News Digest 26.06.2026 — 03.07.2026
Regulators
Roszdravnadzor will receive greater powers in registering medical devices
The Russian Ministry of Health has presented a draft government resolution amending the Regulation on the Federal Service for Surveillance in Healthcare. The agency intends to expand Roszdravnadzor's powers in connection with the updated provisions of the Council Decision of the Eurasian Economic Commission (EEC) regarding the circulation of medical devices. Roszdravnadzor may thus be granted the authority to receive and process notifications of intent to import medical devices into Russia for state registration. Currently, the regulator can only issue permits for such actions.
The amendments are planned to be made to Russian Government Resolution No. 323 of June 30, 2004.
In accordance with the updated EEC regulations, the list of medical devices subject to the permit and notification regimes for clinical and clinical laboratory testing has been amended. In this regard, the Ministry of Health proposed allowing Roszdravnadzor to issue permits for not only clinical but also clinical laboratory trials (studies) of medical devices.
Among other things, the EEC decision establishes a register that must contain information on issued permits and submitted notifications for such studies. Roszdravnadzor may therefore be authorized to enter such information into the register.
The document proposes replacing Roszdravnadzor's authority to receive and record notifications regarding the commencement of activities in the field of medical device circulation with the authority to publish a portion of the official website of the Unified Register of Notifications online for the purpose of displaying information on the regulator's official website.
To bring the Regulation on Roszdravnadzor into line with Article 87 No. 323-FZ of November 21, 2011, "On the Fundamentals of Health Protection of Citizens in the Russian Federation," the Ministry of Health proposes updating several provisions.
Thus, Roszdravnadzor's authority, when conducting state quality and safety monitoring of medical activities through documentary audits, on-site inspections, test purchases, and inspection visits, may include assessing the compliance of medical and pharmaceutical organizations, state extra-budgetary funds, and individual entrepreneurs with mandatory requirements in the area of public health protection, procedures for the provision of medical care, rules for conducting various studies, medical examinations, medical examinations, as well as requirements for the organization and implementation of internal quality and safety monitoring of medical activities. The current document does not specify the activities that may be carried out under state oversight.
The Russian Government has revised localization thresholds for X-ray equipment
The Russian Government has amended Resolution No. 719 of 2015, which regulates the procedure for confirming the production of industrial products in the country. The document updates the localization criteria for several types of medical X-ray equipment, including mammographs, computerized X-ray diagnostic systems, mobile ward X-ray machines, remote-controlled X-ray diagnostic systems, C-arms, and digital flat-panel X-ray detectors.
The new requirements came into effect on June 30, 2026. For each equipment category, lists of technological operations that are taken into account when assigning localization points have been approved: these include the manufacture of units and components, assembly, setup, calibration, testing, software and technical documentation development, and research and development.
At the same time, the minimum points required to recognize products as Russian have been revised. For mammographs and flat-panel digital X-ray detectors, the requirement has been increased from 100 points in 2026 to 110 points in 2027. For CT scanners, as in 2026, the minimum will be set at 90 points next year, for ultrasound machines – 70 points, for ventilators – 75 points, for surgical sterilizers – 90 points, and for PCR analyzers – 120 points.
Certain medical devices will be excluded from the Procedure for Providing Medical Care for Transplantation
The Russian Ministry of Health has published a draft order excluding five medical devices from the Procedure for Providing Medical Care in the Field of "Surgery (Transplantation of Human Organs and/or Tissue)." Specifically, the proposed exclusion from the list includes the intra-aortic balloon pump device (for heart transplantation) and the molecular adsorption-circulation system (for liver transplantation).
The ministry also intends to exclude the mass spectrometer, multichannel thermal cycler, and blot hybridizer from the list. This could reduce the total number of medical devices from 18 to 13.
As stated in the explanatory note to the draft order, the initiative is designed to improve the licensing of medical activities when providing specialized care to patients "by eliminating excessive requirements for additional equipment at medical organizations." The Ministry of Health also notes that there are no registered medical devices for this purpose in Russia.
Market news
Tatarstan Localizes Production of Remote Health Monitoring Devices
Production of medical devices for remote health monitoring under the Tevium brand has been launched in the Republic of Tatarstan. The project is being implemented by Ventum-TMH, a joint venture between the TeleMedHab group of companies and the Ventum Med holding company. The operator intends to develop a full-cycle preventive and predictive medicine ecosystem, combining the development and production of medical devices, a digital platform, telemedicine services, and artificial intelligence tools.
