Article 31 Grounds for Refusal: Five Statutory Reasons Explained

1. Key takeaways

Article 31 of Décret exécutif n° 20-324 lists five grounds for refusal: first, impairment of the characteristics or performance of the device; second, non-conformity with the declared content; third, unfavourable conclusions of the safety report; fourth, a manufacturing process that cannot guarantee quality, safety and effectiveness; and fifth, documents that do not satisfy the requirements of the decree. The same article provides that any refusal must be duly motivated (dûment motivée).

GRZAN’s reading: the fifth ground is a purely procedural ground, and it is also the one most easily avoided through pre-submission checking. The first four grounds concern substantive questions about the product itself; the fifth concerns the file itself, and it is the ground that actually dominates refusal practice in Algeria — a missing document, a non-conforming format, a missing translation, or incomplete legalisation.

Because refusal must be reasoned, a refusal letter is never a dead end: it is a specification of what must change. The follow-up orders confirm this by attaching remediation and appeal windows to the refusal, with the exact mechanics differing from channel to channel.

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 31 (the five grounds for refusal and the obligation to state reasons).
2. 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 13 (a refused regularisation application is handled under Article 31).
3. 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 23 June 2021 on the homologation of locally manufactured medical devices intended exclusively for export, JORADP No. 62, published 15 August 2021, pages 23–25, 20 articles): Article 11 (refusals in the export-only channel must state reasons, with an appeal possible within 30 days).
4. 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 23 June 2021 on modification of the homologation decision, JORADP No. 62, published 15 August 2021, pages 21–22, 16 articles): Article 13 (refusals of modification applications must state reasons, with a corrective application possible within 30 days).

3. Expert insights

Insight 1: the fifth ground, documents not meeting the decree, is the catch-all with the widest coverage.

The first four grounds target substantive problems with the product; the fifth targets the dossier itself. In practice the fifth is by far the most frequently triggered — a missing document, a non-conforming format, a missing translation, or legalisation that falls short. GRZAN therefore concentrates refusal-avoidance work on the pre-submission checklist rather than on the product arguments, because that is where the real exposure lies.

Insight 2: refusal must state reasons, and that gives a handle for appeal and remediation.

Article 31 requires the refusal decision to be motivated. The requirement is confirmed three times over in the 2021 orders: Article 11 of the export-only order, Article 13 of the modification order, and Article 13 of the regularisation order. Where there are reasons, remediation can be targeted — this is one of the comparatively company-friendly features of the Algerian system, and it should be used deliberately.

Insight 3: the remedy after refusal differs by channel.

For export-only devices, Article 11 grants an appeal period of 30 days. For modification applications, Article 14 allows a corrected change application within 30 days, and Article 15 requires the ANPP to reply within 30 days. For regularisation applications, Article 13 simply points back to Article 31 and sets no separate appeal period. Different channels, different remediation windows — this must be confirmed at the start of the project, not after the refusal arrives.

Insight 4: the third ground refers to the safety conclusions formed during the review.

The third ground echoes the fourth phase of Article 25, the clinical data evaluation, and Article 36, which governs the reporting of new post-market information. The consequence: even if the safety documentation was complete at submission, new safety information emerging in the country of origin during the review can still trigger the third ground. Vigilance monitoring does not pause while the homologation is pending.

4. Practical recommendations

1. Before submission, run a reverse pre-assessment against the five grounds of Article 31, asking for each one whether the file could be refused under it.
2. For the fifth ground, apply a double check: the 22-item list of Article 4 and the format of Annex II.
3. For the second ground, ensure the device name, model and manufacturer name are strictly identical across every document in the dossier.
4. Monitor safety information in the country of origin throughout the review, and report new information proactively under Article 36.
5. On the day a refusal arrives, break down the stated reasons and move within the remediation window for the channel, the 30 days for appeal or correction.
6. When resubmitting after remediation, attach an item-by-item response table to the refusal reasons so the review can relocate its position quickly.

5. Verification checklist

• □ A reverse pre-assessment against the five grounds of Article 31 has been completed before submission.
• □ The fifth ground has been double checked against the 22-item list and the Annex II format.
• □ Device names, models and manufacturer names are strictly consistent across the dossier.
• □ A monitoring mechanism for safety information in the country of origin is in place.
• □ The refusal reasons and the 30-day remediation window have been confirmed for the channel.
• □ The resubmission after remediation includes an item-by-item response table to the refusal.

GRZAN supports manufacturers facing Algerian refusal decisions under Article 31, from root-cause analysis of the stated grounds to classification strategy and dossier rebuilding for resubmission across all four channels. If your application has been refused or you want the five grounds pre-empted before filing, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026.