News Digest 27.03.2026 — 03.04.2026
Regulators
Roszdravnadzor to Update Consultation Procedures for Medical Device Registration
Roszdravnadzor has submitted for public comment a draft order approving the procedure for consultations on matters of state registration of medical devices. The document regulates the work of subordinate expert institutions and introduces a formalized consultation procedure, including a preliminary analysis and assessment of dossiers prior to filing a registration application.
As stated in the explanatory note, the draft was developed in compliance with the regulations governing Roszdravnadzor and the rules for state registration of medical devices approved by the government in November 2024. The document establishes the agency's authority to organize such consultations and details their implementation at the level of expert organizations.
According to the draft, consultations will cover procedures related to the preparation and submission of registration dossiers, including an assessment of the completeness and accuracy of the submitted materials, as well as clarification of testing and evidence requirements. A preliminary analysis of the dossier is also provided, effectively introducing a mechanism for the early identification of regulatory risks before the main procedure begins.
The new procedure applies to all expert institutions involved in the Roszdravnadzor system and replaces the current 2017 order, which regulated consulting for a limited number of organizations.
In December 2025, Roszdravnadzor also presented a draft administrative regulation for the provision of the state service for registering medical devices, detailing the procedure and timeframes for the procedures, grounds for refusal, and the scope of administrative actions. Developed based on the medical device registration rules that entered into force in 2025, the document provides for shortened registration periods for certain product categories, regulates changes to dossiers and the conduct of clinical trials, and establishes the use of digital services for submitting applications.
Furthermore, in March 2026, the agency proposed repealing orders establishing the form of registration certificates for medical devices due to the transition to an electronic format. The new registration procedure digitalizes procedures and will be in effect until the end of 2027, taking into account the extension of the transition period to EAEU rules.
A Ministry of Health commission rejected all applications for the inclusion of new medical devices in the compulsory medical insurance (CMI) lists
A commission at the Russian Ministry of Health rejected all applications received in 2025 and early 2026 for the inclusion of new items in the lists of medical devices implantable under the compulsory medical insurance (CMI) program and available by prescription as part of a package of social services. All submitted devices were foreign-made.
In total, the commission reviewed 20 applications from medical device market participants. The proposed addition to the list of devices implantable under the CMI program included the Vanta neurostimulator developed by Medtronic and the TouchCare insulin pump from Medtrum Technologies (China).
Eighteen items in seven categories were submitted for the list of prescription devices. These included the FreeStyle Libre monitoring system and scanner from Abbott, two Chinese CGMs (iCan i3 CGM and Hematonix GS1), an Enlite glucose monitoring sensor from Medtronic, a TouchCare transcutaneous glucose monitoring sensor from Medtrum Technologies, transmitters for the Guardian Medtronic and TouchCare Medtrum Technologies pumps, lancets for the Swiss Microlet lancing device, Akku-Chek Softclix and FastClix lancets from Germany's Roche, OneTouch Delica Plus lancets from Japan's Asahi Polyslider Company, and a NovoPen Echo insulin injector from Denmark's Novo Nordisk.
All items were rejected due to the lack of registered domestically produced medical devices similar to those proposed.
The list of medical devices registered in Russia and approved for use must be updated at least once every two years. The Commission under the Russian Ministry of Health, which includes representatives of interested federal executive bodies, higher education and scientific organizations, and the medical community, has the authority to recommend the development of lists of medical devices.
In 2017, 23 new items were added to the list, including bone screws, fixation plates, and surgical sutures. In 2018, an outpatient insulin administration set and a reservoir for an outpatient insulin infusion pump were added to the list. A year later, four items were added to the list, including a frequency-adaptive dual-chamber pacemaker compatible with magnetic resonance imaging.
In early 2022, the government added three items to the document: a pulse generator for a system for controlling urinary and fecal incontinence using electrical stimulation, a bioprosthetic cardiac aortic valve, a xenoplastic aortic prosthesis, and a synthetic material for embolization of extracerebral vessels. All products are manufactured by Medtronic.
In July 2023, the list was expanded to include a biopolymer composite-based dura mater prosthesis, and in 2024, a rod for the internal spinal fixation system using bone screws was added.
