On June 17, 2026, amendments to the rules for maintaining the state register of medical devices came into force, approved by Government Decree No. 708 of June 8, 2026. The key innovation is that an electronic extract with a QR-code now serves as proof of registration, while paper registration certificates and their electronic copies no longer have legal force.
What exactly has changed?
The main changes concern the procedure for obtaining an extract from the register:
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Requests are now electronic only. Applications can be submitted through the official Roszdravnadzor website or the Gosuslugi portal. Paper requests have been abolished.
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Extracts are issued on the day of application. Previously, the processing time was five working days.
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QR-code instead of an electronic copy of the certificate. The extract now contains a QR-code that links to the official registry page with up‑to‑date information about the device.
Why does this matter for market participants?
The QR-code is an instant verification tool. By scanning the code, users can check in real time:
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the current registration status of the device (active, suspended, or cancelled);
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information about the manufacturer and production sites;
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the composition of accessories and configuration options;
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colour photographs of the device, its labelling, and packaging;
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the current instructions for use.
What else has changed in the registry?
At the same time, requirements for photographs of devices entered into the register have been tightened: images must be in colour, at least 18×24 cm in size, and include all models and accessories. The requirement to include an electronic image of the registration certificate has also been removed.
How does this affect your business?
Using old PDF copies of certificates without verifying the current status via the QR-code places full responsibility for any potential purchase of a device with suspended registration on the distributor or buyer. During inspections by Roszdravnadzor or customs clearance, an electronic extract with a valid QR-code will be required.
Elibrium will help you navigate the new rules and support your medical device registration under the changed conditions
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, instruction manuals, 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 extracts.
Contact us to discuss your task – we will help you adapt to the new requirements and ensure reliable support for the registration of your medical device.
