Algeria medical device registration timeline
Source-linked clocksNational Agency for Pharmaceutical Products (ANPP) 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 |
|---|---|---|---|---|
| Medical-device homologation(ANPP registration) Executive Decree 20-324 Art. 30 sets a maximum 240-day decision clock from admissibility and permits an exceptional extension of up to 90 days; Art. 22 sets an 8-day admissibility review | 240-330 days | 9-14 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesAlgeria Medical Device Registration Process
Step-by-step ANPP registration process. Total estimated timeline: 9-14 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by ANPP. Appoint a Algerian Authorized Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to ANPP including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksANPP reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
240-330 daysIn-depth technical assessment of device safety and performance. ANPP may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, ANPP issues Algeria market authorization certificate.
- Local Authorized Representative required for foreign manufacturers
- Export-only authorisations: 60 days (+30 extension), decision 90 days
- Modification applications: 90 days (+30 extension)
- Manufacturing/importation agrément (approval) issued within 2 months