News Digest 21.03.2025 — 28.03.2025
Regulators
Risk indicators for the medical device market are planned to be revised again
The Russian Ministry of Health presented a draft order, which proposes to reduce the number of risk indicators for the circulation of medical devices by three points. In the current version of the list (since August 2023), the list of markers includes four items. At the same time, in February 2025, the regulator planned to add another position there. The new decision, as noted in the current draft document, was prepared by the department on the instructions of the head of the Russian Government Office Dmitry Grigorenko. It is proposed to leave the indicator that will indicate the risks in the circulation of such products - if the company applies for a renewal of the service license or its registration, but the equipment for service and repair belongs to / is located with another company that is already engaged in this service.
The list of medical products for providing palliative care to patients will be adjusted
The Russian Ministry of Health has developed a draft list of medical products intended for providing palliative care to patients at home. The department decided to supplement the list with such medical products as a professional diagnostic spirometer, a reusable bag for a breathing circuit, a multi-parameter sensor for a breathing circuit, and others. In addition, the ministry plans to exclude 91 medical products from the list. Among them are a reusable breathing tube for an inhalation/exhalation branch pipe, a disposable internal cannula for a tracheostomy tube, and others.
A list of mandatory medical equipment for health centers has been presented
The Russian Ministry of Health has compiled a list of medical equipment for equipping (re-equipping) health centers for adults organized on the basis of hospitals and clinics under the federal project "Health for Everyone". The draft order is aimed at "forming citizens' commitment to a healthy lifestyle and preventing the development of diseases." According to the document, the centers must have express analyzers for determining total cholesterol and glucose in the blood, tonometers, spirometers and other equipment.
The federal project "Health for Everyone" is part of the new national project "Long and Active Life". In addition to upgrading adult health centers at medical organizations, the federal project provides for the creation of adult health centers based on medical prevention departments (offices) in remote areas - to improve preventive care for the population.
The list of equipment for the centers, the Ministry of Health proposes to include analyzers of carbon monoxide in exhaled air with the determination of carboxyhemoglobin (smokelyzer), scales and electronic height meters - at least two units for each position. It is also necessary to purchase one portable tonometer for measuring intraocular pressure, a spirometer with disposable mouthpieces, a container for soaking disposable mouthpieces and test strips, a bioimpedance meter for analyzing the internal environment of the body (determining the ratio of water, muscle and fat tissue in the body). The draft list of equipment also includes a medical couch, a bactericidal lamp, a digital three- or six-channel electrocardiograph with 12 standard leads and manual and automatic measurement, a dynamometer, and an Angioscan with a pulse oximeter.
As stated in the explanatory note to the draft order, the current pressing issues are the slowdown in the growth rate of life expectancy in Russia, significant differentiation in life expectancy between the constituent entities of the Russian Federation (13.31 years), rural and urban populations (1.74 years), as well as the "limited impact of the healthcare system on human health" and population aging.
"Current challenges include low commitment of citizens to a healthy lifestyle; an increase in diseases that affect healthy life expectancy. The combined impact of four risk factors – smoking, unhealthy diet, low physical activity and harmful alcohol consumption – contributes up to 61% to mortality from circulatory diseases, 44% to diabetes, 42% to respiratory diseases and 35% to malignant neoplasms,” the explanatory note notes.
The federal project is designed to form the population’s commitment to a healthy lifestyle and disease prevention, therefore it includes the development and implementation of new strategic and tactical approaches in the work of the prevention system. It is planned that by 2030 the share of citizens leading a healthy lifestyle should increase by 1.5 times.
In mid-February 2025, the Ministry of Health proposed adjusting the standards for equipping offices for dispensary observation and a health center for adults. The regulator intends to equip a workplace for telemedicine consultations there. In addition to n addition, prevention offices and centers should have materials available to demonstrate the harm of smoking, healthy eating behavior and the negative consequences of obesity. The project has not yet been adopted.
Market news
Syringe production to be organized in Nizhny Novgorod region for 1.6 billion rubles
Medical syringes will be produced in Kstovsky district of Nizhny Novgorod region. The regional investment portal is looking for an investor to create a facility with printing and assembly lines, as well as a packaging department. The cost of the facility is estimated at 1.6 billion rubles. The project must be implemented in 2.5 years, while the payback period will be 6 years. 480 people will be able to work there. The production will be equipped with a printing line with a capacity of 5 kW and a productivity of about 200 pieces per minute.
Other
Rostec developed domestic endoprostheses for 116 million rubles
Specialists from the Center for Innovative Technologies in Orthopedics (CITO), part of the Rostec State Corporation, successfully performed the first operation using a domestic endosystem for revision arthroplasty. The medical device is based on a titanium alloy with improved biocompatibility, wear resistance, and bacterial resistance. The development was carried out in cooperation with the Moscow Aviation Institute since 2022. The volume of investment in the project is not disclosed, however, as follows from the documents on the allocation of state subsidies, it was planned to allocate 116.2 million rubles from the federal budget for the creation of production from 2022 under the Science and Universities program - for the development of cooperation between scientific institutions and large Russian enterprises to create high-tech production.
Source: https://vademec.ru/news/2025/03/26/rostekh-razrabotal-otechestvennye-endoprotezy-za-116-mln-rubley/
New registered medical devices
We publish a list of new medical devices registered from 03.21.2025 to 03.28.2025
Link to the list: [see table in the attachment]
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