Serbia medical device registration timeline
Source-linked clocksMedicines and Medical Devices Agency of Serbia (ALIMS) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) — EU-aligned (Law on Medical Devices) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(ALIMS registration) Registration decided within 30 days of an accepted application (Law on Medical Devices) | 30 days | 2-4 months | — | Verified |
| Class IIa(ALIMS registration) Registration decided within 30 days of an accepted application (Law on Medical Devices) | 30 days | 2-4 months | — | Verified |
| Class IIb(ALIMS registration) Registration decided within 30 days of an accepted application (Law on Medical Devices) | 30 days | 3-5 months | — | Verified |
| Class III(ALIMS registration) Registration decided within 30 days of an accepted application (Law on Medical Devices) | 30 days | 3-6 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesSerbia Medical Device Registration Process
Step-by-step ALIMS registration process. Total estimated timeline: 2-4 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by ALIMS. Appoint a Serbian Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to ALIMS including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksALIMS reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
30 daysIn-depth technical assessment of device safety and performance. ALIMS may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, ALIMS issues Serbia market authorization certificate.
- Local Authorized Representative (for foreign manufacturers)
- Completeness check within 15 days; deficiencies cured within 30 days
- Amendments decided within 15 days; renewal within 15 days when filed at least 30 days before expiry (tacit extension to max 90 days)
- Clinical trial authorisation within 40 days; manufacturing/wholesale licence within 60 days