Homologation Commission Composition and Rules

1. Key takeaways

The operating rules of the homologation commission (commission d’homologation) are set out in Articles 2 to 15 of Décret exécutif n° 20-324. The composition is 12 categories of members (Article 3); the term of office is 3 years (Article 4); ordinary meetings are held every 3 months (Article 7); convocation notices are sent 8 days in advance, and 3 days for extraordinary meetings (Article 8); voting is by simple majority with the chair holding a decisive vote (Article 10); and the secretariat sits at the ANPP (Article 12).

These numbers are not trivia; they set the rhythm of every project. Missing one ordinary meeting means, in theory, waiting another 3 months. GRZAN therefore builds the commission calendar into every Algerian project plan before the dossier is even drafted, because the calendar, more than any legal deadline, determines when a decision can realistically arrive.

The commission articles also answer a practical question that puzzles newcomers: why does a file sit without movement for weeks? Because it is waiting for the next session, not because it is lost. Knowing the meeting rhythm turns silence into schedule.

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 November 22, 2020 on the modalities of homologation of medical devices, JORADP No. 69, published 2020-11-22, pages 10–14, 46 articles), Article 3 (12 categories of members, with a representative of the Ministry of Pharmaceutical Industry as chair), Article 4 (a term of 3 years), Article 7 (one ordinary meeting per quarter), Article 8 (convocation at 8 days and 3 days), Article 10 (simple majority, the chair’s vote is decisive) and Article 12 (secretariat at the ANPP).
2. 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 2020-11-22, pages 10–14, 46 articles), Article 5 (confidentiality) and Article 6 (conflicts of interest).
3. 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 2020-11-22, pages 10–14, 46 articles), Article 24 (conflicts of interest of experts) and Articles 26 to 29 (issuance and transmission of the commission’s opinion).
4. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 modifiant l’arrêté du 12 Joumada El Oula 1442 correspondant au 27 décembre 2020 portant désignation du président et des membres de la commission d’homologation des dispositifs médicaux à usage de médecine humaine (Ministerial Order of 28 Ramadhan 1442 corresponding to May 10, 2021 amending the order of 12 Joumada El Oula 1442 corresponding to December 27, 2020 designating the president and members of the homologation commission for medical devices for human medicine, listed by the ANPP website under its device regulatory texts section) — amends the appointment order for the commission president and members.

3. Expert insights

Insight one: the chair comes from the Ministry of Pharmaceutical Industry, not the Ministry of Health.

Among the 12 categories of members listed in Article 3, the chair is a representative of the Ministry of Pharmaceutical Industry. The members include representatives of the Ministry of Health, the national health security agency, experts in physics, chemistry and biophysics, the national toxicology center, metrology, the national center for pharmacovigilance and device vigilance, pharmacology, biomedical engineering, and clinical or biology specialists. This composition shows the commission is technically oriented rather than administratively oriented, which explains the technical depth of the questions it asks.

Insight two: the quarterly ordinary meeting is the hidden bottleneck of the whole cycle.

Article 30 of Décret exécutif n° 20-324 gives the ANPP a 240-day decision period, which looks generous. But Article 27 requires the commission to issue its opinion within 30 days (extendable by 30 days), while the commission meets quarterly under Article 7. If a dossier arrives between two ordinary meetings, the actual wait may far exceed 30 days. GRZAN’s scheduling experience is to plan the submission date backwards from the commission meeting calendar, not backwards from the 240 days.

Insight three: conflict-of-interest rules apply doubly, to members and to experts.

Article 6 binds commission members; Article 24 separately binds the experts involved in the evaluation. The practical effect of this dual arrangement is that companies cannot accelerate anything by contacting reviewers privately. All communication must go in writing through the ANPP secretariat under Article 12, which protects both sides and keeps the record clean.

Insight four: the 3-year term of Article 4 and the appointment order are two different things.

Article 4 governs the term of members; the individual appointments are made by ministerial order — the order of December 27, 2020, itself amended by the ministerial order of May 10, 2021. There is no need to track individual names in practice, but be aware that changes in commission composition can shift the review emphasis, and a composition change is worth noting when interpreting the tone of a new round of questions.

4. Practical recommendations

1. Ask the ANPP secretariat for the year’s ordinary meeting schedule and plan submission dates backwards from the meeting calendar.
2. Compile all technical questions into written lists and submit them through the ANPP; never contact commission members or experts directly.
3. Provide a clear evaluation index on the first pages of the dossier to reduce the time the commission spends searching during sessions.
4. Reserve longer commission waiting periods for high-risk categories (IIb and III) and reflect them in the project plan.
5. Track whether the commission composition changes; composition shifts often accompany small adjustments in review focus.
6. After submission, establish a moderate rhythm of progress confirmation with the secretariat — frequent enough to stay informed, infrequent enough not to be seen as pressure.

5. Verification checklist

• □ The year’s ordinary meeting schedule is known, and submission timing is planned backwards from it.
• □ All technical questions have been submitted in writing through the ANPP secretariat.
• □ The dossier opens with a clear evaluation index.
• □ Additional commission waiting time is reserved for Class IIb and III products.
• □ A tracking mechanism exists for changes in commission composition.
• □ A reasonable post-submission progress-confirmation rhythm has been set.

Related reading in this series

• Article 11, The standard homologation process: six stages from dossier submission to decision — https://www.grzanglobal.com/algeria-medical-device-registration/standard-homologation-process-six-stages/
• Article 13, The four phases of technical evaluation: Article 25 of Executive Decree 20-324 — https://www.grzanglobal.com/algeria-medical-device-registration/article-25-technical-evaluation-four-phases/
• Article 14, Commission opinion in 30 days, 8-day transmission, and the 15-day no-change declaration — https://www.grzanglobal.com/algeria-medical-device-registration/commission-opinion-30-days-15-day-declaration/

Regulatory information verified as of October 30, 2026.

GRZAN supports manufacturers through every stage of the Algerian homologation process, including commission-calendar scheduling, dossier indexing and secretariat correspondence management. For registration and compliance support in the Algerian market, contact info@grzanglobal.com.