AMMPS Establishment Declaration Checklist 2026: Form DE RD-IS-PS/04

1. Key takeaways

The current AMMPS establishment declaration checklist is Form DE RD-IS-PS/04, applicable from 11 May 2026. This is the second checklist changeover within the agency’s transition period, following the ninth version of the registration checklist (Form DE ER DM/01, applicable from 30 January 2025). GRZAN treats the establishment declaration checklist and the registration checklist as two versions that must be tracked in parallel: the former determines whether an establishment can open and submit its declaration, while the latter determines whether a product dossier will be accepted. A mismatch on either list can stall a market-entry project independently of the other, which is why both belong on one controlled version log.

The practical consequence of a checklist changeover is rarely dramatic at the moment it happens, but it accumulates. Declarations filed under a superseded checklist remain valid on their face, yet any supplementary filing triggered by Article 9 must follow the current form. Projects that span a changeover date should therefore map every document already filed against the new list before the next submission, so that gaps surface while there is still time to correct them without delaying a shipment or a product registration.

2. Legal basis

Practical estimate: the form number and application date come from the checklist currently published by AMMPS. These are operational documents of the competent authority and may be superseded; the current version must be re-checked before any submission.

3. Expert insights

Insight 1: The two checklists change on unsynchronised rhythms, which is a source of risk. The ninth version of the registration checklist applies from 30 January 2025, while the establishment declaration checklist applies from 11 May 2026 — roughly 15 months apart. A company that tracks only one of the two can easily stumble on the other, precisely because the changeovers arrive at different moments of the same project timeline. GRZAN recommends managing both in parallel in the same version log, with an owner assigned to each, so that a single monitoring routine covers both change risks instead of assuming they move together.

Insight 2: The establishment declaration checklist governs who may submit at all, and it operates earlier than the registration checklist. Under Article 12, second paragraph, of Law No. 84-12, only establishments duly declared under Article 7 can obtain registration certificates. The establishment declaration checklist is the concrete expression of that threshold, and it takes effect before the registration checklist ever becomes relevant for a given product. In project terms: if the establishment file is rejected or incomplete under the current checklist, no amount of product dossier quality will move the project forward, because the applicant entity itself is not yet validly in the system.

Insight 3: Version changes usually bring finer-grained documentation requirements. The common direction of checklist revisions is more detailed documentation demands and stricter signing and formatting rules. GRZAN recommends that, once a new checklist applies, companies perform a retrospective review of establishment declaration files completed before the changeover, and assess whether a supplementary declaration is required under Article 9. This review should be documented, because it demonstrates diligence if the authority later questions the currency of an establishment’s file.

Insight 4: The wording of declared activities must match the checklist’s own vocabulary. Article 7 lists four activities: manufacture, import, export, and distribution. Checklists typically organise the declaration by activity type in separate columns, and the activity names used in the declaration must correspond to the checklist wording. Divergent phrasing may not block the initial submission, but it can create ambiguity in later queries and inspections, forcing clarifications that cost time. Copying the checklist’s exact terms into the declaration is a low-effort way to prevent this class of problem.

Insight 5: An establishment’s declaration status can be verified in the AMMPS register. AMMPS publishes a register of declared establishments, searchable by business activity. This is the most direct tool available to a Chinese manufacturer for vetting a candidate partner — it does not depend on the partner’s own statements. Checking the register before signing any cooperation agreement converts an unverifiable claim into documented fact, and the same check should be repeated before certificate transfer discussions begin.

4. Practical recommendations

1. Maintain a dual-checklist version log. Record the registration checklist (DE ER DM/01) and the establishment declaration checklist (DE RD-IS-PS/04) side by side, with form numbers, version identifiers, and application dates.
2. Retrospectively review files after a new checklist applies. For establishment declaration files completed before a changeover, assess under Article 9 whether a supplementary declaration is needed.
3. Vet candidates against the AMMPS register. Verify activity type line by line and confirm coverage of the import or manufacturing activity the project requires.
4. Align activity wording with the checklist. Ensure that the activity expressions used in declaration files match the checklist’s column terminology exactly.
5. Write the checklist version into cooperation agreements. Specify which checklist version governs the declaration, and allocate responsibility and costs when a version changes mid-project.

5. Verification checklist

• □ The current AMMPS establishment declaration checklist (DE RD-IS-PS/04) has been obtained
• □ The application date (11 May 2026) has been recorded and a changeover review scheduled
• □ The registration checklist and the establishment declaration checklist are managed in one parallel version log
• □ Declaration files completed before the changeover have been retrospectively reviewed
• □ The candidate establishment has been verified against the AMMPS register by activity type
• □ The activity wording in declaration files matches the checklist terminology
• □ The cooperation agreement specifies the checklist version and cost allocation on changeover

Regulatory information verified as of 30 October 2026

GRZAN supports medical device manufacturers entering the Moroccan market with checklist version management, establishment declaration files, partner verification against the AMMPS register, and cost budgeting for registration and maintenance obligations. For support on the requirements described above, contact info@grzanglobal.com.