Algeria medical device registration timeline

Source-linked clocks

National 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.

3 pathways3 of 3 clocks verifiedvalidity 5 years from the date the homologation decision is signed (Décret 20-324 Art. 34), renewable on request filed at least 90 days before expiryMDSAP not acceptedreviewed 2026-08-30miph.gov.dz

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Medical-device homologation(ANPP registration) Décret exécutif 20-324 Art. 30: the ANPP must decide within 240 days from the date the file is ruled admissible under Art. 22, and the director general may exceptionally extend that by up to 90 days, which is where the 330-day upper bound comes from	240-330 days	9-14 months	—	Verified
Export-only homologation (locally manufactured)(ANPP export-only homologation) Arrêté of 23 June 2021 Art. 9: the ANPP must decide within 90 days from admissibility, exceptionally extendable by the director general by up to 30 days	90-120 days	4-7 months	—	Verified
Modification of a homologation decision(ANPP variation) Arrêté of 23 June 2021 Art. 12: the ANPP must decide within 90 days from receipt of the modification request, exceptionally extendable by the director general by up to 30 days, with the clock suspended while complementary information is outstanding	90-120 days	4-7 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Algeria Medical Device Registration Process

Step-by-step ANPP registration process. Total estimated timeline: 9-14 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by ANPP. Appoint a Algerian Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to ANPP including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

ANPP reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

240-330 days

In-depth technical assessment of device safety and performance. ANPP may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, ANPP issues Algeria market authorization certificate.

Summary: The Algeria medical device registration process through National Agency for Pharmaceutical Products (ANPP) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

CE Mark (EU MDR)Usable as technical and QMS evidence in the dossier. Algeria requires its own registration decision and publishes no recognition route or origin-based reduction.None published

FDA 510(k)/PMAUsable as supporting technical evidence only, with no published reduction.None published

Key requirements

Only an agréé pharmaceutical establishment may hold a homologation decision (Décret 20-324 Art. 32), and the agrément itself is a separately clocked step: the technical commission has 8 days to give its opinion, the minister 30 days to decide on each of the agrément préalable de réalisation and the agrément d'ouverture, experts 10 days to return technical evaluation reports, and the applicant 60 days to lift any reserves
Segments inside the 240-day homologation clock: 8 days for the admissibility examination (Art. 22), up to 30 days for the clinical-expert committee report (Art. 26), up to 30 days for the commission's opinion once seized and a further 30 if complementary information is sought (Art. 27), and 8 days for the commission to transmit that opinion to the director general (Art. 28)
At the end of the technical evaluation the applicant has a maximum of 15 days to certify that nothing changed during the review (Art. 29), and missing that window stalls the file
Local Authorized Representative required for foreign manufacturers
Homologation is valid 5 years from signature (Art. 34) and renewal must be filed at the latest 90 days before expiry (Art. 35)
A homologated device not actually placed on the market or exported within 18 months of notification may have its decision withdrawn (Art. 37)

Primary regulator sources

miph.gov.dz · Algeria décret exécutif n° 20-324 du 22 novembre 2020 — homologation: recevabilité 8 jours (Art. 22), avis de la commission 30 jours (Art. 27), décision 240 jours prorogeable de 90 jours (Art. 30), validité 5 ans (Art. 34) joradp.dz · Algeria arrêté du 23 juin 2021 (JO 62) — homologation des DM fabriqués localement et destinés exclusivement à l'exportation: décision 90 jours prorogeable de 30 jours (Art. 9) joradp.dz · Algeria arrêté du 23 juin 2021 (JO 62) — modification de la décision d'homologation: décision 90 jours prorogeable de 30 jours (Art. 12), demande corrigée traitée en 30 jours (Art. 15) joradp.dz · Algeria arrêté (JO 62 du 15 août 2021) pris en application du décret exécutif n° 21-82 — agrément des établissements pharmaceutiques de fabrication: avis de la commission technique 8 jours, décision ministérielle 30 jours, levée des réserves 60 jours

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

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Source-linked review clocks verified against ANPP publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:algeria:homologation