The AMMPS Medical Device Registration Checklist Version 9 in Morocco
Updated: 2026-11-12 · GRZAN Regulatory Team · Verification date 2026-10-20
1. Key takeaways
In Morocco, what decides whether a dossier is accepted is often not the statute itself but the version number of the working checklist. The current AMMPS checklist for medical device registration is form DE ER DM/01, currently at version 9, applicable from 30 January 2025. The declaration checklist for establishments is form DE RD-IS-PS/04, applicable from 11 May 2026. GRZAN treats checklist version verification as the first mandatory gate before any submission: if the dossier template does not match the current version, rework starts in the very first round.
The reason this gate matters is structural. The law assigns rights and obligations, the decree assigns time limits and validity periods, the order assigns the tiering of documents, and the checklist assigns formats, quantities, and signature arrangements. The reception desk compares the file against the checklist line by line, and a single missing signature identified on the checklist can send the whole dossier back. Understanding this hierarchy of effect explains why version verification is not clerical housekeeping but a genuine risk control.
The practical estimate that GRZAN applies is simple: every submission package must be prepared against a checklist whose form number, version, and applicable date have been re-confirmed on the day of preparation. Checklist versions are working documents of the authority, not legislative texts, and they can change without a lengthy legislative process, so the version used last year is never a safe assumption for this year.
2. Legal basis
| Instrument | Reference / number | Publication date | Provisions |
|---|---|---|---|
| Medical Devices Law (Loi n° 84-12) | Dahir n° 1-13-90 | 30 August 2013 | Article 14 (dossier content determined by regulation according to class) |
| Order on the Registration and Marketing of Medical Devices | Arrêté n° 2855-15 | 4 August 2015 | Dossier tiering and procedure |
| AMMPS registration checklist | Form DE ER DM/01, version 9 | Applicable from 30 January 2025 | Item-by-item documentary requirements |
| AMMPS establishment declaration checklist | Form DE RD-IS-PS/04 | Applicable from 11 May 2026 | Item-by-item declaration requirements |
Practical estimate: the form numbers, versions, and applicable dates above come from the checklists currently published by AMMPS. These are working documents of the authority rather than legislative texts and may be replaced at any time. GRZAN labels them as a practical estimate, and they must be re-verified before submission.
3. Expert insights
Insight one: the checklist is not a regulation, yet it bites harder than one. The statute gives rights and obligations, the decree gives time limits and validity periods, the order gives the tiering of documents, and the checklist gives formats, numbers of copies, and signature arrangements. The reception window compares the file against the checklist item by item, and one missing signature identified through the checklist is enough for the dossier to be returned. Teams that understand this hierarchy of effect know why version verification matters more than almost any other preliminary step.
Insight two: the two version numbers are the direct product of an institutional transition. The checklists of the DMP era and the checklists of the AMMPS era use different numbering systems. Version 9 of the registration checklist, applicable from 30 January 2025, and the establishment declaration checklist, applicable from 11 May 2026, are both products of re-publication after that transition. A company still working from a template inherited from the pre-transition period will almost certainly find that it no longer matches the current requirements.
Insight three: the checklist requires document-by-document signature, not a single stamp on the whole volume. The requirements verified by GRZAN state that every administrative document must individually carry a date, a signature, and the official stamp, and that a single seal applied across the bound volume is not accepted. This rule even affects the physical binding of the dossier: signature positions must be reserved page by page as the file is assembled, which is far easier to do during preparation than to fix after the volume has been bound.
Insight four: the checklist also records the current state of the submission channel. Device dossiers are currently still prepared using AMMPS offline software and submitted on physical media such as optical discs. The Tarkhiss online platform launched in March 2026 currently covers cosmetics rather than medical devices. This item is a practical estimate, and the channel actually in force must be confirmed with the licensed establishment immediately before submission.
