From September 1, 2026, new rules for mandatory marking of medical devices in the "Chestny ZNAK" system come into force in Russia. The Government of the Russian Federation has approved amendments that significantly expand the list of products subject to identification.
Which products fall under the new requirements?
From autumn 2026, mandatory marking will apply to 12 new categories of medical devices:
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syringes, medical wipes, test tubes;
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medical masks and gloves;
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air disinfectors, including bactericidal units and recirculators;
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orthopaedic shoes with insoles;
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coronary stents and hearing aids;
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computed tomography scanners;
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artificial respiration devices;
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incubators for newborns;
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infusion systems, fillers, and cosmetic threads.
Hygiene products for incontinence and implants for plastic surgery will also be subject to marking.
Why was this decision made?
The government explained that the decision was taken in response to requests from manufacturers and importers. Market participants are currently forced to build parallel processes for marked and unmarked products, which complicates operations and increases business costs. Unifying requirements will simplify processes and reduce the administrative burden in the long term.
Transition periods and deadlines
The new rules are being introduced in stages:
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From September 1, 2026 – all listed products must be introduced into circulation already marked.
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For importers – marking may be carried out until September 30, 2026.
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From December 1, 2026 – market participants must submit data on the withdrawal of products from circulation, including sales through cash registers.
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From June 1, 2027 – full unit‑level tracking with data transmission on circulation and supply chain transactions.
What about unmarked stock?
Sales of unmarked stock introduced into circulation before September 1, 2026, are permitted until August 31, 2027. For products with a defined service life, this period extends until February 28, 2027. For stock produced or imported before May 31, 2026, sales without marking are permitted until the expiry date.
Important: how to prepare
Market participants are advised to prepare for the changes in advance:
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conduct inventory of remaining stock;
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register in the "Chestny ZNAK" system;
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set up equipment for applying marking codes;
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integrate accounting systems with the monitoring system.
For certain products, more detailed technical specifications will need to be provided in the system – such as equipment power and voltage.
Elibrium will help you adapt to the new marking requirements
We have extensive experience in the field of medical device registration and circulation and offer a full range of services:
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consulting on marking issues and new requirements;
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assistance with registration in the "Chestny ZNAK" system and preparation for data transmission;
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development of technical documentation taking into account marking requirements;
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full‑cycle support for medical device registration with Roszdravnadzor.
Contact us to discuss your task – we will help you go through all the preparation stages for the new marking rules without risks or delays.
