News Digest 19.06.2026 — 26.06.2026
Regulators
Roszdravnadzor Approves Regulations for Issuing Extracts from the State Register of Medical Devices
Roszdravnadzor has approved an order setting forth administrative regulations for issuing extracts from the state register of medical devices and organizations (individual entrepreneurs) engaged in their production and manufacturing. According to the document, applicants for extracts may be individuals or legal entities, as well as individual entrepreneurs. The service can also be obtained by proxy. The order is valid until March 1, 2028.
The regulation outlines the procedure and standard for issuing extracts from the state register of medical devices and their manufacturers. Roszdravnadzor will issue extracts within five business days from the date of registration of the application and documents required for the service. The extract will be issued electronically, and an application and a power of attorney are required to obtain it. The original application and a copy of the power of attorney must be sent by mail, or the original application and a copy of the power of attorney can be submitted electronically through the Unified Portal of State and Municipal Services.
Under the current regulatory framework, there are no grounds for refusing to accept an application and documents for obtaining an extract. There are also no grounds for suspending the service. However, an extract may be denied in certain cases: if the application contains incomplete information or is illegible; if the applicant has not submitted an application and power of attorney; or if the documents are submitted by an unauthorized person. Furthermore, an extract will be denied if the application does not comply with the rules for maintaining the state register of medical devices and their manufacturers, or if the request for an extract was not signed with an enhanced qualified or unqualified electronic signature.
The order also contains the application form and documents required to obtain an extract from the register.
The Russian Ministry of Health has proposed amending the rules for importing medical devices for vital indications
The Russian Ministry of Health has developed amendments to the Rules for Issuing Permits for the Import of Medical Devices into the Russian Federation for the Provision of Medical Care for Vital Indications to a Specific Patient (approved by Russian Government Resolution No. 1590 of September 22, 2021). The draft resolution is open for public comment until July 1.
The document proposes replacing the reference to the registry used to verify applicants: instead of the registry approved by Russian Government Resolution No. 584 of July 16, 2009, the reference to the registry in Russian Government Resolution No. 725 of May 27, 2025 will be used.
It also proposes increasing the timeframe for verifying the completeness and accuracy of the information contained in the application and attached documents. Roszdravnadzor will now have four business days for the review instead of three. Based on the review results, a decision will be made on whether to grant or deny the permit.
Furthermore, the permit becomes valid indefinitely until the actual import of the medical device for which it was issued (it is currently valid for 30 days).
The document was developed by the Russian Ministry of Health in February, but the previous version of the draft did not include provisions for replacing the register for applicant verification, removing outdated sub-items from the register, or clarifying the refusal and appeal procedures.
The Russian Ministry of Health will update the procedure for calculating the initial contract price for medical devices
The Russian Ministry of Health has proposed amendments to Order No. 450n of May 15, 2020, which regulates the procedure for determining the initial (maximum) contract price (IMCP) for the procurement of medical devices. The amendments remove requirements for medical devices manufactured to individual patient orders for personal use and not subject to registration in Russia.
Furthermore, a number of technical corrections are being made, and several references to current regulations have been replaced. These include taking into account the new national treatment rules for electronic products and the amended list of price sources in accordance with Russian Government Order No. 2227-r of August 16, 2025.
The explanatory note states that the amendments are aimed at improving procurement procedures for medical devices and were developed in response to adjustments to Russian government decrees, including updated regulations for technical rehabilitation equipment. Thus, according to Cabinet Resolution No. 476 of April 27, 2026, the procedure for determining the initial maximum contract price for the procurement of technical rehabilitation equipment and prosthetic manufacturing work is established by the Russian Ministry of Labor in consultation with other agencies and the Federal Antimonopoly Service.
In recent weeks, several regulatory decisions have been made regarding medical devices. In June, the Russian government approved a resolution amending the rules for maintaining the state register of such products. Specifically, the photograph requirements have changed: the photo must be in color, at least 18 x 24 cm in size, and include not only the device itself but also all its models and accessories.
Earlier, the Russian Ministry of Health approved a new procedure for monitoring the safety of medical devices, except for those registered in accordance with international treaties and acts constituting the law of the Eurasian Economic Union (EAEU).
Drug and medical device developers will be able to achieve technology leader status
The Russian Ministry of Economic Development has submitted a draft government resolution for public discussion, creating a new category of technology companies – "technology leaders." This new status will be available to developers of drugs, medical devices, and other innovative healthcare solutions. A separate state registry will be created for these companies, along with priority access to certain government support measures.
According to the draft, technology leaders will be companies with annual revenues between 4 billion and 40 billion rubles, operating in priority economic sectors, including the production of drugs, medical devices, scientific research, and healthcare. In addition to financial criteria, organizations will be required to demonstrate a high level of innovative development. The assessment will take into account the volume of investment in research and development, the presence of registered intellectual property, product competitiveness, production potential, export activity, and the company's development strategy. To achieve this status, a minimum score of 65 points must be achieved following the assessment.
The Ministry of Economic Development of Russia is proposed to be responsible for the creation and maintenance of the register. The assessment of companies will be carried out by the Autonomous Non-Profit Organization "Engineering and Innovation Support Center" and the Skolkovo Foundation, which will also act as support centers for technology leaders. They will advise organizations on obtaining state support measures and interact with federal government agencies and development institutions. For most companies, the assessment will be valid for two years, but for developers of pharmaceuticals and medical devices, it is proposed to extend the validity period to three years.
