Post-Marketing Immediate Declaration Obligations: Article 36 of Executive Decree No. 20-324

1. Key takeaways

Article 36 of Décret exécutif n° 20-324 requires the holder of the homologation decision to declare, immediately and within the validity period of the decision, two categories of matters.

The first category is any modification of the elements declared in the initial application — in other words, changes that the holder itself makes to what was approved.

The second category is external information: prohibitions or restriction measures adopted by the competent authorities of the country of origin or of the countries of sale, as well as any new information that affects the safety report.

Article 36 sets no numerical deadline. The word it uses is “immédiatement” — immediately. Unlike Article 29 (15 days) or Article 35 (90 days), it leaves no day count to fall back on.

GRZAN’s assessment: this is the single most time-pressured post-market obligation in the Algerian framework. The only workable compliance standard is to treat the day of knowledge as the starting point, complete the internal assessment within five working days, and decide whether a declaration must be filed — without waiting for the full impact to be confirmed first.

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 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 36 (the two categories of matters that must be declared immediately during the validity period).
2. 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 (Order of 23 June 2021 on the modalities of homologation of medical devices manufactured locally and destined exclusively for export, JORADP No. 62, published on 15 August 2021, pages 23–25, 20 articles in total), Article 16 (during the validity period, changes to export-only devices must be declared under Article 36 and the 2021 change order).
3. 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 3 (the scope of changes covers the information recorded in the decision under Article 33) and Article 6 (submission through the technical chief pharmacist); Article 9 (reception within 8 days) and Article 12 (decision within 90 days).
4. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (JORADP No. 69, published on 22 November 2020, pages 10–14, 46 articles in total), Article 31 (grounds for refusal include an unfavourable safety report).

3. Expert insights

Insight 1: the second category of Article 36 brings information itself within the scope of declaration.

The first category targets changes to declared elements — the holder’s own actions. The second targets external information: prohibitions or restriction measures taken by the authorities of the country of origin or the countries of sale, and any new information affecting the safety report. The latter covers recalls abroad, vigilance notifications and new findings in the literature. Even if nothing has gone wrong in Algeria, the matter must still be reported.

Insight 2: “immediately” is a legal standard, not 30 days or 60 days.

Article 36 does not give a specific number of days the way Article 29 (15 days) or Article 35 (90 days) does; it uses the word “immediately”. GRZAN’s compliance standard is to take the day of knowledge as the starting point, complete the internal assessment and decide whether to declare within five working days, and never wait until the impact is confirmed before starting. Awaiting certainty is itself a breach of the immediate-declaration standard.

Insight 3: Article 36 and Article 3 of the 2021 change order stand in an obligation-and-procedure relationship.

Article 36 says that the declaration must be made; Article 3 of the order of 23 June 2021 says how it must be made — changes fall into three categories (administrative changes; technical changes; and changes affecting performance, safety, effectiveness and materiovigilance), and each category must be submitted as a separate application. The two texts must be read and applied together, not in isolation.

Insight 4: the Article 36 duty for export-only devices was restated deliberately.

Article 16 of the order of 23 June 2021 provides that, during the validity period, holders and/or operators must immediately declare any change to export-only devices under Article 36 and that order. This removes any doubt about whether devices sold only outside Algeria need to be declared: they do. An export-only homologation does not exempt the holder from the immediate-declaration duty; the monitoring duty follows the certificate, not the destination market.

4. Practical recommendations

1. Establish an internal act-on-knowledge process: foreign vigilance notices, recalls and regulatory restrictions must all be assessed within five working days.
2. Maintain a routine monitoring checklist for announcements by the competent authorities of the country of origin, with a named owner responsible for it.
3. Keep the two categories of Article 36 distinct, with separate trigger conditions and escalation paths for each.
4. When filing, classify the change under Article 3 of the change order and submit one application per category.
5. Retain proof of delivery of every declaration as evidence that the immediate-declaration duty has been met.
6. Include export-only devices in the Article 36 monitoring scope; being exported does not exempt them.

5. Verification checklist

• □ An act-on-knowledge process has been established, with assessment completed within five working days.
• □ A monitoring checklist for announcements by the authorities of the country of origin exists and a named owner is assigned.
• □ Trigger conditions and escalation paths for the two Article 36 categories have been defined.
• □ Declarations have been classified under Article 3 of the change order and submitted separately.
• □ Proof of delivery of declarations has been archived.
• □ Export-only devices have been brought within the Article 36 monitoring scope.

Regulatory information verified as of 30 October 2026.

GRZAN supports manufacturers, importers and local operators across the full Algerian device lifecycle, with a dedicated post-market team covering materiovigilance system maintenance, immediate declarations under Article 36, handling of recalls and withdrawals, responses to regulatory inspections, and coordination with ANPP and local partners. For post-market compliance support in the Algerian market, contact info@grzanglobal.com.