
For comparison, for the significant risk category, such control (supervisory) activities are scheduled once every four years.
Roszdravnadzor will be able to use the "Inspector" mobile app, as it previously did for other types of inspections, in addition to preventive visits. It can also be used by inspectors during on-site inspections and inspection visits.
A new form of inspection during test purchases is being introduced—an experiment.
The President extended the ban on the export of medical devices from the country for several years
Russian President Vladimir Putin signed a decree extending the ban and restrictions on the export of certain products. The deadlines were postponed by two years—from December 31, 2025, to December 31, 2027. Decree No. 657 of September 17, 2025, was published on the legal information portal.
These products include dental materials, medical devices made of vulcanized rubber, paper, cellulose wadding, or cellulose fiber fabric. The list also includes compression garments, tights, and stockings for those suffering from varicose veins, as well as other medical devices. At the same time, the export of products manufactured in special economic zones, including those using foreign components, is permitted.
In March 2022, as part of the implementation of the presidential decree "On the application of special economic measures in the sphere of foreign economic activity to ensure the security of the Russian Federation," the government established a list of goods and equipment banned from export from Russia until the end of 2022. The list included over 200 products, including pharmaceuticals.
The list was later expanded, and Roszdravnadzor approved the procedure for issuing permits for the export of medical devices from the country. The ban was initially scheduled to last until the end of December 2022, but in October of that year it was extended until the end of 2023, and then until the end of 2025.
Information about the Manufacturer's Authorized Representative (MAR): New Requirements for Current Registration Certificates
Russian Government Resolution No. 1684 established that, effective September 1, 2026, all current MARs for medical devices must contain up-to-date information about the authorized representative of the manufacturer (MAR). If a valid power of attorney is missing, Roszdravnadzor will suspend the MAR, and if the requirements are not met, it will revoke the document.
What should be included in a MAR power of attorney?
- Information about the manufacturer and MAR: Taxpayer Identification Number (INN)/Primary State Registration Number (OGRN), date of issue, and validity period.
- Full name, position, and confirmed authority of the person signing the document.
- A clear statement of the right to represent the interests of the manufacturer, be responsible for the circulation of the product in the Russian Federation, certify documents, and supervise conformity assessment and registration procedures.
The deadline for updating is September 1, 2026.
According to paragraph 29 of the Rules and subparagraphs According to Section 137 "e," the manufacturer is obligated to:
- Appoint a new designation of manufacturer or update the current designation.
- Submit an application for amendments and copies of documents confirming the designation's authority to Roszdravnadzor.
Failure to comply will result in automatic cancellation of the designation after September 1, 2026.
Update your designation of manufacturer in advance to avoid supply delays and additional re-registration costs.
Source: https://dzen.ru/a/aNPWiXk4DQ3QXgHW
A copy of the testing and research agreement must be included in the registration dossier for registration under PP 552
To register risk class 1 medical devices (non-sterile), a copy of the testing agreement with the Federal State Budgetary Institution "VNIIIMT" of Roszdravnadzor must now be attached to the registration dossier.
Russian Government Resolution No. 552 "On the Specifics of State Registration of Certain Types of Medical Devices…" (Clause 23) establishes that, as part of the registration dossier, the applicant must submit to Roszdravnadzor a copy of the contract concluded with the institution for technical testing, toxicological studies, and type approval testing of measuring instruments (as applicable).
The contract confirms that the institution will conduct technical testing, toxicological studies, and type approval testing of measuring instruments for a specific device. The existence of the contract obliges the applicant to conduct tests confirming the quality and safety of the medical device.
Furthermore, this allows the applicant, within 150 business days from the date of state registration under PP 552, to submit an Application for Registration and a set of dossier documents for state registration under PP 1684.
Previously, the contract was not included in the mandatory list. Now, the absence of a copy of the contract will result in the materials being returned without review. We recommend concluding an agreement with VNIIIMT in advance and including a copy in the document package to avoid document returns and resubmission of the dossier. for consideration.
Source: https://t.me/vniiimt/1437
Market news
The Dubna Special Economic Zone (SEZ) will launch a 300 million ruble production facility for ventilators and consumables
MedTechPlus, a St. Petersburg company, will build a plant for the production of medical devices for respiratory medicine and artificial lung ventilation, as well as consumables for medical equipment, in the Dubna Special Economic Zone (SEZ) in the Moscow Region. Investment in the project is estimated at 300 million rubles. The facility is scheduled to open in 2027.
The Dubna SEZ management company and a representative of MedTechPlus signed an agreement to implement the project at the 3rd International Forum of Special Economic Zones, which took place on September 18 in Nizhny Novgorod.
The investor has been leased a 0.6 hectare plot of land. The production area will be 3,000 square meters. A total of 35 jobs will be created at the facility. Information on the facility's capacity is not yet available. The company clarified that the production process will implement the international standard ISO 13485, which regulates the quality of medical products.
According to SPARK-Interfax, MedTechPlus LLC was registered in St. Petersburg in 2010. The beneficiary is Grigory Khvorostyanoy. In 2024, the company's revenue amounted to 622 million rubles, with a loss of 33 million rubles. The company manufactures and supplies ventilators, defibrillators, anesthesia machines, patient monitors, infusion pumps, radiofrequency surgery equipment, mammography machines, and a number of other products.
