Algeria Standard Homologation Process: Six Stages from Submission to Decision

1. Key takeaways

Algeria’s standard homologation procedure for medical devices proceeds under Articles 21 to 30 of Décret exécutif n° 20-324 and can be divided into six stages: submission with payment of the homologation fee and issuance of a receipt (Article 21); an admissibility review completed within 8 days (Article 22); technical evaluation (Articles 23 to 26); a commission opinion issued within 30 days (Article 27); the opinion forwarded to the applicant within 8 days and a declaration of no change filed by the applicant within 15 days (Articles 28 and 29); and an ANPP decision issued within 240 days of admissibility, extendable by 90 days (Article 30).

The six stages are not six equal blocks of time. The admissibility review is short but decisive, the technical evaluation and the commission opinion consume most of the calendar, and the 240-day decision window is a statutory ceiling that wraps around everything preceding it. A project plan that treats the six stages as one undifferentiated queue will consistently misjudge where the schedule risk actually sits.

GRZAN’s scheduling experience is direct: the 240 days granted by law are a ceiling, not the norm. The variables that really move an Algerian homologation project are the meeting cadence of the commission and the number of additional-information rounds requested during review. Both sit outside the applicant’s direct control, but both can be anticipated, monitored and managed.

2. Legal basis

1. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (Executive Decree No. 20-324 of 22 November 2020 on the procedures for the homologation of medical devices, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles): Article 21 (payment of the fee and issuance of the récépissé), Article 22 (admissibility review within 8 days), Article 23 (technical evaluation), Article 24 (conflicts of interest of experts), Article 25 (the four phases of evaluation), and Article 26 (the handling of devices that cannot be evaluated).
2. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (Executive Decree No. 20-324 of 22 November 2020 on the procedures for the homologation of medical devices, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles): Article 27 (a commission opinion within 30 days, extendable by 30 days), Article 28 (the opinion forwarded within 8 days), Article 29 (the applicant’s declaration of no change within 15 days), and Article 30 (a decision within 240 days, extendable by 90 days).
3. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant la composition du dossier d’homologation et du dossier de renouvellement de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 10 May 2021 fixing the composition of the homologation dossier and the renewal dossier for medical devices intended for human medicine, JORADP No. 55, published 14 July 2021, pages 21–24, 13 articles): Article 2 (submission requires payment of the fee with proof of payment attached) and Article 3 (submission by the head pharmacist in charge of technology).

3. Expert insights

Insight 1: the receipt under Article 21 is the anchor from which every later deadline is counted.

Article 21 requires payment of the fee at submission, after which the ANPP issues a récépissé. Article 30 counts its 240 days à compter de la date de recevabilité, that is, from the date of admissibility, and that date is in turn fixed by the admissibility review under Article 22. The date on the récépissé is therefore day zero of the entire project, and it should be flagged prominently in the regulatory file rather than buried in correspondence.

Insight 2: an additional-information request both stops the clock and can invalidate the application.

Article 30(2) provides that where additional documentation is requested, the deadline is suspended (suspendu). The same provision states that if the applicant fails to submit the requested items in time, the application becomes caduque. The provision cuts both ways: no time is consumed while the applicant prepares the response, which looks favourable, but the deadline set in the request is a hard deadline. Missing it means starting over, and the fees already paid are generally not refunded.

Insight 3: Article 26 preserves an alternative route for devices that cannot be evaluated.

Under Article 26, when a device cannot be assessed through the standard evaluation, the procedure moves to a documentary evaluation combined with a report from the clinical experts committee, and the report must be issued within 30 days. In practice this is the fallback channel for innovative devices and rare categories that do not fit the conventional assessment grid. GRZAN invokes Article 26 proactively whenever the ANPP indicates that a device cannot be evaluated, using it to keep the procedure moving instead of stalling.

Insight 4: Article 27 and Article 30 are two independent clocks that are easy to confuse.

The 30 days of Article 27 govern the commission’s opinion and may be extended by 30 days; the 240 days of Article 30 govern the ANPP decision and may be extended by 90 days. The former nests inside the latter. When asking the authority about progress, always specify which of the two clocks the question concerns, because a reply about the commission timeline says nothing about the decision timeline.

4. Practical recommendations

1. Set the récépissé date as project day zero and schedule every internal reminder backwards from that date.
2. Start work the same day an additional-information request arrives, and split the request into sub-tasks that can run in parallel rather than serially.
3. When resubmitting, attach a written explanation mapping each additional item to its place in the original dossier.
4. Ask the ANPP about the commission’s meeting calendar and correct the plan against actual meeting dates instead of optimistically assuming the full 240 days.
5. If told the device cannot be evaluated, invoke Article 26 and request the documentary evaluation with the clinical experts committee report.
6. Keep written evidence of submission, payment and every additional-information exchange, so that a complete evidentiary chain on deadlines exists.

5. Verification checklist

• □ The récépissé date is set as project day zero and flagged in the regulatory file.
• □ A parallel-split workflow is in place for handling additional-information requests.
• □ Each resubmission is accompanied by a written mapping to the original dossier.
• □ The commission’s schedule has been confirmed with the ANPP and the plan corrected accordingly.
• □ The conditions and wording for using the Article 26 alternative route are prepared.
• □ Submission, payment and additional-information records form a complete evidentiary chain.

GRZAN supports manufacturers and their authorised representatives entering the Algerian market with homologation pathway selection, classification strategy, dossier assembly and schedule management across the six-stage standard route described above. From the récépissé that starts the clock to the decision under Article 30, GRZAN aligns documentation with the requirements of Décret exécutif n° 20-324 and the Ministerial Order of 10 May 2021. For support with your Algerian registration project, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026.