Regulatory Reliance and Mutual Recognition for Medical Devices in Algeria

1. Key takeaways

So far as the verified official texts are concerned, Algeria’s acceptance of foreign assessment conclusions has only one clear anchor: Article 11 of the order of 23 June 2021 — ANPP may take into account assessments already completed by a strictly regulated pharmaceutical authority or by a body recognised by ANPP, for the purpose of approving change applications for the devices referred to in Article 6.

In addition, ANPP disclosed in a conference presentation made public in January 2026 that three inter-ministerial orders were signed on 10 September 2025, concerning respectively a framework of regulatory trust and mutual recognition, coordination and communication, and the organisation and operation of the national pharmacovigilance and materiovigilance systems.

The official journal texts of these three instruments had not been retrieved as of the verification date of this series; they are marked as pending verification.

2. Legal basis

1. 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 (Order of 23 June 2021 on the modalities of modification of the homologation decision for medical devices intended for human medicine, JORADP No. 62, published on 15 August 2021, pages 21–22, 16 articles in total), Article 11 (assessment conclusions of strictly regulated authorities or ANPP-recognised bodies may be taken into account).
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 22 November 2020 on the modalities of homologation of medical devices, JORADP No. 69, published on 22 November 2020, pages 10–14, 46 articles in total), Article 25 (the four stages of technical assessment) and Article 26 (the alternative pathway where assessment is not possible).
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 (Order of 10 May 2021 fixing the composition of the homologation dossier and the renewal dossier, JORADP No. 55, published on 14 July 2021, pages 21–24, 13 articles in total), Article 4 (the dossier must attach copies of marketing authorisations already obtained in other countries and certificates of conformity with regulatory standards).
4. ANPP presentation made public at the PharmaReg Africa Summit in January 2026 (Dr. Saida Foughalia Fridi), disclosing the three inter-ministerial orders signed on 10 September 2025; the official journal texts are pending verification, and this series draws no figures or time limits from them.

3. Expert insights

Insight 1: Article 11 uses “may take into account (peut prendre en compte)” — it is a discretion, not a duty.

The wording of Article 11 is that ANPP may take into account the assessment conclusions. This differs from the decision deadline of Article 30 of Executive Decree No. 20-324 — the latter is a duty to decide within the period, the former merely a permission to rely. A foreign approval is therefore a plus factor, not a passport: it can shorten the technical discussion, but it cannot replace it, and ANPP retains full discretion to request local evidence.

Insight 2: the scope of Article 11 is confined to change applications.

Article 11 refers expressly to change applications for the devices referred to in Article 6. In the currently verified texts, there is no corresponding reliance clause for first-time homologation. Companies cannot rely on this provision to claim that a first homologation should be accelerated; the argument has no textual basis and risks weakening the file’s credibility.

Insight 3: Article 11 names two categories of reference bodies, but no list is defined in the provision.

Article 11 lists a “strictly regulated pharmaceutical authority (autorité réglementaire pharmaceutique stricte)” or a “body recognised by ANPP”. The provision gives no list and does not designate who decides. GRZAN’s practice is to attach the foreign approval documents proactively in the change application and explain the status of the issuing authority, leaving ANPP to judge case by case — the best available route under an undefined standard.

Insight 4: on the three inter-ministerial orders of 2025, this series records the source and draws no numbers.

The three orders disclosed in the ANPP presentation (signed 10 September 2025, 17 Rabie El Aoual 1447) concern regulatory trust and mutual recognition, coordination and communication, and the organisation and operation of the vigilance systems. As of the verification date, the corresponding French texts had not been retrieved from JORADP. This series therefore cites none of their provisions, figures or effective dates, listing them only as a regulatory-development notice and marking them pending verification.

4. Practical recommendations

1. Attach foreign approval documents proactively in change applications and explain the status of the issuing authority as a strictly regulated authority.
2. Do not claim reliance-based acceleration for first-time homologation; prepare in full under the four stages of Article 25.
3. Prepare the foreign approvals together with the copies of foreign marketing authorisations required by Article 4, in one bound set.
4. Run continuous monitoring of the ANPP website and JORADP to track the official journal texts of the three 2025 orders.
5. Flag the regulatory trust framework internally as pending verification and do not adjust project schedules or budgets on its basis.
6. Once the journal texts are published, immediately re-check whether the scope of Article 11 has been extended to first-time homologation.

5. Verification checklist

• □ Change applications attach foreign approval documents and state the status of the issuing authority.
• □ First-time homologation is prepared in full under the four stages of Article 25, with no reliance-acceleration claim.
• □ Foreign approvals and the Article 4 marketing-authorisation copies are bound into one set.
• □ Monitoring of the ANPP website and JORADP is in place.
• □ The regulatory trust framework is flagged as pending verification and is not used for scheduling or budgeting.
• □ The re-check trigger for publication of the journal texts is defined.

Regulatory information verified as of 30 October 2026.

GRZAN provides post-market compliance support for the Algerian market: monitoring reliance and mutual-recognition developments, preparing change files that leverage foreign approvals, and handling vigilance, recalls and inspection responses. For post-market compliance support in Algeria, contact info@grzanglobal.com.