The turnover of medical products in the Russian Federation is a complex of regulated processes, including production, registration, import, storage, sale, operation and withdrawal of products from circulation.
The basis of regulation is Federal Law No. 323-FZ "On the Basics of Public Health Protection", as well as by-laws of the Government of the Russian Federation and the requirements of the Eurasian Economic Union. In accordance with current legislation, only those medical devices that have passed state registration or are registered under the EAEU procedures are allowed to be handled in Russia. Any product, from consumables to complex equipment, must have a registration certificate confirming its safety, quality and effectiveness.
The structure of the turnover of medical products
The turnover of medical products includes several interrelated stages.
After development and production, the product undergoes state registration. Then it can be put into circulation - put in a warehouse, sold by a distributor or transferred to a medical organization. Requirements for traceability, labeling, documentation, and storage conditions apply at all stages.
Special attention is paid to quality control and safety. Roszdravnadzor oversees the circulation of medical devices, including inspections of market participants, monitoring of unsafe products, and withdrawal of products from circulation if violations are detected.
Mandatory registration as a condition of admission to the market
A key element of the turnover is the registration of a medical device. The product cannot be legally in circulation without a registration certificate. This applies not only to the sale, but also to the storage, importation and use of products.
Violation of this requirement is considered a serious offense. The legislation provides for liability for the handling of unregistered, substandard or falsified medical devices, up to criminal liability.
Marking and traceability
One of the key areas of regulation in 2026 remains the development of a digital labeling system for medical devices.
Starting from September 1, 2026, the list of products subject to mandatory labeling in the Honest Sign system will be expanded. The requirements apply to both consumables and complex equipment.
Labeling ensures product traceability at all stages of turnover - from the manufacturer to the end user.
Peculiarities of treatment in the conditions of the EAEU
In 2026, the turnover of medical products is also regulated within the framework of the Eurasian Economic Union.
Products registered according to national regulations can only be traded within one country. At the same time, products registered under the EAEU procedure gain access to all markets of the union.
In parallel, transitional provisions related to the gradual transition to a unified registration system continue to operate. This affects the product launch strategy and requires companies to take future changes into account when planning projects.
State control and supervision
Control over the turnover of medical products in Russia is carried out on several levels.
Roszdravnadzor conducts inspections of manufacturers, distributors, and medical organizations, analyzes reports of unsafe products, and makes decisions to suspend or ban their circulation.
In addition, the government implements measures to protect the market from counterfeit and counterfeit products, as well as regulates pricing and procurement issues within the framework of the public and corporate procurement system.
