News Digest 28.02.2025 — 07.03.2025
Regulators
The government has changed the specifics of registering defective medical devices
The Russian government has adjusted the resolution regulating the specifics of circulation and state registration of medical devices in the event of their defect or risk of its occurrence "in connection with the introduction of restrictive economic measures against the Russian Federation." The changes came into force on March 1, 2025. Among other things, the document stipulates that an application for state registration of such goods must be submitted by a representative of the manufacturer through the state services portal.
According to the innovations, information about the defect of such goods, instead of their registration certificate, must be entered in the thematic entry in the state register of medical devices and organizations engaged in their production and manufacture. In addition, the fact of registration of the medical device must also be confirmed by data in the register.
To register a medical device, the applicant must submit a thematic application to the expert institution through the state services portal, and in the case of registration of a foreign medical device - the full and abbreviated name (with transliteration), the address of the manufacturer's location and other data. All required documents must be sent in electronic format and certified with an enhanced unqualified electronic signature. In the case of paper documents, their certified electronic images must be provided.
If the expert institution reveals incompleteness, unreliability or insufficiency of the information provided, it must send the applicant a thematic request to the personal account on the public services portal within five working days. The decision on state registration of a medical device must be made in the form of an order, and it is also necessary to notify the applicant by electronic document.
The resolution specifies that state registration of a medical device with a low degree of potential risk (except for those produced in sterile form), included in the thematic list, is carried out once in relation to one name of one manufacturer of such goods. The authorized representative of the manufacturer is obliged to send an application to the registration authority, as well as the required set of documents on state registration of such a product no later than 150 days after the thematic decision is made. The Russian government introduced a simplified procedure for registering medical devices with the option of obtaining an indefinite dossier and a simplified algorithm for replacing raw materials and components in already registered medical equipment in early April 2022. Initially, the document was supposed to be valid until September 1, 2023, but this period was repeatedly extended, once again until the end of 2028. In addition, in January 2025, Roszdravnadzor extended the work of the interdepartmental commission for the formation of a list of types of medical devices subject to simplified registration, from January 1, 2025 until the same date in 2028. Such a commission was established in November 2023. It includes one representative from each of the Ministry of Health, the Ministry of Finance, the Ministry of Economic Development, the Ministry of Industry and Trade, the Federal Tax Service, the Federal Customs Service, the Federal Antimonopoly Service and two representatives of Roszdravnadzor itself, as well as one representative from other bodies and organizations - "if necessary". The composition of the commission is approved by an order of Roszdravnadzor.
The last time Roszdravnadzor reported on updating the list of medical devices covered by the simplified registration mechanism was in July 2024. Then the list expanded to 2,208 items.
The Ministry of Health will approve a list of medical products to provide assistance to patients with diabetes
The Ministry of Health of the Russian Federation proposed to approve a list of medical products and other equipment for equipping regional, inter-district (district) centers providing medical care to patients with carbohydrate metabolism disorders and diabetes. The draft order was developed for the federal project "Fight against diabetes". The draft list consists of 27 items: a podiatry chair with power supply, a portable Doppler apparatus, a medical couch, a table for ophthalmic instruments with power supply, a set of trial lenses with trial frames and accessories, an automatic refractometer, a stationary slit lamp with accessories, an electric ophthalmoscope. In addition, the list includes an automatic perimeter for kinetic, static and special types of perimetry, an automatic tonometer-tonograph, a pachymeter, a retinal camera for fluorescent angiography, an optical coherence tomograph (anterior, posterior), an endothelial microscope, an aberometer, a keratotopograph, a device for ultrasound A-B scanning with a sensor for ultrasound biometry, a complex for EFI studies, an automatic pneumotonometer, an exophthalmometer, a binocular ophthalmoscope for reverse ophthalmoscopy with head fixation, a perimeter, a laser photocoagulator with a green beam complete with a slit lamp, a YAG laser (yttrium-aluminum garnet) complete with a slit lamp. mpoy, laser for selective trabeculoplasty, lenses for iridotomy-capsulotomy and pedicure apparatus.
The federal project "Fight against diabetes" is part of the state program "Healthcare development". In January 2025, the Government of the Russian Federation approved an updated version of the state program, supplementing the list of types of inter-budget federal transfers for the modernization of regional health care systems.
The total funding for the state program "Healthcare development" is set at 1.542 trillion rubles, of which 370 billion rubles are allocated for the new national project "Long and active life", 25.6 billion rubles for the federal project "Protection of motherhood and childhood" and 4.8 billion rubles for the national project "New technologies for preserving health".
The monthly standard for medicines and medical devices for beneficiaries may increase by 115 rubles
The Russian Ministry of Health presented a draft government resolution with an indicator of the monthly standard for spending on social assistance for beneficiaries in 2025. It is proposed to increase it to 1,326.4 rubles, which is 115.1 rubles more than now. From April 2024, the standard is 1,211.3 rubles per month.
