News Digest 27.06.2025 — 04.07.2025
Regulators
The Ministry of Health has asked to postpone certain provisions of the new rules for registering medical devices
The Ministry of Health plans to postpone the entry into force of certain clauses of Government Resolution No. 1684 of November 30, 2024 on the new rules for state registration of medical devices for another year. The draft document with adjustments was published on July 1 on the regulation.gov.ru portal.
The procedure was supposed to come into effect on September 1 of this year. The Ministry refers to the fact that market participants have encountered difficulties in updating documents confirming the authority of the authorized representative of a foreign manufacturer, and an increase in the time to prepare the necessary documentation.
According to the Ministry of Health, critical problems with re-registration may affect approximately 13 thousand registration certificates (RC) for foreign-made medical devices. Due to the absence of a valid authorized representative of the manufacturer (producer) of a medical device in Russia, this may lead to the risk of defects and negatively affect the healthcare system, according to the explanatory note to the document.
Despite the introduction of an accelerated procedure within the national registration system, from 2021 to 2024, the number of registration certificates RU issued in Russia for medical devices decreased from 3,098 to 2,422 items. The share of Russian manufacturers during the period under review remained stable, from 47 to 53%. At the same time, their absolute number decreased annually. The share of Japan, the EU and the USA fell significantly, while that of India and China increased. Last year alone, the number of registration certificates issued in Russia for medical devices by Chinese manufacturers increased by 76% compared to 2023. The corresponding calculations were provided by Dmitry Likhaev, an expert at the Association of Participants in the Circulation of Medical Devices (AUSOMI).
Earlier, the government updated the list of medical devices, the sale and import of which is subject to a zero VAT rate. It included "Other plastic tubes, hoses and sleeves", "Implants for exoprosthetics, orthopedic fixing systems" and other types of medical devices.
Market news
The government may soften the rules for purchasing medical equipment
The Ministry of Industry and Trade has developed amendments to the RF Government Resolution No. 1875 of 12/23/2024 "On measures to provide national treatment in the procurement of goods, works, services to meet state and municipal needs, procurement of goods, works, services by certain types of legal entities." The document is undergoing public discussion on the regulation.gov.ru portal until June 30.
The government established a scoring system for assessing the degree of localization of 18 types of medical equipment by Resolution No. 1293 of 08/08/2023. In particular, the list includes computer tomographs, mammographs, hardware and software systems for recording and processing X-ray images, as well as ultrasound machines. At the same time, as stated in the explanatory note to the draft, for certain types of medical equipment, registry entries created before the introduction of the point system are still valid, based on certificates of origin of goods of form ST-1 and expert reports of the Chamber of Commerce and Industry of the Russian Federation. The validity periods of these registry entries will expire by the end of 2026. At the same time, in accordance with Resolution No. 1875, the registry entry number serves as information to confirm the country of origin of goods. "A situation has arisen in which the numbers of current registry entries are not accepted by customers within the framework of the implementation of the "national procurement regime" if the extracts from the product registry entries do not indicate the amount of points, although the entries themselves are relevant, since the documents on the basis of which they were formed were received before the introduction of the point system of assessment," the authors of the document indicate.
It is proposed to extend the national procurement regime to manufacturers of medical devices that have current registry entries. The document establishes an exemption from the mandatory indication of the amount of points in the extracts for certain types of medical devices for which the point system was previously introduced.
Considering that the validity periods of such registry entries will expire before the end of 2026, it is proposed to make the draft norm temporary - until December 31, 2026.
The volume of medical purchases may reach 2 trillion rubles in 2025
The volume of medical government purchases in Russia is showing steady growth and, if the pace is maintained, may approach 2 trillion rubles by the end of 2025. This forecast was presented to MV by experts from the B2B-RTS IT platform (which unites RTS-tender, B2B-Center and OTS), having studied the dynamics of purchases of medical devices and drugs in the specialized Unified Information System (UIS) within the framework of Federal Law No. 44-FZ "On the Contract System".
According to calculations, almost 770 thousand such contracts were concluded in 2024 (+10% compared to 2023) for a total of 1.6 trillion rubles (+33%). Thus, if the pace is maintained, the volume of purchases of medical devices and medicines by the end of 2025 could reach 2 trillion rubles.
In January-May 2025, this category of goods was purchased for 466 billion rubles - 20% less than in the same period last year. But the number of customers (7.4 thousand) and suppliers (about 11 thousand) remains at the 2024 level, and the number of posted procedures (366 thousand) increased by 7%. Since the beginning of this year, 140 thousand procedures have been carried out at the RTS tender, the amount of concluded contracts exceeded 180.5 billion rubles.
Analysts note that the volumes of purchases and the dynamics vary depending on the level of customers. The largest among them — hospitals, clinics and polyclinics (OKVED 86.10) — purchased medical products and medicines for 205 billion rubles in the first five months of 2025 (-10% compared to the same period last year). State pharmacies signed contracts for 5.5 billion rubles (six times more), sanatoriums and boarding houses — for 524 million rubles (+5%).
Last week, the Russian president signed a law on the creation of an information system for the prevention, detection and suppression of cartel agreements — GIS "Anti-Cartel". The system will scan information about trades using artificial intelligence from August 1, MV reported.
The Accounts Chamber pointed out the insufficient availability of medical rehabilitation programs
Despite the positive dynamics, the availability of medical care within the framework of the federal project "Optimal Medical Rehabilitation for Health Restoration" is insufficient. Some of the purchased rehabilitation equipment in a number of regions was idle due to a shortage of qualified personnel or incomplete occupancy of beds, the Accounts Chamber reported.
In some regions, the actual need for medical rehabilitation among patients with disabilities and after illnesses is several times higher than the volumes paid for from compulsory medical insurance funds. Despite the increase in the number of services provided, the availability of care within the framework of the federal project "Optimal Medical Rehabilitation for Health Restoration" is assessed as insufficient, the Accounts Chamber report says.
Other
Roszdravnadzor automates the collection of data on errors in medical artificial intelligence
Roszdravnadzor has prepared a Procedure for transferring information on processed data and the results of actions of medical programs based on artificial intelligence (AI). The data will be sent to the automated information system (AIS). The draft order was published on the portal regulation.gov.ru.
The transferred information includes data on the registration certificate of a medical device with AI, the version of the program and its scope of application, information on the number of studies processed, and data identifying the medical organization that is the user of software with AI.
Reports are also required on:
- network errors related to data quality;
- errors related to the operation of a medical device with AI;
- errors that occurred during the processing of studies or objects by a medical device with AI.
The document does not contain information about the obligation of medical organizations to provide this information. On the contrary, it is stated that they have the right to provide data on a monthly basis. At the same time, automated sending of information is possible when connecting medical devices to a special software interface of Roszdravnadzor. Information on the method of connecting to this interface should be posted on the service's website in the "Services" section.
Earlier, the Ministry of Health updated the requirements for the content of technical and operational documentation of medical devices. Now it is necessary to indicate the presence or absence of artificial intelligence technologies in software related to medical devices. In addition, a description of the operation of these technologies and data on the presence of the software function for automatic transmission of data on the use of AI to Roszdravnadzor are required.
New registered medical devices
We publish a list of new medical devices registered from 06.27.2025 to 07.04.2025
Link to the list: [see table in the attachment]
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