News Digest 13.02.2026 — 20.02.2026
Regulators
The list of cases in which medical devices may be circulated without registration in the EAEU has been expanded
The states of the Eurasian Economic Union (EAEU) have agreed to expand the list of medical devices that may be circulated within the union without registration. The corresponding changes are set out in the protocol to the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices, signed on February 9, 2026, in Moscow.
The document supplements paragraph 11 of Article 4 of the Agreement with new grounds for excluding registration of medical devices in the EAEU. Specifically, the following devices may be circulated without registration:
- imported into the customs territory of the union for vital indications of a specific patient, based on permission from the authorized body of a member state;
- manufactured in the territory of a member state exclusively for export from the customs territory of the union and not intended for sale in the EAEU markets;
- sets of medical devices and medicinal products (packages, kits, sets, first aid kits) in common packaging, while maintaining their consumer packaging, if they are registered and completed in accordance with the legislation of the relevant Member State and are intended only for circulation within its territory.
The Protocol shall be subject to provisional application 10 days after signing. The document shall enter into force on the date the depositary receives, through diplomatic channels, the last written notification of the Member States' completion of the necessary domestic procedures.
The Government of the Russian Federation approved Order No. 2920-r dated October 17, 2025, on the signing of the Protocol in October 2025, according to FV.
Applications for registration of a medical device under the old, national rules can be submitted until December 31, 2027 (previously, until the end of 2025). Documents can be renewed (re-registered or amended) for medical devices already registered under national regulations until December 31, 2028 (previously until the end of 2026).
The list of alcohol-containing medical devices has expanded to 608 items
The Russian government has updated the list of medical devices containing ethyl alcohol and not subject to regulation by the Federal Service for the Control of Alcohol and Tobacco Markets (Rosalkogoltobakkontrol, RATK). Thirteen medical devices have been removed from the list, and another 41 products have been added.
The list includes updated AmpliSens DNA/RNA extraction kits from biomaterials, as well as AmpliTest kits for the diagnosis of tuberculosis, measles, rubella, and mumps, as well as enterovirus, hepatitis B, C, and HIV RNA, and influenza virus RNA, as well as the MAGNO-Sorb molecular diagnostic test system. In addition, the list includes seven Diakhim-Gram Gram staining kits, a reagent kit for Ziehl-Neelson staining, and a clinical sputum analysis kit from Diakhim.
The AmpliSens and AmpliTest detection kits, as well as Diakhim reagent kits, have been removed from the list due to their no longer being relevant.
Four years ago, the Russian Ministry of Health developed and approved specialized rules for compiling a list of alcohol-containing medical devices whose production, manufacture, and distribution are not covered by the Federal Law "On State Regulation of the Production and Circulation of Ethyl Alcohol, Alcoholic and Alcohol-Containing Products, and on Limiting the Consumption (Drinking) of Alcoholic Products" and which are not subject to the control of the Russian Alcohol and Container Control Committee (RATK). Specifically, all alcohol-containing medical devices, regardless of their ethanol content, are now subject to regulation.
Now, to remain exempt from the law, medical device manufacturers must include their products in a special list, confirming their compliance with one of the criteria. Furthermore, medical device manufacturers are required to record and declare the volume of ethanol production, supply, and use and submit the data to the Unified State Automated Information System (EGAIS). A commission consisting of representatives from the Ministry of Health, the Ministry of Industry and Trade, Rospotrebnadzor, Roszdravnadzor, the Russian Association of Antimonopoly Committees (RATK), the Federal Antimonopoly Service (FAS), the National Medical Research Center (NMIC), and industry associations, including Delovaya Rossiya (Business Russia), has been empowered to develop the list.
In October 2025, the Roszdravnadzor Commission recommended adding 18 new items to the list of alcohol-containing medical devices and deleting five more. The privileged list will include reagents manufactured by the Central Scientific and Production Association of the Federal Medical and Biological Agency (CSP FMBA), Abris Scientific and Production Company (NPF), Rospotrebnadzor's Central Research Institute of Epidemiology, BD Major, and China's Lituo Biotech.
