The five parts of the Algerian homologation dossier under Article 5

1. Key takeaways

The organisational format of the Algerian homologation dossier is laid down by Article 5 of the Ministerial Order of 10 May 2021, which requires the dossier to be assembled in 5 parts (Partie I–V). The format, the content and the numbering system of each part are set out in detail in Annex II of the same order. Article 6 adds an important rule of scope: this 5-part format applies not only to homologation applications but equally to renewal applications and to modification applications, and it applies to every device type, including in vitro diagnostic devices and active implantable devices.

The practical estimate used by GRZAN when assembling dossiers is simple: the numbering system of Annex II must be reproduced exactly, chapter by chapter, because reviewers locate content by its Annex II number. Any deviation from that numbering forces the reviewer to search, and searching is what triggers questions, delays and requests for additional documents.

Three consequences follow. First, the dossier is a fixed-structure document, not a free-form technical file. Second, the same structure is reused across the whole lifecycle of the approval decision. Third, Part III contains four fixed sub-items that can never be omitted, and the renewal dossier uses a condensed 2-part consolidated format that ANPP may at any time upgrade back to the full 5-part format.

2. Legal basis

1. 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 (Ministerial Order of 10 May 2021 on the composition of the homologation dossier and the renewal dossier of the homologation decision for medical devices, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 5 (5-part format and Annex II); Article 6 (application to homologation, renewal, modification and to all device types);

and Article 11 (consolidated 2-part format for the renewal dossier, with Annex III).

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 N° 69, published 2020-11-22, pages 10–14, 46 articles in total): Article 19 (the dossier comprises administrative, technical and scientific-clinical groups of data, whose composition is set by ministerial order).
2. 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 (Ministerial Order of 10 May 2021, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 4 (22 items for the first dossier); Article 10 (21 items for the renewal dossier).
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 (Ministerial Order of 10 May 2021, JORADP N° 55, published 2021-07-14, pages 21–24, 13 articles in total): Article 7 (submission of samples, raw materials, intermediates, reagents and specific means at the request of ANPP).

3. Expert insights

Insight one: the 5-part division maps onto the three groups of data defined by Article 19 of Executive Decree No. 20-324.

Article 19 states that the dossier contains administrative, technical (from design to finished product), and scientific and clinical groups of data. Article 5 translates that triad into five parts: Part I holds the administrative data; Part II holds the technical, performance, non-clinical and clinical summaries; Part III holds the chemical, physical, mechanical and biological information; Part IV holds the performance and non-clinical reports; Part V holds the clinical reports.

The key observation is that the technical group is split across Parts II, III and IV. This is the largest structural difference between a device dossier and a pharmaceutical dossier, where the technical content sits in fewer, larger sections. Companies that prepare dossiers by analogy with drug registration files routinely misplace sterilisation validation or stability data, because they expect a single technical chapter. In Algeria the technical content is deliberately fragmented, and each fragment has its own Annex II number.

Insight two: Part III contains 4 fixed sub-items that cannot be omitted.

The third item of Article 5 enumerates them: the manufacturing process; the sterilisation and sterilisation method validation report; the inspection procedures and stability of raw materials, components, excipients and the finished product; and the risk evaluation. These 4 sub-items correspond to the second and third phases of the technical evaluation under Article 25 of Executive Decree No. 20-324, which makes them mandatory checkpoints for reviewers. A dossier that merges these sub-items into a single chapter, or that omits one of them because it seems not applicable, invites a finding of incompleteness and a request for regularisation.

Insight three: Part II asks for summaries, Parts IV and V ask for reports, and the two cannot substitute for each other.

Part II requires summaries (résumés), Part IV requires non-clinical reports and Part V requires clinical reports. The final paragraph of Article 4 of the Ministerial Order reinforces this: test results and related data must be accompanied by a detailed summary prepared in accordance with the prescribed rules. In other words, the reports must be submitted, and the summaries must also be submitted. A common failure mode is to submit full study reports with no Part II summary, or a Part II summary with no underlying report; both are treated as incomplete.

Insight four: the renewal dossier is a consolidated 2-part version, but ANPP can demand the full 5-part dossier.

Article 11 provides that the renewal dossier is submitted under Annex III as a consolidated version containing all changes since the decision was issued, divided into Part I (administrative data) and Part II (technical, performance, non-clinical and clinical summaries) — 2 parts in total. However, the closing paragraph of the same article states that ANPP may require the complete 5-part dossier under Article 5. The pending verification point here is that no applicant can assume the 2-part format will be accepted; the consolidated version is the default, the full version is the fallback, and the fallback must be maintained in a state of readiness.

4. Practical recommendations

1. Copy the Annex II numbering system into the dossier table-of-contents template, so that every chapter number matches the annex exactly.
2. Keep the 4 sub-items of Part III as fixed, separate chapters; do not merge them and do not omit any of them.
3. Prepare the Part II summaries and the Part IV and Part V reports in parallel; never submit only one of the two layers.
4. For renewal, prepare the 2-part consolidated version first, and keep the latest 5-part full dossier on standby.
5. Use the 5-part format for modification applications as well (Article 6 is explicit); do not invent a separate numbering scheme for changes.
6. Attach a review index on the dossier cover page, showing which chapters correspond to each of the four phases of the technical evaluation under Article 25.

5. Verification checklist

• □ The dossier table of contents is fully consistent with the Annex II numbering.
• □ The 4 sub-items of Part III are fixed as separate chapters.
• □ Summaries and reports have been prepared in parallel.
• □ Both the 2-part consolidated renewal version and the 5-part full dossier are in place.
• □ Modification applications follow the 5-part format.
• □ The review index on the dossier cover page is complete.

• Article 21 — The five parts of the homologation dossier: Article 5 of the Ministerial Order of 10 May 2021: https://www.grzanglobal.com/algeria-medical-device-registration/dossier-five-parts-article-5/
• Article 30 — The 21-item renewal dossier and the two formats: the consolidated version rule of Article 11: https://www.grzanglobal.com/algeria-medical-device-registration/renewal-dossier-21-items-consolidated-format/
• Article 13 — The four phases of technical evaluation: Article 25 of Executive Decree No. 20-324: https://www.grzanglobal.com/algeria-medical-device-registration/article-25-technical-evaluation-four-phases/

Regulatory information verified as of 30 October 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and conformity documentation for the Algerian market, from Annex II mapping and Part I–V assembly to renewal consolidated formats and reviewer-ready indexes. For tailored assistance with your Algeria medical device documentation, contact us at info@grzanglobal.com.