Regularisation Fast Track: Four-Day Admissibility and 90-Day Decision

1. Key takeaways

Regularisation (régularisation) is the catch-up channel Algeria opened for devices already being marketed without a homologation decision, based on the Ministerial Order of 10 May 2021 and Article 44 of Décret exécutif n° 20-324. Its deadlines are clearly shorter: an admissibility review of 4 days (Article 7), submission of the file to the commission within 30 days after the technical evaluation (Article 11), and an ANPP decision within 90 days (Article 12, extendable by 30 days).

Compared with the standard channel’s 8 days and 240 days, the admissibility period is halved and the decision period shrinks to roughly one third. The channel is therefore attractive, but it is not relaxed: the same review standards apply in a shorter time, and the dossier requirements, though reduced, remain subject to completion requests by the ANPP.

The channel also contains its own internal fork. Class I and IIa devices follow a simplified evaluation, while Class IIb and III devices run the full four-phase evaluation of Article 25. Treating regularisation as one uniform fast lane, regardless of class, is the most common planning error GRZAN sees in this pathway.

2. Legal basis

1. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant les modalités de régularisation du dossier d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 10 May 2021 on the regularisation of the homologation dossier, JORADP No. 55, published 14 July 2021, pages 24–26, 14 articles): Article 2 (persons and devices covered), Article 3 (the two-year submission period), Article 4 (submission by the head pharmacist in charge of technology), Article 7 (the 4-day admissibility review), Articles 8 to 10 (the technical evaluation), Article 11 (submission to the commission within 30 days) and Article 12 (the 90-day decision).
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 44 (the transitional provision, as amended by Executive Decree No. 23-101).
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 starting date was changed to 22 November 2022).
4. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant les modalités de régularisation du dossier d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 10 May 2021 on the regularisation of the homologation dossier, JORADP No. 55, published 14 July 2021, pages 24–26, 14 articles): Article 6 (the 19-item dossier).

3. Expert insights

Insight 1: the regularisation dossier is a reduced version of only 19 items, and the ANPP can require completion.

The first-application dossier under the standard channel contains 22 items (Article 4 of the Ministerial Order of 10 May 2021), while the regularisation dossier contains 19 items (Article 6 of the order of the same day). The three omitted items are the environmental risk assessment, the description of the manufacturing method (replaced by a where-applicable formulation) and the quality control methods (also where applicable). But Article 4(2) keeps a lever in reserve: the director general of the ANPP may require the applicant to complete the dossier already submitted. Filing 19 items therefore never means the other three can stay missing forever.

Insight 2: the scope of the channel was widened in 2023.

The original Article 44 of Executive Decree No. 20-324 limited the transitional arrangement to devices already on the market on the date the decree was signed. Executive Decree No. 23-101 of 5 March 2023 reformulated the scope as devices that have not yet obtained a homologation decision, removing the already-marketed limitation, and set the starting date at 22 November 2022, so that the two-year period ended on 22 November 2024.

Insight 3: Class I and IIa on one side, Class IIb and III on the other, follow two different evaluation paths.

Under Article 9, four situations, including Class I and IIa devices, receive an evaluation consisting of the technical regulations evaluation plus the clinical data evaluation where applicable. Under Article 10, Class IIb and III devices remain subject to the full four-phase evaluation of Article 25 of Executive Decree No. 20-324. This is the most important fork inside the regularisation channel, and it decides the depth of preparation.

Insight 4: the 90-day decision runs from the date of admissibility, as in the standard channel.

Article 12 requires the ANPP to decide within 90 days from the date of admissibility, with an exceptional extension of no more than 30 days, and the deadline is suspended when supplementary information is requested. The starting-point logic is identical to Article 30; only the numbers differ. Reading the two provisions as one template shortens the learning curve considerably.

4. Practical recommendations

1. First determine whether the product falls within the scope of regularisation; if uncertain, ask the ANPP in writing to confirm the channel.
2. Prepare the dossier against the 19 items of Article 6, while keeping the three omitted items of the standard 22-item list at hand.
3. For the high-risk classes IIb and III, prepare to the four phases of Article 25, not to the light evaluation.
4. Use the 4-day standard of Article 7 to back-calculate the internal checking deadline, with double the margin of the standard channel.
5. Schedule on the basis of 90 days plus the 30-day extension plus additional-information time, never on the standard channel’s 240 days.
6. If the post-2023 window has closed, evaluate the transitional marketing arrangements under the Ministerial Order of 20 February 2025 instead.

5. Verification checklist

• □ Eligibility for the regularisation channel has been confirmed in writing by the ANPP or otherwise substantiated.
• □ The dossier has been prepared against the 19 items of Article 6, with the three omitted items kept at hand.
• □ Class IIb and III devices have been prepared to the four phases of Article 25.
• □ The internal checking deadline has been back-calculated against the 4-day standard.
• □ The schedule is estimated at 90 days plus the 30-day extension plus additional-information time.
• □ The fallback route after the window (the 2025 order) has been evaluated.

GRZAN advises manufacturers on the Algerian regularisation fast track and on the registration pathway and classification strategy that fit each device class, from the 19-item dossier to the fork between the light evaluation and the full four-phase review. If you are deciding between regularisation and the standard channel, GRZAN can model both timelines against your portfolio. For support, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026.