News Digest 17.10.2025 — 24.10.2025
Regulators
The transition to a single market for medical devices in the Eurasian Economic Union (EAEU) will be postponed for two years
The Russian Government approved Decree No. 2920-r dated October 17, 2025, on the signing of a Protocol amending Article 11 of the Agreement on Unified Principles and Rules for the Circulation of Medical Devices and Medical Equipment within the Eurasian Economic Union (EAEU) dated December 23, 2014.
Applications for registration of a medical device under national regulations can now be submitted until December 31, 2027 (previously until the end of 2025). Documents can be renewed (re-registered or amended) for medical devices already registered under national regulations until December 31, 2028 (previously until the end of 2026).
The Protocol will come into provisional application ten days after it is signed by all EAEU countries.
A draft resolution amending the Rules for State Registration of Medical Devices (RF Government Resolution No. 1684 of November 30, 2024) is undergoing public discussion until November 1. The document provides for an extension of the transition period for registering medical devices in EAEU countries.
The document was previously approved by the Council of the Eurasian Economic Commission (EEC). The EEC Council also approved Resolution No. 25 of August 1, 2025, which proposes amending the list of medical devices permitted for circulation without registration. It is proposed to add the following categories of medical devices to the existing list:
- Unregistered medical devices for vital indications for a specific patient;
- Medical devices intended for export;
- Kits, first aid kits, and kits containing medical devices and medicines (for use only within the country; the medicines and medical devices inside must remain in their original consumer packaging).
Source: https://medvestnik.ru/content/news/Perehod-k-edinomu-rynku-medizdelii-EAES-otlojat-na-dva-goda.html
The Russian Ministry of Health has compiled a list of medical equipment for the modernization of regional cancer centers
The Russian Ministry of Health has prepared a list of equipment and medical products for the modernization and retrofitting of departments of regional medical organizations providing care using radiological diagnostic and therapeutic methods. The draft order was published on October 21 on the regulation.gov.ru portal.
The list includes 14 types of medical devices and 37 types of technological equipment. These include gamma cameras, positron emission tomography (PET/CT) systems, single-photon emission computed tomography (SPECT and SPECT/CT), automatic syringe injectors for contrast agents, radiation shielding cabinets, and equipment for producing ultrapure water. The list also includes radiopharmaceutical synthesis units, dosimetry equipment, and radioactive waste storage systems.
Modernization is necessary to update equipment whose service life exceeds the standard, as well as to equip new and existing radionuclide departments at regional oncology centers with modern technologies. Procurement may be financed from the federal budget through subsidies under the federal project "Fight Against Cancer." Previously, the regulator postponed the entry into force of the requirements for hospital beds in the Procedure for the Provision of Medical Care to Adults with Oncology to January 1, 2030. The National Association of Non-State Medical Organizations (NANMO) and the National Association of Healthcare Managers (NAHM) requested the deferment. Experts warned that strict hospital bed requirements would lead to the closure of the overwhelming majority of existing non-state clinics in this specialty, MV reported. At the same time, they would have to write off high-tech equipment, including the CyberKnife device, which, given Western sanctions, is, at the very least, irrational.
The manufacturer of ELTA glucometers has challenged Roszdravnadzor's claims in court
The lawsuit against the territorial division of Roszdravnadzor was filed in early October 2025. The company intends to bring in the All-Russian Scientific Research and Testing Institute of Medical Equipment (VNIIIMT) of Roszdravnadzor, which conducted the examinations, as third parties, as well as the Center for Drug Supply of the Moscow Department of Health. The first hearing is scheduled for the second half of November 2025. Vademecum sent a request to ELTA.
The regulator previously raised concerns about the quality of devices manufactured by ELTA. In early September 2025, Roszdravnadzor issued 32 information letters concerning the Satellite Express, Satellite Express Mini, and Satellite Online glucometers. Following an examination, the regulatory agency deemed the products to be of substandard quality. In addition to discrepancies in dimensions, documentation, and labeling, 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 the GOST standard and quality management system, was required. 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.
ELTA glucometers have previously been purchased by Moscow medical institutions. In June 2023, the Gormedtekhnika Scientific and Production Center purchased 1,400 devices for 2.7 million rubles, and in February 2024, another 3,000 units for 4.9 million rubles. The price of one glucometer was 1,500-1,900 rubles.
ELTA is one of the oldest medical device manufacturers in Russia, founded in 1993. According to SPARK-Interfax, the beneficiary of the key legal entity, 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.
In 2024, the company completed construction of production lines for glucometers and continuous blood glucose monitoring devices in the Technopolis Moscow special economic zone. Investment in the project is estimated at 2.2 billion rubles. The company produces the "Satellite Online" glucometer—ELTA's flagship product, the first domestic device that allows for the transmission of patient glucose data via Bluetooth to smartphones and then to medical facilities. In the first quarter of 2025, the company produced over 180,000 glucometers and 2.7 million test strips.
Market news
KhimMed invested 30 million rubles in launching histology reagent production
KhimMed, a domestic vendor and distributor of reagents for pharmaceuticals, laboratory diagnostics, and microelectronics, has launched its own production of reagents for pathological examinations. The company aims to capture a 20% market share in this field by 2030 in monetary terms by expanding its product line. The initial investment in the project was at least 30 million rubles.
