2025 Ministerial Order: Two-Year Transitional Marketing Window in Algeria

1. Key takeaways

The Ministerial Order of 20 February 2025 (JORADP No. 13, published 25 February 2025, page 24) contains only 2 articles, but its reach is wide. Article 1 authorises the marketing, for 2 years, of medical devices that are locally manufactured or imported, ready to use, and that have not yet obtained an ANPP homologation decision, counted from the date of publication of the order. The publication date is 25 February 2025, so the window ends in February 2027.

GRZAN’s assessment: this is currently the most urgent compliance deadline in the Algerian medical device landscape. Every SKU on the market without a homologation decision has a fixed expiry, and the work of filing applications must be sequenced backwards from February 2027, not forwards from whenever the internal project team becomes available.

The window is an authorisation to sell, not an abolition of the homologation requirement. Devices sold under it remain subject to Article 16 of Executive Decree No. 20-324, and when the window closes, any device still without a decision loses its basis for marketing. The window buys time for filings; it does not replace them.

2. Legal basis

1. Arrêté du 21 Chaâbane 1446 correspondant au 20 février 2025 autorisant la commercialisation des dispositifs médicaux (Ministerial Order of 20 February 2025 authorising the commercialisation of medical devices, JORADP No. 13, published 25 February 2025, page 24, 2 articles): Article 1 (marketing authorised for 2 years, counted from the date of publication) and Article 2 (publication).
2. Arrêté du 21 Chaâbane 1446 correspondant au 20 février 2025 autorisant la commercialisation des dispositifs médicaux (Ministerial Order of 20 February 2025 authorising the commercialisation of medical devices, JORADP No. 13, published 25 February 2025, page 24, 2 articles) (JORADP No. 13, 25 February 2025, page 24; signed by Ouacim KOUIDRI, Minister of Pharmaceutical Industry).
3. 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 5 March 2023 amending Executive Decree No. 20-324, JORADP No. 15, published 12 March 2023, page 19) (the earlier version of the transitional provision and the starting date of 22 November 2022).
4. 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 16 (the principle that a homologation decision is required before placing on the market).

3. Expert insights

Insight 1: this round is broader than the 2020 round.

The original Article 44 of Executive Decree No. 20-324 covered only devices already on the market on the date the decree was signed. The 2023 amendment removed the already-marketed limitation but still tied the arrangement to the regularisation dossier. The 2025 order goes furthest: it directly authorises the commercialisation of devices, with no limitation tied to prior marketing. The three arrangements rank from narrowest to broadest as 2020, then 2023, then 2025.

Insight 2: the starting date is the date of publication, not the date of signature.

The order was signed on 20 February 2025 and published on 25 February 2025 in JORADP No. 13. Article 1 states expressly that the 2 years are counted from the date of publication of the order, so the calculation must run from 25 February 2025 and the window ends in February 2027. Calculating from the signature date loses 5 days — a small error, but an unnecessary one in any schedule built around a fixed expiry.

Insight 3: the window authorises sale; it does not exempt from homologation.

The title of the order speaks of authorising the commercialisation of medical devices (autorisant la commercialisation), not of exempting devices from homologation. The pre-market homologation obligation of Article 16 of Executive Decree No. 20-324 has not been repealed. The accurate reading: selling within the window is lawful, but once the window ends, any device without a homologation decision loses its legal basis for remaining on the market.

Insight 4: the window can run in parallel with the regularisation channel, but the pacing must be staggered.

During the window, companies can still file through the regularisation channel with its 90-day decision or through the standard channel with its 240-day decision. GRZAN’s advice is not to push regularisation filings to the end of the window: the channel carries a 4-day admissibility review, suspension during additional-information rounds and other timing uncertainties that need calendar space to absorb.

4. Practical recommendations

1. Inventory all SKUs currently marketed and flag those without a homologation decision, producing a pending-homologation list.
2. Back-plan from the window of 25 February 2025 to expiry in February 2027; do not defer filings to the second half of 2026.
3. Sequence high-volume, high-risk SKUs (Classes IIb and III) at the front of the filing queue.
4. For SKUs on the regularisation channel, reserve the full chain of the 4-day review, the 30 days to the commission and the 90-day decision.
5. Review the list quarterly: move certified SKUs out and newly introduced SKUs in.
6. Set February 2027 as a zero-tolerance milestone internally, with a final sprint beginning 6 months ahead.

5. Verification checklist

• □ Marketed SKUs have been inventoried, with those lacking a homologation decision flagged.
• □ The back-plan has been built on 25 February 2025 as the start and February 2027 as expiry.
• □ High-volume and high-risk SKUs are at the front of the filing sequence.
• □ The regularisation chain of the 4-day review and the 90-day decision has been reserved.
• □ The SKU list has a quarterly review mechanism.
• □ February 2027 has been set as a zero-tolerance milestone with a 6-month advance sprint.

GRZAN runs portfolio triage for the Algerian transitional marketing window of the Ministerial Order of 20 February 2025, from SKU-level gap analysis to registration pathway and classification strategy and a filing sequence that lands every application before February 2027. If part of your portfolio is still selling without a homologation decision, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026.