News Digest 23.05.2025 — 30.05.2025
Regulators
Sanitary rules and regulations for the production, operation and disposal of medical X-ray equipment will become invalid from September 2025
Chief State Sanitary Doctor of Russia Anna Popova declared invalid Sanitary rules and regulations 2.6.1.2891-11, which regulated radiation safety requirements for the production, operation and disposal of medical equipment containing sources of ionizing radiation. Previously, the regulation was included in the legislative list "On mandatory requirements", which made it possible to amend it by adopting a new document and recognizing the old one as invalid.
Sanitary rules, in accordance with the resolution of the Chief State Sanitary Doctor of the Russian Federation dated May 22, 2025 No. 9, will become invalid from September 1, 2025.
Sanitary rules and regulations were approved by the resolution of the Chief State Sanitary Doctor of the Russian Federation Gennady Onishchenko in July 2011 and entered into force on October 28, 2011.
The rules and regulations governed the requirements for ensuring radiation safety during the production, operation, decommissioning and disposal of medical equipment containing sources of ionizing radiation and were mandatory for all companies and individuals whose activities are related to the production, operation and decommissioning of medical equipment, installations using radionuclide or generating sources of ionizing radiation.
The regulations applied to all operating medical installations using sources of ionizing radiation, to the processes of their design, production, approval for operation, storage, transportation, sale, decommissioning and disposal of specialized medical equipment.
The regulator has reduced the list of risk indicators for state control over the circulation of medical devices
The Ministry of Health of the Russian Federation has excluded three items from the list of risk indicators for violation of mandatory requirements used by Roszdravnadzor when monitoring the circulation of medical devices. Previously, there were five reasons for inspection by the supervisory service, now there are two left. The regulator excluded from the list a twofold or more increase in the number of documents on the results of clinical studies of medical devices for a calendar year compared to the previous year, the receipt by the licensing authority within one year of an application for a license to carry out activities for the maintenance of medical devices or for making changes to the register of licenses from a license applicant (licensee), as well as the presence of an employee of the license applicant who carries out technical maintenance of medical devices and who has concluded an employment contract with another licensee located in another region during the calendar year. As a result, two risk markers remained on the list: the first is the receipt of an application for a license for maintenance of medical devices (or amendments to the relevant documents), the second is the failure to receive a repeated application from the developer or manufacturer to amend the documents contained in the registration dossier for the medical device (within 180 working days from the date of Roszdravnadzor's refusal to change the registration dossier), and the return of the application for amendments and documents, termination of further consideration of the application, subject to the availability of an offer to sell such a medical device, including remotely. The agency established the previously applicable criteria in the summer of 2023. In October 2024, the Ministry of Health planned to increase the number of risk indicators for violation of mandatory requirements used by Roszdravnadzor in monitoring the circulation of medical devices. The regulator proposed to include in the reasons for inspection the presence of information about two or more deviations in the functioning of a medical device within six months of its use in a clinic, and to count deviations that did not entail a threat of harm to the health and life of citizens. However, the corresponding order has not yet been approved.
The last time this list was updated was in April 2025. Then the Ministry of Health added one of the risk indicators to the list, which now remains in the document.
In November 2021, the Government of Russia approved a new regulation on licensing the maintenance of medical devices. The document exempts from regulation the maintenance of medical devices with a low risk class, as well as legal entities or individual entrepreneurs engaged in the maintenance of their own medical equipment.
The new regulation also exempts manufacturers or authorized persons of foreign manufacturers who service only their own brand of equipment from some of the licensing requirements, including the presence of a quality management system, a list of equipment and measuring instruments.
Requirements for the purchase of medicines and medical devices from small businesses and NPOs have been changed
The Government of the Russian Federation relaxed the requirements for government customers to purchase goods from small businesses and socially oriented non-profit organizations (SONPO). Previously, according to the federal law "On the contract system in the sphere of procurement of goods, works, services to meet state and municipal needs", the minimum volume of purchases from such business entities was set at 25% of the total annual volume of purchases. Now, when calculating the total annual volume of purchases, the cost of purchasing medicines and medical devices by a customer whose annual volume of such purchases exceeds 20 million rubles will not be taken into account.
The regulator will lower the risk class of alcohol wipes for treating the hands of medical personnel
The Ministry of Health has developed amendments to the nomenclature classification of medical devices by classes depending on the potential risk of their use. The draft order was published on the portal regulation.gov.ru.
The classification was approved by order of the Ministry of Health No. 4n dated 06.06.2012, amendments are made to subparagraph 4.13 of paragraph 4 of the document. It states that medical devices, the components of which include a substance that is a drug or other biologically active agent and affects the human body in addition to the effect of the medical device, belong to class 3.