The funds are sent to preferential groups of citizens in the form of state social assistance for obtaining medicines, medical devices and specialized therapeutic nutrition products for disabled children on prescription from a doctor or paramedic.
If the document is approved, it will apply to legal relations that arose from February 1, 2025.
According to the explanatory note to the draft resolution, the indexation coefficient for payments, benefits and compensations is set at 1.095. The indexation of the standard for financial costs for medicines and medical devices is determined taking into account the new coefficient.
In 2020, the monthly standard was 886.4 rubles (increased by 26 rubles compared to 2019), in 2021 it was 929.8 rubles (increased by 43 rubles), and in 2022 it was increased to 1,007.9 rubles (increased by 78.1 rubles). In 2023, the amount per person per month increased by 119.9 rubles and amounted to 1,127.8 rubles.
In April 2024, the government set a new standard for monthly social assistance costs for beneficiaries - 1,211.3 rubles per month, which is 83.5 rubles more than the previous figure.
In January 2025, the government also expanded the list of specialized therapeutic nutrition products for disabled children to 116 items, adding food for children with cystic fibrosis of different age categories. The updated list included a dietary therapeutic nutrition product - dry mixture "Resource Junior" for enteral nutrition of children from 1 year to 11 years old suffering from cystic fibrosis, as well as the product "Resource Optimum" with vanilla flavor for enteral nutrition of children over 7 years old suffering from cystic fibrosis.
Market news
"Medetour" will launch gauze production in the Chelyabinsk region for 37.5 million rubles
The Industrial Development Fund (IDF) of the Chelyabinsk region announced plans for the medical materials manufacturer "Medetour" to start producing sterile and non-sterile gauze. The total investment is estimated at 37.5 million rubles, of which almost 13.8 million rubles will be provided by the IDF in the form of a preferential loan under the "Development Projects" program. The investments will be used to purchase and install equipment, commissioning work, and launch serial production. According to Alexey Melnik, Deputy Director of Medetur, the start of the enterprise is scheduled for mid-2025.
VIP Kamilla Wins Second Moscow Offset Contract for Medical Products for 11.4 Billion Rubles
VIP Kamilla, a company close to the Turkish multi-industry manufactory UCAR Group, has won an offset contract for the production of urological inserts for the needs of the Moscow Department of Labor and Social Protection. The city authorities will purchase the products from March 2025 to the end of 2034, the total offset volume is estimated at 11.402 billion rubles. In exchange, the company must invest at least 200 million rubles in the design and construction of production or its technical re-equipment this year, and also include industrial sites in the registration certificate of the medical device. In 2023, VIP Kamilla already won the Moscow offset for the production and supply of absorbent underwear for almost 12 billion rubles.
Sechenov University to launch a master's degree program "Architect of Medical Products"
A new master's degree program, "Architect of Medical Products", is being developed at the First Moscow State Medical University named after I.M. Sechenov, designed to train employees of enterprises developing medical equipment I and graduates of the bachelor's and specialist's degree programs in technical fields. The duration of study will be 2 years. The university plans to accept its first students in the upcoming academic year; classes will begin on September 1, 2025.
Other
ETU "LETI" has created a prototype of a "smart" bracelet for emergency insulin administration
The drug (up to 4 ml) is administered into the body by pressing a button once. Micron-sized needles pierce the stratum corneum of the skin, delivering the drug to the epidermis or upper layer of the dermis, from where it freely penetrates into the systemic bloodstream. A person will not experience pain, since the needles do not reach the nerve endings. Skin damage is minimal, and healing occurs quite quickly, which, compared to conventional injections, reduces the risk of human infection, and can also be used independently and ensures rapid penetration of the drug into the body.
The development is equipped with an array of microneedles created using 3D printing. In the future, such devices may find mass application and be used as individual means for diabetes therapy.
Sechenov University is developing a digital platform based on AI for diagnosing chronic gastritis
Specialists from the Institute of Clinical Morphology and Digital Pathology of the First Moscow State Medical University named after I.M. Sechenov, together with VimpelCom, are developing a system to support medical decision-making based on artificial intelligence technology for diagnosing chronic gastritis and identifying patients with a high risk of developing stomach cancer. The goal of the development team is to improve the accuracy and quality of morphological diagnostics and reduce the likelihood of diagnostic errors in routine pathomorphological examination of gastrobiopsy specimens - tissue samples obtained during gastric endoscopy. There are no analogues to this digital solution on the Russian and international markets.
New registered medical devices
We publish a list of new medical devices registered from 02.28.2025 to 03.07.2025
Link to the list: [see table in the attachment]
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