Since 2024, the Ministry of Health Commission has not made any positive decisions on the inclusion of new products in the lists. In December 2025, the Commission also rejected all applications received during 2024.
Market news
The government intends to reduce the share of illegal medical device trafficking to 21% by 2030
The Russian government has approved a Strategy for Combating Illegal Industrial Product Trafficking through 2030 and its implementation plan. The document calls for developing a product labeling and traceability system, strengthening oversight and accountability, and reducing the share of illegal products, including in the medical device segment, to 17.4-21% by the end of the decade.
The new strategy places special emphasis on pharmaceuticals and medical devices. Short-term priorities include combating drug counterfeiting, including oncology drugs, where risks are associated with substitution of composition and origin. In the medium term, emphasis is placed on medical devices and rehabilitation products, where instances of non-compliance with safety requirements and the use of counterfeit documentation have been recorded.
The order also introduces additional requirements for digital platforms: marketplace operators are required to ensure the posting of information on product registration, certification, and labeling, as well as block offers for the sale of unregistered drugs and medical devices.
The key areas of the strategy include improving legislation and liability measures, developing risk-based control, expanding international cooperation, including interaction with the EAEU and BRICS member countries, and integrating government information systems. Further expansion of the list of products subject to mandatory labeling is also envisaged, as well as the implementation of automated control mechanisms, including an "automatic fine" system.
Target indicators for reducing the share of illegal trafficking have been established for the medical device market: from 30.6-31.8% in 2026 to 17.4-21% by 2030. Roszdravnadzor, the Ministry of Health, the Ministry of Industry and Trade, the Federal Customs Service, and other federal executive bodies have been designated as responsible for achieving these indicators.
The implementation of the strategy is expected to improve product safety, reduce counterfeiting, increase tax revenues, and create more favorable conditions for bona fide market participants.
Other
The first patient with melanoma has received a Russian personalized cancer vaccine
The first patient in Russia has received the domestically produced personalized mRNA antitumor vaccine "NeoOncovac" at the National Medical Research Center of Radiology of the Russian Ministry of Health, TASS reports, citing the ministry's press service.
The first patient was a 60-year-old resident of the Kursk region, diagnosed with melanoma. He is currently undergoing immunotherapy.
According to Russian Health Minister Mikhail Murashko, the domestic cancer vaccine may be included in the compulsory medical insurance system in the near future. Work in this direction is already being completed.
Earlier, the Russian Ministry of Health proposed including new treatment methods using cancer vaccines in the state-guaranteed program for free medical care for 2026. The cost of a course of the personalized mRNA vaccine is estimated at 5.8 million rubles.
Experts have identified the medical devices most vulnerable to hacker attacks
The Industrial and Medical Internet of Things (IoT) have become the main targets of cybercriminals – the number of network attacks on devices in these industries has increased significantly. Ransomware, hacktivists, and APT groups are showing interest in these industries. In the medical sector, the focus of attacks is shifting from theft of money and data to direct disruption of medical care processes and physical damage to patients and equipment, which is particularly alarming, according to a study by the InfoWatch Group's analytical center (available to MV).
The most frequently attacked devices in healthcare include infusion pumps, CT and MRI machines, patient monitoring devices, and medical workstations. "We see that cybersecurity is no longer solely an IT issue in healthcare; it is inextricably linked to and directly impacts patient safety and treatment outcomes," says Sergey Sleptsov, chief analyst at InfoWatch.
According to ScienceSoft, the leading consequences of cyberattacks include delays in tests and procedures (reported by 56% of organizations), increased complications after procedures (53%), length of stay (52%), increased patient transfers (44%), and even higher mortality rates (28%). Unsurprisingly, healthcare has the highest cost of an incident among industries—an average global cost of $7.42 million, according to IBM.
At the same time, the healthcare industry remains the leader in ransomware attacks: analysts predict that four out of ten organizations will experience such incidents by 2026. The most common targets of ransomware attacks are government healthcare institutions (21%), clinics (19%), hospitals (18%), companies providing nursing and caregiving services (9%), and psychiatric and drug treatment facilities (8%).
New registered medical devices
We publish a list of new medical devices registered from 03.27.2026 to 04.03.2026
Link to the list: [see table in the attachment]
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