News Digest 24.01.2025 — 31.01.2025
Regulators
The Ministry of Health has proposed to regulate the circulation of medical devices by the acts of the Eurasian Economic Union
The Russian Ministry of Health has presented a draft federal law, according to which it is proposed to transfer the regulation of the circulation of medical devices in Russia to the acts of the Eurasian Economic Union (EAEU). The changes are necessary for the implementation of the Agreement on uniform principles and rules for the circulation of medical devices and medical equipment in the EAEU. If the document is approved, it will enter into force on January 1, 2027.
According to the explanatory note, the purpose of the bill is to eliminate state fees for the actions taken by the authorized federal executive body when registering medical devices. The document states that December 31, 2025 will be the deadline for filing an application for registration of a medical device under the national procedure.
"The basic current approaches of national legislation regulating state control over the circulation of medical devices, measures to prevent the circulation and withdrawal from circulation of counterfeit, counterfeit and poor-quality medical devices, monitoring of medical devices were taken into account when developing new EAEU acts," the Russian Ministry of Health explained.
In early December 2024, the Russian Government approved new Rules for the Registration of Medical Devices, which will be in effect from March 1 to December 31, 2025 - until the transition to the EAEU rules. The rules will replace the procedure approved in 2012. According to the updated rules, a one-stage procedure for registering domestically produced medical devices will be in effect in Russia, subject to technical and toxicological tests at the All-Russian Research and Testing Institute of Medical Equipment of Roszdravnadzor, and clinical trials - in federal medical centers accredited by the Ministry of Health. The mechanism for accelerated entry of medical devices into the domestic market will apply to devices that have a low degree of potential risk, for in vitro diagnostics, as well as IT solutions, including those based on artificial intelligence technologies. The duration of their registration is from 32 to 112 business days versus 50–180 days in the case of the usual procedure.
The regulator will approve the list of medical devices for equipping perinatal centers
The Ministry of Health of the Russian Federation has developed a draft list of medical devices for equipping perinatal centers and maternity hospitals (departments), including those within other organizations. Additional equipment of such institutions will be carried out under the federal project "Protection of Motherhood and Childhood", which is part of the national project "Family". The explanatory note states that the document was developed to improve the provision of medical care to pregnant women, women in labor and newborns, as well as to eliminate corruption factors.
According to the draft order, the list includes 51 items in total. The medical devices that will be supplied to perinatal centers and maternity hospitals if the document is approved include a central anesthesia monitor station, artificial lung ventilation devices, as well as infusion solution heaters (blood and fluid heaters), ultrasound, X-ray, surgical aspirator, defibrillator, tables for delivering babies and performing surgeries, plasma defroster, anesthesia and respiratory apparatus for children, resuscitation systems for newborns and other products.
The standards for equipping maternity hospitals (departments) and perinatal centers are already spelled out in the Procedure for the provision of medical care in the profile of "obstetrics and gynecology" from 2020. The new draft order of the Ministry of Health does not say that these regulations are no longer in effect. Thus, the standard for equipping perinatal centers specifies lists of medical products for the obstetrician-gynecologist's office (gynecological chair, couch, scales, thermometer, etc.), procedure room, operating room, functional diagnostics room and other rooms.
The standard for equipping a maternity hospital specifies medical products that must be placed in various departments of the institution. Thus, lists are provided for the admissions department, examination room, pregnancy pathology department, procedure room, delivery room, operating unit and other rooms. Among the medical products specified in the regulations are an artificial lung ventilation device, a module for storing sterile disposable medical products, ultrasound machines, medical couches, etc.
In January 2025, the Government of the Russian Federation approved an updated version of the state program "Healthcare Development". The regulator has expanded the list of types of inter-budget federal transfers for the modernization of regional healthcare systems. It was decided to direct federal budget funds to the implementation of a new federal project - "Protection of Motherhood and Childhood" (equipping perinatal centers). In 2025, 25.6 billion rubles have been allocated for the implementation of the national project "Family" and the federal project "Protection of Motherhood and Childhood" included in it. It is expected that by 2030, 120 perinatal centers will be equipped and re-equipped (the total costs for these purposes will amount to 48 billion rubles) , 330 new women's consultations will open (46 billion rubles). In addition, it is planned to allocate 50.5 billion rubles for the purchase of medical equipment for institutions providing assistance to children.
