News Digest 21.08.2026 — 28.08.2026
Regulators
The Russian Ministry of Health will repeal the administrative regulation on registering medical devices within the Eurasian Economic Union (EAEU)
The Russian Ministry of Health intends to repeal the administrative regulation of Roszdravnadzor (Federal Service for Surveillance in Healthcare) on registering medical devices in accordance with the rules of the Eurasian Economic Union (EAEU). The draft order is undergoing public comment until September 9.
The administrative regulation in question was approved by Order No. 133n of March 27, 2017. This document regulated the procedure for Roszdravnadzor to provide the state service for registering medical devices in accordance with the Rules for Registration and Evaluation of the Safety, Quality, and Efficacy of Medical Devices, approved by Resolution No. 46 of the Council of the Eurasian Economic Commission (EEC) of February 12, 2016.
The document will become invalid once Roszdravnadzor approves and registers a new, similar regulation.
The document's cancellation is due to the need to align the administrative regulations with current legislation, including the new Rules for State Registration of Medical Devices, approved by Russian Government Resolution No. 1684 of November 30, 2024.
The Russian government previously postponed the deadline for updating information on authorized representatives of medical devices.
The simplified declaration option for certain goods has been extended for another year
The Russian Ministry of Industry and Trade has extended the validity period of the list of products to which certain provisions of the permit regime do not apply. Order No. 3917 of June 20, 2026, was published on the legal information portal.
Changes are being made to the list of products, specifying the codes of the Unified Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union (EAEU), to which the provisions of paragraph six of Appendix No. 18 to Resolution No. 353 "On the specifics of licensing activities in the Russian Federation in 2022" do not apply.
The list in question was approved by Order No. 4114 dated September 10, 2024. It includes hygiene products and goods for the care of children and adolescents, taking into account the following TN VED codes:
- milk nipples, pacifiers made of latex, rubber, or silicone (TN VED 3926 90 970 9; 4014 90 000 0);
- molded or unmolded rubber products for child care (4014 90 000 0);
- Diapers, underpants, and diapers, as well as hygienic cotton swabs (for the nose and ears) and their equivalents for child care (3005 90 100 0; 4803 00; 4818; 4823; 5601; 9619 00);
- Regular and electric toothbrushes, gum massagers, and similar products for children under 12 years of age and adolescents (3924 90 000 9; 3926 90 970 9; 4014 90 000 0; 8590 80 000 0; 9603 21 000 0).
This list is being extended for one year, until September 1, 2027. Previously, the simplified procedure was in effect until September 1, 2025, and was then extended for another year.
The order comes into effect on August 31, 2026.
Market news
The Russian Science Foundation (RSF) will allocate 480 million rubles for the development of three innovative medical devices
The Russian Science Foundation (RSF) has selected three winners of a competition for targeted and applied projects to develop in-demand medical devices and innovative equipment to implement the roadmap for meeting the needs of the domestic healthcare system. 480 million rubles will be allocated for the projects' implementation between 2026 and 2028, with grants of up to 80 million rubles per year for each development.
The results of the selection process, based on a list of topics approved by Deputy Prime Minister Tatyana Golikova, were announced in early March 2026. The projects submitted by Ortho-Innovations Moscow LLC, PC Prometey LLC, and the All-Russian Research and Testing Institute of Medical Equipment (VNIIIMT) of Roszdravnadzor were selected. They became the qualified bidders.
According to the results of the competition, the National Research University of Electronic Technology (MIET) will develop the antiepileptic vagus nerve stimulation system proposed by VNIIIMT. The institution will receive 240 million rubles – 80 million rubles each in 2026, 2027, and 2028.
The second lot, initiated by Ortho-Innovations Moscow LLC – a project to develop a pulse generator for a deep brain electrical stimulation system – was won by Neuroimplants Elvis LLC. Funding will total 90 million rubles – 45 million rubles each in 2026 and 2027.
