News Digest 19.12.2025 — 26.12.2025
Regulators
ELTA Wins Lawsuit Against Roszdravnadzor Over Destruction of 17,000 Glucometers
The Moscow Arbitration Court partially upheld the claim of ELTA Company, a Russian manufacturer of medical devices for diabetes patients, against Roszdravnadzor. The vendor sought to have the orders and decisions of the Roszdravnadzor Territorial Office for Moscow and the Moscow Region declared illegal. The regulator had previously issued 32 information letters identifying the company's glucometers as defective. As a result, the court declared the order, which required the regulator to seize and destroy 17,000 devices from batches, illegal. The court rejected the remaining claims.
ELTA filed a claim with the Arbitration Court against the Territorial Authority of Roszdravnadzor for Moscow and the Moscow Region, demanding that the decision to conduct a random quality control of medical devices, the defendant's actions in conducting the inspection itself (including the random quality control report), and the order No. 241/25 of July 1, 2025, to eliminate the identified violations, which required the seizure and destruction of medical devices deemed "deficient" by the regulator, be declared unlawful.
Company representatives cited violations committed during the examination. According to the plaintiffs, the examination was conducted with a gross deviation from the mandatory GOST standard regarding temperature control, which could have distorted the measurement results, and the expert institution conducted significantly fewer tests than required by the standard to obtain reliable statistical data.
Furthermore, the standard requires evaluating the system's accuracy at seven different glucose concentrations to verify the device's performance across its entire range. However, the Federal State Budgetary Institution "VNIIIMT" only conducted tests on two concentrations, casting doubt on the accuracy of the assessment.
The company also emphasized that in a number of negative reports, the actual subject of the study was a different medical device – the "Satellite Online" Glucometer. The results obtained for this device were extended to the tested devices (PKG-03 "Satellite Express" and "Satellite Express Mini") without conducting full testing.
The defendant, Roszdravnadzor, and third parties, including the Moscow Department of Healthcare's Central Laboratory for Disease Control and Prevention and the Federal State Budgetary Institution "VNIIIMT," which is subordinate to the regulator, objected to the claim. They argued that the inspection was initiated legally – based on Roszdravnadzor's instructions following the receipt of information about adverse events associated with the use of the plaintiff's medical devices. During an inspection coordinated with the prosecutor's office, samples were collected, and an examination by the Federal State Budgetary Institution "VNIIIMT" confirmed their non-compliance with regulatory and technical documentation, deeming the products defective.
As a result, the court partially upheld ELTA's claims and declared the July 1, 2025, order No. 241/25 to rectify the identified violations illegal. It also ordered the regulator to pay the 50,000-ruble state fee paid when filing the claim. However, the company's remaining claims were denied.
In early September 2025, Roszdravnadzor issued 32 informational letters concerning the Satellite Express, Satellite Express Mini, and Satellite Online glucometers. Following an inspection, the regulatory agency deemed the products to be of substandard quality. In addition to discrepancies in dimensions, documentation, and labeling, the testing revealed that the accuracy of the results ranged from 56% to 83%, while the manufacturer's stated accuracy of at least 95%, as stated in its GOST and quality management system. As a result, on September 23, the agency ordered the seizure and destruction of the questionable devices from batches totaling over 17,000 units by December 2025.
The company disagreed with the inspection results and filed a lawsuit in the Moscow Arbitration Court. "ELTA believes that product testing conducted with fundamental violations of regulatory documents, which have an unconditional impact on the test results, cannot be used as the basis for decisions made by the regional offices of Roszdravnadzor," the company told Vademecum.
ELTA is one of the oldest medical device manufacturers in Russia, founded in 1993. According to SPARK-Interfax, the key beneficiary of ELTA Company LLC is Yuri Glukhov (75%). Other co-owners include Vladimir and Galina Vaschenko (8.3% and 4.7%, respectively), Vyacheslav Gorenbein, Alexander Kalyan, Boris Mishchenko, and Alexey Miyuzov. The company's current financial performance is not disclosed; in 2020, revenue amounted to 2.61 billion rubles, with net profit of 667 million rubles.
A list of equipment for the modernization of radiology centers has been approved
The Russian Ministry of Health has approved a list of equipment and medical devices for the modernization and retrofitting of departments of regional medical organizations providing care using radiological diagnostic and therapeutic methods. The document is available on MV.