Golikova clarified the parameters of the national project "New Health Saving Technologies"
Deputy Prime Minister of the Russian Federation Tatyana Golikova held the first meeting of the project committee for the national project (NP) "New Health Saving Technologies". At the event, she reported that during the implementation of the NP, support will be provided, in particular, to organizations conducting clinical trials of original drugs for the treatment of cancer, acute myocardial infarction, pain syndrome, lung damage, diabetes mellitus, cognitive impairment. The national project will also finance original developments of biomedical cell products and tissue engineering products.
According to Golikova, support will also be provided to developers of medical devices. The group of priority projects includes clinical trials of products for the diagnosis and treatment of diseases of the musculoskeletal system, diagnosis of allergies, diagnosis and medical rehabilitation of people with post-traumatic stress disorder (PTSD), surgical treatment of a number of diseases and radiological treatment of oncological diseases.
Assistance will be provided to projects to create new technologies for the diagnosis and treatment of neurodegenerative and cognitive disorders, original bioprinting solutions for healthcare, as well as innovations that make it possible to determine a person's biological age and slow down cell aging.
Market news
Moscow announced an offset contract for the production of medical devices worth 11.4 billion rubles
The Moscow Department of Labor and Social Protection of the Population announced a competition for the conclusion of an offset contract (with counter obligations of the investor) for the production of urological absorbent inserts for urinary incontinence. The initial maximum contract price is set at 11.4 billion rubles. The deadline for submitting applications is scheduled for February 14, 2025.
The procurement documentation states that the supplier will have to allocate at least 200 million rubles for the creation, modernization and development of the production of absorbent urological inserts for urinary incontinence no later than eight months from the date of the contract. The creation of production means, among other things, the design and construction of facilities, technical re-equipment of capital construction projects, purchase, installation and commissioning of equipment, inclusion of the production site in the registration certificate for medical devices manufactured at the facility.
In turn, the Moscow Department of Labor and Social Protection of the Population will purchase urological absorbent pads from the contractor in the period from March 2025 to the end of 2034 at an initial unit price of 1.4 thousand rubles. Every year, the customer will purchase three types of male and female pads with different absorption capacities. Payment for the state purchase will be made from the Moscow budget.
Among other offsets is a contract for the production and supply of absorbent underwear (diapers and nappies) for the needs of Moscow for a total of 11.8 billion rubles. The winner of the competition of the Moscow Department of Competition Policy was the company "VIP Kamilla", which is part of the Turkish multidisciplinary manufactory UCAR Group. The company became the only participant in the auction, as a result of which the commission declared the competition invalid and in January 2023 recommended concluding a contract with VIP Kamilla LLC.
Med TeKo to launch production of medical equipment in Mytishchi for 850 million rubles
Med TeKo, a manufacturer of medical equipment, has acquired production facilities in Mytishchi (Moscow Region). The investment amounted to 850 million rubles, of which the company received 500 million under the Industrial Mortgage program, and 100 million under a preferential loan from the government of the Moscow Region. At the new site, Med TeKo intends to begin production of steam sterilizers and other devices. The area of the production facilities in Mytishchi is more than 13.4 thousand square meters. Due to the acquired capacities, the company intends to improve the enterprise, launch new production areas and create over one hundred high-tech jobs, as noted by the Minister of Investments, Industry and Science of the Moscow Region Ekaterina Zinovieva.
Med TeKo plans to start producing steam sterilizers, shock wave therapy devices for ultrasound SMAS lifting, physiotherapy combines.
Other
Research: 98% of cases on the circulation of substandard medical products are completed are guilty verdicts
The Kitsing & Partners law firm analyzed court verdicts for 2015–2023 on the illegal circulation of medical devices under Article 238.1 of the Criminal Code of the Russian Federation (circulation of counterfeit, poor-quality and unregistered medicines, medical devices and circulation of counterfeit dietary supplements). Lawyers noted that 98% of decisions made under this article of the Criminal Code in relation to suppliers and manufacturers are guilty verdicts. Moreover, in 79% of cases, it is the top managers or beneficiaries of companies who are held accountable.
Newly registered medical devices
We publish a list of new medical devices registered from 01.24.2025 to 01.31.2025
Link to the list: [see table in the attachment]
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