Article 30 Decision Deadline: 240 Days with a 90-Day Extension

1. Key takeaways

Article 30 of Décret exécutif n° 20-324 is the single most consequential deadline provision in the decree: the ANPP must issue its decision within 240 days from the date of admissibility; the period may be extended by 90 days; the deadline is suspended when additional documentation is requested; and if the applicant fails to submit the requested items in time, the application becomes caduque.

GRZAN’s scheduling conclusion: the statutory worst case is 240 + 90 = 330 days, and once the suspended periods during additional-information rounds are added, the actual cycle can be markedly longer. Any project plan built on the nominal 240 days alone is systematically optimistic and will produce missed internal milestones even when the authority itself performs strictly within the law.

Article 30 also matters because it interacts with everything around it: the starting date depends on the Article 22 review, the commission opinion of Article 27 nests inside it, and the refusal regime of Article 31 applies only if the decision is negative. Understanding this one article correctly is a precondition for understanding the whole procedure.

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 30 (the 240-day decision, the 90-day extension, suspension during additional-information rounds, and lapse on expiry).
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 12 (regularisation channel: a decision within 90 days, extendable by 30 days, with suspension during additional-information rounds).
3. Arrêté du 12 Dhou El Kaâda 1442 correspondant au 23 juin 2021 fixant les modalités de modification de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Ministerial Order of 23 June 2021 on modification of the homologation decision, JORADP No. 62, published 15 August 2021, pages 21–22, 16 articles): Article 12 (modification channel: a decision within 90 days, extendable by 30 days, with suspension during additional-information rounds).
4. 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 9 (export-only channel: a decision within 90 days, extendable by 30 days, with lapse on expiry).

3. Expert insights

Insight 1: 240 days on the standard channel versus 90 days on every other channel is a gap of 150 days.

Set the four channels side by side: the standard route allows 240 days, extendable by 90 days; the regularisation route 90 days, extendable by 30 days; the modification route 90 days, extendable by 30 days; and the export-only route 90 days, extendable by 30 days. The standard route is conspicuously longer, which is consistent with its obligation to run the full four-phase evaluation of Article 25 rather than a reduced scope.

Insight 2: suspension and extension are two different mechanisms and must not be conflated.

Article 30 first allows the period to be extended by 90 days, an affirmative extension, and then provides that the deadline is suspended when additional documentation is requested. Suspension means the clock stops during the additional-information round and resumes with the remaining time once the response is filed. The practical consequence: however long the applicant takes to respond, that time does not consume the 240 days, but it does delay the actual certificate.

Insight 3: lapse is a heavier outcome than refusal.

A refusal under Article 31 is a negative decision by the ANPP, and the applicant can remediate the stated grounds and apply again with a targeted file. Lapse (caduque) extinguishes the application itself, generally meaning a new submission and a new payment of fees. GRZAN therefore classifies the additional-information deadline as the single red-alert item of the whole project, with escalation above every other milestone.

Insight 4: the starting point is the date of admissibility, not the date of submission.

Article 30 counts à compter de la date de recevabilité, from the date of admissibility, and that date is fixed by the 8-day review of Article 22. The complete chain is therefore: submission, then up to 8 days, then admissibility, and only then does the 240-day clock start. Plans that start counting at submission quietly overstate the time available by the length of the review.

4. Practical recommendations

1. Maintain a ledger of the date of admissibility, with separate reminders set for the 240-day deadline and the 90-day extension.
2. Break down every additional-information request the day it arrives and process the items in parallel; never approach the response deadline.
3. Record suspension and extension differently: log the frozen interval for suspensions and the added days for extensions.
4. Estimate the real schedule at 330 days plus additional-information time, not at an optimistic 240 days.
5. If the 240 days are nearly exhausted without a decision, ask the ANPP in writing whether it is exercising the 90-day extension.
6. Archive all additional-information correspondence as evidence that no delay is attributable to the applicant.

5. Verification checklist

• □ The date of admissibility is recorded in a ledger, with reminders for the 240 days and the 90-day extension.
• □ A parallel-processing mechanism for additional-information requests is in place.
• □ Suspensions and extensions are recorded separately.
• □ The schedule is estimated at 330 days plus additional-information time.
• □ A written template for querying the ANPP about an extension near the deadline is ready.
• □ Additional-information correspondence has been archived as evidence on deadlines.

GRZAN builds and defends deadline models for Algerian medical device registrations, covering the 240-day standard decision clock, the 90-day regularisation and export-only clocks, and the interaction of suspension and extension under Article 30. If your timeline has stalled or your plan was built on optimistic numbers, GRZAN can rebuild it against the statutory text. For support, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026.