News Digest 03.07.2026 — 10.07.2026
Regulators
Roszdravnadzor to Update Checklists for Monitoring Medical Devices
Roszdravnadzor has developed new checklist forms for monitoring the circulation of medical devices. The draft order is undergoing public comment and an independent anti-corruption review on the regulation.gov.ru portal until July 18.
This document will replace Roszdravnadzor Orders No. 1 of January 10, 2022, and No. 5169 of September 17, 2025, which are now considered invalid. All seven checklist forms are being updated:
- Technical testing and toxicological studies of medical devices;
- Clinical trials of medical devices;
- Use of medical devices in a healthcare facility;
- Circulation of medical devices by manufacturers and/or authorized representatives of the manufacturer;
- Maintenance, adjustment, installation, and repair of medical devices;
- Transportation of medical devices;
- Storage and/or sale of medical devices.
All checklist forms have updated references to regulatory documents: references to orders of the Russian Ministry of Health and decisions of the Eurasian Economic Commission (EEC) have been updated. Furthermore, the wording in the clinical trial checklist has been clarified: when conducting multicenter trials, approval is now required not only from medical organizations but also from the coordinating investigator.
If approved, the document will come into force on September 1.
The Russian Ministry of Health will amend the Procedure for Organizing Medical Rehabilitation
The Russian Ministry of Health plans to make further amendments to the Procedure for Organizing Medical Rehabilitation for Adults. Amendments to departmental order No. 788n of July 31, 2020, are currently undergoing public discussion on regulation.gov.ru.
Licensing requirements for specialized clinics are planned to be simplified. This will be accomplished by amending the equipment standards for medical rehabilitation departments.
For example, the standards will exclude medical devices for which, according to Roszdravnadzor, registration certificates are lacking, making their acquisition impossible. The range of available medical device nomenclature classifications will also be expanded without expanding the list of mandatory equipment items, "enabling a medical organization to choose between medical devices with the same functional and medical purpose, but from different price groups and manufacturers, when purchasing, without creating an additional financial burden on regulated entities." The names of individual medical devices will be aligned with the nomenclature classification.
Furthermore, it is planned to remove wooden chairs from the list of medical devices. Their transfer to the "Other Equipment" section will allow for the procurement of such chairs without a medical device registration certificate.
Amendments to Order No. 788n were previously introduced in 2022. At that time, existing departments, exercise therapy rooms, physiotherapy rooms, and other similar units of medical organizations were authorized to provide medical rehabilitation services without the need to establish a specialized department.
In 2023, the Russian Ministry of Health authorized home rehabilitation if the patient lives in a remote location or has mobility restrictions. The document also allows for rehabilitation via telemedicine.
The Russian Ministry of Health has updated the list of medications and medical devices for ambulance crews
The Russian Ministry of Health has amended the Procedure for the Provision of Emergency Medical Care (approved by Order No. 388n of the Russian Ministry of Health dated June 20, 2013). Order No. 424n dated May 14, 2026, was published on the legal information portal.
The amendments include Appendix No. 16 to the Procedure, which establishes uniform requirements for the assembly of six types of equipment for ambulance crews: a general kit, a specialized (resuscitation) kit, an obstetric kit, and three resuscitation kits (for adults, newborns, and children). Lists of medications and medical devices with precise quantities have been approved for each of these kits.
The general kit includes 99 medications and 54 types of medical devices. It includes cardiovascular medications, anticoagulants, fibrinolytics, analgesics, antidotes, hormonal agents, antibiotics, and infusion solutions. Medical supplies include syringes, catheters, tourniquets, dressings, hemostasis agents, thermometers, stethoscopes, masks, and gloves.
The specialized resuscitation kit includes 111 medications and 55 types of medical supplies. The obstetric kit, as well as resuscitation kits for adults, newborns, and children, are equipped only with medical supplies; medications are not included.
Market news
The Government Approved Rules for Verifying Medicines and Medical Devices on Marketplaces
The Russian Government has approved a procedure for verifying information on medicines, medical devices, dietary supplements, and other product categories posted on digital intermediary platforms.
The document defines the information marketplaces must verify against state registries before publishing product cards and when making changes to them. Most of the provisions of the resolution will come into force 90 days after official publication.
