News Digest 07.11.2025 — 14.11.2025
Regulators
Russia to Launch Post-Market Quality Monitoring of Urological Medical Devices
Next year, a digital registry of the quality of medical devices used in urology will be launched in Russia. The National Analytical and Expert Center for Healthcare (NAECH) has become the operator of the pilot project. A partnership agreement was signed on November 10 by Alexander Rumyantsev, Chairman of the Center's Expert Council and Academician of the Russian Academy of Sciences; Dmitry Pushkar, Chief Urologist of the Ministry of Health of the Russian Federation and Academician of the Russian Academy of Sciences; and Igor Ivanov, Director General of the All-Russian Research and Testing Institute of Medical Equipment (VNIIIMT) of Roszdravnadzor (MV has a copy of the document).
In the initial phase, the pilot project is planned to include approximately 100 devices, including urethroscopes, hysteroscopes, nephroscopes, resectoscopes, and various surgical systems. This represents the entire range of medical devices used in urology. Urology surgeons will be responsible for reporting adverse events during their use.
"Currently, a multitude of medical devices with registration certificates are circulating on the market. However, their quality is low: in reality, many don't even meet the manufacturer's stated specifications. The use of low-quality devices results in harm to patients and legal risks for doctors. Doctors rarely report adverse events to the Roszdravnadzor system. The result is chaos and the absence of a proper monitoring system. We hope that this project will help bring order to this area," Polina Gabay, a member of the working group on oncology, hematology, and transplantation of the State Duma Committee on Health Protection and an expert on the "regulatory guillotine," told MV.
According to her, similar practices for monitoring the quality of medical products during the post-registration stage exist in other countries. Importantly, notifications will be submitted to the registry for various checklist items, not just adverse events. The reports are planned to be presented to senior external specialists on specialized commissions and forwarded to Roszdravnadzor. The resulting materials may be used, in particular, to recall a series or batch of a particular manufacturer from the market, for example, if complications from the use of medical devices are found to be too frequent.
A number of medical device manufacturers in Russia face increased scrutiny from regulatory authorities. Roszdravnadzor will also subject companies conducting clinical trials of such products to more frequent inspections. These changes are envisaged in the draft Regulation on Federal State Control (Supervision) over the Circulation of Medical Devices, published in late September, MV reported.
It was previously reported that Russia has finally overcome its dependence on imported resuscitation equipment. Domestic companies and research institutes are jointly developing unique developments—from defibrillators and ventilators to an innovative, world-class device for preserving donor livers. Russia will also restrict government procurement of foreign coronary stents and balloon catheters. The initiative aims to support domestic producers and reduce dependence on imports.
The Moscow Department of Health has included medical devices and therapeutic nutrition products in its regulations for the use of electronic prescriptions
The Moscow Department of Health (DH) has amended its Order No. 221, dated March 13, 2023, which regulates the information exchange procedures for the creation and use of electronic prescriptions. The regulations now apply not only to medications but also to medical devices and specialized therapeutic nutrition products.
The amendments expand the scope of Order No. 221, which establishes requirements for data exchange between pharmacies and the Unified Medical Information and Analytical System (UMIAS).
Oksana Borozdina, Deputy Head of the DH and Head of the Contract Service, and Deputy Heads of the Department, Saida Gadzhieva, Konstantin Pokrovsky, Nikolai Rubtsov, and Ilya Tyrov, have been assigned to oversee the implementation of the order.
The updated document has already entered into force.
Previously, the Russian Government approved a pilot program for the implementation of electronic graphic signatures in Moscow clinics for the registration of informed voluntary consent for or refusal of medical interventions. The pilot is aimed at improving patient convenience and speeding up processes in the capital's healthcare system.
Expanding the "second-odd-person" rule could increase healthcare facilities' costs
The Russian Ministry of Industry and Trade proposed to Deputy Prime Minister Tatyana Golikova that the "second-odd-person" support mechanism be extended to all medical devices. The initiative was supported by the federal Ministry of Health and Roszdravnadzor. This measure could benefit the medical industry, but will increase healthcare facilities' costs, according to Pharmaceutical Bulletin, citing experts.
Currently, the rule applies to the procurement of 110 medical devices. The Russian Ministry of Health proposed adding another 200 items to this list, but the Russian Ministry of Industry and Trade "went further."
Most experts interviewed by FV agree that the blanket application of the "second wheel" for medical device procurement will support domestic manufacturers. "The proposed measure effectively places the entire medical device sector under a restricted access regime: if there is even one properly confirmed application for a Russian-made device, foreign proposals are subject to rejection. This approach should generate sustainable demand for local products and create additional incentives for the development of domestic production," says Polina Gabay, Chair of the Board of Founders of the National Analytical and Expert Center for Healthcare.
At the same time, such a regime inevitably narrows the competitive field and increases the risk of unavailability of foreign medical devices due to reduced supplies. "This is a concern, especially given that the medical device market remains highly dependent on imports," the expert noted.
According to current regulations, 100% of Russian-made medical devices are already covered by support measures, noted Alexey Fedorov, an expert with the All-Russian Union of Patients (VSP). A 15% price preference applies to the purchase of devices not included in the appendices to Russian Government Resolution No. 1875 of December 23, 2024.
