Uzbekistan medical device registration timeline
Source-linked clocksMinistry of Health of the Republic of Uzbekistan (MoH) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — EU-aligned classification system.
| 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 estimatesUzbekistan Medical Device Registration Process
Step-by-step MoH registration process. Total estimated timeline: 3-5 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by MoH. Appoint a Uzbek Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to MoH including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksMoH reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
60 working daysIn-depth technical assessment of device safety and performance. MoH may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, MoH issues Uzbekistan market authorization certificate.
- 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