Materiovigilance Obligations in Algeria: Who Bears the Responsibility

1. Key takeaways

Algeria’s materiovigilance duties for medical devices are built by the superposition of three layers of rules.

Loi 18-11 and Article 5 of Executive Decree No. 21-82 require the five categories of pharmaceutical establishments to comply with the standards of BPF, storage, distribution, pharmacovigilance and materiovigilance;

Article 9 places the concrete operations of materiovigilance on the operating establishments;

Article 10 of the order of 10 May 2021 requires the renewal dossier to contain a summary of the materiovigilance system.

Article 40 of Executive Decree No. 20-324 additionally lists the materiovigilance body as one of the seven categories of bodies that may request withdrawal.

2. Legal basis

1. Décret exécutif n° 21-82 du 11 Rajab 1442 correspondant au 23 février 2021 relatif aux établissements pharmaceutiques et les conditions de leur agrément (Executive Decree No. 21-82 of 23 February 2021 on pharmaceutical establishments and the conditions of their approval, JORADP No. 14, published on 28 February 2021, pages 9–12, 29 articles in total), Article 5 (establishments must comply with the BPF, storage, distribution, pharmacovigilance and materiovigilance requirements) and Article 9 (operating establishments carry out materiovigilance operations).
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 40 (the materiovigilance body is one of the seven categories that may request withdrawal) and Article 36 (new information affecting the safety report must be declared immediately).
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 10 (the renewal dossier must contain a summary of the materiovigilance system and a benefit-risk assessment).
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 (Order of 23 June 2021 on the modalities of modification of the homologation decision, JORADP No. 62, published on 15 August 2021, pages 21–22, 16 articles in total), Articles 9 and 4 (the change categories include performance, safety, effectiveness and materiovigilance).

3. Expert insights

Insight 1: the normative layer addresses all establishments, while the operational layer falls on the operating establishment.

Article 5 is a general requirement addressed to the five categories of establishments (compliance with the various standards). Article 9, second paragraph, then lists specifically the operations that operating establishments must carry out, expressly including materiovigilance. The system is therefore built jointly, but executed by the operator — the holder must verify, not assume.

Insight 2: at renewal the system must be written up as a summary — that is the test of whether it truly runs.

Article 10 requires the renewal dossier to contain a “summary of the materiovigilance system (le résumé du système de matériovigilance)”. Whether such a summary can actually be written is a direct test of whether the system operates in reality — including the channels for collecting adverse events, the reporting routes, the time limits, the responsible persons, and the interfaces with the holder and with ANPP.

Insight 3: vigilance data and the benefit-risk assessment go together.

Article 10 also requires the “benefit-risk assessment of the device in Algeria and in the country of origin”. The pairing of the two geographic dimensions shows that ANPP cares about real-world performance in local use, while accepting data from the country of origin as a reference. Companies that keep only one of the two assessments will find the renewal dossier incomplete.

Insight 4: vigilance information can trigger withdrawal in the reverse direction.

The seventh category of Article 40 lists the materiovigilance body among the bodies that may request withdrawal; the second category of Article 36 requires the declaration of “new information affecting the safety report”. Taken together, the two provisions close a loop: vigilance information → declaration → possible withdrawal procedure. Vigilance is therefore not paperwork; it is a live input into market-access decisions.

Insight 5: materiovigilance also has a place in the change classification.

Article 3 of the order of 23 June 2021 lists “changes affecting performance, safety, effectiveness and materiovigilance” as one of the three change categories. In other words, adjustments to the vigilance system itself may constitute a declarable change, and must be assessed through the change channel rather than implemented silently.

4. Practical recommendations

1. Establish written materiovigilance procedures inside the local operating establishment, covering collection, assessment, reporting and archiving.
2. Name the vigilance responsible person and set up a two-way transmission mechanism and time limits with the holder’s vigilance department.
3. Open reporting channels with ANPP and the vigilance body referred to in the seventh category of Article 40, and retain proof of delivery.
4. Prepare the summary of the materiovigilance system required by Article 10 and update it once a year.
5. Maintain the benefit-risk assessments for Algeria and the country of origin in parallel.
6. When the vigilance system itself is adjusted, assess under Article 3 of the change order whether a declaration is required.

5. Verification checklist

• □ Written materiovigilance procedures exist, covering collection, assessment, reporting and archiving.
• □ A two-way transmission mechanism between the vigilance responsible person and the holder is in place.
• □ Reporting channels with ANPP and the vigilance body exist, with proof of delivery retained.
• □ The summary of the materiovigilance system has been prepared under Article 10 and is updated annually.
• □ The benefit-risk assessments for both geographies are maintained.
• □ The rule for assessing vigilance-system adjustments as changes is defined.

Regulatory information verified as of 30 October 2026.

GRZAN provides post-market compliance support for the Algerian market: building and running materiovigilance systems, preparing the Article 10 system summary, managing vigilance reporting to ANPP, and handling recalls, withdrawals and inspection responses. For post-market compliance support in Algeria, contact info@grzanglobal.com.