According to the approved rules, digital platform operators will verify information on medicines against the State Register of Medicines and the Unified Register of Registered Medicines of the Eurasian Economic Union (EAEU). For medical devices, a similar verification is required against the State Register of Medical Devices and the Unified Register of Medical Devices of the Eurasian Economic Union (EAEU), including the registration number, state registration date, and manufacturer information. A separate procedure has been established for dietary supplements: their data will be compared with the Unified Register of Certificates of State Registration of Products of the Eurasian Economic Union (EAEU).
Furthermore, the resolution provides for verification of drug labeling through the State System for Monitoring the Movement of Medicines. Based on the results of the verification, the operator decides whether to post the product card or notify the seller of any discrepancies. The verification will be conducted both during the initial posting of information and when changes are made to registration information.
At the same time, the government approved the Regulation on Federal State Control (Supervision) of Compliance with Requirements in the Platform Economy. According to the document, the authority to exercise state control is vested in the Federal Antimonopoly Service (FAS) of Russia. The resolution will come into force on October 1, 2026.
Other
FIFA has developed the first three-minute concussion test for football players
A team of researchers led by Kerry Peake of FIFA Medical has developed the FOCUS (Football-Specific On-Pitch Concussion Assessment) protocol – the first three-minute checklist designed specifically for football. The test was based on a systematic review of 65 studies, a two-round Delphi survey, and final approval by a steering committee. The survey involved 57 medical professionals from 69 national associations (out of 211 invited), each of whom had conducted at least five on-pitch concussion assessments in the past year. Consensus was defined as agreement of ≥80% of respondents.
Until now, professional football lacked a standardized protocol for the initial on-pitch assessment of a player following a head impact, according to a study published in the journal Jama Neurology. Existing tools (such as SCAT6) require 10-15 minutes and a quiet environment, which is unacceptable in match conditions. Universal checklists from other sports do not take into account the specifics of football rules and playing culture.
The protocol includes 45 points, grouped into 11 blocks, and is designed for a standard pause in play. The test is carried out in stages: on the sidelines, the physician records the injury history and visual signs, then tests memory, coordination, balance with eyes closed, and tracking of a moving object.
The key principle is a low threshold for suspension. Any unexplained symptom or sign serves as a signal for the immediate substitution of the player for a more in-depth diagnosis. Moreover, the test is deliberately simplified: instead of the complex Glasgow Coma Scale, a quick assessment is used – whether the player is oriented, whether he responds to voice or pain, and whether he is unconscious. This makes the method applicable even in areas without extensive medical staff.
The concussion rate in football is significantly lower than in rugby (0.44 versus 3.89 per 1,000 hours of playing time for men), so many doctors may not conduct such an assessment at all during a season. FOCUS offers a clear, reproducible algorithm adapted for a wide range of specialists (doctors, physiotherapists, nurses) and applicable both in elite tournament settings and in matches with limited medical resources. However, the researchers emphasize that FOCUS is not perfect. It relies more on expert opinion than on hard data, which could theoretically miss mild concussions. Therefore, a larger study will soon begin to test the accuracy of the method.
An AI model has been developed for contactless sleep assessment at home
Researchers from the Icahn School of Medicine at Mount Sinai and other US research centers have developed the BCGNet artificial intelligence system, designed for contactless sleep monitoring at home. Unlike traditional polysomnography, which requires multiple sensors attached to the patient's body, the new technology uses a ballistocardiographic sensor placed under the pillow to record microvibrations caused by a person's heartbeat, breathing, and movement during sleep. The results of the study were published in the journal Digital Medicine.
BCGNet automatically determines sleep stages, assesses sleep duration, efficiency, and other key indicators, and identifies signs of obstructive sleep apnea. According to the authors, combining several tasks in a single model enables a comprehensive sleep quality assessment without the need for specialized laboratory equipment.
During testing, the system demonstrated high accuracy in analyzing sleep structure and identifying breathing disorders, maintaining stable performance with data from a large number of users. The authors note that training on a large sample allowed the model to be more robust to differences between patients and measurement conditions.
According to the researchers, the technology could expand the capabilities for early detection of sleep disorders and make long-term monitoring more accessible. The use of a contactless sensor allows for examinations to be conducted in the comfort of one's own home, which is especially important for patients who require long-term monitoring.
The developers believe that such systems could be used not only for diagnosing sleep disorders but also for remote monitoring of patients with chronic diseases. In the future, such solutions could become part of a home health monitoring ecosystem that integrates data from sensors, AI, and digital health services.
New registered medical devices
We publish a list of new medical devices registered from 07.03.2026 to 07.10.2026
Link to the list: [see table in the attachment]
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