Endoscopic instruments are not just "tubes with a camera." They are complex medical devices that provide visualisation, manipulation, and diagnostics inside hollow organs. Without a registration certificate from Roszdravnadzor, no endoscope, no biopsy or coagulation instrument can be legally used in a clinic. In 2026, the registration procedure has undergone significant changes, and new deadlines have emerged for foreign manufacturers.
What risk class and what it means
Endoscopic instruments may fall under different risk classes depending on their intended purpose and degree of invasiveness. Flexible diagnostic endoscopes are usually classified as Class 2a, while instruments for surgical manipulations (e.g., resection or coagulation) may be classified as Class 2b.
For Class 2b, technical tests, toxicological studies (for tissue-contacting elements), and clinical trials are mandatory. For Class 2a, clinical trials may be replaced by a clinical evaluation if the device has confirmed analogues and sufficient clinical data.
What has changed in 2026
On September 1, 2026, a new procedure for conformity assessment of medical devices came into force (Ministry of Health Order No. 421n). The key change is the impartiality of testing organisations: they must not be dependent on the applicant. Information on conducted tests is entered into the Roszdravnadzor information system.
In addition, Roszdravnadzor has approved a new administrative regulation for registration (Order No. 750 of August 19, 2026). The developer of a medical device can no longer be an independent applicant – only the manufacturer or its authorised representative may apply for the service. The result of registration is now a registry entry, and paper certificates are no longer issued.
Registration timelines
For domestic endoscopic devices that do not require clinical trials on humans, the registration period is up to 31 working days. For devices with clinical trials, the timelines are longer. Amendments to the dossier without expert review take up to 18 working days; with expert review – up to 36 working days.
Important for foreign manufacturers
The transitional period for national registration of medical devices in the EAEU has been extended: applications for registration under national rules may be submitted until December 31, 2027, and for re-registration and amendments – until December 31, 2028. This provides additional time for adaptation.
What to consider when registering endoscopic instruments
1. Component compatibility. An endoscopic system often consists of a video processor, light source, endoscope, and instruments. The dossier must list all compatible components, especially if instruments are supplied separately from the main unit.
2. Sterility and reprocessing. Flexible endoscopes may be reusable, requiring disinfection and sterilisation. The documentation must confirm processing methods and material compatibility.
3. Software. Modern endoscopic systems use software for image processing. If the software has functions affecting diagnostics (e.g., magnification or image filtering), this must be reflected in the dossier.
4. Clinical data. For Class 2b instruments, clinical trials are mandatory. For Class 2a, a clinical evaluation based on literature analysis and data on registered analogues is possible.
How Elibrium helps with registration
At Elibrium, we specialise in registering complex medical devices, including endoscopic equipment. Our experts:
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audit your documentation and determine the correct risk class;
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develop technical and operational documentation taking into account the requirements for endoscopic systems;
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select accredited laboratories for technical testing;
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organise clinical trials at centres authorised by Roszdravnadzor;
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prepare the dossier taking into account all specifics – from component compatibility to sterility;
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submit the application through the Gosuslugi personal account and support the expert review until the registration certificate is issued.
Important: every modification of the endoscope, change in configuration, or software update is a potential reason for refusal if not covered in the dossier. We operate transparently: all timelines and costs are fixed in the contract.
Registering endoscopic instruments is a strategy where risk class, component compatibility, sterility, and clinical data must all be accounted for. Elibrium offers a route where risks are calculated and the result is guaranteed.
Contact us through our website, and our specialists will assess your project and prepare a tailored offer.
