News Digest 22.05.2026 — 29.05.2026
Regulators
Roszdravnadzor Warns of Mandatory Update of Medical Device State Registration Service
Next week, June 2, 2026, a mandatory update of the "State Registration of Medical Devices" service on the public services portal is scheduled, the Roszdravnadzor press service announced. As part of this update, all draft versions of applications will be deleted.
For applications that are in the violation correction or additional information submission stages, all data will need to be re-entered. Roszdravnadzor noted that it is not possible to change the procedure during this stage; to do so, the application must be resubmitted. The information must be entered as in the original application, the statement added.
If you encounter the error "Error sending to agency" during the violation correction stage of the "State Registration of Medical Devices" public service, please contact the Roszdravnadzor automated information system (AIS) technical support.
In early May, Roszdravnadzor declared departmental orders establishing the requirements and format for paper registration certificates for medical devices no longer valid, as reported by MV. Now, only the entry in the state register of medical devices and the organizations that produce and manufacture them will be used to confirm registration. In April, the regulator prepared administrative regulations for the state service for registering medical devices in accordance with EAEU rules.
New rules have been approved for the import of unregistered medical devices
The Russian government has approved a resolution on the rules for the import of certain medical devices into the country without registration in Russia and the EAEU. The document strengthens digital control over such imports: import notifications are proposed to be submitted to Roszdravnadzor via the State Services portal, the agency's personal account, and the Unified Identification and Authentication System (ESIA). The new rules affect the supply of medical devices imported under exceptions to the general registration procedure—for example, for research, for vital indications of a specific patient, for individual use, for humanitarian aid, and as part of medical kits and first aid kits.
The document will replace the 2021 resolution and will be in effect until September 2032.
The document does not provide for a significant revision of the import categories themselves, but it does change the notification and accounting mechanism for such supplies. Specifically, the resolution specifically establishes the use of digital services for submitting notifications, expands the list of mandatory information about the product, manufacturer, importer, and final recipient, and details requirements for information on product registration in the country of origin, product circulation periods, and delivery parameters. Compared to the 2021 resolution, the document more fully defines the requirements for data that must be submitted to Roszdravnadzor upon import of the product.
Furthermore, the new resolution no longer contains a provision prohibiting the use of imported medical devices for research and testing for the purpose of subsequent product registration in Russia or under EAEU rules.
The document also partially aligns Russian regulations with the amendments to the EAEU Single Market for Medical Devices Agreement. In November 2025, the union countries agreed to expand the list of cases in which medical devices can be circulated without registration, including supplies for vital indications, individual devices, and medical kits. Furthermore, the EAEU extended the transition period during which manufacturers can continue to register products under both national and Eurasian rules.
The transition to uniform rules for medical device registration in the EAEU has been under discussion for several years. Initially, the union countries planned to completely abandon national procedures starting in 2022, but the deadline has been repeatedly postponed due to lengthy approval processes and the economic situation. As a result, the EAEU member states extended the national registration of medical devices until 2028, while Russia extended its own national registration rules until the end of 2027.
The Government will regulate the import of medical devices into Russia for specific patients
The Russian Ministry of Health has submitted for public discussion a draft federal law amending Article 38 of Federal Law No. 323-FZ "On the Fundamentals of Protecting Citizens' Health." The amendments are intended in connection with the amendments to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union (EAEU). The Ministry proposes granting the Russian Government the authority to regulate the import of medical devices intended to provide life-saving medical care to a specific patient.
Furthermore, according to the bill, the government will be able to establish the procedure for issuing permits for the import of such medical devices. If approved, the amendments will come into force on January 1, 2027.
As stated in the explanatory note, the provisions of the document should be adopted "in order to mitigate the risk of a legal gap." The amended agreement was approved by the EAEU members on February 9, 2026.
The protocol stipulates that, according to paragraph 11 of Article Article 4 of the Agreement excludes the term "manufactured in the territory of a member state" for medical devices designed for a specific patient. This is necessary to ensure that the same requirements are applied to devices manufactured in the EAEU or imported into the customs territory from third countries.
The Ministry of Health also proposed amending the list of medical devices that are not subject to registration in the Russian Federation. This decision is necessary in connection with the expansion of the list of medical devices not subject to registration in the EAEU.
The draft Federal Law specifies that it proposes excluding medical devices imported into the customs territory of the Union to provide life-saving care for a specific patient, manufactured in a member state for export, and comprising a collection of medical devices and medicines (kits, kits, sets, and first aid kits) packaged together (provided their consumer packaging is preserved) and registered in a member state, assembled in accordance with the law, and intended exclusively for circulation within its territory. Furthermore, medical devices designed for use within the international medical cluster or at innovative scientific and technological centers, as well as unregistered medical devices for in vitro diagnostics, may be excluded from the list.
