Article 25 Technical Evaluation: Four Phases of the Algerian Homologation Review

1. Key takeaways

Article 25 of Décret exécutif n° 20-324 divides the technical evaluation into four phases: first, the evaluation of technical regulations; second, the evaluation of physical, chemical and biological testing; third, the evaluation of the risk analysis report; and fourth, the evaluation of clinical data. These four phases are parallel subjects of review, not sequential steps, and this determines how the dossier must be organised.

Because the phases run in parallel, each family of materials in the dossier must stand as an independent, separately retrievable block. A reviewer looking for the risk analysis report should not have to dig through sterilisation validation data to find it, and a reviewer assessing clinical data should not find it merged with non-clinical performance results. GRZAN’s organising principle is to structure the dossier in reverse order of the four phases, so that the evaluator can go directly from each phase to the corresponding material.

The four-phase structure also defines the ceiling of what the review can demand. Materials that serve none of the four phases add weight to the dossier without adding value at the review table, while materials missing from any of the four blocks create a visible hole that the evaluator is obliged to flag.

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 22 November 2020 on the procedures for the homologation of medical devices, JORADP No. 69, published 22 November 2020, pages 10–14, 46 articles): Article 25 (the four phases of the technical evaluation) and Article 26 (the alternative route and the 30-day report when evaluation is not possible).
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 fixing the composition of the homologation dossier and the renewal dossier for medical devices intended for human medicine, JORADP No. 55, published 14 July 2021, pages 21–24, 13 articles): Article 5 (the five-part format, where Part III corresponds to physico-chemical, mechanical and biological information, Part IV to performance and non-clinical reports, and Part V to the clinical report).
3. 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 No. 69, published 22 November 2020, pages 10–14, 46 articles): Article 24 (conflicts of interest of experts).
4. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant les modalités de régularisation du dossier d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 10 May 2021 on the regularisation of the homologation dossier, JORADP No. 55, published 14 July 2021, pages 24–26, 14 articles): Article 9 (the simplified evaluation for Class I and IIa devices) and Article 10 (Class IIb and III devices remain subject to Article 25).

3. Expert insights

Insight 1: the four phases map clearly onto the five parts of the dossier.

Article 5 of the Ministerial Order of 10 May 2021 divides the dossier into five parts: Part I administrative data; Part II the technical performance and the non-clinical and clinical summary; Part III chemical, physical, mechanical and biological information, including the manufacturing process, sterilisation validation, the test procedures for raw materials and finished products, stability, and risk assessment; Part IV performance and non-clinical reports; and Part V the clinical report. Setting this division against the four phases of Article 25 shows that Part III serves both the second phase and the third phase at once, which is why it is the thickest part of the dossier in practice.

Insight 2: risk assessment is a standalone phase, not an attachment.

The independent position of the third phase matches the requirement in Article 4 of the 2021 Ministerial Order that the dossier include an assessment of the risks of the device for the environment, and the requirement in Article 5 that Part III contain the risk assessment (l’évaluation du risque). The provisions corroborate one another. GRZAN builds the risk management file as an independently searchable chapter, not as remarks scattered across technical appendices, so that the third-phase reviewer can extract it without assistance.

Insight 3: Article 26 is the exit when the four phases cannot be run.

Under Article 26, when evaluation through the four phases is not possible, the procedure relies on a documentary evaluation combined with a report from the clinical experts committee, and the report must be issued within 30 days. This matters most for innovative devices and devices without an equivalent comparator, because it converts the situation from a dead end into a change of assessment route.

Insight 4: the expert conflict-of-interest rule sits deliberately next to the evaluation provisions.

Article 24 on conflicts of interest of experts stands between Article 23 on the technical evaluation and Article 25 on its four phases. The legislative intent is legible: the independence of the evaluating experts is treated as being as important as the evaluation itself. The practical implication for companies is that no attempt should be made to influence review conclusions through personal channels; the law has pre-empted that path.

4. Practical recommendations

1. Organise the dossier in reverse order of the four phases of Article 25, with one independently searchable chapter per phase.
2. Make the risk management report a standalone chapter covering both product risk and environmental risk.
3. Concentrate sterilisation validation, the test procedures for raw materials and finished products, and stability data in Part III.
4. File the clinical report separately as Part V, cross-referenced to the clinical summary in Part II.
5. For innovative or comparator-free devices, prepare in advance the argumentation needed to invoke Article 26.
6. Do not contact evaluating experts through private channels; route all communication through the ANPP in writing.

5. Verification checklist

• □ The dossier has been organised in reverse order of the four phases of Article 25.
• □ The risk management report is a standalone chapter covering product and environmental dimensions.
• □ Sterilisation validation, test procedures and stability data are concentrated in Part III.
• □ The clinical report and the Part II clinical summary are cross-referenced.
• □ Article 26 argumentation has been prepared for innovative devices.
• □ All communication has gone through the ANPP in writing, with no contact with evaluating experts.

GRZAN designs Algerian homologation dossiers around the four evaluation phases of Article 25, from dossier architecture and classification strategy to risk management documentation that survives the third-phase review. Whether your device follows the full four-phase route or the simplified evaluation for Class I and IIa devices, GRZAN aligns every chapter with what the evaluators actually read. For support, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026.