The draft also proposes amendments to the current rules for granting subsidies. If approved, technology leaders will be given priority in the distribution of certain state support measures, including subsidies and grants. As noted in the explanatory note, the creation of this new category will create a unified mechanism for identifying companies with high technological potential, improve the targeting of state support, attract private investment, and create the conditions for scaling Russian developers to the level of globally competitive technology companies.
Market news
Deputies approved a mechanism for emergency blocking of dangerous dietary supplements and medical products
The State Duma adopted in the first reading a bill expanding the powers of Rospotrebnadzor (the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing) to promptly ban the sale of products that pose a threat to the life and health of citizens. Among the products that, if the law is finally approved, will be covered by the regulator's new powers are medical devices, dietary supplements, specialized food products, and other products subject to sanitary and epidemiological supervision. For products subject to mandatory labeling, enforcement of the ban is proposed through the State Commodity Circulation Monitoring System.
If adopted, the majority of the law's provisions will enter into force on September 1, 2026, and certain provisions will enter into force on March 1, 2027.
The bill proposes amendments to five federal laws regulating consumer protection, the sanitary and epidemiological well-being of the population, technical regulation, trade activities, and state control. As the initiative's authors note, current legislation does not allow for the prompt cessation of sales of dangerous products, as control measures require compliance with a number of procedures. As a result, products posing a threat to consumers may remain in circulation for an extended period.
The document establishes grounds for the prompt ban on the sale of products if they pose a threat to the life and health of citizens. Such decisions can be made based on the results of control measures, sanitary and epidemiological investigations, the registration of infectious diseases or mass poisonings, as well as information from law enforcement agencies on criminal cases and information from international organizations, member states of the Eurasian Economic Union, and third countries.
Depending on the nature of the violations identified, restrictions may apply to a specific batch of products, a specific type of product, products from one manufacturer over a certain period, or all products from a manufacturer. For products subject to mandatory labeling, information about the ban will be posted in the state monitoring system, allowing for their prompt cessation. Information about the imposed restrictions must also be published on the official website of the supervisory authority.
The bill also establishes a procedure for appealing orders and stipulates that, after the grounds for the ban have been eliminated, a decision to resume product sales must be made within three business days.
Other
The "NOVAMED-2026 Medical Device Circulation" forum has opened in Kazan
The 6th All-Russian forum with international participation, "NOVAMED-2026 Medical Device Circulation," is taking place in Kazan from June 22–23. In previous years, the forum was held in Moscow.
NOVAMED brings together representatives of government agencies, medical device manufacturers and developers, research centers, medical and educational organizations, and the business community. Participants will focus on improving the medical device circulation system, registration and government oversight, the implementation of AI in medicine, the development of domestic manufacturing, localization, international cooperation, and the safety and quality of medical care.
The forum is organized by Roszdravnadzor and the Federal State Budgetary Institution "VNIIIMT" with the support of the Russian Ministry of Health, the Russian Ministry of Industry and Trade, and the Government of the Republic of Tatarstan.
Alla Samoilova, Head of Roszdravnadzor, outlined the regulators' main task: providing the healthcare system with high-quality and safe medical devices. An important aspect is the approval of only registered, verified medical devices for circulation. Therefore, ongoing efforts are underway to improve registration procedures, develop electronic services, and support domestic medical device manufacturers. Samoylova noted the positive dynamics of Russian production and emphasized that accelerating product launches must be accompanied by maintaining high quality and safety standards.
Representatives from 11 countries have joined the forum this year: four foreign delegations are participating in person, and another seven are participating online. The international agenda focuses on cooperation in the medical device market and interaction with foreign regulators and partners.
In addition to the business program, the forum features an exhibition of domestic medical device manufacturers, a mobile clinic and a mobile blood transfusion station, and an Olympiad to assess skills and abilities in providing emergency medical care, with 18 teams from 11 Russian regions participating. Participants will also be able to participate in on-site visits to industrial enterprises and medical organizations in Kazan. The forum program includes the signing of important agreements and other events.
An AI system for performing ultrasound examinations based on physician voice commands has been developed in China
Specialists from the Shanghai Sixth People's Hospital and the Shanghai Jiaotong University School of Medicine have developed a system based on multimodal large-scale language models that automates super-resolution ultrasound examinations, from setting scanning parameters to generating a structured medical report. The system is controlled by the physician's voice commands, and the entire data processing cycle takes approximately four minutes. The results of the study were published in the journal Digital Medicine.
Super-resolution ultrasound imaging enables microvascular imaging with a level of detail unattainable by traditional ultrasound diagnostics and is considered a promising tool for detecting neurological, oncological, and cardiovascular diseases. However, the widespread use of this technology is limited by complex equipment setup, the need for manual selection of numerous parameters, and the dependence of examination quality on the specialist's experience.
The development was tested on data from patients with Alzheimer's disease, ischemic stroke, and small vessel disease, as well as in the visualization of carotid atherosclerotic plaques. According to the authors, the system reduced the time it took to prepare a medical report to approximately four minutes after completion of the examination and standardized the presentation of results.
The quality of the automatically generated reports was assessed by 14 physicians from various specialties. For most criteria, including completeness of information, document structure, correct terminology, and clinical value, the system received scores of approximately four or higher on a five-point scale. The authors believe the development can be used as a tool to support medical decision-making, reduce the number of manual steps required during high-resolution ultrasound, and make the technology less dependent on operator experience.
Despite the obtained results, the researchers note that the technology requires further clinical validation on larger patient samples and in various medical organizations before being implemented into routine practice.
New registered medical devices
We publish a list of new medical devices registered from 06.19.2026 to 06.26.2026
Link to the list: [see table in the attachment]
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