Dear clients and partners! Registering medical equipment, including ultrasound diagnostic systems, is a mandatory procedure for legal use in Russian healthcare facilities. At Elibrium, we have prepared a brief guide to help you navigate the key stages.
Main steps for registering an ultrasound system:
- Document preparation. A package is required: an application, technical documentation, operating instructions, manufacturer details, and test results (if available).
- Submitting an application to Roszdravnadzor. Documents can be submitted electronically via the government services portal or in person at a territorial office.
- Quality and safety expert review. The equipment is checked for compliance with standards (GOST, EAEU technical regulations). The review period is up to30 business days.
- Obtaining a registration certificate. Upon a positive decision, an indefinite certificate is issued and entered into the unified registry.
- Entry into the medical devices register. After this, the ultrasound system can be officially operated.
Important: If the ultrasound system is already registered abroad, a procedure for recognition of registration may be required. Elibrium provides full support at every stage — from consultation to document submission.
Contact our specialists for a detailed consultation! We will help you avoid mistakes and speed up the process.