News Digest 20.02.2026 — 27.02.2026
Regulators
What does the EAEU's expansion of the list of grounds for the circulation of medical devices without registration mean?
On February 9, 2026, the member states of the Eurasian Economic Union (EAEU) signed a protocol amending the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the Union, expanding the list of cases in which such products may be circulated without registration under EAEU rules. Effective February 19, the provisions of the protocol are subject to temporary application in the territory of the Union's member states.
Changes in the regulatory framework for medical technologies typically occur gradually and selectively, often having a delayed impact on businesses.
The expansion of the list of exceptions for the circulation of medical devices is regulatory in nature and applies only in specified situations and does not replace the general requirement to confirm the safety and quality of products.
The legal regime for the circulation of products without registration is restrictive and cannot be considered as an alternative method for introducing a product into commercial circulation. Failure to comply with the intended purpose of circulation or exceeding the established exceptions entails government oversight measures, including administrative liability.
The circulation of medical devices without registration is permitted primarily for exhibitions, scientific research, individual use for vital indications, or in emergency situations. In recent years, such mechanisms have become anti-crisis tools, helping to prevent shortages and ensure prompt delivery of critical products.
Manufacturers and suppliers are now able to respond quickly to changes. However, expanding the list does not reduce the level of oversight: the product must meet safety requirements, be accompanied by the necessary documentation, and be used strictly for its intended purpose. In practice, attempts to make an exception the basis for commercial activity inevitably attract the attention of regulatory authorities.
Permits for the import of medical devices into the Russian Federation for vital indications may become indefinite
The Russian Ministry of Health has developed amendments to the Rules for issuing permits for the import of medical devices for the provision of medical care for vital indications for a specific patient. The draft amendments to Russian Government Resolution No. 1590 of September 22, 2021, have been published on regulation.gov.ru.
It is proposed to increase the time period for verifying the completeness and accuracy of the information contained in the application and attached documents. Roszdravnadzor will be given four business days for this purpose instead of three.
The procedure for entering data into the register and notifying the applicant will also change. Currently, the decision to grant or deny a permit is made based on the results of the verification. It is expected that Roszdravnadzor will first decide whether to grant or deny a permit, and then, within one business day, enter the entry into the registry and send the applicant an extract from the registry in their personal account on the State Services portal.
Furthermore, the permit will be valid indefinitely until the actual import of the medical device (currently, it is valid for 30 days).
If approved, the document will enter into force on the day of its official publication.
The regulator has clarified the rules for handling methanol-containing products for laboratories
Medical devices with OKPD2 codes 21.20.23.110 (diagnostic reagents); 21.10.60.196 (diagnostic preparations (reagents) of microbial and viral origin; diagnostic kits); 26.60.12.119 (other electrodiagnostic devices) are not subject to the requirements of Federal Law No. 108-FZ, including those regarding labeling, storage, and disposal, the Russian Ministry of Industry and Trade reported in response to a request from the Association of Laboratory Service Specialists and Organizations "Federation of Laboratory Medicine."
According to Federal Law No. 108-FZ of April 3, 2023, all legal entities using methanol-containing products were required to submit data for inclusion in a special registry by November 1, 2025. Organizations and individual entrepreneurs not included in the registry were not permitted to handle methanol-containing liquids. This conflicted with current regulations governing the circulation of medical devices and requirements for medical activities. The response from the Russian Ministry of Industry and Trade resolved the discrepancy.
An issue remains unresolved regarding medical devices with OKPD2 code 20.59.52.195 (reagents for determining analytes for in vitro diagnostics). The Russian Ministry of Industry and Trade stated that this aspect is also planned to be addressed.
The production of diagnostic reagents for medical laboratories in Russia increased by 10% between 2023 and 2025, reaching 126 million packages. Amid import substitution and government support. Specifically, in vitro diagnostic medical devices were included in the list of critical products. This opened access to subsidies and stimulated production expansion. Analysts expect further market growth.
The Russian Ministry of Health intends to update the rules for importing unregistered medical devices
The Russian Ministry of Health has developed amendments to the Rules for Importing Unregistered Medical Devices into Russia. The draft resolution is undergoing public discussion until March 2.
The document establishes a uniform requirement for importers: they can only be legal entities or individual entrepreneurs (IEs) whose information is included in the unified register of notifications, submissions, and records of notifications on the commencement of certain types of business activities.
The regulatory framework governing the registration of importers is also changing. The old registry, established by Russian Government Resolution No. 584 of July 16, 2009, is being replaced by a new unified registry, approved by Russian Government Resolution No. 725 of May 27, 2025.
This document will replace Russian Government Resolution No. 1321 of August 9, 2021.
If approved, the resolution will enter into force on September 1, 2026, and remain in effect until September 1, 2032.