The authors of the changes want to make an exception from this clause for antiseptic wipes for treating the hands of medical personnel, as well as for treating the operating and injection fields. These products are intended to be classified as class 2a.
Market news
The volume of the medical equipment market in Russia by the end of 2024 was estimated at 850 billion rubles
In 2024, the volume of the Russian medical devices market grew by 14% compared to the previous year and reached 850 billion rubles. At the same time, the share of domestic solutions is increasing in all key segments, as shown by the analysis of the Rostec subsidiary RT-Medical Technologies. Its results were presented at the forum "Russia and the World: Healthy Longevity Trends", the press service of the state corporation told MV.
According to the study, the greatest dynamics of import substitution is observed in the laboratory research segment: medical products and consumables worth 176 billion rubles were produced in a year. The market volume in the field of diagnostic imaging amounted to 90 billion rubles.
An increase in the production of high-tech equipment for clinical and surgical profile was noted. Last year, the country produced products for general surgery and endoscopy, cardiovascular and neurosurgery, as well as anesthesiology and intensive care worth more than 263 billion rubles. The market volume in the field of orthopedics and rehabilitation is estimated at 121 billion rubles.
The public procurement segment demonstrates a growing share of domestic solutions. In 2024, the market structure showed a redistribution towards local suppliers, which corresponds to the state's strategic objectives of ensuring technological sovereignty and accessibility of high-tech medical care, Rostec emphasized.
The state corporation's portfolio includes 150 types of high-tech equipment for equipping clinics and laboratories. Last year, Rostec enterprises transferred 85 thousand units of medical equipment and about 8 million units of consumables to medical institutions.
Medical products were not subject to Western sanctions, but the unfavorable ruble exchange rate, difficulties with supplies and the departure of some foreign companies from Russia forced the authorities to intensify the long-announced import substitution strategy. Experts point out that excessive "technological sovereignty" can harm domestic producers and patients. MV investigated where reasonable limits of import substitution end and what prevents them from being reached.
A list of medical products for equipping emergency departments of regional clinics has been presented
The Ministry of Health of the Russian Federation has prepared a draft order approving the list of medical products for additional equipping and equipping emergency departments of clinics subordinate to the executive bodies of the constituent entities of the Russian Federation. The document was developed for the implementation of the federal project "Improvement of emergency medical care" (part of the national project "Long and active life"), which includes the creation of emergency departments with modern infrastructure. The list contains 190 types of medical products. The regulator prepared the list of medical products in accordance with the standards for equipping medical organizations, the procedures for providing medical care and the rules for conducting laboratory, instrumental, pathological logistical and other types of diagnostic studies.
The document specifies equipment standards for a clinical laboratory diagnostics room (express laboratory), ultrasound diagnostics rooms, endoscopy, radiology, computed tomography, transfusiology, electrocardiography, a resuscitation and intensive care unit with 6 beds with a nurse's station, a dynamic observation room with a nurse's station, a dressing room, a plastering room and an operating room.
The list includes, for example, ultrasound machines, endoscopic visualization systems, endoscopes, a stationary X-ray machine, CT with a multi-row detector (multislice) for 16 or more slices, ventilators, a thromboelastograph, an anti-decubitus mattress, an automatic device for cardiopulmonary resuscitation. The list also includes a mobile X-ray television surgical unit with a C-arm, trolleys, sets of surgical and other instruments, bactericidal irradiators and cleaners, as well as other medical products.
In early April 2025, the Russian government approved the distribution of 11.4 billion rubles to upgrade emergency departments in 21 regions under the federal project "Improving Emergency Medical Care." The funds will be received in 2025. The largest tranches of 564.3 million rubles will be received by eight regions, including the Donetsk People's Republic, the republics of Dagestan and Crimea, and the Stavropol Territory. The regions themselves reported the need to upgrade emergency departments in medical organizations.
Other
A floating clinic worth 1.2 billion rubles was launched in Kolomna
A ceremony was held in Kolomna (Moscow Region) to launch the floating clinic "Svyatitel Luka", which became the first river motor ship in Russia, originally designed as a specialized medical vessel. It will be able to accommodate 25 doctors on board and be in autonomous navigation for up to 30 days. In the near future, the ship will be sent to the customer - the Center for Occupational Pathology of the Khanty-Mansiysk Autonomous Okrug - and will replace the only medical ship in Russia "Nikolay Pirogov", which will go for major repairs in the fall of 2026. The volume of investments in the project amounted to 1.155 billion rubles.
New registered medical devices
We publish a list of new medical devices registered from 05.23.2025 to 05.30.2025
Link to the list: [see table in the attachment]
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