News Digest 15.05.2026 — 22.05.2026
Regulators
The Eurasian Economic Commission (EEC) Council Amends Requirements for Quality Management Systems for Medical Devices
The Eurasian Economic Commission (EEC) Council approved Decision No. 43 of April 27, 2026, amending the Requirements for Quality Management Systems for Medical Devices. The document was published on the Eurasian Economic Union (EAEU) legal portal.
The amendments are being made to the requirements approved by EEC Council Decision No. 106 of November 10, 2017. According to the amendments, the medical device manufacturer's authorized representative will participate in all procedures alongside its manufacturer. This applies to:
- submitting applications for inspections;
- interaction with inspection organizations;
- signing contracts for inspections.
The document also establishes a timeframe for conducting production inspections: no more than 90 working days are allocated for both periodic and unscheduled inspections. Applications for a scheduled inspection must now be submitted no later than 90 business days before the expiration of the previous report.
Issuance of permits for the use of in vitro diagnostic medical devices has been transferred to digital format
The Russian government has amended the rules for granting, reissuing, confirming, and revoking permits for the use of in vitro diagnostic medical devices manufactured and used in clinics. Electronic interaction via the Unified Portal of State and Municipal Services has been introduced, and a number of administrative deadlines have been reduced, including the decision-making period for issuing a permit, from 33 to 28 business days.
The draft of the now-adopted government resolution was developed by the Russian Ministry of Health in March 2026. According to the approved regulations, paperwork will no longer be used during the procedure, and document submission by mail is also prohibited. Applications for obtaining, confirming, renewing, or revoking medical organization permits must be submitted electronically through the public services portal using an electronic signature.
As a result, provisions regulating paper document submission, including requirements for document inventories and sending notifications by registered mail, have been excluded from the regulations. Notification of the regulator's decision and entry into the permit register must also be sent automatically through the portal.
A separate set of adjustments is devoted to changes in the timeframes for administrative procedures. Now, a decision on granting a permit will be made within 28 business days of the start of application review. Previously, the deadline was 33 days. The permit confirmation period has also been reduced from 14 to 13 business days.
The timeframes for individual stages of document review have also been reduced. For example, verifying the completeness and accuracy of information will take two business days instead of three, and the decision to begin application review will take one day after the completion of the verification. In addition, a number of procedures for interaction with expert institutions and applicants are being expedited.
The resolution clarifies the procedures for interaction between the licensing authority and the institutions. A request for additional expert assessment materials can be submitted once, within one business day of receipt. The period for renewing a permit is limited to five business days. A decision to revoke a permit based on an application from a medical organization must now be made within one business day of completing the application review.
Changes also affect the procedure for maintaining the permit register: subject-specific entries must be added to the register within one business day of the registration of the corresponding order. Extracts from the register must be sent to applicants electronically with a QR code containing a link to the permit entry.
Roszdravnadzor's territorial offices will be granted new powers to license medical device maintenance
The Russian Ministry of Health has prepared a draft order expanding the powers of Roszdravnadzor's territorial offices in licensing medical device maintenance activities. The document proposes transferring some functions from the service's central office to regional offices to implement customer-centric principles in the provision of public services.
According to the draft, Roszdravnadzor's territorial offices will be able to independently update information in the license registry and verify compliance with mandatory requirements by companies applying for license updates. The new powers will apply to organizations engaged in medical device maintenance, with the exception of servicing equipment for their own needs and medical devices with a low potential risk of use.
The proposed amendments are to the standard Regulation on the Roszdravnadzor territorial office, approved by the Ministry of Health's order dated August 13, 2020. A separate subclause is planned to be added to the document, establishing the new functions of the service's regional offices in licensing medical device maintenance. This draft was prepared following the entry into force on March 1, 2026, of a Russian Government decree amending the Regulation on Licensing Activities Related to the Technical Maintenance of Medical Devices. At that time, the government had already redistributed some of Roszdravnadzor's powers between its central office and its regional offices: the federal service retained the authority to issue, revoke, and suspend licenses, while regional offices were given the responsibility for amending the license register and assessing companies' compliance with license adjustment requirements.
The Ministry of Health's current draft consolidates the already adopted amendments to the standard Regulation on Roszdravnadzor's regional offices and brings departmental documents into line with the updated regulations.
In May 2025, the Ministry of Health also adjusted its approach to oversight of medical device circulation, reducing the list of risk indicators for Roszdravnadzor inspections from five to two. In particular, several criteria related to licensing medical device maintenance activities and personnel changes at licensees were removed from the list.
A bill regulating medical events has been submitted to the State Duma
A group of deputies, led by Sergei Leonov, Chairman of the Health Protection Committee, and Vyacheslav Davankov, First Deputy Head of the New People faction, have submitted a bill to the lower house of parliament introducing the concept of a "medical or pharmaceutical scientific event" into legislation. The bill also establishes requirements for organizing and holding such events, including mandatory approval from Roszdravnadzor and a ban on advertising campaigns under the guise of scientific conferences and forums. If passed, the law will come into force on March 1, 2027.
According to the bill, a medical or pharmaceutical scientific event is defined as exhibitions, seminars, conferences, forums, and other events held to exchange professional experience, test scientific results, and implement new technologies in medicine, pharmaceuticals, and the production of medical devices and drugs.
The authors of the initiative propose requiring organizers to coordinate the date and procedure for holding events with the federal executive body responsible for oversight and supervision of healthcare. The approval procedure is to be determined by the Russian Government. The document also specifies the possibility of establishing requirements for the event venue, the composition of participants, and the approval process with the Ministry of Health's chief external specialists.
