Commission Opinion in 30 Days, 8-Day Forwarding, 15-Day No-Change Declaration

1. Key takeaways

Once the technical evaluation is complete, the file moves to the commission stage. Articles 27 to 29 of Décret exécutif n° 20-324 set three consecutive deadlines: the commission issues its opinion within 30 days of the materials being transmitted, extendable by a further 30 days (Article 27); the opinion must be forwarded to the applicant within 8 days (Article 28); and the applicant must submit a declaration of no change within 15 days (Article 29).

The 15 days of Article 29 are the applicant’s own deadline. Missing it slows the entire procedure, and this is the one obligation that is completely absent from many project plans. GRZAN treats it as a first-class milestone, prepared before the opinion even arrives, because the declaration is a short document whose only real risk is time.

Taken together, the three deadlines form a chain: the commission forms an opinion, the authority transmits it, the applicant attests that nothing has changed since submission. Each link has its own clock, its own responsible party and its own failure mode, and a schedule that lumps them together will hide the only deadline the applicant directly controls.

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 27 (a commission opinion within 30 days, extendable by 30 days), Article 28 (the opinion forwarded within 8 days) and Article 29 (the applicant’s declaration of no change within 15 days).
2. 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 11 (the technical evaluation materials and report are submitted to the commission by the director general of the ANPP within 30 days, extendable by 30 days).
3. Arrêté du 12 Dhou El Kaâda 1442 correspondant au 23 juin 2021 fixant les modalités d’homologation des dispositifs médicaux fabriqués localement et destinés exclusivement à l’exportation (Ministerial Order of 23 June 2021 on the homologation of locally manufactured medical devices intended exclusively for export, JORADP No. 62, published 15 August 2021, pages 23–25, 20 articles): Article 8 (materials submitted to the commission within 60 days, extendable by 30 days).
4. 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 30 (the overall 240-day decision deadline).

3. Expert insights

Insight 1: Article 27 and Article 28 describe two different periods, for two different actors.

Article 27 binds the commission, which issues the opinion; Article 28 binds the step of forwarding the opinion to the applicant. Added together, from transmission of the materials to the commission until the applicant actually sees the opinion, up to 30 + 30 + 8 = 68 days can elapse if the commission exercises its extension. Project schedules should reserve this worst case rather than the nominal 30 days.

Insight 2: the declaration of no change is a one-time self-declaration obligation after submission.

Article 29 requires the applicant to file, within 15 days, a document attesting that the declared elements have not changed since submission. Its substance is a guarantee that the product was not quietly modified during the review. GRZAN pre-fills the template of this declaration at submission time and completes the signature within 24 hours of receiving the opinion, so that the 15-day window is never the bottleneck.

Insight 3: each channel has a different deadline for submitting the file to the commission, and this is the easiest figure to get wrong.

The standard channel has no separate deadline for submitting to the commission, that step being contained within the 240 days of Article 30; the regularisation channel under Article 11 allows 30 days after admissibility, extendable by 30 days; and the export-only channel under Article 8 allows 60 days, also extendable by 30 days. Three figures: not separately specified, 30 days, 60 days. Mixing them up is a common cause of misplanned projects.

Insight 4: the ground for extension is limited to requests for additional information.

Article 11(2) of the regularisation order and Article 8(2) of the export-only order both state that the extension applies only where the applicant is asked to provide supplementary information. The commission therefore cannot extend its deadline on grounds of workload. If an extension is announced without such a request, it is legitimate to ask the authority to state the legal basis for it.

4. Practical recommendations

1. Pre-fill the Article 29 declaration of no change template at submission and sign it within 24 hours of receiving the opinion.
2. Reserve 68 days, the worst case of 30 + 30 + 8, for the commission stage in the project plan.
3. Schedule each channel with its own submission-to-commission deadline: contained in the 240 days for the standard route, 30 days for regularisation, 60 days for export-only devices.
4. Establish an internal change freeze during the review so that the declaration of no change can never become inaccurate.
5. If a change during the review is genuinely unavoidable, file a separate change application under Article 3 of the Ministerial Order of 23 June 2021 on modification of the homologation decision.
6. Circulate the opinion internally on the day it arrives, with a two-level reminder system on the 15-day deadline.

5. Verification checklist

• □ The Article 29 declaration of no change template has been pre-filled.
• □ The commission stage has been budgeted at the 68-day worst case.
• □ The submission-to-commission deadline has been confirmed for the applicable channel.
• □ A change freeze during the review has been established.
• □ The separate filing route for changes arising during the review has been identified.
• □ The opinion forwarding has a two-level reminder and the 15-day deadline is under control.

GRZAN manages the commission stage of the Algerian homologation for its clients, from tracking the 30-day opinion clock to executing the 15-day declaration of no change, across the standard, regularisation and export-only channels. If your project is approaching this stage, GRZAN can audit your schedule against the statutory deadlines and close the gaps. Contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026.