In the first stage, the company established its own production of reagents for histological sample preparation, including specialized buffered formalin, isopropyl alcohol, and xylene. In 2025-2026, KhimMed plans to expand production by adding more than 20 products to its portfolio. Priorities include compatibility with all types of histology equipment installed in laboratories, reducing the toxicological burden on personnel, and reproducibility of results. The products will be produced under the HistoKhim and HistoMed sub-brands.
The company aims to capture approximately 15% of the histology reagent segment by value by 2029, and to consolidate its share to at least 20% by 2030, taking into account the expansion of its product line and the completion of regulatory procedures. Accelerated growth of in-house production as a driver of revenue and margins is a key element of KhimMed's strategy.
The decision to launch production was made amid a steady increase in demand for morphological diagnostics and a decline in supply after 2022, driven by the withdrawal of foreign suppliers from the Russian market. Industry representatives estimate that approximately 48-50 million histological examinations are performed in Russia annually. According to KhimMed, based on the average cost of a basic examination of approximately 2,000 rubles, the market size for these services is approximately 100 billion rubles per year. In 2024, according to industry statistics, 8.3 million cases of intravital biopsy examinations were recorded. Meanwhile, consumption of key consumables continued to grow in volume terms: according to KhimMed, the market for wiring reagents grew by approximately 21% year-on-year, paraffin media by approximately 17%, and buffered formalin by approximately 9%.
KhimMed Group is a Russian manufacturer and distributor of reagents for pharmaceuticals, laboratory diagnostics, and microelectronics, and is considered a systemically important enterprise. The group of companies was founded in 1991; the beneficiaries are not disclosed. Revenue under IFRS for 2024 amounted to 6.343 billion rubles, with net profit of 781 million rubles. In September 2025, the company began preparing for an IPO on the St. Petersburg Exchange.
Other
The Russian Ministry of Health has updated its guidelines for the management of influenza in adults
The Russian Ministry of Health has published new clinical guidelines for the management of influenza in adults.
Kagocel has been removed from the list of second-line drugs with immunomodulatory and antiviral properties. At the same time, Aterixen, Ergoferon, Rafamin, and inosine pranobex have been added to the list of immunotropic drugs recommended for the treatment of mild and moderate influenza in outpatient settings.
Aterixen (INN: 1-[2-(1-Methylimidazol-4-yl)-ethyl]perhydroazine-2,6-dione) reduces the production of acute-phase inflammatory mediators, fever, and the "cytokine storm," and is recommended from the onset of the first symptoms of the disease.
According to the recommendations, Ergoferon (antibodies to human gamma interferon, affinity purified - 10,000 EMU, antibodies to histamine, affinity purified - 10,000 EMU, antibodies to CD4, affinity purified - 10,000 EMU) has antiviral, immunomodulatory, anti-inflammatory and antihistamine effects. According to the document, "Rafamine" (affinity-purified antibodies to human gamma interferon — 10,000 EMU1, affinity-purified antibodies to CD4 — 10,000 EMU, affinity-purified antibodies to β2-microglobulin MHC class I — 10,000 EMU, affinity-purified antibodies to the β1-domain of MHC class II — 10,000 EMU) has antiviral, antibacterial, and anti-inflammatory effects and increases the effectiveness of antibiotic therapy.
According to the State Register of Medicines, inosine pranobex is classified as a direct-acting antiviral agent. Use during pregnancy and lactation is contraindicated.
Furthermore, "Eladis" (N-[2-(1H-imidazol-4-yl)-ethyl]-6-oxo-delta-lactam) has been added to the list of antitussives. It inhibits the enzyme Golgi-resident human glutaminyl cyclase, which helps reduce inflammatory symptoms, and has antitussive activity. The document states that the drug has anti-inflammatory, antitussive, bronchodilator, and antiallergic effects, reduces mucus hypersecretion, improves respiratory function, and reduces the severity and frequency of respiratory symptoms, including coughing fits and shortness of breath.
WHO lays off nearly half its senior executives due to financial difficulties
The World Health Organization (WHO) has laid off nearly half of its senior executives and directors, marking one of the largest management cuts in recent years, according to the WHO website.
According to WHO Director-General Tedros Adhanom Ghebreyesus, the restructuring covers both headquarters and regional offices, including countries in the Western Pacific region. He called the process "painful" but a necessary step in reforming the WHO's structure.
According to the Director-General, despite the difficult personnel decisions, the organization plans to focus on its core mission and improve its effectiveness with limited resources.
"We see this crisis as an opportunity to build a WHO that is more focused on its core mandate, more independent, and better able to deliver value to the countries and people we serve. We are seeking models that allow us to do more with less," said Tedros Adhanom Ghebreyesus.
WHO has faced serious financial difficulties following the withdrawal of the United States, one of its largest donors. US funding was previously provided, in part, through the United States Agency for International Development (USAID), which was suspended in February 2025.
Previously, the Medical Herald reported that the WHO was short of funds due to the US withdrawal and that massive layoffs were imminent. As a result of prioritization, a streamlined headquarters structure was developed, reducing the number of executive management members from 14 to 7, and departments from 76 to 34.
New registered medical devices
We publish a list of new medical devices registered from 10.17.2025 to 10.24.2025
Link to the list: [see table in the attachment]
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