Decree 20-324 Structure Overview

1. Key takeaways

Décret exécutif n° 20-324 contains 46 articles organized into 5 chapters: Chapter 1 (Articles 2 to 15) covers the homologation commission; Chapter 2 (Articles 16 to 43) covers the homologation procedure and the management of decisions; the supervision and inspection provisions before Article 44 cover regulatory measures; Chapter 4 (Article 44) contains transitional provisions; and Chapter 5 (Articles 45 and 46) covers repeal and publication.

GRZAN recommends a specific reading order: start with Articles 16 to 18 (whether homologation is required, and who may apply), then move to Articles 21 to 30 (the process and its deadlines), and finish with Articles 31 to 43 (rejection, withdrawal, transfer). The commission articles are reference material, consulted only when a review logic needs to be explained. Reading the decree in article order wastes time on procedural detail before the core obligations are understood.

This structure also tells you where risk lives. The obligation trigger sits in one short article, the operational risk sits in the deadline articles, and the rescue mechanisms sit at the end. Each of the three zones deserves its own checklist inside a project team.

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 6 Rabie Ethani 1442 corresponding to November 22, 2020 on the modalities of homologation of medical devices, JORADP No. 69, published 2020-11-22, pages 10–14, 46 articles).
2. Décret exécutif n° 23-101 du 12 Chaâbane 1444 correspondant au 5 mars 2023 modifiant le décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 (Executive Decree No. 23-101 of 12 Chaâbane 1444 corresponding to March 5, 2023 amending Executive Decree No. 20-324 of 6 Rabie Ethani 1442 corresponding to November 22, 2020, JORADP No. 15, published 2023-03-12, page 19) — Article 44 was amended, and the transitional starting date was moved to 2022-11-22.
3. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (JORADP No. 69, published 2020-11-22, pages 10–14, 46 articles), Articles 19 and 35 (dossier composition and renewal are set by ministerial order).
4. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (JORADP No. 69, published 2020-11-22, pages 10–14, 46 articles), Article 16 (devices manufactured locally and intended exclusively for export are governed by a separate ministerial order).

3. Expert insights

Insight one: the fourteen articles of Chapter 1 are commission mechanics, but Article 12 carries a critical consequence.

Article 12 places the secretariat of the commission at the ANPP. All commission correspondence, transmission of opinions and meeting arrangements run through the ANPP; companies neither need nor should contact members directly. Article 5 imposes confidentiality and Article 6 imposes conflict-of-interest recusal (repeated for experts in Article 24), and together these provisions form the firewall around the evaluation. The practical lesson is that all substantive interaction happens at a single written address: the secretariat.

Insight two: Article 16 is the master switch of the whole decree.

Article 16, first paragraph: any ready-to-use, industrially manufactured device that is imported or exported must, before being placed on the market, obtain a homologation decision from the ANPP. All four qualifiers must hold simultaneously for the obligation to trigger — ready-to-use, industrially manufactured, imported or exported, and placed on the market. GRZAN’s reading is that clinical trial samples and non-industrially-made custom items each land differently on those qualifiers, and each case needs its own documented argument rather than a blanket assumption in either direction.

Insight three: Article 44 has already been amended once; it is the only substantive article revised so far.

Executive Decree n° 23-101 of 2023 changed the starting date of Article 44 from the date of publication of the decree to November 22, 2022, and removed the phrase about products already on sale at signing, replacing it with devices not yet holding a homologation decision may continue to be supplied. This amendment pushed the practical endpoint of the transition to November 22, 2024 — two years later than the original text implied, but fixed rather than rolling.

Insight four: Article 45 repeals the old commission regime by name.

Article 45 explicitly repeals the provisions of Décret exécutif n° 15-309 (2015-12-06) relating to the commission for pharmaceutical products and devices. The significance is that the technical committees created under the 2015 regime lost their legal basis, and the current procedure rests exclusively on Decree 20-324. Any process document still referencing the 2015 committees is obsolete.

4. Practical recommendations

1. Split the 46 articles into three self-check tables along the obligation–process–remedy axis, and assign each table to a different owner in the project team.
2. The first table holds only Articles 16 to 18, used for the applicability assessment of every new project.
3. The second table holds the timing nodes of Articles 21 to 30, built as a countdown Gantt chart.
4. The third table holds Articles 31 to 43, used to prepare response plans for the three risks of rejection, withdrawal and transfer.
5. Archive the commission articles separately and consult Articles 3 and 25 only when explaining why a category of data was requested.
6. Periodically check whether Article 44 has been amended again; it is the most likely article in the whole text to be touched by a future amending decree.

5. Verification checklist

• □ Self-check tables exist, split along the obligation–process–remedy axis.
• □ Every project is assessed against the four qualifiers of Article 16, one by one.
• □ The timing nodes of Articles 21 to 30 are built into a countdown Gantt chart.
• □ Written response plans exist for rejection, withdrawal and transfer risks.
• □ The commission composition and the four evaluation phases are archived separately for reference.
• □ A periodic monitoring mechanism exists for amendments to Article 44.

Related reading in this series

• Article 05, The four-class classification of devices in Algeria: Classe I, IIa, IIb, III — https://www.grzanglobal.com/algeria-medical-device-registration/algeria-device-classification-class-i-iia-iib-iii/
• Article 11, The standard homologation process: six stages from dossier submission to decision — https://www.grzanglobal.com/algeria-medical-device-registration/standard-homologation-process-six-stages/
• Article 15, The 240-day decision deadline and the 90-day extension: Article 30 of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/article-30-decision-deadline-240-days/

Regulatory information verified as of October 30, 2026.

GRZAN provides Algeria-focused regulatory interpretation, homologation strategy and dossier services for medical device manufacturers, including structured analysis of Décret exécutif n° 20-324 and its amendments. For registration and compliance support in the Algerian market, contact info@grzanglobal.com.