Uzbekistan medical device registration timeline

Source-linked clocks

Ministry of Health of the Republic of Uzbekistan (Pharmaceutical Safety Center) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — EU-aligned classification system.

4 pathways4 of 4 clocks verifiedvalidity 5 yearsMDSAP not acceptedreviewed 2026-08-30lex.uz

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class I(MoH registration) Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 60 working days for Class I	60 working days	3-5 months	—	Verified
Class IIa(MoH registration) Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 90 working days for Class IIa	90 working days	5-7 months	—	Verified
Class IIb(MoH registration) Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 120 working days for Class IIb/III	120 working days	7-10 months	—	Verified
Class III(MoH registration) Cabinet of Ministers Resolution No. 738: Annex-1 staged registration 120 working days for Class IIb/III	120 working days	8-12 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Uzbekistan Medical Device Registration Process

Step-by-step Pharmaceutical Safety Center registration process. Total estimated timeline: 3-5 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by Pharmaceutical Safety Center. Appoint a Uzbek Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to Pharmaceutical Safety Center including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

Pharmaceutical Safety Center reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

60 working days

In-depth technical assessment of device safety and performance. Pharmaceutical Safety Center may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, Pharmaceutical Safety Center issues Uzbekistan market authorization certificate.

Summary: The Uzbekistan medical device registration process through Ministry of Health of the Republic of Uzbekistan (Pharmaceutical Safety Center) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

CE Mark (EU MDR)Reference-jurisdiction registration is the trigger for the recognition route below; on the ordinary route the CE dossier is reused but the Annex-1 periods are unchanged.None published

FDA 510(k)/PMAReference-jurisdiction registration is the trigger for the recognition route below; on the ordinary route the FDA dossier is reused but the Annex-1 periods are unchanged.None published

Recognition route (device already registered in a reference jurisdiction)Cabinet of Ministers Resolution No. 738 decides recognition applications in 15 working days against the ordinary Annex-1 periods of 60, 90 and 120 working days15 working days instead of 60 to 120

WHO prequalificationSeparate 60-working-day route under Resolution No. 73860 working days instead of 90 or 120 for Class IIa and above

Key requirements

Local Authorized Representative required for foreign manufacturers
Recognition route: decisions within 15 working days where the device is registered in a reference jurisdiction
Epidemic-need import authorisation: 30 working days; WHO-prequalified devices: 60 working days
Annex-1 staged breakdown: application 1 wd, expertise scheduling 15 wd, expertise 30-90 wd by class, decision 10 wd, certificate 5 wd; excluded categories and changes up to 50% of the dossier follow separate tracks

Primary regulator sources

lex.uz · Uzbekistan CM Resolution 738 Annex 1 — registration review by route and class

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against Pharmaceutical Safety Center publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:uzbekistan:class-i