On March 1, 2025, new rules for state registration of medical devices came into force, approved by Government Decree No. 1684. The key change is that the registration certificate is now issued exclusively as an entry in the state register, rather than on a paper form.
What exactly has changed?
To implement the new rules, Roszdravnadzor issued Order No. 310 of April 3, 2026, which declared all previously valid orders establishing the paper certificate form as void:
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Order No. 40-Pr/13 of January 16, 2013;
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Order No. 3380-Pr/13 of July 23, 2013;
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Order No. 1636 of March 3, 2017;
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Order No. 1450 of July 10, 2017.
The registry entry now serves as the sole proof of registration. This applies even to medical devices for which applications were submitted before Decree No. 1684 came into force.
What other changes took effect on June 17, 2026?
The Government of the Russian Federation adopted Decree No. 708 of June 8, 2026, clarifying the procedure for maintaining the register:
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Extracts are issued on the day of application. Previously, the processing time was five working days.
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Requests are electronic only. Paper requests are no longer accepted. Extracts are sent via the Unified Portal of State Services or the Roszdravnadzor website.
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A QR‑code is applied to the extract. Scanning the code opens a webpage with current information from the register.
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The electronic image of the registration certificate is no longer included in the register. It was previously a mandatory element of the registry entry.
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Requirements for photographs have been clarified. Images must be in colour, at least 18×24 cm in size, and include all models, accessories, as well as labelling and packaging.
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Instructions for use or operating manuals are now mandatory as part of the operational documentation.
What does this mean for market participants?
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During Roszdravnadzor inspections or customs clearance, an electronic extract with a valid QR‑code is now required. Using old PDF copies of certificates without verifying the current status via the QR‑code places risks on the distributor or buyer.
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The transition to fully electronic document flow speeds up the process of obtaining extracts (on the same day), but requires digital literacy and access to the Gosuslugi portal or the Roszdravnadzor website.
Elibrium will help you adapt to the new medical device registration rules
We have extensive experience in the field of medical device registration and offer a full range of services:
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preparation and submission of registration dossiers to Roszdravnadzor via the elk.Roszdravnadzor system;
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development of technical documentation (technical specifications, operating manuals, instructions for use, risk analysis);
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organisation and support of technical, toxicological, and clinical trials;
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interaction with government authorities at all stages;
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consulting on registry record management and obtaining electronic extracts with QR‑codes.
Contact us to discuss your task – we will help you navigate the new requirements and ensure reliable support for the registration of your medical device.
