News Digest 05.12.2025 — 12.12.2025
Regulators
Roszdravnadzor (the Federal Service for Surveillance in Healthcare) regulates the issuance of permits for clinical trials of medical devices in accordance with EAEU rules
Roszdravnadzor has presented a draft regulation on issuing permits for clinical trials of medical devices for their registration in accordance with EAEU rules. The maximum period for providing this service will be 45 business days from the date of registration of the application for clinical trials for medical devices and one day for notification of clinical laboratory testing of in vitro diagnostic medical devices.
Similar to permits for clinical trials under national regulations, the application, according to the draft, can be submitted by the medical device manufacturer or its authorized representative. The document pool should include the manufacturer's statement that the medical device meets safety and efficacy requirements, the authorized representative's agreement with the manufacturer, the ethics committee's conclusion issued in accordance with the Rules for Conducting Clinical and Clinical Laboratory Trials (Studies), the investigator's brochure, the technical file, and a sample individual registration card for the research subject, the trial program, and a list of adverse events (incidents) that must be reported to the authorized body.
For in vitro testing of medical devices, the draft states, notification of such testing will be required. The document package and notification can be submitted either through Roszdravnadzor, including by mail, or through the Unified Portal of State Services.
The agency proposes setting the service provision deadline at 45 business days from registration, and one business day for validation of notifications of in vitro testing.
Roszdravnadzor is authorized to refuse permission if the applicant fails to provide relevant documentation confirming the acceptability of the risks associated with clinical trials, fails to correct document violations identified during the inspection, or fails to provide the necessary information.
The draft regulates application templates for submitting applications for clinical trials of medical devices, including software testing.
The service of issuing permission and adding to the clinical trial registry will remain free for applicants. If approved, the agency will post trial documents in the specialized registry of clinical trials of EAEU medical devices.
The rules for conducting clinical trials under the EAEU regulations were approved in February 2016. In February 2024, the Council of the Eurasian Economic Commission updated the Rules for Conducting Clinical and Clinical Laboratory Studies during Registration of Medical Devices. The new version includes parameters for determining the equivalence of medical devices for the validation of clinical trial results and specifies the parameters and conditions for testing medical devices for in vitro diagnostics, as well as IT solutions in the healthcare sector.
In addition, the document outlines the conditions for obtaining permission to initiate clinical trials, as well as the requirements and grounds for excluding clinics from the specialized list of organizations authorized to conduct trials in the format of medical device registration under EAEU rules. The amendment does not apply to devices currently undergoing registration and for which research contracts have already been concluded. The new version of the Procedure for Conducting Clinical Trials entered into force in July 2024.
The ability to confirm localization of production with the ST-1 certificate may be extended until June 30, 2026
The Russian Ministry of Industry and Trade has developed a draft Government Resolution "On Amending Russian Government Resolution No. 1875 of December 23, 2024" - https://regulation.gov.ru/projects/162978/.
The explanatory note to the Resolution states that "the Russian Ministry of Industry and Trade is currently working to convert medical devices and technical rehabilitation equipment included in the Appendix to Resolution No. 719 and the Appendix to Resolution No. 1875 to a point-based assessment system. The relevant regulatory legal acts are undergoing the procedures stipulated by the regulations of the Russian Government, approved by Russian Government Resolution No. 260 of June 1, 2004."
The draft will extend the ability to confirm the country of origin for certain medical devices and technical rehabilitation equipment through a Certificate of Origin Form ST-1, documents specified in subparagraph "g" of paragraph 10 of Resolution No. 1875, or a registry entry in the industrial product register obtained without points.
Public comment on the draft will last until December 19, 2025. If approved, the document will enter into force on January 1, 2026.
Source: https://t.me/MedTechIndustry/1593
The Ministry of Labor will establish technical specifications for hearing aids
The Russian Ministry of Labor has submitted for public comment draft amendments to several departmental regulations on the provision of technical rehabilitation equipment (TRA) to persons with disabilities. Specifically, Order No. 687n of December 10, 2024, listing indications and contraindications for providing TRA to persons with disabilities, is proposed to be supplemented with a subsection on the technical specifications of hearing aids.
The seven-item list of characteristics includes the following parameters: hearing aid power, control method, number of compression channels, feedback suppression technology, noise reduction and directional microphone systems, and pediatric hearing aid settings. The authors of the initiative believe that this innovation will ensure full compensation for hearing loss in individuals with disabilities.
The explanatory note notes that "the adoption of the draft order will allow specialists at medical and social expert institutions to individually determine the TMR in an individual rehabilitation and habilitation program for a disabled person (child with disabilities), taking into account the underlying pathology."
In November 2025, the Government of the Russian Federation approved the Strategy for the Development of Industrial Rehabilitation Products through 2030. It will be a continuation of a similar strategy in effect since 2017. The goal of the updated program is to achieve a sustainable level of development in the rehabilitation industry, enabling the provision of high-quality, effective, and safe TMR to individuals with disabilities.
In mid-October 2025, Dmitry Galkin, Director of the Department for Development of the Pharmaceutical and Medical Industry at the Russian Ministry of Industry and Trade, announced plans to increase production volume to 105.6 billion rubles. Among the non-financial state support measures, he cited the elimination of VAT on 11 categories of technical rehabilitation equipment and the introduction of digital labeling for nine types of products, including wheelchairs, hearing aids, orthopedic shoes, orthoses, and prostheses.
Market news
Production of domestically produced breast augmentation implants will be launched in Nizhny Novgorod
Plastic surgeon Nadezhda Rozhdestvenskaya announced this, citing Natalia Manturova, Chief Plastic Surgeon of the Russian Ministry of Health, at the 14th National Congress "Plastic Surgery, Aesthetic Medicine, and Cosmetology," currently underway in Moscow.
