Expansion of the list of medical products for mandatory labeling from September 2026

In 2026, the system of regulating the turnover of medical devices in Russia is entering a new stage of development, associated with a large-scale expansion of mandatory digital labeling. By Decree of the Government of the Russian Federation No. 375 dated April 6, 2026, the list of medical products subject to labeling in the Honest Sign state system has been significantly expanded. The new requirements will come into force on September 1, 2026 and affect a wide range of products, from mass-produced consumables to sophisticated medical equipment.
The expansion of the list means the transition from limited labeling to comprehensive control of a significant part of the medical device market. The updated list includes both basic product categories such as syringes, medical masks, gloves, napkins and test tubes, as well as high-tech products, including coronary stents, CT scanners, ventilators, incubators for newborns, hearing aids and orthopedic products. Thus, regulation covers almost all key segments of the medical market, including both consumables and long-term equipment.
The main objective of labeling is to ensure transparency in the turnover of medical products and reduce the proportion of counterfeit and substandard products. The Honest Sign system allows you to track the movement of goods at all stages - from the manufacturer or importer to the end user. Each product receives a unique code, which is recorded in a digital system and accompanies the products throughout the entire supply chain. This makes it possible to control the legality of the origin of the goods, track their movement and promptly identify violations.
The decision was a logical continuation of the experimental work started in 2024. The pilot project made it possible to test the mechanisms of applying codes, integrating information systems and interacting market participants with the state labeling system. In 2025, the experiment was extended, which made it possible to refine the approaches taking into account practical difficulties. The result was the establishment of a single deadline for the introduction of mandatory labeling for an expanded list of products, which allows market participants to synchronize the preparation processes.
Additionally, it is planned to clarify the classification of products by expanding the list of OKPD2 codes for certain categories of medical devices. This applies, in particular, to air purifiers, coronary stents, computed tomographs and sanitary products. Clarifying the classifier is necessary to more accurately identify products in the system and increase the effectiveness of state control. A more detailed classification allows not only to track the movement of products, but also to generate more accurate market analytics.