Morocco medical device registration timeline
Source-linked clocksAgence Marocaine des Médicaments et des Produits de Santé (AMMPS) review clocks and end-to-end planning ranges, using the 4-class (I, II A, II B, III) — loi 84-12 art. 4 classification system.
5 pathways5 of 5 clocks verifiedvalidity 5 years, renewable, in the conditions fixed by arrêté of the Minister of Health (décret n° 2-14-607 art. 6)MDSAP not acceptedreviewed 2026-09-16sante.gov.ma
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Initial device registration — all risk classes(National dossier review: the application is addressed to the Minister of Health and the certificat d'enregistrement is delivered by the administration after consultation of the commission nationale consultative des dispositifs médicaux (loi 84-12 arts. 12 and 14; décret n° 2-14-607 art. 4)) 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. | 120 days | 6-12 months | — | Verified |
| Post-registration update (mise à jour) of the certificate(Update application under arrêté n° 2855-15, distinct from a fresh registration application where the change bears on the nature of the device (loi 84-12 art. 16)) 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. | 20 days | 2-4 months | — | Verified |
| ANRT agrément — radio and telecommunications terminal equipment(Prior agrément by equipment, delivered by the ANRT on application to its services (Décision ANRT/DG/N°16/24 arts. 2, 3 and 11)) 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. | 15 days | 2-4 months | — | Verified |
| AMSSNuR authorisation — ionizing-radiation installations, activities and sources(Authorisation from the Agence for the installation or activity and the ionizing-radiation sources associated with it (loi n° 142-12 arts. 7 and 45)) 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. | 2-6 months | 6-12 months | — | Verified |
| Advertising of medical devices to the public — visa de publicité(Application for the visa de publicité addressed to the Minister of Health, on a dossier whose content and grant procedure are fixed by ministerial arrêté; the Minister decides after the opinion (avis) of the Commission nationale consultative des dispositifs médicaux (décret n° 2-14-607 art. 14, implementing art. 34 of loi n° 84-12)) 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. | 60 days | 3-6 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Morocco Medical Device Registration Process
Step-by-step AMMPS registration process. Total estimated timeline: 6-12 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by AMMPS. Appoint a Établissement marocain déclaré (fabricant ou importateur) — the registration certificate is granted only to an establishment declared to the administration under loi n° 84-12 art. 7.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to AMMPS including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksAMMPS reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
120 daysIn-depth technical assessment of device safety and performance. AMMPS may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, AMMPS issues Morocco market authorization certificate.
Summary: The Morocco medical device registration process through Agence Marocaine des Médicaments et des Produits de Santé (AMMPS) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
EU CE marking certificateMandatory dossier item 4 for classes Is, Im, II A, II B and III, with a CE design-examination certificate additionally required for class III. It does not shorten the review: the device is still registered nationally by the AMMPS, and the AMMPS recognition framework covers medicines and vaccines only.
US FDA attestationAccepted as an alternative to the CE certificate for dossier item 4. Dossier evidence only — no abridged or recognition route for devices exists.
Origin-country free-sale certificate (certificat de vente libre, CVL)The third accepted form of dossier item 4 evidence, and the one a manufacturer outside the EU, US and comparable regimes would normally use. It must be issued by the competent authority of the country of origin, and it is evidence inside the national review rather than a substitute for it.
Japan PMDA / Korea MFDS / other non-listed approvalsNo Moroccan device instrument examined in this round names them, and the AMMPS reliance framework is scoped to medicines and vaccines, so they carry no listed documentary route for a device.
Key requirements
- The applicant must be a Moroccan manufacturing or importing establishment declared to the administration under loi n° 84-12 art. 7; the registration certificate is granted only to such an establishment.
- The registration dossier is a fixed seventeen-item paper file (application letter and fiche signalétique in triplicate, manufacturer's attestation, the competent authority's certificate of the country of origin, declaration of conformity, GMP certificate, labelling and instructions-for-use drafts, technical documentation, colour catalogue and a sample), all dated, signed and stamped by the legal representative of the Moroccan establishment.
- A copy of the quittance for the registration fees, obtained from the régie, must be filed with the dossier.
- The competent-authority certificate of the country of origin (CE marking certificate, FDA attestation, free-sale certificate or equivalent) is mandatory for classes Is, Im, II A, II B and III, and a CE design-examination certificate is additionally required for class III.
- For imported devices the technical documentation item is waived and only clinical data are required, and only for class III; the rest of the dossier still applies.
- Customs release of imported devices is conditioned on presentation of a registration certificate or, as the case may be, a specific authorisation under loi 84-12 art. 13.
- Only devices holding a registration certificate may be advertised, and advertising requires a prior visa from the Minister of Health.
- The registration holder must report any incident or risk of incident to the administration — the materiovigilance duty covers every incident and any quality failure, not only serious ones.
Primary regulator sources
sante.gov.ma · Décret n° 2-14-607 du 18 septembre 2014, article 4, troisième alinéa — the Minister of Health decides within a maximum of one hundred and twenty days from filing of the complete dossier ammps.gov.ma · Décret n° 2-14-607 du 18 septembre 2014 pris pour l'application de la loi n° 84-12 relative aux dispositifs médicaux, article 14 troisième alinéa — visa de publicité decision within a maximum of sixty days (AMMPS clean text version; the Bulletin officiel two-column print truncates article 14) ammps.gov.ma · Arrêté n° 2855-15 du 4 août 2015, article 11 — a maximum of 20 days from filing of the complete dossier to decide on an update anrt.ma · Décision ANRT/DG/N°16/24, article 11 — notification within fifteen (15) working days of receipt of the complete application mem.gov.ma · Loi n° 142-12, article 46 — authorisations delivered within a period of two (2) to six (6) months from receipt of the complete dossier ammps.gov.ma · Arrêté n° 2855-15 du 4 août 2015, article 7 — renewal dossier, including the five-year materiovigilance review issued by the manufacturing establishment
Reviewed 2026-09-16. End-to-end totals remain planning estimates.
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Source-linked review clocks verified against AMMPS publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:morocco:ammps-initial-registration