News Digest 31.07.2026 — 14.08.2026
Regulators
The Russian Government has postponed the deadline for updating information on authorized representatives of medical devices
The Russian Government has postponed the deadline for confirming compliance with the requirements for clinical trials of medical devices and appointing authorized representatives for foreign companies from September 2026 to September 2027.
Amendments have been made to the Rules for State Registration of Medical Devices. Government Resolution No. 974 of the Russian Federation dated August 3, 2026, has been published on the legal information portal.
The new Rules for State Registration of Medical Devices were approved by Government Resolution No. 1684 of November 30, 2024. This document establishes the transition to a registry-based model for issuing registration certificates. According to the new resolution, organizations planning to conduct clinical trials of medical devices must confirm their compliance with the new requirements and notify Roszdravnadzor thereof by September 2027 (previously, this was required by September 2026).
Another deadline has also been pushed back: foreign companies are now required to appoint an authorized representative in Russia or update their details to continue marketing their products on the Russian market until September 2027 (instead of September of this year).
Earlier, in connection with the transition to a registry-based registration model, Roszdravnadzor abolished paper registration certificate forms for medical devices. All orders that described them have been declared invalid.
Extension of the transition to the single market for medical devices in the EAEU has been ratified
Amendments to the Agreement on Uniform Rules for the Circulation of Medical Devices in the EAEU have been ratified; the corresponding law has been signed by the President of the Russian Federation. The discussion concerns postponing the transition to a single market for medical devices.
The protocol amending the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union (EAEU) has been ratified. Russian President Vladimir Putin signed Federal Law No. 288-FZ of August 4, 2026, to this effect.
This protocol amends Article 11 of the Agreement on Uniform Principles and Rules for the Circulation of Medical Devices (Medical Products and Medical Equipment) within the EAEU of December 23, 2014. With this document, the Russian government approved a two-year postponement of the transition to uniform rules for the circulation of medical devices in EAEU countries. Registration applications can now be submitted until the end of 2027, and renewals can be submitted until 2028.
Market news
ITMO University Scientists Create "Smart" Packaging for Food Quality Control
Specialists from ITMO University have completed the development of "smart" food packaging that enables quality control using fluorescent indicators. In their work, the scientists created optical test systems and carbon dot-based biosensors for food quality control, as well as a smartphone-compatible portable device for signal recording outside of a laboratory setting. The Russian Science Foundation (RSF) has allocated 6 million rubles for the project – 3 million rubles each in 2025 and 2026.
During their research, the scientists created a sensor system for detecting hydrogen peroxide, as well as enzymatic biosensors for glucose, lactose, and starch. The developed materials demonstrated high sensitivity, reproducibility, and stability. Furthermore, the specialists created a portable fluorescent device compatible with a smartphone, which enables quantitative analysis outside of a laboratory setting. The sensor systems' performance was confirmed using real food samples: the researchers determined the hydrogen peroxide content in milk and glucose in apple juice, and the results matched those of reference analytical methods.
Following the second stage, the researchers stated that the developed biosensor systems could form the basis for the creation of new "smart" food packaging materials, enabling rapid monitoring of product quality and reducing the risk of spoiled products being sold.
Other
Health pavilions have reopened in Moscow
Health pavilions opened in the capital in early August, where residents can undergo a series of free express tests and receive personalized lifestyle recommendations, the Moscow City Hall press service reported. The cost of the project, which plans to open three such locations, and the funding sources were not specified.
There is also no information about the types of medical equipment used in the pavilions. The only information reported is the installation of "various devices" that can measure a person's biological age, pulse, blood pressure, body mass index, stress level, blood oxygen saturation, body composition, fluid balance, and bone health in a single visit.
Following these tests, Muscovites receive lifestyle recommendations. The city's express diagnostics are not a substitute for a full medical examination, the City Hall press service emphasized, urging people to take the "Moscow Checkup" in the EMIAS.INFO mobile app.
Prior to this, from 2019 to 2023, the city ran another seasonal project, the "Healthy Moscow" pavilions, with estimated costs in 2023 at 462 million rubles, MV reported. Authorities then curtailed this program and began sending residents to outpatient clinics for medical checkups.
Source: https://medvestnik.ru/content/news/v-moskve-snova-nachali-rabotat-pavilony-zdorovya.html
Experts predict a technological breakthrough in wearable AI devices in 2026
Artificial intelligence in medicine will be the top technology trend of 2026, according to an IEEE forecast. Experts expect a breakthrough in wearable medical devices, as well as the development of cellular and molecular therapies.
The Institute of Electrical and Electronics Engineers (IEEE) has released its technology forecast for 2026. All trends are directly or indirectly related to artificial intelligence (AI). In terms of its importance to humanity, AI in medicine has surpassed other sectors, including agriculture, driverless transport, education, and quantum computing. Breakthroughs in wearable devices, as well as cellular and molecular therapies, are expected in medicine, according to a report (available to MV).
Experts believe that adaptive AI-powered biointerfaces that continuously perceive human biological signals will become a breakthrough technology in 2026 and will lead to the creation of new markets. Their development is driven by the growing need for continuous health analysis instead of periodic checkups. Pilot tests of devices combining different types of biosensors (for example, for assessing EEG, EMG, skin metabolite concentrations, and heart rate variability) are already underway. Generative AI will be able to find patterns between the dynamics of biological signals and human health, stress levels, and attention span.
The accuracy of such devices is expected to reach clinical levels this year, enabling their use in:
- neurorehabilitation,
- medication dosage adjustment,
- stress management,
- early disease detection,
- metabolic correction.
The report's authors believe the likelihood of a technological breakthrough in wearables is very high and recommend that industry representatives consider investing in the sector. Beyond clinical applications, business opportunities include the creation of subscription platforms for sleep, stress, and cognitive function management, and the integration of biosensors with smart homes (lighting, sound, and HVAC systems that respond to physiological changes).
New AI-powered wearable devices, including helmets, gloves, glasses, and suits, will become part of everyday life. They will be particularly in demand among the elderly for fall prevention and vision and hearing preservation. Experts cite examples of vibrating and "talking" T-shirts to assist the blind and glasses with automatic text translation.
New registered medical devices
We publish a list of new medical devices registered from 07.31.2026 to 08.14.2026
Link to the list: [see table in the attachment]
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