"Strengthening support measures with the transition to bans and the 'second-odds-to-buy' policy could lead to increased costs for medical organizations. Currently, they can purchase foreign devices not included in the lists in two cases: if no bids for domestic medical devices have been submitted for the procurement, or if the foreign device is offered at a price 15% or more lower than the price of the Russian device," explained Alexey Fedorov. "After the transition to the 'second-odds-to-buy' policy, where a medical organization previously received foreign devices at a reduced price, it will receive domestic devices at a higher price."
The Russian Ministry of Industry and Trade's initiative could support the domestic medical industry if two barriers are removed. "First, if the customer initially sets the starting price based on the prices of cheaper foreign equivalents, then suppliers of Russian products will simply not participate in procurement, and therefore, the 'second wheel' will not work. Second, if the customer has an objectively justified need for a product with characteristics that only foreign products meet, then by including such characteristics in the procurement notice, the customer immediately excludes the supply of Russian products," the expert says.
Market news
Roszdravnadzor (Federal Service for Surveillance in Healthcare) has connected marketplaces to the medical device registry
Four of Russia's largest online marketplaces—Wildberries, Yandex Market, MegaMarket, and Ozon—have been connected to Roszdravnadzor's medical device registry. This allows the legality of products to be verified directly from the product card, according to the Pharmaceutical Bulletin.
Sellers must now indicate the registration certificate number issued by Roszdravnadzor when creating new product cards. Marketplaces have committed to bringing all listings created before March 1, 2025, into compliance with this requirement by the end of the year.
Currently, admission of medical devices to the Russian market requires a registration certificate issued under the national procedure or under the laws of the Eurasian Economic Union, as well as a registry entry on the Roszdravnadzor website effective March 1, 2025.
In 2024–2025, the largest trading platforms began requesting registration certificates for medical products from sellers en masse; cards without these documents are blocked. This decision changes not only the trading rules but also the very philosophy of the market, MV reported.
According to expert estimates, a significant portion of medical products listed on marketplaces lack valid registration certificates, in part due to a lack of information among sellers and the complexity of the registration process. However, companies that complete product registration in a timely manner gain many competitive advantages, including consumer trust, business security, and brand reputation.
Source: https://medvestnik.ru/content/news/roszdravnadzor-podkluchil-marketpleisy-k-reestru-medizdelii.html
Production of CT scanners and angiographs has begun in Moscow
Zanton MS has begun production of CT scanners and angiographs for diagnosing tumors and cardiovascular diseases at a site in the Technopolis Moscow special economic zone. The city administration press service announced that 60 devices are expected to be produced annually. The press service also noted that residents of the special economic zone are entitled to a number of tax breaks.
According to SPARK, Zanton MS LLC was registered in Moscow two years ago, in August 2023. At its inception, the company had two co-owners: Russian and Chinese entrepreneurs Veniamin Tonky (45%) and Zhan Zhenyu (55%). In 2024, a Chinese citizen became the 100% beneficiary. The legal entity's revenue in 2024 amounted to 4,000 rubles, with a net loss of 61.5 million rubles.
According to information on the Zanton MS LLC website, the company supplies medical equipment and spare parts from Russia and China. The catalog features, among other things, the domestically produced DiaVision angiograph and DiaVision PET/CT system, as well as cyclotrons for the preparation of radiopharmaceuticals (RPs) manufactured by the Chinese company LBT. The level of localization of production and the cost of the equipment are not specified.
Source: https://medvestnik.ru/content/news/v-moskve-nachalos-proizvodstvo-tomografov-i-angiografov.html
Other
Manufacturers of small-unit medical devices fear the introduction of labeling
The introduction of a medical device labeling system, according to some manufacturers, creates critical problems for producers of small-unit items such as syringes, alcohol wipes, and dressings. Applying codes to small-unit packaging is technically impossible, and when combined with the economic infeasibility, this could lead to shortages and price increases of up to 30%.
The labeling system effectively combats counterfeiting and improves control, but for small consumables such as syringes and alcohol wipes, it creates critical problems, stated Ekaterina Nechitailova, Development Project Manager at M.K. Aseptika LLC, at the Novamed conference, according to a correspondent for FV.
Ekaterina Nechitailova emphasized the economic infeasibility of labeling each product unit. According to her, this increases production costs and will lead to price increases of 15 to 30%.
She also noted that very small packaging already contains all the required information and simply lacks space for a Data Matrix code. As a result, stickers could obscure important data, which violates existing GOST standards.
The speaker proposed giving manufacturers the right to independently choose where to apply the code on the packaging, citing existing successful experience in other product categories. She also advocated for simplifying the procedures for withdrawing products from circulation after sale, which is especially relevant for government-ordered supplies to medical institutions. The expert also urged a revision of printing house warranties to ensure their liability extends throughout the product's shelf life. In her opinion, these steps are necessary to ensure traceability, stable supply, and maintain affordable prices for socially significant products.
A voluntary experiment on labeling certain types of medical devices is being conducted in Russia until February 28, 2026. There are no regulatory requirements for applying identification to each unit of small-piece products, and none are planned, Honest Sign assured FV.
New registered medical devices
We publish a list of new medical devices registered from 11.07.2025 to 11.14.2025
Link to the list: [see table in the attachment]
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