Source: https://vademec.ru/news/2026/02/16/perechen-spirtosoderzhashchikh-medizdeliy-vyros-do-608-punktov/
The regulator proposed allowing the inclusion of AI data in X-ray protocols
The Russian Ministry of Health presented a draft order amending the Rules for Conducting X-ray Examinations. The document proposes to formalize the inclusion of the results of the use of medical devices based on artificial intelligence (AI) technologies in the protocol. The amendments are aimed at changing the standard for X-ray room equipment and aligning them with the current regulatory framework.
The proposed amendments are to Order No. 560n of the Russian Ministry of Health dated June 9, 2020.
According to the draft, the X-ray protocol should include "electronic medical records (including the results of the use of medical devices based on AI technologies, if technically feasible)." Under the current regulations, the list of information is limited to a description of the examination results, the radiologist's report, and patient data.
In addition to formalizing the use of AI in the protocol structure, the document clarifies the requirements for its content. The draft specifies the effective radiation dose in millisieverts when using ionizing radiation, specifies the name of the diagnostic system, expands the section on the use of drugs used for pharmacological loading, and introduces comparisons with previous studies where technically feasible.
In March 2025, the Interdepartmental Working Group of the Russian Ministry of Health on the Creation, Development, and Clinical Implementation of AI-Based Medical Devices and Services approved the Code of Ethics for its Use in Healthcare. The document marks the transition from pilot implementation to a regulated model, where safety and manageability are equated in importance with technological efficiency. The Code applies to all stages of the lifecycle of medical AI systems and establishes requirements for algorithm transparency, personal data protection, non-discrimination, decision control, and the distribution of responsibility among participants.
Roszdravnadzor will share the responsibilities for licensing medical equipment maintenance with the regions
Amendments to the licensing rules for medical device maintenance have been approved. According to amendments to Russian Government Resolution No. 2129 of November 30, 2021, these amendments will affect the powers of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) and its regional offices, as well as the deadlines for amending the license register. The document is scheduled to enter into force on March 1, 2026.
It states that Roszdravnadzor will continue to issue licenses, provide extracts from the register, and assess applicants' compliance with licensing requirements. At the same time, the service's regional offices will be able to independently amend the license register and assess the compliance of applicants who have submitted documents. If a region does not have a Roszdravnadzor regional office, these functions may be assigned to another licensing authority.
The amendments also affect the deadlines for amending the license register. According to the current version of the document, this period is allotted a maximum of five business days from the date of receipt of the application through the public services portal. Now, this period will be three days.
The Russian Ministry of Health's decision to transfer authority for licensing medical device maintenance activities from Roszdravnadzor to its regional offices was announced back in 2024. The draft order was published on August 26 on regulation.gov.ru. The document was developed to ensure compliance with the deadlines for providing the public service for licensing medical device maintenance activities and is aimed at improving its accessibility, territorial consistency, and applicant satisfaction with the quality of the public licensing service, according to the explanatory note.
Market news
The court has settled a case involving fictitious commercial proposals and the supply of medical devices
The Deputy Prosecutor of the Samara Region has secured the invalidation of a contract for the supply of medical devices executed in 2022 by the New Medical Company. The company submitted fictitious commercial proposals on behalf of three different companies, which formed the basis for the customer's calculation of the initial maximum contract price (IMCP). The Arbitration Court of the Samara Region ordered the supplier to return 33 million rubles to the customer, the State Public Institution Samarafarmacia. The Eleventh Arbitration Court of Appeal upheld this decision, and it has entered into force. The relevant information is published in the "My Arbitrator" system.
During an inspection of compliance with legislation on contract systems in the procurement of goods and services for state needs, employees of the Samara Region Prosecutor's Office drew attention to a contract concluded in 2022 between Samarafarmacia and the New Medical Company. In the interests of regional hospitals, the customer purchased medical products (universal operating tables) from the supplier, along with a package of services for commissioning, employee training, and maintenance. The initial maximum contract price for the contract, completed that same year, was based on commercial proposals from three different companies. However, an audit revealed that some of these proposals were fictitious: they had been manufactured and shipped at the request of the head of the New Medical Company. This constituted a restriction of competition.