The list includes 14 types of medical devices and 37 types of technological equipment, including gamma cameras, positron emission tomography (PET/CT) systems, single-photon emission computed tomography (SPECT and SPECT/CT) scanners, automatic syringe injectors for contrast agents, radiation protection cabinets, and ultrapure water production equipment. The list also includes dosimetry equipment, radioactive waste storage systems, and radiopharmaceutical synthesis units.
The draft order was published on October 21 on the regulation.gov.ru portal. The explanatory note states that it is possible to finance procurement from the federal budget through subsidies under the federal project "Fight Against Cancer."
In November, it was reported that, according to the Russian Ministry of Health, almost a quarter of the equipment in public medical institutions requires replacement. The share of medical equipment that has been in use for more than ten years was 24.8% by the end of 2024. The main obstacle is the lack of certain domestically produced devices.
Earlier, the regulator postponed the entry into force of the requirements for hospital beds in medical organizations providing oncology care. The postponement applies to clinics opened before January 1, 2022, MV reported.
Market news
Diakon-DS to Raise 332 Million Rubles for Import-Substituting Reagent Production
The Industrial Development Fund (IDF) has approved a 332 million ruble concessional loan for Diakon-DS. The funds will be used to establish a production facility for biochemical blood test kits in Pushchino (Moscow Region). The total project budget is estimated at 462 million rubles. The company plans to establish import-substituting production of multicalibrators and laboratory reagents used in clinical diagnostics.
Diakon-DS products are expected to be supplied to public and private laboratories and used to detect diseases and assess the risk of developing pathologies. According to the company, approximately 80% of the Russian market for such reagents will be supplied by imports in 2025. The company believes that the project's implementation will significantly reduce dependence on foreign supplies, and Diakon-DS's share of the domestic market, once it reaches its design capacity, could exceed 10%.
The new financing is part of the company's long-term investment program in Pushchino, which began in 2021. At the time, Diakon-DS announced plans to invest 350 million rubles in the construction of a production and warehouse building to expand its reagent and diagnostic equipment production capacity.
Later, in 2024, the company clarified the parameters of the investment program and announced its intention to allocate 600 million rubles to expand the production of medical equipment for laboratory testing. Completion of construction and commissioning of the production complex are scheduled for the fourth quarter of 2026. To implement the project, the company took advantage of the regional "Land for 1 Ruble" program.
According to Rusprofile, Diakon-DS has been operating since 1998 and specializes in the production of medical materials. The company is registered in Pushchino and is managed by CEO Tatyana Korzun. The company's revenue for 2024 amounted to 1.08 billion rubles.
The funding decision was made by the IDF Supervisory Board, chaired by Anton Alikhanov, Minister of Industry and Trade of the Russian Federation. The Ministry of Industry and Trade notes strong demand from industrial businesses for the fund's concessional loans, as evidenced by the growing number of applications and repeat requests from companies.
Other projects in the pharmaceutical and medical industry will be implemented with the support of IDF programs in 2025. For example, Nova has launched production of glucometer components in the Tula Region, Medetur is planning to launch production of sterile and non-sterile medical gauze in the Chelyabinsk Region, and Kvadrat-S has begun production of dietary supplements in Obolensk, Moscow Region, and plans further expansion with the help of concessional financing.
Rosatom to Acquire Rights to Develop Biodegradable Implants for 439 Million Rubles
Rusatom RDS (a high-tech integrator of civilian products), a division of Rosatom State Corporation, will acquire the intellectual property rights to develop biodegradable implants created in partnership with the Kurchatov Institute National Research Center for 185.5 million rubles. The total project cost, including previous development costs, is estimated at 439 million rubles.
The implants are a series of innovative composite materials based on lactide polymers filled with calcium phosphates. The key feature of the new technology is the use of nanoscale filler particles, which provides the medical devices with increased strength and bioactivity.
This innovation should address the shortcomings of traditional metal implants and existing polymer biodegradable alternatives. Metal implants often cause osteolysis due to insufficient mechanical properties and require repeated surgeries for removal. Patients with such implants have problems with diagnostics using MRI machines.
Polymer analogs can degrade more quickly due to insufficient strength and uncontrolled biodegradation time, which increases the frequency of repeat surgeries and increases the risk of inflammation. This new development aims to address these drawbacks: according to the developers, the devices offer increased biocompatibility, are completely replaceable by bone tissue, and allow for unlimited MRI diagnostics.
In Russia, the current demand for these devices is estimated at approximately 100,000 surgeries per year. The main consumers are the Central Clinical Hospital of the Russian Academy of Sciences, the A.V. Vishnevsky Institute of Surgery, the N.N. Priorov National Medical Research Center of Traumatology and Orthopedics, and other institutions.
