On November 28, 2025, sweeping changes to the procedure for federal state control over the circulation of medical devices came into force, approved by Government Decree No. 1829 of November 19, 2025. The innovations introduce a risk‑based approach to inspection planning and change the frequency of control measures for different manufacturer categories.
A new risk category – "high risk" – has been introduced
The key change is the introduction of a "high risk" category. This category covers control objects related to:
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the production and manufacture of medical devices for in vitro diagnostics;
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the production and manufacture of implantable medical devices classified as risk class 3;
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the conduct of clinical trials of medical devices of risk classes 2b and 3.
How has the frequency of inspections changed?
Planned control measures (on‑site and documentary inspections, inspection visits, test purchases) for high‑risk facilities are now conducted once every two years. At the same time, a scheduled inspection may be replaced by an annual preventive visit.
For facilities with significant, medium, moderate, and low risk, scheduled inspections are not conducted. Instead, preventive visits are provided with the following frequency:
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significant risk – no more than once every 3 years;
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medium risk – no more than once every 5 years;
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moderate risk – no more than once every 6 years.
A mandatory preventive visit is conducted within 6 months of receiving notification of the start of activities.
New control tools – remote interaction
An important innovation is the ability to conduct control measures using remote interaction tools, including video conferencing and the mobile application "Inspector." The application can now be used for photography and video recording during inspections, on‑site visits, and documentary inspections.
What's next: updating Roszdravnadzor checklists
Roszdravnadzor is developing new forms of inspection checklists for monitoring the circulation of medical devices, which will replace the documents from 2022. The draft order is undergoing public consultation, and if approved, the new checklists will come into force on September 1, 2026. All seven forms will be updated, including checks for technical trials, clinical trials, use of devices in medical organisations, manufacturer circulation, technical maintenance, transportation, storage, and sales.
Elibrium will help you prepare for the new state control rules
We have extensive experience in the field of medical device registration and circulation and offer:
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audit of documentation and production processes for compliance with new requirements;
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consulting on risk categorisation and inspection frequency;
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assistance in preparing for preventive visits and scheduled inspections;
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development and updating of technical documentation;
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full‑cycle support for medical device registration with Roszdravnadzor.
Contact us to discuss your task – we will help you minimise regulatory risks and pass control measures without complications.