A contract concluded in violation of procurement laws is voidable (Part 2, Article 8 of Federal Law No. 44-FZ "On Public Procurement" and Clause 2, Article 168 of the Civil Code of the Russian Federation). The Arbitration Court of the Samara Region upheld the deputy prosecutor's claim to invalidate the transaction. The supplier was ordered to pay 33.2 million rubles. The company appealed the verdict to the appellate court and was denied.
The court's decision has entered into force.
Other
A method for diagnosing spinal diseases without open incisions has been patented in Russia
A team of specialists from the Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency has received a patent for a "Method for Modeling Radiculopathy in an Experiment." The new technique allows for highly accurate recreation of spinal nerve root compression conditions and the evaluation of treatment effectiveness, according to the Federal Medical and Biological Agency's press service.
Until now, spinal pathology simulations were performed exclusively through open incisions, which significantly complicated the study. The patented method is completely minimally invasive.
The procedure is performed under X-ray guidance using a surgical needle and a thread impregnated with a contrast agent. The thread is inserted through the intervertebral foramen, creating the necessary compression of the spinal nerve root. This simulates the patient's condition with a spinal pathology, such as a herniated disc.
The Russian Ministry of Health has determined the deadline for extending frequent sick leave with the participation of a medical commission
The Russian Ministry of Health has published another draft order amending the Terms and Procedure for Issuing Sick Leave Certificates. The amendments are aimed at systematizing the attending physician's record of cases of multiple sick leave certificates issued electronically in order to identify the causes of prolonged disability and take the necessary measures, according to the document published on regulation.gov.ru.
The amendments are being made to Order No. 1089n of the Russian Ministry of Health dated November 23, 2021. They update the current Procedure for Conducting Temporary Disability Assessments (Order of the Ministry of Health of the Russian Federation No. 195n dated April 11, 2025).
This is the third document amending the procedure for issuing sick leave. This week, it was announced that self-employed citizens—individuals who use the special tax regime "Tax on Professional Income"—will be able to receive sick leave, MV reported. And on February 10, legal and technical amendments were made to the draft order regulating the procedure for issuing sick leave, a similar document published for public comment on the portal regulation.gov.ru in June 2025 and still unapproved. At the same time, it was announced that the Ministry of Health of the Russian Federation allowed doctors to remotely close sick leave certificates via the MAX messenger when using telemedicine. The ministry first proposed issuing sick leave certificates with the participation of a medical commission back in November 2024.
Under the new draft, as originally planned, the issuance of four or more sick leave certificates within six months will be considered a "red flag." (Along with caring for a sick family member, medical rehabilitation, and renal replacement therapy, the list of exceptions now includes pregnancy and childbirth, quarantine, and all cases of inpatient medical care.) In this case, the attending physician (paramedic, dentist) will be able to issue a sick leave certificate for only five calendar days.
During this period, the healthcare professional will be required to arrange for a review of the individual's medical records by a medical commission, with their participation if necessary. Telemedicine technologies may be used for this purpose. The commission will analyze the causes of frequent illnesses "in order to improve the patient's treatment, establish grounds for referral for additional examinations, and/or decide on the need for inpatient medical care."
A frequently ill patient's sick leave may be extended for the period established by the current procedure (Order No. 1089n)—until the day of recovery, with extensions determined by the medical commission at least every 15 calendar days, but for a period of no more than ten months from the onset of temporary disability, and for tuberculosis treatment, no more than 12 months.
A sick leave is terminated by the medical commission upon its decision regarding the individual's fitness to work, including if additional examinations are not required and/or there are no indications for inpatient medical care.
New registered medical devices
We publish a list of new medical devices registered from 02.13.2026 to 02.20.2026
Link to the list: [see table in the attachment]
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