News Digest 03.04.2026 — 10.04.2026
Regulators
The Russian Government has expanded the list of medical devices subject to labeling
The Russian Government has expanded the list of medical devices subject to mandatory digital labeling in the Honest Sign system, effective September 1, 2026. According to Resolution No. 375 of April 6, 2026, this list now includes syringes, wipes, test tubes, medical masks, air purifiers (including bactericidal units), orthopedic shoes, coronary stents, hearing aids, CT scanners, medical gloves, artificial respiration devices, and neonatal incubators.
In September, the Russian Ministry of Industry and Trade proposed extending the medical device labeling pilot. The pilot program began on September 1, 2024, and was extended in August 2025 at the initiative of the Public Council under Roszdravnadzor, MV reported. Previously, the Ministry planned to automatically transfer data on medical devices supplied under government contracts to the "Honest Sign" product monitoring system starting September 1, 2026.
Late last year, the Russian Ministry of Industry and Trade proposed introducing mandatory labeling of respiratory equipment, incubators, condoms, syringes, masks, and other medical devices starting June 1, 2026. Furthermore, authorities plan to add codes from the All-Russian Classifier of Products by Type of Economic Activity (OKPD) for a number of medical devices already labeled by manufacturers. These include air purifiers, coronary stents, CT scanners, and sanitary and hygienic products used for incontinence.
The Ministry of Labor will update the regulatory framework for the technical rehabilitation equipment (TRE) market
The Russian Ministry of Labor has submitted a draft order repealing several regulations governing the classification of technical rehabilitation equipment (TRE), as well as a technical amendment to the list used to determine their useful life. The document was prepared in pursuance of the Russian Government Resolution of December 18, 2024, which updated the Rules for Providing TRE, including the repeal of certain provisions and adjustments to the procedure for applying electronic certificates.
The regulator proposes repealing orders issued in 2018–2024. The explanatory note states that the relevant provision of the TRE Rules, which was the basis for this classification, has ceased to be effective, making it unnecessary to retain such regulations.
Additionally, changes introduced by a government decree in March 2026, which eliminated the reference to the classification of technical means of rehabilitation when creating an electronic catalog of such products, were taken into account. This document also updated the Rules for Providing Technical Means of Relief to Persons with Disabilities: the use of state information systems was strengthened, the procedure for applying electronic certificates was clarified, decision-making periods were reduced to two business days, and a proactive mechanism for providing technical means of rehabilitation without submitting an application was introduced for those disabled due to military injuries.
At the same time, the current draft includes a technical amendment to the current order: the product name is clarified in the "ocular prosthesis" section, adding the characteristic "glass."
Source: https://vademec.ru/news/2026/04/09/mintrud-obnovit-normativnuyu-bazu-dlya-rynka-tsr/
Market news
Russia's first telemedicine stethoscope has received a patent in the United States
The Russian-made electronic stethoscope Phonendo, used for in-person and telemedicine consultations and patented as an invention in Russia, has received a patent in the United States. The process took nearly four years. The company is also awaiting the results of its applications in China and India, which were filed simultaneously with the American one, the press service of Medhard, the developer, told MV.
The company has decided to protect its intellectual property in its core markets. Work on obtaining a US patent began in 2022. The application is undergoing expert review in China and India.
Phonendo is a completely Russian development. Its innovative feature lies in its ability not only to listen to the patient's heart and lungs but also to simultaneously view sound as audio and spectrograms. All this in real time. The electronic stethoscope was registered as a Class 2a risk medical device in 2022, MV reported, and is included in orders for equipment lists for medical organizations.
According to a report by Market Research Future, the global digital stethoscope market was valued at $0.871 billion in 2024. It is projected to reach $2.933 billion by 2035, registering a compound annual growth rate (CAGR) of 11.67% over the forecast period.
Other
Russia to create a federal vaccination registry containing data on refusals and contraindications
The Russian Ministry of Health has submitted a draft government resolution on the creation of a federal vaccination registry for public discussion. The document calls for the creation of a unified database that will include information on vaccinations administered, post-vaccination complications, medical contraindications, vaccination refusals, and planned vaccination campaigns. If adopted, the regulation will enter into force on September 1, 2028, and will be valid for six years.
The resolution establishes tight deadlines for updating information: vaccination information, contraindications, and complications must be submitted to the system within one day of being entered into medical records. It also provides for the recording of data on post-vaccination immunity if laboratory tests are available.
A separate section will be devoted to vaccination refusals and medical contraindications, indicating their validity periods and diagnoses. Importantly, entries in the registry cannot be deleted; each is assigned a unique number. This will allow for the creation of a continuous history of a patient's vaccination status.
Federal authorities, including Rospotrebnadzor, Roszdravnadzor, the Ministry of Digital Development, Communications, and the Federal Compulsory Medical Insurance Fund, as well as regional healthcare authorities and medical organizations, will have access to the data. Some users will have access to aggregated and anonymized information, while medical organizations will be able to work with personalized data.
In January 2026, the Russian Government adjusted the implementation plan for the Strategy for the Development of Immunoprophylaxis until 2035, shifting the deadlines for several key measures. Specifically, the introduction of rotavirus vaccination has been postponed to 2029, chickenpox vaccination to 2031, and human papillomavirus vaccination to 2027. At the same time, approaches to the prevention of meningococcal infection have been clarified, with an emphasis on the use of at least quadrivalent vaccines, and certain parameters for assessing herd immunity have been modified.
New registered medical devices
We publish a list of new medical devices registered from 04.03.2026 to 04.10.2026
Link to the list: [see table in the attachment]
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