The bill imposes a number of restrictions on organizers, participants, and their representatives. Specifically, it proposes prohibiting the presentation of gifts and cash payments to relevant employees, payment for vacations and entertainment events, and the conclusion of agreements on the prescription or recommendation of specific medications. An exception is provided for agreements related to clinical research and scientific or educational activities.
Furthermore, the document prohibits the distribution of drug samples for distribution to patients, the provision of false or incomplete information about them, and the use of scientific events for false advertising. Organizers are required to publish information about the location, time, program, and composition of participants on official websites no later than two months prior to the event.
According to Sergei Leonov, such an innovation is necessary because it is currently common for commercial entities, under the guise of "false congresses" and "pseudo-congresses," to conduct medical procedures that not only deceive consumers but also lead to health complications or death among participants.
In their explanatory note, the authors of the initiative note that current legislation does not define the status of scientific events and does not contain criteria to distinguish them from commercial ones. Introducing mandatory approval will create a mechanism to oversee the conduct of specialized forums and prevent the use of pseudo-scientific platforms to promote questionable services and products.
Market news
Revenue of the largest medical technology companies in 2025 exceeded 60 billion rubles
The Russian medical technology market grew by 21.4% in 2025, after slowing to 18% the year before. According to Kommersant, citing Smart Ranking data, the combined revenue of the 70 largest companies in the industry reached 60.6 billion rubles. The highest growth rate was recorded in the medical devices segment, where revenue increased by 38.1%.
Telemedicine remains the main driver of market growth, accounting for 21 billion rubles in revenue and 35% of the entire segment, up from 30% the year before. Smart Ranking attributes the sector's growth to more affordable service costs, as well as the development of partnerships with medical equipment manufacturers, laboratories, and insurance companies. Software developers increased their revenue by 16.3% to 16.6 billion rubles, including through government contracts.
SberZdorovye remained the market leader with revenue of 13.4 billion rubles (up 26.3%). The top five also included bionic prosthetics manufacturer Motorika with revenue of 7.1 billion rubles (up 69.6%), Tsifromed, part of Rostelecom's digital cluster, with 3.2 billion rubles (up 36.9%), telemedicine service Doctis, and insurance company Luchi. Analysts named Prosebya as the fastest-growing company, increasing revenue by 627%.
According to Smart Ranking's forecast, the medical technology market will grow by an additional 15-17% year-on-year in the first half of 2026. Market participants attribute further development to the implementation of AI services, import substitution, and expanded government support.
In the medical device segment, the introduction of the Ministry of Industry and Trade's scoring system for medical devices is cited as an additional growth factor. In October 2025, the regulator proposed extending the localization mechanism to a number of product categories, including endoprostheses, bionic prostheses, hearing aids, and other technical rehabilitation devices.
Market participants also attribute the growth of the medical technology market to increased demand for modern prostheses and expanded government support for rehabilitation. In November 2025, the Russian Government approved the Strategy for the Development of Industrial Rehabilitation Products through 2030, which envisages the development of localization, support for high-tech rehabilitation products, and an increase in the share of domestically produced technical rehabilitation devices in the domestic market.
In November 2025, Trust Technologies reported that the Russian medical technology market in the assistive technology segment could more than double by 2030, from 1.084 trillion to 2.341 trillion rubles. Mobility solutions, including prosthetics, wheelchairs, and orthopedic devices, remain the segment's largest area of focus, with analysts citing increased demand for modern rehabilitation equipment as a key growth driver.
Other
A surgical suture with adjustable absorption time has been developed in Russia
Scientists from Perm National Research Polytechnic University (PNRPU) have developed a composite surgical suture with adjustable absorption time and created a computer model that predicts its behavior with 98% accuracy. The development aims to solve the problem of existing suture materials, which either last too long and increase the risk of inflammation, or, conversely, degrade too quickly and fail to reliably hold the wound edges together, according to the university's press service.
The medical device is based on a tourniquet of 19 polyglycolide fibers coated with a hybrid composition of polymers and starch. Three components were required to create the suture: 60-70% polyglycolic acid, 25-35% starch, and 5-10% polylactic acid. This mixture allows for precise control of the absorption rate. By varying the coating thickness, the thread's disappearance can be "programmed" after exactly 15, 20, 25, or 30 days. Initially, the outer layer protects the inner tourniquet from water; as it thins, the liquid reaches the fibers and initiates hydrolysis, explained Stanislav Slovikov, Associate Professor of the Department of Experimental Mechanics and Structural Materials Science at Perm National Research Polytechnic University.
Tests have shown that one tourniquet can withstand a load of up to 28 Newtons, while the actual load is no more than 5 N. This provides a sixfold safety margin and reduces the risk of rupture both during surgery and during the recovery period. The developed computer model takes into account the uneven nature of material failure and the autocatalytic effect, allowing for the optimal thread parameters to be selected almost instantly without lengthy series of experiments.
According to the authors, with a given coating thickness, the thread maintains the required strength throughout the healing period and then completely dissolves without leaving any residue under conditions simulating the human body. Thanks to its combination of high strength and controlled biodegradation, the new multifilament suture is considered a promising solution for temporary sutures in plastic, pediatric, and general surgery, according to scientists.
New registered medical devices
We publish a list of new medical devices registered from 05.15.2026 to 05.22.2026
Link to the list: [see table in the attachment]
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