We help bring a device to the Uzbekistan market — from determining the risk class to obtaining the registration certificate. We prepare the dossier and support testing, the expert review and communication with the authority.
Why it matters
Importing and selling a medical device without state registration is prohibited. A device undergoes a review of quality, efficacy and safety — and, for higher-risk classes, additional technical and clinical testing — and only receives a registration certificate after being entered into the State Register.
New registration procedure 2025–2026
Resolution of the Cabinet of Ministers No. 738 of 24 November 2025 approved the regulation on the state registration of medical devices: requirements and conditions, the list of documents and samples, and the step-by-step procedure via the Center for Pharmaceutical Product Safety under the Ministry of Health.
How registration works
- Determining the device risk class under Uzbekistan’s requirements
- Building the dossier and the testing scope for the risk class
- Technical and, where required, clinical testing
- Submission and support through the quality, safety and efficacy review
- Entry into the State Register and issuance of the registration certificate
Why us
We know the procedure inside out and stay in contact with the authorities. We verify the declared risk class against Uzbekistan’s requirements, help build the dossier and testing scope, support the device at every stage and keep timelines under control. You don’t lose time on mistakes: we get it right the first time.
Ready to start?
Send us the device name and intended use — we’ll determine the risk class and document set for free.