GRZAN Services for Medical Device Compliance in Algeria

1. Key takeaways

GRZAN’s services in Algeria are organised around the regulatory chain verified in this series:

entity structure design (the division and agreements between the détenteur and the exploitant);

due diligence on local partners (agrément activity types and the presence of the technical chief pharmacist);

homologation dossier drafting (following the five-part format of Article 5 of the order of 10 May 2021 and the numbering of Annex II);

pathway selection (the different time limits of the four routes: ordinary, regularisation, export-only and change);

sample submission and testing coordination, fee estimation and payment-order processing,

and, after market entry, immediate declarations under Article 36 and maintenance of the materiovigilance system.

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 18 (who submits), Article 33 (the nine items recorded in the decision), Article 36 (immediate declaration) and Article 43 (transfer).
2. 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 4 (holder and operator), Article 9 (joint responsibility) and Article 23 (expiry after 2 years).
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 22-item list), Article 5 (the five-part format) and Article 10 (the 21 renewal items).
4. Décret exécutif n° 21-551 du 25 Joumada El Oula 1443 correspondant au 30 décembre 2021 fixant les modalités de recouvrement et d’affectation du produit de la redevance des produits pharmaceutiques et des dispositifs médicaux (Executive Decree No. 21-551 of 30 December 2021, JORADP No. 02, published on 5 January 2022, pages 14–15), Article 2 (three fee tiers); and Décret exécutif n° 21-552 du 25 Joumada El Oula 1443 correspondant au 30 décembre 2021 fixant les modalités d’acquittement et d’affectation du produit de la taxe de contrôle et expertise de lot de produit pharmaceutique et/ou de dispositif médical (Executive Decree No. 21-552 of 30 December 2021, JORADP No. 02, published on 5 January 2022, pages 15–16), Article 2 (three lot-control tax tiers).

3. Expert insights

Insight 1: every conclusion in this series can be traced back to the official journal text.

The regulation names, numbers, publication dates and article numbers cited in this series can each be re-checked in the corresponding issue of the Algerian official journal (JORADP): Loi 18-11 in No. 46 (2018); Executive Decree No. 20-324 in No. 69 (2020); Executive Decree No. 23-101 in No. 15 (2023); the four 2021 orders in No. 55 and No. 62; the two fee decrees in No. 02 (2022); and the 2025 transitional marketing order in No. 13 (2025).

Insight 2: for figures without an official source, this series consistently applies a practical estimate.

Take the fee for first-time homologation: Article 21 of Executive Decree No. 20-324 and Article 2 of the 2021 order only state that a fee is due, and the fee table of Article 2 of Executive Decree No. 21-551 lists only the change, renewal and transfer tiers, not first-time homologation. This series therefore gives no specific figure for first-time homologation and follows the payment order issued by ANPP (practical estimate).

Insight 3: for developments whose journal text has not been retrieved, this series records the source and draws no conclusion.

The three inter-ministerial orders of 10 September 2025 disclosed in the official ANPP presentation are listed in this series with the express annotation that the official journal texts are pending verification; no provision, figure or effective date is derived from them.

Insight 4: the form of each service deliverable is aligned with the regulatory requirement.

Dossiers are delivered in the five-part format with Annex II numbering; packaging artwork is prepared in Arabic and French versions under Annex I; renewal deliveries follow the two-part consolidated format of Annex III, with the full five-part dossier held ready; and vigilance deliverables take the form of the system summary required by Article 10, updated year by year.

4. Practical recommendations

1. Start every project with entity structure design: fix the détenteur and the exploitant and draft the delegation agreements.
2. Launch local-partner due diligence in parallel, verifying agrément activity types and the pharmacist presence status.
3. Fix the time-limit baseline by pathway selection (240 days / 90 days / 90 days / 90 days).
4. Draft the dossier in the five-part format with Annex II numbering, with Arabic and French packaging artwork.
5. Estimate fees across the three redevance tiers and the three lot-control tax tiers; follow the ANPP payment order for first-time homologation (practical estimate).
6. After market entry, build the Article 36 immediate-declaration mechanism and update the Article 10 materiovigilance system summary annually.

5. Verification checklist

• □ Entity structure design and delegation agreements are complete.
• □ Local-partner due diligence is complete (agrément and pharmacist status).
• □ Pathway selection and the time-limit baseline are fixed.
• □ The dossier is drafted in the five-part format with Annex II numbering.
• □ Packaging artwork is prepared in two language versions under Annex I.
• □ Fee estimation is complete, with first-time homologation flagged as a practical estimate.
• □ The Article 36 immediate-declaration mechanism and the Article 10 vigilance summary maintenance are running.

Regulatory information verified as of 30 October 2026.

GRZAN supports companies in the Algerian market across registration and post-market compliance: materiovigilance system maintenance, immediate declarations under Article 36, withdrawal and recall management, and inspection response coordination with ANPP and local partners. For post-market compliance support in Algeria, contact info@grzanglobal.com.