Uzbekistan Medical Device Registration Certificate Validity: Five-Year Term and Renewal

1. Key takeaways

The validity period of the Uzbek national registration certificate is uniformly 5 years, with domestic and foreign manufacturers treated equally; moreover, indefinite registration certificates previously issued to domestic manufacturers are converted to a 5-year term across the board from the entry into force of Presidential Decree No. UP-137 of August 19, 2025. Uzbekistan therefore has no pathway of registration valid once and forever, and no arrangement of the Kazakh type in which medical device registration certificates carry no expiry date. The compliance focus consequently extends from obtaining the certificate to two long-term actions: renewal and change management. For portfolio holders this conversion changes the nature of the asset: certificates that previously required no scheduling now carry a first renewal deadline measured from the decree effective date. Companies should treat the 5-year term as a fixed compliance cycle with its own preparation workload, covering updated powers of attorney, refreshed foreign approval status, post-market evidence and accumulated change requests, all of which must be assembled inside a narrow statutory window before expiry.

2. Legal basis

3. Expert insights

Insight one: the 5-year term is the most unifying element of this reform. Presidential Decree No. UP-137 both brought foreign manufacturers under the 5-year term and converted the prior indefinite certificates of domestic manufacturers to 5 years. Before the reform, domestic manufacturers held certificates without a term while foreign manufacturers held 5-year certificates, and the two sets of rules ran in parallel; after the reform, the term is uniformly 5 years. The impact on existing certificate holders is that certificates which previously required no scheduling now need their first renewal completed within 5 years after the conversion starting point, which makes certificate portfolio planning an immediate task rather than a future one.

Insight two: the conversion starting point is the effective date of the decree, not the certificate issue date. Prior indefinite certificates run their 5 years from the date the decree took effect. This starting point directly determines the window for the first renewal, and companies should calculate backwards from the effective date after August 19, 2025, not from the issue date of the original certificate. A portfolio keyed to old issue dates will systematically misstate renewal deadlines, in some cases by several years, and the error typically surfaces only when an import consignment is checked against certificate validity.

Insight three: renewal is not automatic, and it requires post-market evidence. The renewal rules established by Resolution No. 213 require the applicant to file 3 months before expiry, with the fee charged at half the standard amount; at renewal, the registration file, post-market evidence and quality system status must also be updated. In practice, collecting local clinical use feedback, updating foreign approval status and re-authenticating powers of attorney all consume time, so 3 months is only the statutory floor. A preparation runway of two to three quarters is the realistic planning assumption for a renewal that passes without deficiencies.

Insight four: the treatment after expiry differs from the Kazakh approach. Under the old rules of Resolution No. 213, after a registration certificate expires, products manufactured during its validity may still be sold and used. This run-down arrangement prevents expiry from immediately cutting off all circulation. New applications and import actions, however, must be completed within the validity period, otherwise the goods constitute unregistered devices. Importers should therefore freeze new consignments against the expiry date even where legacy stock may continue to be sold.

4. Practical recommendations

1. Build a registration certificate ledger recording, certificate by certificate, the issue date, the expiry date and the statutory renewal window (3 months before expiry).
2. For legacy indefinite certificates, run the 5 years from the decree effective date after August 19, 2025 and mark the first renewal point separately.
3. Start renewal preparation early: update powers of attorney and their authentication, refresh foreign approval status, and collect post-market use feedback.
4. Handle accumulated changes together with the renewal application, avoiding a separate change procedure after renewal.
5. Set an early warning before expiry in the ledger, with import and shipment plans suspended automatically once the certificate lapses.

5. Verification checklist

• □ A registration certificate ledger has been established with issue dates and expiry dates marked certificate by certificate
• □ The statutory renewal window (3 months before expiry) has been entered in the ledger with an early warning
• □ Legacy indefinite certificates run their 5 years from the decree effective date with the first renewal point marked
• □ Power of attorney authentication, foreign approval status and post-market evidence required for renewal are on the preparation list
• □ The national GMP certificate requirement for medicine renewals (from January 1, 2026) has been confirmed
• □ Import and shipment of goods after certificate expiry are subject to an automatic suspension mechanism

Regulatory information verified as of October 29, 2026.

GRZAN provides registration support in Uzbekistan for manufacturers, importers and authorized representatives. For assistance with certificate renewal and portfolio management, contact info@grzanglobal.com.