Algeria Medical Device Regulatory Timeline

1. Key takeaways

The current Algerian device regime is built from five legislative milestones. In 2018, Loi n° 18-11 established the pre-market licensing principle. In 2020, Décret exécutif n° 20-324 built the homologation procedure. In 2021, four ministerial orders completed the dossier, regularization, change and export-only tracks, and Executive Decrees n° 21-551 and n° 21-552 fixed the fee rates. In 2023, Executive Decree n° 23-101 moved the transitional starting date to 2022-11-22. And on February 20, 2025, a ministerial order opened a further 2-year transitional marketing window.

Understanding this timeline is the precondition for answering the practical question every company asks: can the product still be sold today? Each milestone changed who could sell what, under which track, until when — and the answers differ by product and by history, not by blanket rules.

GRZAN advises mapping every product in the Algerian portfolio against all five milestones before making any market decision, because the compliance status of a legacy product and a new product are assessed against entirely different points on this axis.

2. Legal basis

1. Loi n° 18-11 du 18 Chaoual 1439 correspondant au 2 juillet 2018 relative à la santé (Law No. 18-11 of 18 Chaoual 1439 corresponding to July 2, 2018 on health, JORADP No. 46, published 2018-07-29) (2018-07-02, JORADP No. 46).
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 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) (2020-11-22, JORADP No. 69).
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 May 10, 2021 on the dossier composition, JORADP No. 55, published 2021-07-14, pages 21–24, 13 articles) (2021-05-10); Arrêté du 12 Dhou El Kaâda 1442 correspondant au 23 juin 2021 fixant les modalités de modification de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of June 23, 2021 on changes to the homologation decision, JORADP No. 62, published 2021-08-15, pages 21–22, 16 articles) (2021-06-23); Arrêté du 12 Dhou El Kaâda 1442 correspondant au 23 juin 2021 fixant les modalités d’homologation des dispositifs médicaux fabriqués localement et destinés exclusivement à l’exportation (Ministerial Order of June 23, 2021 on homologation of locally manufactured devices intended exclusively for export, JORADP No. 62, published 2021-08-15, pages 23–25, 20 articles) (2021-06-23).
4. Décret exécutif n° 21-551 du 25 Joumada El Oula 1443 correspondant au 30 décembre 2021 fixant les modalités de recouvrement et d’affectation du produit de la redevance des produits pharmaceutiques et des dispositifs médicaux (Executive Decree No. 21-551 of December 30, 2021, JORADP No. 02, published 2022-01-05, pages 14–15) and Décret exécutif n° 21-552 du 25 Joumada El Oula 1443 correspondant au 30 décembre 2021 fixant les modalités d’acquittement et d’affectation du produit de la taxe de contrôle et expertise de lot de produit pharmaceutique et/ou de dispositif médical (Executive Decree No. 21-552 of December 30, 2021, JORADP No. 02, published 2022-01-05, pages 15–16) (2021-12-30).
5. 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 March 5, 2023 amending Executive Decree No. 20-324, JORADP No. 15, published 2023-03-12, page 19) (2023-03-05).
6. Arrêté du 21 Chaâbane 1446 correspondant au 20 février 2025 autorisant la commercialisation des dispositifs médicaux (Ministerial Order of February 20, 2025 authorizing the commercialization of medical devices, JORADP No. 13, published 2025-02-25, page 24, 2 articles) (2025-02-20, JORADP No. 13).

3. Expert insights

Insight one: the 2020 step went from nothing to something; the 2021 step went from something to usable.

Executive Decree n° 20-324 built only the procedural skeleton. What the dossier must contain, and how changes are reported, were left entirely to ministerial orders. The four orders of 2021 are therefore the source of operability: a company reading only the executive decree cannot actually file. Budget reading time accordingly — the decree tells you whether and when; the orders tell you how.

Insight two: the transition period was amended once, and the two versions had different endpoints.

The original text of Article 44 required devices already on sale at signing (2020-11-22) but without a homologation decision to complete their dossiers within 2 years of publication of the decree. Executive Decree n° 23-101 of 2023 changed it: devices not yet holding a homologation decision may continue to be supplied, subject to regularization within 2 years from November 22, 2022 — that is, an endpoint of November 22, 2024. The amendment both lengthened and fixed the runway, ending the uncertainty of a floating deadline.

Insight three: the 2025 ministerial order is a second buffer, and its wording is broader.

Article 1 of order No. 25 of 2025 (JORADP No. 13) provides that ready-to-use devices manufactured locally or imported that do not yet hold an ANPP homologation decision are authorized to be placed on the market for 2 years from the date of publication of the order. Publication was 2025-02-25, so the window closes in February 2027. Unlike the 2020 transition, there is no requirement that the product was already on sale at signing — the coverage is wider than the first buffer, extending to new entrants as well as legacy stock.

Insight four: the fee system only landed at the end of 2021.

Executive Decrees n° 21-551 and n° 21-552 were both signed on 2021-12-30 and published on 2022-01-05. They converted the fee rates established by Articles 31 and 32 of Regulation n° 21-07 into executable collection and allocation rules. Before planning any budget, check the current rates under these two decrees, because they control both the redevance and the lot-control tax actually payable per dossier and per batch.

4. Practical recommendations

1. Draw the five milestones into a single timeline and mark the specific impact of each on the products currently on sale.
2. Assess each on-sale product one by one: does it hold a homologation decision, has it entered regularization, does it fall within the 2025 window?
3. For products inside the 2025 window, work backwards from the remaining time to build the dossier preparation plan; do not leave everything to the final year.
4. Build the fee budget on the current rates of Executive Decrees n° 21-551 and n° 21-552, with a margin for exchange-rate movement.
5. Maintain a regulatory tracking table focused on subsequent JORADP issues for any new amending decree to n° 20-324.
6. Keep copies of the official journal pages for each milestone in the project file to evidence the compliance basis when explaining positions to the ANPP.

5. Verification checklist

• □ The five milestones have been drawn as a timeline and shared within the project team.
• □ Each on-sale product has been tagged with its compliance status and applicable track.
• □ Products inside the 2025 window have a dossier plan built backwards from the remaining time.
• □ The fee budget reflects current rates and includes an exchange-rate margin.
• □ A regulatory tracking table exists, focused on amending decrees to n° 20-324.
• □ Copies of the official journal pages for each milestone are archived in the project file.

Related reading in this series

• Article 20, Transitional marketing for devices without homologation: the February 20, 2025 ministerial order and the 2-year window — https://www.grzanglobal.com/algeria-medical-device-registration/2025-order-transitional-marketing-window/
• Article 17, The regularization track: a fast route of 4-day admissibility plus a 90-day decision — https://www.grzanglobal.com/algeria-medical-device-registration/regularisation-fast-track-four-days-90-days/
• Article 49, The Algerian compliance calendar for the next 12 months — https://www.grzanglobal.com/algeria-medical-device-registration/algeria-compliance-calendar-next-12-months/

Regulatory information verified as of October 30, 2026.

GRZAN tracks the full Algerian regulatory timeline for its clients, from the 2018 health law to the 2025 transitional window, and provides transition planning, regularization filings and compliance calendar management. For registration and compliance support in the Algerian market, contact info@grzanglobal.com.