Market news
A verdict has been issued in the case of supplying the Ministry of Defense with substandard equipment to combat COVID-19
Moscow's Basmanny District Court found Larisa Leontyeva, former deputy director of the Ministry of Defense-affiliated Main Military Construction Directorate No. 4, and fashion designer Ferutdin Zakirov guilty of large-scale fraud (Part 4, Article 159 of the Russian Criminal Code). The defendants were each sentenced to six years in prison. It was established that the Russian Ministry of Defense, while purchasing medical equipment to combat the coronavirus during the pandemic, received substandard medical equipment—instead of ventilators, the ministry received sleep-improvement devices at an inflated price. Damages are estimated at nearly 400 million rubles.
The Main Military Investigative Directorate of the Investigative Committee of the Russian Federation launched a criminal investigation on September 17, 2020, based on materials from the FSB's military counterintelligence service. According to the Investigative Committee, as Minister of Defense of the Russian Federation, Sergei Shoigu instructed the Federal State Autonomous Institution "Special Projects Property Management" (UISP) to purchase medical equipment and personal protective equipment (PPE) for the needs of the Main Military Medical Directorate of the Ministry of Defense.
The equipment was planned for delivery to 16 prefabricated multifunctional medical centers. Ventilators were also planned for purchase. Investigators reported that Larisa Leontyeva was to assist UISP Head Andrei Tulupov in quickly identifying suppliers of medical equipment and concluding contracts with them.
The case materials note that the acquisition of medical equipment was complicated by sanctions and restrictions on business transactions imposed in various countries due to the COVID-19 pandemic. Through mutual acquaintances, Leontyeva met designer Ferutdin Zakirov, who promised to help with the supply of ventilators, including the Chinese Yuwell YH-730.
In the spring of 2020, the Russian Ministry of Defense received 350 ventilators for 400 million rubles. According to the FSB and the Investigative Committee, the ministry was ultimately provided with devices designed to improve the sleep quality of patients suffering from sleep apnea syndrome (a breathing disorder during sleep) at a price 10 times inflated.
Larisa Leontyeva and Ferutdin Zakirov were arrested and charged with large-scale fraud. They denied the charges and insisted that the procurement data had been verified and approved by specialists and heads of the Ministry of Defense's medical units. Moreover, the documents in the case allegedly refute the fact of price gouging, and Leontyeva and Zakirov stated their incomprehension of how the damages could be equal to the entire contract amount, as if no deliveries had taken place, despite the fact that a special Defense Ministry transport plane had flown to China to pick up the devices.
Former Head of the UISP, Andrei Tulupov, was in turn charged with abuse of office (Part 1, Article 285 of the Russian Criminal Code). He pleaded guilty not only to this charge but also to bribery (Part 6, Article 290 of the Russian Criminal Code) in other cases involving the military department's procurement of medical supplies to combat COVID-19. As a result, the case was separated into a separate proceeding. In January 2023, the Basmanny District Court of Moscow sentenced Tulupov to eight years in a maximum-security penal colony.
Other
Sales of therapeutic allergoids derived from house dust have skyrocketed in Russia
Demand for allergens and allergoids for allergen-specific immunotherapy (ASIT) and skin testing is growing in Russia. Over the past two years, sales of these medications have increased by 64% in monetary terms and by almost 48% in volume, according to the press service of the Natsimbio holding company (part of Rostec). NPO Mikrogen, whose subsidiary is the only manufacturer of water-salt allergens and allergoids in Russia, reports the press service.
ASIT is a treatment method for allergic diseases aimed at reducing the body's sensitivity to the causative allergen through its gradual introduction in gradually increasing doses. This helps modify the natural course of an allergic disease, reduce the severity of symptoms and the risk of complications, and prevent the development of bronchial asthma and sensitization to new allergens.
According to Natsimbio, medical organizations purchased 24,100 packages of ASIT medications in 2025 for a total of 136.6 million rubles. Food and epidermal allergens, used for skin testing (scarification and prick tests), demonstrated the most significant demand. Sales of these products increased by 173% and 77%, respectively. Demand for therapeutic allergoids derived from house dust increased by 150%.
Manufacturers attribute this growth to improved medical quality: skin tests are included in clinical guidelines as the "gold standard" for allergy diagnostics. A number of medical organizations have begun using skin tests and injection ASIT with compulsory medical insurance (CMI) funds. Furthermore, more and more clinics are using injection ASIT as part of their standard treatment regimens.
However, despite numerous clinical studies confirming the method's effectiveness, ASIT remains underused: experts estimate that less than 10% of patients with allergic rhinitis or bronchial asthma receive it worldwide, the report notes.
New registered medical devices
We publish a list of new medical devices registered from 02.20.2026 to 02.27.2026
Link to the list: [see table in the attachment]
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