News Digest 29.05.2026 — 05.06.2026
Regulators
The rule regarding the cancellation of registration of medical devices without an authorized representative is proposed to be postponed for a year
The Russian Ministry of Health intends to amend the Rules for the State Registration of Medical Devices, which establishes the transition to a registry-based model for issuing registration certificates (RF Government Resolution No. 1684 of November 30, 2024). The draft resolution is undergoing public comment until June 16.
The document proposes postponing by one year the entry into force of the rule regarding the cancellation of registration of a medical device if the foreign manufacturer does not have an authorized representative in Russia. The transition period for updating information on authorized representatives of medical device manufacturers is also proposed to be extended by one year, until September 1, 2027.
The explanatory note to the draft states that preparing the necessary documents now takes longer, and without a postponement, many foreign manufacturers may be left without representatives in the Russian Federation, which will create risks to the safety and circulation of their products.
The Russian Ministry of Health has updated its procedures for monitoring the safety of medical devices and assessing their conformity
The Russian Ministry of Health has approved two new procedures: for monitoring the safety of medical devices and for assessing their conformity. These procedures will come into force on September 1 and will remain in effect until 2032.
The Russian Ministry of Health has approved a new procedure for monitoring the safety of medical devices (MD), with the exception of those registered in accordance with international treaties and acts constituting the law of the Eurasian Economic Union (EAEU). Order No. 540n dated May 26, 2026, was published on the legal information portal.
The document will replace Order No. 980n of the Russian Ministry of Health dated September 15, 2020, "On Approval of the Procedure for Monitoring the Safety of Medical Devices," which is now deemed invalid. Now, only monitoring of medical devices registered under Russian national regulations will be regulated; medical devices registered under EAEU regulations are excluded from this scope.
Furthermore, the order includes information automatically transmitted by AI-enabled software that is a medical device.
The Russian Ministry of Health also approved Order No. 421n dated May 13, 2026, updating the Procedure for Conformity Assessment of Medical Devices through Technical Testing, Toxicology Studies, and Clinical Trials for Their State Registration. As previously reported by FV, the document was developed as part of the regulatory guillotine and will replace Order No. 885n of the Russian Ministry of Health dated August 30, 2021.
Pre-registration test results can now be submitted electronically. Reagents and their kits, as well as control materials, calibrators, washing solutions, and culture media, are no longer subject to mandatory technical testing.
Both documents will enter into force on September 1 and remain in effect until September 1, 2032.
Amendments have been made to the Medical Device Safety Monitoring Procedure
The Russian Ministry of Justice registered Order No. 541n of the Russian Ministry of Health dated May 26, 2026, approving a new Procedure for reporting adverse events at all stages of medical device (MD) circulation in Russia and other countries.
The document (available on MV) will enter into force on September 1, 2026, and will replace similar departmental order No. 1113n dated October 19, 2020.
The terminology is also being changed: instead of "side effects not specified in the instructions," "adverse reactions," "interaction characteristics," and "facts and circumstances creating a risk," a single term—"adverse event"—is proposed. Reports of incidents involving medical devices at all stages of their circulation, both in Russia and abroad, must be registered in a special section of the automated information system (AIS) of Roszdravnadzor on the day of receipt.
Furthermore, a requirement has been introduced for post-registration clinical monitoring of medical devices with potential risk class 3, as well as medical devices implanted in the human body with potential risk class 2b, for the first three years from their market launch. This period may be extended by Roszdravnadzor at the request of the entity handling the medical devices.
Russia approves uniform rules for accounting for medical waste
The Russian government has approved new Rules for accounting for medical waste and data transfer to Rospotrebnadzor, which introduce a uniform statistical accounting procedure for all classes of medical waste. The document (available on MV) will come into force on September 1, 2026.
According to the resolution, medical organizations and other system participants are required to record the amount of waste accumulated, decontaminated, neutralized, and transferred during the calendar year. The data must be submitted to the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor) in the form of federal statistical monitoring.
Recording must be based on the mass of waste, regardless of its class. Two methods are permitted: actual weighing or calculation based on container volume and average waste density. Additionally, the federal service must be provided with a range of information—from the volumes generated and decontaminated to data on waste transfers to other organizations and the balances at the beginning and end of the reporting period.
Special accounting regimes are established for certain waste categories. For example, Class A waste after transfer to a regional municipal solid waste (MSW) management operator, Class G waste after transfer to a federal operator for the management of I-II hazard classes waste, and Class D radioactive waste will be accounted for in accordance with the relevant legislation regulating these areas.
