Clinical data and the equivalence route under Article 20

1. Key takeaways

Article 20 of Executive Decree No. 20-324 opens an important route for clinical data in Algeria: data requiring clinical investigation must enter the dossier, but existing clinical data may be cited where a demonstration of equivalence (démonstration d’équivalence) is provided. In other words, Algeria does not default to requiring local clinical trials, but it does require the equivalence argument to be made. The burden of proof rests with the applicant, not the reviewer.

Article 19 of the same decree organises the dossier data into administrative, technical, and scientific and clinical groups, and Article 5 of the Ministerial Order of 10 May 2021 places the clinical summary in Part II and the clinical report in Part V. The equivalence argument, being substantive reasoning rather than a summary, belongs in Part V with a pointer from Part II.

The practical estimate applied by GRZAN is that the equivalence file should be planned at project initiation, covering four dimensions — intended use, technical characteristics, biological characteristics and clinical performance — because retrofitting an equivalence argument after the dossier structure is frozen is far more disruptive.

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 N° 69, published 2020-11-22, pages 10–14, 46 articles in total): Article 19 (the dossier comprises administrative, technical, and scientific and clinical groups of data),

and Article 20 (clinical data entering the dossier and the citation of existing data through equivalence).

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 (the clinical summary in Part II and the clinical report in Part V); Article 4 (test results must be accompanied by a detailed summary).
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 22 November 2020, JORADP N° 69, published 2020-11-22, pages 10–14, 46 articles in total): Article 25 (the fourth phase, the assessment of clinical data); Article 26 (where evaluation is not possible, referral to a clinical expert committee report, 30 days).
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, JORADP N° 69, published 2020-11-22, pages 10–14, 46 articles in total): Article 23 (technical evaluation); Article 24 (conflicts of interest of experts).

3. Expert insights

Insight one: Article 20 is structured as obligation plus exception, and the burden of proof lies with the company.

Article 20 first states that data requiring clinical research must be included in the dossier, and then that existing clinical data may be cited unless — or rather, where — a demonstration of equivalence is provided. This sentence structure determines that the burden of proof lies with the company: the equivalence argument must be submitted proactively, and it cannot be assumed to be granted simply because nobody asked for it. Silence from the reviewer is not a licence; the argument must be on the table, structured and evidenced, before the evaluation begins.

Insight two: the equivalence argument belongs in Part V of the dossier, not in the Part II summary.

Article 5 of the Ministerial Order designates Part II as the technical, performance, non-clinical and clinical summaries, and Part V as the clinical report. The equivalence argument is substantive reasoning material, so it should be placed in Part V, with a pointer given in the Part II summary. Teams that compress the equivalence discussion into a Part II paragraph leave Part V thin, and a thin Part V reads as a missing clinical report. The two parts must be written together, one summarising the other.

Insight three: Article 26 is the fallback when routine evaluation cannot be completed, with a 30-day timeline.

Article 26 provides that where the device cannot be assessed through the routine route, the file proceeds through documentary assessment plus a clinical expert committee report, and the report must be issued within 30 days. This provision matters especially for devices without a comparator and for innovative devices — it converts cannot be evaluated into evaluate through another path, rather than terminating the application. Preparing the documentary evidence and the justification for using this route in advance keeps the file moving instead of stalling.

Insight four: the fourth phase of Article 25 evaluates clinical data, not a clinical investigation protocol.

The wording of the fourth phase of Article 25 is l’évaluation des données cliniques — the evaluation of clinical data. Unlike two-step markets where a clinical protocol is approved first and the trial follows, in the Algerian routine channel completed clinical data are reviewed directly. There is no protocol-approval gate inside the homologation procedure. If a local investigation is genuinely needed, it is a separate undertaking, with its own application path and fees under Executive Decree No. 21-551, distinct from the dossier evaluation described here.

4. Practical recommendations

1. Decide at project initiation whether clinical data are needed, and if so prepare the equivalence argument in parallel.
2. Place the equivalence argument in Part V of the dossier, and give a pointer to it in Part II.
3. Cover four dimensions in the equivalence argument: intended use, technical characteristics, biological characteristics and clinical performance.
4. For devices without a comparator and for innovative devices, prepare the Article 26 supporting materials in advance.
5. Attach a detailed summary, prepared under the prescribed rules, to every set of test results, whether pharmaceutical, technical, non-clinical or clinical.
6. If a local clinical investigation is truly required, apply separately and pay the corresponding fees under Executive Decree No. 21-551.

5. Verification checklist

• □ The need for clinical data has been determined, and the equivalence argument prepared in parallel.
• □ The equivalence argument is in Part V, with a pointer in Part II.
• □ The argument covers all four dimensions.
• □ The Article 26 fallback materials are ready.
• □ Every set of test results carries a detailed summary.
• □ The fees and application path for a local clinical investigation have been confirmed.

• 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/
• 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 05 — The four-level classification of Algerian devices: Classe I, IIa, IIb, III: https://www.grzanglobal.com/algeria-medical-device-registration/algeria-device-classification-class-i-iia-iib-iii/

Regulatory information verified as of 30 October 2026.

GRZAN supports manufacturers and authorised representatives preparing registration dossiers and conformity documentation for the Algerian market, including equivalence argument drafting and clinical data positioning. For tailored assistance with your Algeria medical device documentation, contact us at info@grzanglobal.com.