In 2025, MedTechPlus signed 37 government contracts for the supply of medical equipment and consumables totaling 72 million rubles. Among its customers are the S.S. Sechenov City Clinical Hospital. Yudina of the Moscow Department of Health (purchase of a laser surgical system for 14.1 million rubles), Perm Regional Hospital (laser surgical diode system for 13.95 million rubles), and the Northwestern District Scientific and Clinical Center named after L.G. Sokolov of the Federal Medical and Biological Agency (supply of fiber instruments for 5 million rubles).
Another Dubna SEZ resident, Megatech, announced in August 2025 that it would launch a production facility in the Moscow region to produce hemostatic agents for stopping bleeding during surgical procedures. Megatech plans to open production in mid-2026. Investment in the project is estimated at 100 million rubles. The facility will manufacture a sponge with a high absorption rate: it absorbs 50 times its own weight in blood.
Other
Financial Times: US patient costs will rise due to tariffs on EU medical devices
The Trump administration's decision to impose a 15% tariff on imports of medical devices from the European Union could lead to higher costs for American patients and increase logistics vulnerability, experts note in a Financial Times review. Companies will offset the losses by increasing prices in future contracts and restructuring supply chains. According to MedTech Europe, medical technology exports from the EU to the US amounted to €27.4 billion ($32.6 billion) in 2024.
Manufacturers Siemens Healthineers and Philips forecast losses following the tariff of up to €250 million in the current financial year, and potentially up to €400-500 million annually.
Price increases could be particularly significant for items such as stents and artificial joints, the costs of which will be borne by patients, hospitals, or manufacturers depending on contract terms, said Prashant Yadav, a senior fellow for global health at the Council on Foreign Relations think tank.
Experts warn that the imposition of tariffs threatens the sustainability of global supply chains. Even minor disruptions in logistics can quickly impact diagnostic and therapeutic procedures.
Some companies are already considering relocating production. For example, the Swiss company Ypsomed, which produces injection systems, may reallocate capacity between factories in Germany and Switzerland and plans to build new production sites for the US market by 2028.
In July 2025, Donald Trump once again raised the possibility of imposing tariffs of up to 200% on foreign-made pharmaceuticals. Trump stated that he could give pharmaceutical manufacturers about a year or more to relocate their operations to the US.
Meanwhile, the global pharmaceutical industry is experiencing a wave of large-scale layoffs in 2025: since January, at least 178 international companies have announced layoffs of thousands of workers. Management explains these measures by the need to reduce costs, restructure business models, and reallocate resources to priority research areas.
Performance labeling experiment for hygiene products will begin on September 25
Performance labeling experiment for household, sanitary, and hygienic products, as well as toiletries, will take place in Russia from September 25, 2025, to August 31, 2026. The government approved Resolution No. 1457 dated September 20, 2025.
The following product categories will be included in the experiment:
- pumice;
- dental floss;
- cleaning pads, sponges, and loofahs made of various materials;
- toilet paper;
- handkerchiefs, cosmetic wipes (except for wipes with antiseptic properties);
- paper towels (except for towels with antiseptic properties);
- cotton wool and cotton wool products;
- tweezers;
- manicure and pedicure sets (including nail files);
- massage devices;
- toothbrushes (including denture brushes);
- hairbrushes;
- shaving brushes, nail and eyelash brushes, and other personal brushes;
- combs and combs;
- sanitary pads, tampons, diapers, and nappies (except for products registered as medical devices).
The Ministry of Industry and Trade is the main coordinator of the pilot project, along with other agencies: the Ministry of Digital Development, the Ministry of Economic Development, the Federal Tax Service, the Federal Security Service, the Federal Accreditation Service, Rospotrebnadzor, and the Federal Customs Service. The technical operator is Operator-CRPT LLC (responsible for the Honest Sign labeling system). The operator will provide labeling codes to participants free of charge for the duration of the experiment.
Participation in the pilot project is voluntary for businesses. The Ministry of Industry and Trade will develop and publish detailed guidelines on how to join the experiment and how to conduct it. As part of the pilot project, all government agencies will be required to exchange data between their systems and the experimental labeling system.
Digital Gaming Tools Helped People Quit Smoking
Malaysian researchers conducted a systematic review and meta-analysis to evaluate the effectiveness of gamified smoking cessation apps. The results were published in the journal Tobacco Inducted Diseases. The analysis showed that gaming interventions significantly increased smoking abstinence rates compared to control groups without gaming features. The greatest effect was observed in the first six months (relative risk (RR) 1.91). Long-term benefits were maintained beyond six months, although less pronounced (RR 1.37).
Key elements of gamification included competitions, a reward system, storytelling, and recognition of achievements. These methods enhanced intrinsic motivation and helped users maintain smoking cessation for longer.
Data from 5,075 participants enrolled in 15 randomized controlled trials was analyzed. The primary outcomes assessed were short-term (up to six months) and long-term (more than six months) smoking abstinence rates.
The authors concluded that gamification could be an effective and scalable tool in smoking cessation programs, especially in the early stages. However, to maintain long-term effects, new engagement strategies and adaptive feedback are needed.
Source: https://medvestnik.ru/content/news/Cifrovye-igrovye-instrumenty-pomogali-otkazatsya-ot-kureniya.html
New registered medical devices
We publish a list of new medical devices registered from 09.19.2025 to 09.26.2025
Link to the list: [see table in the attachment]
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