Uzbekistan Medical Device Registration Renewal: Deadlines and Preparation Plan

1. Key takeaways

The registration certificate is valid for 5 years, and the renewal application must be filed with the Center at least 3 months before expiry (a rule established by Resolution No. 213), with the renewal fee charged at half rate. But the 3-month period is only the statutory floor. A renewal requires updating the registration documents, the post-market safety evidence and the quality system status, and collecting local clinical feedback and updating the foreign approval status all consume time. GRZAN recommends starting renewal preparation in year 4 of the certificate cycle. The reasoning is straightforward: the renewal is processed with review depth comparable to an initial registration, so the dossier must be rebuilt, the power of attorney may need a new legalization chain, and any accumulated but unfiled variations must be resolved before the renewal can succeed. Companies that start three months before expiry routinely face one of two bad outcomes — a renewal filed with an incomplete dossier, or a certificate that lapses while the renewal is still under review. Either outcome interrupts imports and sales, and neither is recoverable by asking the Center for an extension. Renewal is therefore not an administrative formality at the end of a certificate cycle; it is a project that should be planned, budgeted and executed across the final eighteen months of the validity period. The half-rate renewal fee makes the event cheaper than a fresh registration, but it does not make it lighter in workload, and the two should not be conflated in resource planning. Teams that allocate the same effort to a renewal as to a first filing are consistently the ones whose renewals complete inside the statutory window without last-minute gaps.

2. Legal basis

3. Expert insights

Insight 1: the 3-month period is the latest filing date, not the preparation start date. Resolution No. 213 requires the renewal application to be filed 3 months before expiry. But the renewal itself requires updating the power of attorney (which may involve a new legalization chain), updating foreign approval documents and supplementing post-market safety data. None of that can be completed inside 3 months, so preparation must start in year 4. Treating the statutory window as the working window is the single most common renewal failure in practice.

Insight 2: a renewal is a re-registration, not an automatic extension. Resolution No. 213 states that renewal follows the procedure for issuance of a registration certificate. This means the renewal goes through review depth comparable to a registration, not a formal check. The volume of technical document updates needed depends on how many changes accumulated over the 5 years — companies with disciplined variation management face a significantly lighter renewal workload. The renewal is, in effect, the audit of everything done or not done during the certificate cycle.

Insight 3: the legacy stock arrangement after expiry is a buffer, but it cannot be relied on. Resolution No. 213 provides that after expiry of the certificate, products manufactured during the validity period may still be sold and used. This avoids a full stop-sale at the moment of expiry, but new filings and new imports must be completed within the validity period. Treating the buffer as permission to delay leads directly to interrupted imports, because the moment a shipment is manufactured after expiry, it falls outside the protection.

Insight 4: the first renewal date of a converted certificate must be calculated separately. Previously indefinite certificates issued to domestic manufacturers are converted to 5 years from August 19, 2025, the effective date of the presidential decree. The first renewal window for such certificates is calculated from the conversion starting point, not from the original issue date. The certificate register should carry a dedicated column for these converted certificates to prevent missed windows.

4. Practical recommendations

1. Maintain a certificate register marking the issue date, expiry date and statutory renewal window for every certificate (3 months before expiry).
2. Start renewal preparation in year 4: update the power of attorney and its legalization, update foreign approvals, and supplement post-market safety data.
3. Resolve changes accumulated over the 5 years within the renewal application, to avoid running variation procedures after renewal.
4. Record the conversion starting point and first renewal date of previously indefinite certificates in a dedicated register column.
5. For medicines, confirm the national GMP certificate requirement for renewal (from January 1, 2026).

5. Verification checklist

• □ Certificate register marks issue dates, expiry dates and statutory renewal windows (3 months before expiry)
• □ Renewal preparation started in year 4 of the certificate cycle
• □ Accumulated changes resolved within the renewal application
• □ Conversion starting point and first renewal date recorded for previously indefinite certificates
• □ National GMP certificate requirement confirmed for medicine renewals
• □ Renewal fee estimated on the half-rate basis

GRZAN supports manufacturers, importers and authorized representatives with medical device registration renewal, certificate lifecycle management and market access in Uzbekistan. For assistance with your product portfolio, contact info@grzanglobal.com.

Regulatory information verified as of October 29, 2026.