The new document continues the reform of the medical waste management system. In May 2026, the Cabinet of Ministers approved requirements for the procedure for providing services for their transportation and disposal. This resolution sets out requirements for the services themselves, the vehicles, facilities, and installations where disposal is performed, as well as the availability of waste mass and volume measurement equipment. A list of Class G medical waste, similar in composition to extremely hazardous and highly hazardous waste, was previously approved. This includes, in particular, laboratory waste and chemical residues, battery waste and vehicle batteries, and battery electrolyte waste. Both documents will come into force on September 1.
Source: https://medvestnik.ru/content/news/v-rossii-utverdili-edinye-pravila-ucheta-medicinskih-othodov.html
The Ministry of Industry and Trade will adjust the country-of-origin classification system for stents and catheters
The Russian Ministry of Industry and Trade has submitted a draft government resolution for public comment that amends the country-of-origin classification system for certain catheters and stents. The regulator notes that the adjustments are necessary to "further enhance the localization of medical device manufacturing in the Russian Federation and create additional incentives for the development and adoption of promising technologies."
The proposed amendments are to Government Resolution No. 719 of July 17, 2015, which defines the procedure for recognizing the country of origin of products. The resolution applies to medical devices classified under OKPD2 codes 32.50.22.195, 32.50.22.190, and 32.50.13.110. These include drug-eluting coronary stents, bare-metal coronary stents, and standard balloon catheters for angioplasty.
The explanatory note to the draft clarifies that the decision was made, in part, to further reduce the domestic market's dependence on foreign supplies. The amendments provide for a gradual increase in points to enhance localization.
The Ministry of Industry and Trade proposes using a number of indicators in the calculation. For components, raw materials, and supplies produced in EAEU member states, 30 points are planned (for medicines, radiopaque markers, and steel and alloy blanks for tubes).
The Ministry of Industry and Trade proposes setting the effective date of the updated resolution as January 1, 2027, "in order to establish benchmarks for enhancing localization, while also smoothly transitioning to country-of-origin verification through a points-based assessment system, taking into account manufacturers' efforts to include their products in the register of Russian industrial products."
Market news
A 2 billion ruble production facility for complex medical equipment will be established in St. Petersburg
The Sergei Berezin International Institute of Biological Systems plans to establish a facility in St. Petersburg to manufacture components and spare parts for high-tech medical equipment. Investment in the project will amount to at least 2 billion rubles, according to the press service of the city's Committee for Industrial Policy, Innovation, and Trade.
A cooperation agreement was signed on the sidelines of the St. Petersburg International Economic Forum on June 3. The facility will be established at a site with preferential treatment. No further details were provided.
Late last year, the National Association of Healthcare Managers proposed that the Russian government launch a localization program for critical components to address the shortage of imported spare parts for medical equipment, MV reported. This requires the adoption of a package of government support measures. The letter emphasized that the problem is widespread and affects many regions. The failure of even one key component leads to months of downtime for expensive medical equipment, and thousands of patients are deprived of timely diagnosis and treatment for oncological, cardiac, and neurological diseases.
Other
Scientists Create a Virtual Hospital for Testing Medical AI Algorithms
Researchers from Seoul National University Hospital and Harvard Medical School have developed a virtual hospital to test medical artificial intelligence systems based on large-scale language models. The project's authors believe that their Clinical Environment Simulator allows for the first time to evaluate medical AI not on static datasets, but in conditions as close as possible to real clinical practice, including time, personnel, and equipment constraints. The results of the study were published in the journal Nature Medicine.
The developed system includes two interconnected modules. The first, the Patient Engine, simulates virtual patients based on electronic medical record data and pre-defined disease scenarios. The second, the Hospital Engine, simulates hospital operations in a manner close to real life, taking into account bed occupancy, equipment and medical staff availability, and the order of care for patients based on the severity of their condition.
A comprehensive evaluation system combining clinical and organizational metrics is used to test the algorithms. The calculations include patient survival, timeliness of treatment, and adherence to clinical guidelines, as well as hospital stay duration, emergency room utilization, bed utilization, and medical equipment. Furthermore, the platform enables AI stress testing under conditions of massive patient influx, resource shortages, and large-scale information system failures.
The authors believe that a virtual hospital could serve as a safe interim stage between laboratory testing and the implementation of medical AI in clinical practice. They believe this approach will allow for more reliable testing of artificial intelligence systems before working with real patients and will accelerate the integration of AI into healthcare processes.
New registered medical devices
We publish a list of new medical devices registered from 05.29.2026 to 06.05.2026
Link to the list: [see table in the attachment]
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