Since March 1, 2025, new rules for state registration of medical devices have been in effect in Russia, approved by Government Decree No. 1684. The new procedure has affected all stages of the registration process – from document submission to entry of information into the register.
What has changed in the registration procedure?
First of all, the fact of state registration is now confirmed exclusively by an entry in the State Register of Medical Devices (GRMI). Paper registration certificates are no longer issued. Previously issued certificates remain valid indefinitely, but the possibility of making changes to them will be limited until December 31, 2026.
Another important change concerns clinical trials. Since September 1, 2025, medical organisations are required to upload trial results to the Roszdravnadzor automated information system in electronic format, whereas previously paper copies were permitted.
How to confirm registration in procurement?
For participation in state and municipal procurement (under 44-FZ and 223-FZ), customers are entitled to require confirmation of state registration of a medical device. This can be done in several ways:
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submit a copy of a valid registration certificate (if previously issued);
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provide information about the registration certificate details (number, date, or unique registry entry number);
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provide an extract from the State Register of Medical Devices, which is generated electronically with a QR‑code.
Important: since June 17, 2026, extracts from the register are issued on the day of application exclusively in electronic form, and the confirmation of registration is the registry entry itself.
Registration of multiple devices: strategies and approaches
When registering multiple medical devices, it is important to consider their classification by risk class. For devices with different OKPD‑2 codes, separate registration dossiers will be required. However, in some cases, the legislation permits the inclusion of several models or variants in a single registry entry, provided they have the same intended purpose and classification characteristics.
Registration timelines may vary: for low‑risk devices, the procedure takes up to 6–8 months; for high‑risk devices (including implantables), it takes longer, especially considering the need for clinical trials.
Important changes that have come into effect
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Authorised representatives of foreign manufacturers must update their information in the registration dossier by September 1, 2026. This deadline was previously set for September 2025 but was extended by Government Decree No. 1206 of August 13, 2025.
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For procurement purposes, it is now sufficient to provide information from the GRMI register – submission of a paper copy of the certificate is not mandatory.
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Inclusion of medical devices in the Ministry of Industry and Trade register (to obtain Russian product status) requires prior receipt of a Roszdravnadzor registration certificate, as well as passing an expert review by the Chamber of Commerce and Industry to confirm the level of localisation.
Elibrium is ready to help you with medical device registration
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, photographic images);
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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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assistance with inclusion of devices in the Ministry of Industry and Trade register for participation in public procurement;
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consulting on updating information about the manufacturer's authorised representative.
Contact us to discuss your task – we will develop an optimal registration strategy for your medical devices under the new conditions.