At the same time, the Ministry of Health proposed removing from Federal Law No. 323-FZ the clause requiring medical devices to be divided into classes based on the potential risk of their use and into types in accordance with the nomenclature classification.
In mid-April 2026, Roszdravnadzor submitted for public comment a draft order approving administrative regulations for the registration of medical devices in accordance with EAEU rules. If approved, the document will replace the Ministry of Healthcare of the Russian Federation regulation in effect since 2017 and detail the procedure for registering medical devices on the common market.
The proposal outlines the full procedure cycle—from application submission and document review to expert assessment, production inspection, and decision-making. The service will be available to medical device manufacturers and their authorized representatives, including through the government services portal.
In May 2026, the Russian government approved a resolution on the rules for importing certain medical devices without registration in Russia and the Eurasian Economic Union. The document strengthens digital controls over such imports: import notifications are proposed to be submitted to Roszdravnadzor via the State Services portal, the agency's personal account, and the Unified Identification and Authentication System (ESIA). The new rules apply to medical devices imported under exceptions to the general registration procedure, such as for research, for vital indications of a specific patient, for individual use, for humanitarian aid, and as part of medical kits and first aid kits.
Market news
Russian scientists have created a heat-sensitive burn dressing
Scientists from the V.A. Rakhmanov Institute of Regenerative Medicine and the Clinic of Skin and Venereal Diseases at Sechenov University have developed a hybrid hydrogel system for the treatment of burn injuries, the press service of the Russian Science Foundation (RSF) reported to MV. Unlike traditional hydrogel dressings, the new system combines heat-sensitive micro- and nanogels with a hydrogel carrier (macromatrix), allowing for controlled release of therapeutic agents depending on the temperature of the wound surface.
The researchers took advantage of the fact that the temperature of a burn wound is higher than that of the surrounding tissue and gradually decreases as it heals. Synthesized from N-isopropylacrylamide copolymers, the gels change their properties within a range of 37–42°C, enabling precise "thermocontrol" of the release rate of antibacterial, anti-inflammatory, and regenerative components.
According to project leader Anastasia Shpichka, this self-regulating system adapts to the dynamics of the wound healing process and provides more targeted therapy. The resulting micro- and nanoparticles are resistant to sterilization and demonstrate stable retention and controlled release of model drugs. Incorporating these particles into a hydrogel matrix enables multi-stage release and the combination of several therapeutic effects in a single dressing.
The system's biocompatibility has been confirmed in vitro experiments on skin models and in vivo on laboratory animals. The authors note that the technology, supported by a grant from the Russian Science Foundation, could improve the effectiveness of burn wound treatment, including severe burns.
Other
Russia and China to hold joint disaster medicine exercises
Primorsky Krai will host the first joint Russian-Chinese exercise and international scientific and practical conference on disaster medicine. Doctors, emergency services personnel, representatives of the scientific community, and other specialists from both countries will practice procedures for providing emergency medical care and evacuating victims in emergency situations, including coordinating assistance to foreign nationals.
The practical portion of the exercise will take place on Russky Island near the "Russian Ski Track" trail. The scenario involves a collision between two passenger tourist buses carrying Russian and Chinese citizens. Emergency services will practice rescuing and evacuating 40 victims using air ambulances and specialized vehicles.
Participants in the events will include doctors, emergency services personnel, representatives of relevant agencies, and the scientific community from Russia and China. The program includes practical training and discussions on the development of air ambulances, specialist training, the implementation of modern technologies, and international cooperation in disaster medicine.
The organizers intend to place special emphasis on coordinating the efforts of specialists from both countries in providing assistance to foreign citizens in emergency situations. As Wang Tian Ming, Deputy Director of the Peking University People's Hospital of Peking, noted, the development of cross-border cooperation and the growth of tourism between Russia and China require the development of unified approaches to providing emergency medical care.
The events are timed to coincide with the 30th anniversary of the disaster medicine service in the Far East and are being held with the support of the Russian Ministry of Health, the State Health Committee of the People's Republic of China, the Russian Ministry of Emergency Situations, the Russian Ministry of Internal Affairs, the N.I. Pirogov National Medical and Surgical Center, and relevant agencies of Primorsky Krai. The Territorial Center for Disaster Medicine and the Vladivostok Ambulance Service are also involved in the preparation and implementation.
New registered medical devices
We publish a list of new medical devices registered from 05.22.2026 to 05.29.2026
Link to the list: [see table in the attachment]
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