Insight five: version errors are a low-level but high-frequency cause of failure. Compared with a technical challenge to the substance of the evidence, a wrong checklist version is a particularly painful way to lose a round. The failure occurs in the first review cycle, it consumes the entire waiting period, and it was entirely avoidable through one verification step that costs minutes to perform.
4. Practical recommendations
- Maintain a checklist version register. Record the form number, version, applicable date, date of retrieval, and source link for every checklist, and re-review the register before each submission. A register turns a one-off memory task into a repeatable control.
- Write the checklist version into cooperation agreements. Agree with the licensed establishment on which version of the checklist the dossier will be prepared against, and settle in advance how responsibility and costs are shared if the version changes mid-project.
- Reserve signature positions document by document. When binding the dossier, reserve space for the date, signature, and stamp on every administrative document, exactly as the checklist requires, instead of relying on a single volume-level seal.
- Run a reverse verification from checklist to dossier before submission. Walk the checklist item by item and locate the matching document in the dossier, rather than scanning the dossier and hoping nothing on the checklist was missed. The reverse direction catches gaps that the forward direction hides.
- Set a re-verification trigger for version changes. The moment AMMPS publishes a new checklist version, freeze any dossier in preparation and re-compare it against the new version before proceeding.
5. Verification checklist
- □ Current AMMPS registration checklist (DE ER DM/01) obtained together with its version number
- □ Applicable date of the registration checklist recorded (currently 30 January 2025)
- □ Establishment declaration checklist (DE RD-IS-PS/04) obtained together with its applicable date (11 May 2026)
- □ Dossier template compared item by item against the checklist currently in force
- □ Date, signature, and stamp positions reserved separately for every administrative document
- □ Current submission channel (offline software or online platform) confirmed with the licensed establishment
- □ Checklist version register established with a re-verification trigger for new versions
GRZAN helps manufacturers and licensed establishments keep Moroccan registration submissions aligned with the checklist versions currently in force. Our team maintains version registers, runs checklist-to-dossier reverse verifications, coordinates signature and stamping workflows, and confirms the applicable submission channel before every filing. For support with registration documentation and conformity files for the Moroccan market, contact GRZAN at info@grzanglobal.com.
Regulatory information verified as of 30 October 2026
Disclaimer
Prepared by GRZAN from publicly available regulation. It is provided for general information only and does not constitute legal advice. Legislation and official fees are subject to change by the competent authority.
About GRZAN
GRZAN (Global Regulatory Zone Access Navigator) — the global market-access navigator for medical devices and IVDs.
GRZAN is a specialist consultancy for medical device and IVD market access, providing end-to-end regulatory solutions across the product lifecycle and making international market entry simpler and faster.
Key figures. More than 25 wholly owned subsidiaries worldwide covering 50+ countries and regions; chosen by 100+ listed and leading Chinese device manufacturers, with 4,000+ successful cases; 12+ years in the sector and 200+ regulatory training sessions and seminars delivered.
What we do. Global market access: multi-country registration programmes, technical documentation, regulatory advice. Clinical evidence: clinical evaluation reports (CER), usability studies, overseas clinical investigations. Quality systems: ISO 13485, MDSAP, FDA QMSR and BGMP implementation and audit readiness. Authorised representative and licence-holder services across Southeast Asia, Latin America, the Middle East, Africa, Europe and North America.
Why GRZAN. A real operating entity, with the certificate held by the manufacturer: our direct overseas subsidiaries act as the compliant local holder, so the regulatory relationship stays clear and you keep control rather than being tied to a distributor. Direct access to the team: no time-zone gap, no language barrier, no cultural gap. Review points anticipated: we know what FDA 510(k), EU MDR, Southeast Asian, Latin American and Middle Eastern reviewers look for, which shortens timelines and reduces deficiency letters. Pathway planning: pre-decision analysis and risk assessment before you commit.
Every engagement rests on three commitments: efficiency through pre-submission review, certainty through a clear pathway, and stability through a licence-holder that stays in place.
Take your devices global with GRZAN
We work with manufacturers worldwide to open new markets with a clear regulatory pathway.
Contact us