The first Russian silicone breast implant was registered in late November, and the medical devices will be manufactured at a cluster in Nizhny Novgorod.
The plant's capacity will be 45,000 implants annually. Production will begin in 2028. The manufactured products will be comparable in quality to similar products from the USA, France, Germany, and Brazil, but will be less expensive.
The next step, following the launch of production, is to expand the range of domestically produced silicone-filled medical implants.
Source: https://t.me/MedTechIndustry/1594
Russia will begin identifying medical cartels using AI
The Russian government has approved regulations on the state information system (GIS) "Anti-Cartel," which will use artificial intelligence (AI) to identify anticompetitive collusion in government procurement tenders. The document was published on the Cabinet of Ministers' website.
The Federal Antimonopoly Service (FAS) has been appointed the GIS operator, and the system is being developed on the GosTech platform using AI for automated analysis of tenders and commodity markets. Deputy Prime Minister Dmitry Grigorenko stated that digitalization will improve the efficiency of budget expenditures and the transparency of procurement, reducing the burden on public procurement participants. The GIS regulations will come into force on July 1, 2026.
The system provides:
- automated collusion risk analysis based on 20 technical and behavioral criteria, tender ranking, and machine learning for new schemes;
- integration with the Unified Information System for Procurement, torgi.gov.ru, the Federal Tax Service, the Registry of Control Activities, and other databases for processing data on participants, contracts, and behavior;
- subsystems for administration, alerts, violation detection, analytics, affiliation search, AI, and visualization.
The first phase of the service, analyzing 9.6 million tenders, has already been launched; the second phase, powered by AI, will be completed by the end of 2025 for 100% control of open tenders and prices for socially significant goods. It will replace the FAS's manual analysis.
Previously, the government approved the National Competition Development Plan for 2026-2030, as reported by MV. Plans include completing the digitalization of procurement appeals, developing regional roadmaps, and launching a number of new modules for the Anti-Cartel State Information System.
In October, Deputy Head of the Federal Antimonopoly Service Timofey Nizhegorodtsev explained that discussions were underway to weaken the "antimonopoly immunity" that allows medical device manufacturers to avoid complying with competition law. This would help lower prices for products protected as intellectual property. The issue is not about violating such rights, but rather combating their abuse by monopolists with unreasonably high prices.
Source: https://medvestnik.ru/content/news/v-rossii-nachnut-vyyavlyat-medicinskie-karteli-s-pomoshu-ii.html
Other
The manufacturer's documentation will guide you through the disposal procedure for medical devices
"How are unused, single-use medical devices with expired expiration dates (e.g., masks, scalpels, etc.) stored in a medical facility disposed of?"
Alexander Vasilevitsky, expert at the Garant legal consulting service, answers:
"According to Article 49 of Federal Law No. 323-FZ of November 21, 2011, 'On the Fundamentals of Health Protection for Citizens in the Russian Federation,' any waste generated during medical activities is considered medical waste. This includes unused, single-use medical devices stored in a medical facility with expired expiration dates. These devices are divided into five classes based on their epidemiological, toxicological, and radiation hazards, as well as their negative impact on the human environment:
- "A" – epidemiologically safe waste, similar in composition to municipal solid waste;
- "B" – epidemiologically hazardous waste;
- "C" – extremely epidemiologically hazardous waste;
- "G" – toxicologically hazardous waste, similar in composition to industrial waste;
- "D" – radioactive waste.
The criteria for classifying medical waste are approved by RF Government Resolution No. 681 of July 4, 2012. The specifics of medical waste management are established by Article 22.1 of Federal Law No. 52-FZ of March 30, 1999, "On the Sanitary and Epidemiological Welfare of the Population."
Medical waste management requirements are established by Section X of SanPiN 2.1.3684-21 "Sanitary and Epidemiological Requirements for the Maintenance of Urban and Rural Settlements, Water Bodies, Drinking Water and Drinking Water Supply, Atmospheric Air, Soils, Residential Premises, Operation of Industrial and Public Facilities, and the Organization and Implementation of Sanitary and Anti-Epidemic (Preventive) Measures," approved by Resolution No. 3 of the Chief State Sanitary Doctor of the Russian Federation dated January 28, 2021.
These regulations do not specify specific requirements for the disposal of unused disposable medical devices, which are only required for disposal upon expiration of their shelf life. However, Part 3 of Article 38 of Federal Law No. 323-FZ states that the circulation of medical devices includes their technical testing, toxicological studies, clinical trials, quality, efficacy, and safety assessments, state registration, … as well as repair, disposal, or destruction. The manufacturer (producer) of a medical device develops technical and/or operational documentation, which governs the production, manufacture, storage, transportation, installation, adjustment, use, operation, including maintenance, as well as repair, disposal, or destruction of the medical device. Requirements for the content of such documentation are established by the authorized federal executive body.
As follows from the cited article, the disposal or destruction of medical devices is covered by the concept of "circulation of medical devices," and requirements for disposal or destruction must be contained in the manufacturer's technical and/or operational documentation for each specific medical device. This is also supported by the Requirements for the Contents of Technical and Operating Documentation of the Manufacturer of Medical Devices, approved by Order No. 11n of the Russian Ministry of Health dated January 19, 2017. These requirements stipulate that the manufacturer of a medical device develops technical and/or operating documentation, which includes its disposal or destruction (clause 2).
These standards do not make exceptions for disposable medical devices, nor for cases of disposal of unused medical devices due to expiration of their shelf life, shelf life, and/or service life. Therefore, when deciding on the disposal of a medical device, please refer to the manufacturer's technical and operating documentation.
New registered medical devices
We publish a list of new medical devices registered from 12.05.2025 to 12.12.2025
Link to the list: [see table in the attachment]
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