Administrative and Technical Dossier for Medical Device Registration in Morocco

1. Key takeaways

Article 14 of Law No. 84-12 requires a registration application to be accompanied by two distinct parts: an administrative dossier and a technical dossier. The purpose of the dossier is to enable the competent authority to evaluate the performance of the device and its conformity with the essential requirements set out in Article 5. This dual objective is not decorative wording. It defines what reviewers look for when they open a registration file, and it should therefore define how manufacturers and authorized establishments organize every document they submit.

The second paragraph of Article 14 adds a critical procedural rule: the content of the dossier and the registration procedure are determined by regulation according to the class of the device. Dossier preparation in Morocco therefore cannot follow a one-size-fits-all template. A Class I device and a Class III device move through the same framework, but the depth of evidence, the number of certificates, and the administrative attachments differ materially. Teams that ignore this tiered logic either over-prepare low-risk products or under-prepare high-risk ones, and both mistakes cost time.

GRZAN’s practical estimate of the current framework is that the tiering operates on three levels: a common baseline for all classes, an intermediate tier for the Class IIs and Class Im subcategories that mirrors the Class IIA evidence level, and a top tier for Class IIA and above that adds the manufacturer’s ISO 13485 certificate, with Class III additionally requiring a CE design examination certificate. Locating a product on this ladder before drafting begins is the most effective way to keep the project on schedule.

2. Legal basis

Practical estimate: the form number and version cited above come from the checklist currently published by AMMPS. Checklist versions may be updated at any time, and the applicable version must be re-verified immediately before submission.

3. Expert insights

Insight one: the dividing line between administrative and technical documents is drawn by who signs. Article 3 of Arrêté n° 2855-15 requires that all administrative documents in the registration dossier, together with the declaration of conformity issued by the establishment regarding the device’s conformity with the essential requirements, must be dated, signed, and stamped by the legal representative of the Moroccan establishment. Technical documents, by contrast, are issued by the manufacturer. This rule splits the dossier into two halves: one half is completed and executed in Morocco, and the other half is produced at the manufacturing site. Coordinating these halves, especially when the legal representative must sign documents referencing technical content they did not prepare, is a project-management task to plan from day one rather than improvise in the final week.

Insight two: the tiering is a ladder, not a switch. The tiering verified by GRZAN from the order and the current checklist operates as a three-step ladder. For all classes, the dossier must include a covering application letter, a copy of the payment receipt, the fiche signalétique, and the attestation of the relationship between the manufacturing site and the applying establishment. For Class IIA and above, and for the Is and Im subcategories of Class I, the dossier must additionally include a CE marking certificate, a certificate from the United States Food and Drug Administration, or a marketing authorization or free sale certificate issued by the competent authority of the country of origin. For Class IIA and above, the manufacturer’s ISO 13485 certificate or equivalent documentation is also required, and Class III devices additionally require a CE design examination certificate. The meaning of the ladder is straightforward: sterility and measuring functions raise a Class I device to the same evidence level as Class IIA.

Insight three: imported devices are not required to submit a complete technical dossier. The current AMMPS checklist states that a complete technical dossier is not required for imported devices, and that clinical data is mainly required for Class III. This significantly lowers the documentation threshold for low and medium-risk products. It also means that the competent authority relies heavily on the market access evidence from the country of origin when forming its judgment. The quality, validity, and internal consistency of that evidence chain directly determine the outcome, so the certificates submitted are the substantive basis of the decision, not mere formalities.

Insight four: the purpose stated in Article 14, evaluating performance and conformity, is the substantive standard of review. The provision states the purpose of the dossier clearly: to enable the competent authority to evaluate the performance of the device and its conformity with the essential requirements. Companies should organize the dossier around these two objectives rather than stacking documents in the order of their own product catalog. A dossier that maps each document to a performance characteristic or to a specific essential requirement is easier to review and harder to challenge.

Insight five: the attestation of relationship is an administrative document specific to Morocco. Article 2 of Arrêté n° 2855-15 requires the administrative documents to include an attestation issued by the manufacturing site or its mandatary describing the relationship between that site and the applying establishment. This is a local mechanism that takes the place of the authorized representative appointment letter familiar from the European Union system. Because the wording identifies the parties, the nature of the relationship, and the scope of the arrangement, it should be finalized early, well before the rest of the dossier is assembled.

4. Practical recommendations

1. Split the dossier into two halves with clear ownership. The manufacturer prepares the technical documents and product-side materials; the licensed establishment prepares the administrative documents and executes all signatures. Fix this responsibility matrix at project kickoff so neither party assumes the other holds a document at submission time.
2. Prepare evidence according to the tier ladder, not by blanket over-preparation. Work through a tier table item by item for the actual class of the device. This avoids excessive preparation for low-risk products and prevents the Is and Im subcategories from being missed when a nominally Class I product carries sterile or measuring functions.
3. Finalize the wording of the attestation of relationship early. Confirm with the licensed establishment who issues the attestation, how the relationship is described, and at what level of authority it is signed.
4. Organize the dossier around performance plus essential requirements. Structure the technical section against the two purposes stated in Article 14, so a reviewer can trace each claim to supporting evidence without searching across the file.
5. Record the checklist version on the dossier cover page. Display the form number, the version number, and the applicable date on the cover, so the authority can see at a glance that the file follows the current requirements.

5. Verification checklist

• □ Confirmed under Article 14 that the dossier contains both the administrative and the technical parts
• □ Cross-checked every item against the tier table for the device class
• □ Administrative documents dated, signed, and stamped by the legal representative of the Moroccan establishment
• □ Attestation of relationship issued as required by Article 2 of Arrêté n° 2855-15
• □ Is and Im subcategories prepared to the Class IIA evidence level
• □ CE design examination certificate prepared for Class III
• □ Checklist form number, version, and applicable date recorded on the dossier cover

GRZAN supports manufacturers and authorized establishments preparing registration dossiers for the Moroccan market. Our team helps assemble the administrative and technical parts of the dossier, align every document with the tier applicable to the device class, coordinate signature and stamping workflows with the Moroccan establishment, and keep the evidence chain consistent from the covering letter through to the technical description. For assistance with dossier preparation and conformity documentation for Morocco, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026