The production site is located in the Pharmmedpolis industrial zone in Tatarstan, where assembly and quality control of medical devices are organized. Plans also include opening a research and development unit to conduct R&D work and prepare in-house design documentation. Investments in the first phase of the project amounted to 300 million rubles, and the launch of production has created up to 50 jobs.
Initially, the company plans to produce tonometers with automatic data transmission, continuous glucose monitoring systems, ECG patches, electronic stethoscopes, spirometers, and peak flow meters. Over the next 6-12 months, the line is planned to be expanded to include otoscopes, CTG Doppler devices for monitoring pregnant women, and digital thermometers. All devices will be integrated into the Tevium mobile app, after which they will undergo registration with Roszdravnadzor and clinical validation.
The company intends to focus primarily on the B2B and B2C commercial segments, while entering the public procurement market is planned through a B2B2G model. For this purpose, the devices will support an open data transfer protocol, enabling integration with both commercial platforms and government remote monitoring information systems.
Other
Russian scientists have created a capsule-based antibiotic with a five-day effect
Scientists from Perm National Research Polytechnic University (PNRPU), together with colleagues from Siberian Federal University, the Institute of Biophysics SB RAS, and the N.D. Zelinsky Institute of Organic Chemistry RAS, have developed a new antibiotic in a biodegradable capsule. According to the researchers, a single injection allows the drug to be gradually released into the body over five days, without frequent injections or sudden changes in concentration, the PNRPU press service told MV.
The study was published in the Journal of Polymers and the Environment. The authors note that in severe infections, such as blood poisoning and purulent pneumonia, tablets act too slowly or are not absorbed in the intestines due to digestive problems. In such cases, antibiotics must be administered intravenously every 4-6 hours to maintain therapeutic concentrations, which places additional strain on the body and increases the risk of side effects. The new molecule is based on antipyrine derivatives and has already demonstrated activity against dangerous bacteria, including Staphylococcus aureus, as well as against Candida fungus, which can cause severe infections of the oral and esophageal mucosa. For the dosed delivery of the drug, the scientists used microscopic capsules made of a biodegradable polymer, which breaks down over time into water and carbon dioxide and does not cause rejection.
In the experiment, the capsules initially provided a "shock dose" during the first 12 hours, during which time they released up to a third of the drug, followed by a steady release of the antibiotic over 120 hours. According to the authors, this regimen allows for a sustained therapeutic effect without dangerous peaks and valleys, and the development itself could form the basis for extended-release drugs. The safety of the system was also tested on human cells and red blood cells. Tests showed that neither the compound nor the capsules damaged cell membranes.
Elon Musk's SpaceX launched a secret capsule for producing drugs in zero gravity
SpaceX conducted the first demonstration launch of the Starfall cargo delivery system, sending a capsule into low Earth orbit from Cape Canaveral, Florida, USA, New Scientist reports. Among the key payloads planned to be produced and returned to Earth using the new system are pharmaceutical compounds synthesized in zero gravity.
The unmanned capsule is shaped like a hockey puck. It is approximately 3 meters in diameter, less than 1 meter in height, and has a maximum payload of 1 ton. Upon re-entry, the spacecraft separates into two modules: a cargo compartment and a carbon fiber heat shield equipped with a gas maneuvering system.
The launch broadcast was conducted under conditions of heightened secrecy. The live feed was cut shortly after liftoff, and footage of the capsule in orbit was never released.
Besides SpaceX, smaller players are also operating in the space manufacturing segment. The American company Varda Space Industries (VSI) has already conducted six orbital missions and successfully synthesized ritonavir, an anti-HIV drug, in space. VSI capsules are significantly smaller than Starfall capsules: they are about a meter in diameter and weigh 300 kg. This difference significantly hinders the potential for commercial scalability. The market for microgravity pharmaceutical production was estimated at $1.5 billion in 2025 and is projected to reach $9.8 billion by 2034, with a compound annual growth rate of 24%.
New registered medical devices
We publish a list of new medical devices registered from 06.26.2026 to 07.03.2026
Link to the list: [see table in the attachment]
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