Another 150 million rubles will be awarded to the Saint Petersburg Electrotechnical University (LETI) named after V.I. Ulyanov (Lenin). The university, commissioned by PC Prometey LLC, will develop a urological endoscopic video system consisting of a flexible reusable video cystoscope and an endoscopic video processor. The project is allocated 60 million rubles in 2026, 50 million rubles in 2027, and 40 million rubles in 2028.
Russia has developed an injector for breast reconstruction after cancer surgery
Scientists from the National University of Science and Technology MISIS (NUST MISIS), together with specialists from the A.S. Loginov Moscow Clinical Scientific and Practical Center, have developed the "Injector 3.0" fat injector. The device allows surgeons to reduce the number of punctures required during soft tissue reconstruction of the breast in patients who have undergone tumor removal by tens of times, TASS reports.
Two main approaches are used in traditional reconstructive surgeries: manual injection of biomaterial, which requires the surgeon to make dozens of punctures and use up to 40 syringes, and the use of heavy, bulky stationary equipment. The domestically produced injector solves both problems: it simplifies the surgeon's procedures, reduces the physical strain on the physician, and ensures high-quality delivery of the patient's own fat tissue into the breast.
Furthermore, the device's design is based on readily available standard medical supplies—syringes and needles—making the technology cost-effective for clinics.
The development has already successfully completed clinical trials. NUST MISIS and the Loginov Center have submitted a joint application to Rospatent. After completing the patent procedures, the authors plan to submit documents to the Russian Ministry of Health for registration. Prior to official registration, the device can be used as a customized medical device, the developers noted.
Other
Artificial intelligence detected hypertension and diabetes from a 5-second facial video
Researchers from the University of Tokyo and the Tokyo Institute of Science studied the possibility of diagnosing hypertension and diabetes using facial video analysis. The results of the study were published on the European Society of Cardiology (ESC) portal.
The authors reported that the algorithm detected hypertension with 90.3% accuracy from a 5-second facial video. For diabetes, the accuracy was 81.2%. When analyzing 30-second videos, the accuracy reached 95% for hypertension and 88.2% for diabetes.
The algorithm could also estimate systolic blood pressure from facial video alone, without using a cuff. The average error was -2.6 mmHg, and the average absolute percentage error was 8.6%.
The algorithm analyzed pulse wave dynamics, skin blood flow characteristics, and the spectral features of skin color. The study used short video recordings of faces and palms, captured using a spectroscopic camera.
The authors concluded that analyzing 5-second facial videos using artificial intelligence allows for highly accurate detection of hypertension and diabetes. If these results are confirmed in larger, more diverse groups, this contactless approach could become a tool for large-scale disease screening.
Customs officers prevent smuggling of psychotropic substances from India
Officers at the Mineralnye Vody Customs Office have disrupted a smuggling ring for psychotropic and potent substances in parcels from India. According to the press service of the Federal Customs Service (FCS) of Russia, over 1,000 capsules and 240 tablets were seized from illegal circulation.
According to the Federal Customs Service of the Russian Federation, the criminal scheme was orchestrated by a 30-year-old resident of Nevinnomyssk. He ordered medications from abroad and sold them online in various regions of the country.
"He used fictitious post office accounts and electronic accounts with credit institutions, purchasing them through foreign messaging apps and digital asset exchange platforms. He received the goods through proxies," the customs service said.
The offender was caught red-handed while receiving a package at a post office in the city. A search of his home revealed additional potent and psychotropic substances, as well as a laptop, several phones, and blank prescription forms. The seized capsules and tablets contained the potent substances pregabalin and tapentadol, as well as the psychotropic substance tramadol, weighing over 400 grams. The total value of the goods on the black market exceeds 1 million rubles.
Four criminal cases have been opened under Part 1.1 of Article 226.1 of the Russian Criminal Code (smuggling of potent substances). The perpetrator faces up to seven years in prison and a fine of up to 1 million rubles.
New registered medical devices
We publish a list of new medical devices registered from 08.21.2026 to 08.28.2026
Link to the list: [see table in the attachment]
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