A mammography system is not just an X-ray machine. It is specialised diagnostic equipment whose accuracy determines the detection of breast cancer at early stages. In Russia, such devices fall under Class 2b (elevated risk) — due to the use of ionising radiation. This means registration will require a full range of testing, including confirmation of radiation safety.
Why mammography systems require a special approach
Radiation safety is the key criterion. Mammography systems undergo testing according to standards governing dose characteristics and the protection of patients and personnel. Without confirmation of these parameters, registration is impossible.
Class 2b means a full testing cycle. For mammography systems, technical testing (including dosimetry), toxicological studies (for elements contacting the patient), and clinical trials are mandatory. The latter confirm the diagnostic effectiveness of the device in real practice.
Image processing systems are included in the assessment. Software for acquiring and processing images is evaluated as part of the medical device.
What has changed in 2026
New administrative regulation for registration. By Roszdravnadzor Order No. 750 of August 19, 2026, an updated regulation for the provision of state registration services for medical devices has been approved. Key changes:
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The developer can no longer be the applicant — only the manufacturer or its authorised representative may apply for the service.
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The result of the service is a registry entry, not the issuance of a paper certificate.
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Timelines: registration without clinical trials — 31 working days; domestic devices and AI software — 10 working days.
Extension of the deadline for updating authorised representative data. The opportunity to update information on the representative has been extended to September 1, 2027 — this is important for imported mammography systems.
Expert review fee for Class 2b. The state fee for the quality, efficacy, and safety expert review during registration for Class 2b is 136,000 rubles.
What to consider when registering a mammography system
1. Configuration. The dossier must list all components: X-ray tube, detector, compression plates, filters, software. Each element is evaluated as part of the system.
2. Radiation characteristics. It is necessary to confirm the dose load, compliance with radiation safety standards, and operator protection.
3. Software. If the software includes automatic image analysis functions (including AI), this must be reflected in the dossier.
4. Authorised representative. For imported devices, the representative's data must be up to date — otherwise registration may be cancelled.
How Elibrium helps with registration
We specialise in registering complex diagnostic equipment, including mammography systems. 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 radiation equipment;
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select accredited laboratories for technical testing, including dosimetry;
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organise clinical trials at medical centres authorised by Roszdravnadzor;
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prepare the dossier taking into account all specifics of mammography systems;
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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 device, change in configuration, or software update is a potential reason for refusal if not covered in the dossier. Timelines and costs are fixed in the contract.
Registering a mammography system is a strategy where radiation safety, clinical data, and correct configuration all matter. 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.
