News Digest 06.06.2025 — 20.06.2025
Regulators
The Ministry of Health has approved a list of equipment for health centers
The Ministry of Health has approved a list of equipment for identifying and correcting risk factors for the development of chronic non-communicable diseases for equipping health centers for adults in the structure of medical organizations. Order No. 183n dated April 11, 2025 was published on the legal information portal.
The list of equipment includes the following names of medical products:
- tonometers (automatic, mechanical or telemetric);
- express analyzer for determining blood glucose;
- exhaled air carbon monoxide analyzer with determination of carboxyhemoglobin (smokelyzer);
- spirometer (portable with disposable mouthpieces);
- scales;
- height meter;
- bioimpedance meter for analyzing the internal environment of the body (determining the ratio of water, muscle and fat tissue in the body).
The list was approved within the framework of the federal project "Health for Everyone", which is part of the state program "Healthcare Development".
The government has tightened the requirements for the localization of medical devices
The Russian government has changed the rules for maintaining the register of industrial products, adding the authority for the Ministry of Industry and Trade to exclude products from the register if the manufacturer has not provided information on manufactured and shipped goods within 90 days after April 1. In addition, the rules for determining the country of origin of medical clothing have been revised.
Amendments have been made to RF Government Resolution No. 719, which regulates the parameters for localizing products to obtain preferences in the government procurement market.
In particular, in Section VII "Medical Products", products classified by OKPD2 codes 14.12.11, 14.12.21, 14.12.30.131, 14.12.30.132, 14.12.30.160, and radiation protection equipment under code 14.12.30.160 "Specialized protection equipment against radiation and exposure to other adverse environmental factors that do not contain built-in breathing apparatus" are excluded and transferred from the medical products block to Section XVII "Products of the light industry" of OKPD2 "Workwear", classified by code 14.12.
It assumes stricter localization rules, including a point system that takes into account the implementation of technological manipulations on the territory of the country. It is assumed that the amendments will help to eliminate the loophole that allowed manufacturers to choose an easier way to confirm the localization of products.
As noted in the explanatory note to the draft document, the Ministry of Industry and Trade, by its order No. 5065 of December 6, 2022, planned to transfer the category "Medical clothing" to a point system for assessing the localization of production. However, at the moment, it has not been implemented. At the same time, Government Resolution No. 610 of May 17, 2024 established a point system for the entire category of the OKDP2 code "Special clothing", classified by code 14.12. Since medical products are in a separate section of the list, this created an opportunity for manufacturers to apply a more lenient localization system than the point system.
Another change concerns the grounds on which products can be excluded from the register. In particular, the Ministry of Industry and Trade received the right to exclude products from the register if the manufacturer has not provided a report on manufactured and shipped goods within 90 days after April 1 of each year. This rule will come into force on January 1, 2026.
Market news
Optical tomograph used in heart surgery for the first time in Russia
An operation using an optical coherence tomograph was performed at the Yekaterinburg "New Hospital". This is the only device of this class operating in Russia, and the first such intervention using it in the country, the press service of the Ministry of Health of the Sverdlovsk Region reported. The device allows for real-time acquisition of highly accurate images of heart vessels and helps doctors make more informed decisions during the operation. The equipment was purchased as part of the federal project "Combating Cardiovascular Diseases" of the national project "Long and Active Life".
The patient was a 70-year-old resident of the Sverdlovsk Region, who had previously undergone several operations. Using new equipment, X-ray surgeons assessed the condition of her arteries, expanded narrowed areas with a special balloon and installed stents.
The tomograph transmits a light signal into the artery through a catheter and forms 3D images of the vascular wall with high resolution - ten times higher than that of standard angiography. The obtained data is analyzed using built-in artificial intelligence algorithms. This allows the doctor to see the internal structure of the vessel right during the operation, determine the degree of damage, the presence of calcium and the risk of rupture of atherosclerotic plaques. As explained in the hospital itse, the method allows you to notice even the smallest plaques that are not visible on conventional coronary angiography, but can lead to a heart attack or sudden cardiac arrest.
Other
Rostec has begun serial production of the CardioRobot for indirect cardiac massage
Roszdravnadzor has included the automated chest compression complex CardioRobot, developed by the Rosel holding (part of the Rostec Group), in the state register of medical devices. Roszdravnadzor has included the automated chest compression complex CardioRobot, developed by the Rosel holding (part of the Rostec Group), in the state register of medical devices. The complex is designed for indirect cardiac massage for up to 45 minutes without interruption.
"CardioRobot" can turn on automatically when the heart stops and adjust the pressure and depth of compressions, based on data from the sensors. The complex informs doctors about the actions using messages on the display.
The project is being implemented by specialists from the Almaz research and production enterprise (part of Rosel) with the support of the Ministry of Industry and Trade of Russia. Serial production has already been launched.
It is planned that the medical device will be used in intensive care units, ambulances, transplant departments, and feldsher-obstetric stations.
A pilot copy of the robot was presented in July 2023.
The volume of investments in the project was then estimated at 329 million rubles.
Source: https://t.me/vademecum_live/18181
Sber and Sechenov University to develop an AI assistant to combat excess weight
The parties signed the corresponding agreement at the St. Petersburg International Economic Forum. The project will be implemented with the support of the Russian Ministry of Health.
The joint initiative includes the development of the mobile application "Lose Weight for Health". The innovativeness of the project, according to the parties, lies in the use of an intelligent system based on Sber's GigaChat neural network model, which will analyze individual user indicators, create adapted weight correction programs and provide ongoing psychological support in the process of changing lifestyle.
Source: https://t.me/vademecum_live/18247
New registered medical devices
We publish a list of new medical devices registered from 06.06.2025 to 06.20.2025
Link to the list: [see table in the attachment]
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