Morocco medical device registration timeline

The clock is décret n° 2-14-607 art. 4, third paragraph: the Minister of Health decides within a maximum of one hundred and twenty days from the date the COMPLETE dossier is filed. The instrument sets no period for completing a dossier, so time spent answering deficiencies and producing missing items falls outside the 120 days.

This is a national dossier review, not a reliance route: the AMMPS recognition framework published in 2026 states that it covers medicines and vaccines only, so a CE, FDA, PMDA or MFDS approval does not shorten this clock — it is dossier item 4 evidence alongside the national file.

One clock is set for every risk class, so no riskLevel is recorded on this row.

The dossier is filed by the declared Moroccan establishment, not by the foreign manufacturer.

Arrêté n° 2855-15 art. 11: the administration decides on an update application within a maximum of 20 days from filing of the complete dossier, and any refusal must be justified and communicated to the establishment.

This 20-day clock is the modification clock only; the 120-day clock applies to a first registration application.

Changes bearing on the nature of the device require a new registration application instead of an update.

Article 11 of the décision expresses the period as fifteen (15) jours ouvrables; the 15-day figure is the instrument's own number and the working-day basis is recorded here because the registry's unit vocabulary is days, weeks and months only.

The clock runs from receipt of the complete application and is suspended where the ANRT issues a deficiency notice, which gives the applicant ten days to respond; it resumes from the requested supplement.

Article 7 gives the agrément a validity of ten years, and art. 15 requires the specific absorption rate to be displayed from 1 May 2025.

Applies only where the device contains radio transmitting or receiving equipment or terminal equipment attachable to a public network; a stand-alone device is not caught.

Loi n° 142-12 art. 46: the authorisations are delivered by the Agence within a period of two (2) to six (6) months running from the date of receipt of the complete dossier, and the period is fixed by regulation for each of the classes set by art. 4 of the law.

Article 45 makes the authorisation conditional on, among other things, the conformity of the radiation sources to the design and manufacturing standards required for their certification, the radioprotection qualifications of the personnel, and the safety analysis of the installation.

The authorisation attaches to the installation, the activity and their operator, so it is separate from the AMMPS device registration and is held at the site of installation and use.

The implementing decree is décret n° 2-20-131 du 25 février 2021; its class-by-class rules were not retrieved and are not asserted on this row.

NOT A REGISTRATION CLOCK — this row is deliberately separate from the registration rows. Décret n° 2-14-607 art. 14, troisième alinéa: 'Le ministre de la santé décide de l'octroi du visa de publicité après avis de la commission nationale consultative des dispositifs médicaux, et ce dans un délai maximum de soixante jours à compter de la date du dépôt du dossier complet.' It governs advertising to the public, not market access, and it must not be folded into the 120-day registration clock.

METHOD NOTE for reviewers: article 14 is invisible in the Bulletin officiel print hosted on sante.gov.ma, whose two-column layout makes text extraction truncate the article mid-way; it was recovered from the AMMPS-hosted clean text version of the same decree, where articles 4 and 14 both read cleanly. The two copies agree word for word on art. 4.

The clock runs from filing of the complete dossier, like the registration clock, and the same limitation applies: the decree fixes no period for the administration to raise a completeness objection, so the start is in practice controlled by the administration.

Two periods in the decree are internal to the administration rather than decision clocks and are not published here: art. 17 second alinéa gives the commission a second deliberation within fifteen days of a first meeting that lacked a quorum, which bounds the delay an avis can cause; art. 23 quatrième alinéa gives the inspection service seven days to transmit its report to the Minister.

Only a device holding a certificat d'enregistrement may be advertised, so this row sits behind the registration rows rather than beside them.