The Science and Innovation Division of Rosatom State Corporation announced R&D for the development of copolymers and the production of a pilot version of a screw, plate, and rod in October 2023. At the time, it was anticipated that the medical devices could find application in traumatology, orthopedics, and maxillofacial surgery. The initial maximum contract price was 215 million rubles. The winner of the tender was required to evaluate raw materials for implant production on the Russian and friendly markets, develop laboratory procedures for their production, and conduct technical and biomedical testing of prototype medical devices. Pilot batches of 4- and 6-mm-diameter interference screws have already been produced, and successful preclinical trials on large animals have been completed.
In August 2024, the Rusatom RDS division placed a tender for the full acquisition of exclusive rights to the development from the contractor, the Kurchatov Institute National Research Center. The purchase price was 253.3 million rubles.
Other
The head of Bashkortostan's capital construction department was convicted of purchasing counterfeit ultrasound machines
A court sentenced Inna Iksanova, head of Bashkortostan's capital construction department, for supplying counterfeit medical equipment to medical institutions in the republic. She was found guilty of abuse of office, causing grave consequences (Part 3, Article 286 of the Russian Criminal Code), the press service of the regional Investigative Committee reported.
As established by the investigation and the court, Inna Iksanova accepted and paid for ten substandard, counterfeit, and falsified ultrasound imaging systems, worth a total of over 57 million rubles, which were purchased from a commercial organization under the national Healthcare project. However, the convicted woman knew that the equipment did not meet the required specifications.
It had previously been reported that four government contracts had been awarded to the supplier. A criminal case was also opened under articles on the sale of substandard and unregistered medical devices on a large scale (Part 1 of Article 238.1 of the Russian Criminal Code) and causing property damage by deception (Part 1 of Article 165 of the Russian Criminal Code).
The purchase caused 57 million rubles in budget losses. The counterfeit medical equipment was seized from hospitals. The convicted woman's property was seized as security.
The court sentenced Inna Iksanova to five years in a penal colony. She was granted a deferment until her child reaches 14 years of age.
The Russian State Duma approved an increase in fines for soliciting paid medical services
The Russian State Duma adopted a law increasing fines for soliciting additional services and goods, including medical ones, on consumers. Fines will increase for officials and individual entrepreneurs from 2,000-4,000 to 150,000 rubles, and for legal entities from 20,000-40,000 to 500,000 rubles.
A group of deputies proposed amendments to the Code of Administrative Offenses (CAO) in May 2025, introducing a multiple increase in fines for soliciting paid goods and services. The amendments were adopted in the second and third readings at the plenary session on December 23.
A ban on the imposition of paid services is already in effect, but increased penalties will improve consumer protection from unscrupulous sellers, said State Duma Speaker Vyacheslav Volodin. He stated that in April, a federal law established that the sale of additional goods, services, and work for a separate fee can only be carried out with the consumer's consent. In recent years, Volodin noted, the number of such violations has been increasing. In 2022, there were 782 cases, in 2023, 3,179, and in 2024, 4,132.
"Citizens most often encounter imposition of additional services when purchasing airline and train tickets, banking products, and medical services," the speaker of the lower house of parliament said.
In November, Yaroslav Nilov, Chairman of the State Duma Committee on Labor, Social Policy, and Veterans' Affairs, asked Russian Health Minister Mikhail Murashko to develop a mechanism to combat the push for unnecessary medical services in private clinics. He believes that the KPI system encourages doctors to abuse patients' trust and undermines the quality of medicine, MV reported.
According to a report by the National Rating Agency (NRA) analyzing Rosstat data, Russians spend an average of 6,000 rubles per year on private healthcare. Last year, Rospotrebnadzor proposed amending Article 16 of Federal Law No. 2300-I of February 7, 1992, "On the Protection of Consumer Rights," with a new clause prohibiting the push for additional goods (works, services), including through the seller (contractor, aggregator owner) automatically marking consent to their purchase. The need for such a ban is dictated, among other things, by the problem of patients being forced to pay for additional medical services.
Rospotrebnadzor cited data from the All-Russian Public Opinion Research Center (VTsIOM) as of November 2023, according to which four out of ten Russians surveyed (43%) noticed that services covered by their compulsory medical insurance policy were being offered for a fee. MV examined how a state-owned clinic should properly organize the signing of contracts for paid services here.
New registered medical devices
We publish a list of new medical devices registered from 12.19.2025 to 12.26.2025
Link to the list: [see table in the attachment]
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