Technical Summary and the Fiche Signaletique in Moroccan Device Registration

1. Key takeaways

The fiche signalétique is one of the administrative documents that must be submitted for all device classes in a Moroccan registration dossier, listed alongside the application letter, the copy of the payment receipt, and the attestation of relationship. Its function is to compress the identity information of the product into a single page that can be checked at a glance. For that reason, every field it carries, including model, manufacturer, and class, must be fully consistent with the CE certificate, the ISO 13485 certificate, the declaration of conformity, and the draft labelling. The fiche signalétique is dated, signed, and stamped by the legal representative of the Moroccan establishment.

Two documents carry the substance of the technical side of the dossier: the fiche signalétique and the technical description. The fiche solves identification; the technical description answers Article 14’s demand that the authority be able to evaluate device performance and conformity with the essential requirements of Article 5. The two have different jobs, and neither can stand in for the other.

The scope of technical documents demanded by the current checklist is lighter than many teams expect. The AMMPS checklist states that a complete technical dossier is not required for imported devices, and what is usually required is the user manual, technical descriptions, colour photographs, and a colour product catalogue. That lightness rests on trust in the market access evidence of the country of origin, and where that evidence chain is weak, the authority can still ask for more.

2. Legal basis

Practical estimate: the status of the fiche signalétique as a mandatory document and its required scope come from the public positions of Arrêté n° 2855-15 and the current AMMPS checklist. The specific fields required are governed by the checklist in force.

3. Expert insights

Insight one: the fiche signalétique is the index page of the review. The competent authority and its advisory committee handle hundreds of dossiers, and the fiche shapes the impression a reviewer forms in the first few minutes. A fiche with muddled fields, or one that contradicts its attachments, steers the reviewer toward hunting for inconsistencies in the rest of the file. A clean, internally consistent fiche does the opposite: it sets a baseline of care that colours how the whole dossier is read.

Insight two: the technical description carries the substantive function of Article 14. Article 14 requires the technical dossier to enable the authority to evaluate the performance of the device and its conformity with the essential requirements of Article 5. The fiche signalétique solves identification; the technical description solves the explanation of performance. The two divide the work, and the fiche cannot substitute for the technical description no matter how carefully it is filled in.

Insight three: the range of technical documents required by the checklist is lighter than expected. The current AMMPS checklist states that a complete technical dossier is not required for imported devices, and what is usually required is the user manual, technical descriptions, colour photographs, and a colour product catalogue. This lightness is built on trust in the market access evidence of the country of origin. Where that evidence chain is thin, the competent authority can still request supplementation, so the light regime is an opportunity, not a licence for weak documents.

Insight four: the signature rules apply to the fiche signalétique as well. Article 3 of Arrêté n° 2855-15 covers all administrative documents, and the fiche is an administrative document, so it must be dated, signed, and stamped by the legal representative of the Moroccan establishment. A fiche signed and stamped by the manufacturer alone is not accepted. Teams should route the fiche through the establishment’s signature workflow like every other administrative document, with the same lead time reserved for it.

Insight five: colour photographs and the catalogue are not formalism. The checklist requires colour photographs and a colour product catalogue because, in the absence of a physical sample, they are the authority’s principal means of identifying the product’s form and configuration. Photographs should clearly show the complete device, the nameplate, and the key interfaces. Poor photography forces reviewers to reconstruct the product from text alone, which invites questions the file could have answered.

4. Practical recommendations

1. Make the fiche signalétique the single source of truth. Finalize the fiche first and derive the product information appearing on every other document from it, eliminating multi-source inconsistencies at the root rather than reconciling them later.
2. Build a field consistency matrix. Cross-check the manufacturer name, address, trade name, model, class, and UDI or batch number rules across the fiche signalétique, the CE certificate, the ISO certificate, the declaration of conformity, and the draft labelling, once, before filing.
3. Organize the technical description around performance. Following the purpose stated in Article 14, state the performance characteristics, conditions of use, and intended purpose clearly; design minutiae that do not serve those two purposes do not earn their page count.
4. Prepare colour photographs as a complete set per the checklist. Cover the overall view, a close-up of the nameplate, key interfaces, and accessories, and use high-resolution images throughout.
5. Reserve signature positions in advance. Leave space for the date, signature, and stamp on the final page of the fiche, so the document does not have to be unbound and re-signed after the volume is assembled.

5. Verification checklist

• □ Fiche signalétique completed in full according to the fields of the current checklist
• □ Manufacturer name and address on the fiche consistent with the CE and ISO certificates
• □ Trade name and model consistent with the draft labelling and the declaration of conformity
• □ Class indicated on the fiche consistent with the classification conclusion under Article 4
• □ Technical description organized around performance and intended purpose
• □ Colour photographs and colour product catalogue prepared as a complete set
• □ Fiche dated, signed, and stamped by the legal representative of the Moroccan establishment

GRZAN assists manufacturers preparing Moroccan registration dossiers with the fiche signalétique and technical description, including single-source field management, cross-document consistency matrices, photograph and catalogue sets prepared to checklist requirements, and signature workflow coordination with the Moroccan establishment. For support with registration documentation and conformity files for Morocco, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026