FAQ guide on registering medical devices for export to Uzbekistan, covering the local authorized representative, required documents, Uzbek or Russian labeling, registration certificate, review timelines, and Uzpharmsanoat requirements.
To export medical devices to Uzbekistan, a locally authorized representative must submit a registration application to the competent authority for pharmaceuticals and medical devices. The application package includes technical documentation, quality management system evidence, proof of approval in the country of origin, labels and instructions for use in Uzbek or Russian, and authorization documents. Import and sale are permitted only after the registration certificate is obtained. Specific classification, review timelines, and certificate validity are subject to the authority's latest requirements; the authority has not published them uniformly.
Key Requirements
- Competent authority: Uzbekistan Agency for the Development of Pharmaceuticals and Medical Devices (Uzpharmsanoat) — https://uzpharmagency.uz/
- Local requirement: The application must be submitted by an authorized representative in Uzbekistan, who also bears post-market obligations.
- Core documents: (1) authorized representative documents; (2) technical documentation; (3) ISO 13485 or equivalent quality management system evidence; (4) proof of approval in the country of origin; (5) labels and instructions for use in Uzbek or Russian.
- Language: Uzbek or Russian.
- Validity: As stated on the registration certificate; the authority has not published a uniform validity period.
Professional Notes
Official website of Uzpharmsanoat: https://uzpharmagency.uz/
Verification date: 2026-11-02.
Frequently Asked Questions
Can I apply directly by myself?
In general, a local authorized representative is required. Applications submitted directly by a foreign manufacturer are typically not accepted.
How long does the review take?
The authority has not published a uniform review timeline. In practice, the timeline depends on the completeness of the dossier and the product classification.
Source and Disclaimer
Compiled by the Ameli Regulatory Editorial Team based on public pages of the target country's regulatory authority. Sources: the official website and regulatory pages of the authority identified above. Verification date: 2026-11-02.
This article summarizes regulatory information and does not constitute legal advice. Specific requirements are subject to the authority's latest requirements. Ameli is an overseas registration work platform for medical device companies; it is not a CRO and not an agent.
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