Spare Parts Import Authorisation 2026: Form DE RD DM/10

1. Key takeaways

A decision of 3 July 2026 requires that imports of spare parts used for the maintenance of registered medical devices must obtain a separate import authorisation (Form DE RD DM/10), which may be applied for only by the Moroccan establishment holding the registration certificate for the device concerned, with an authorisation validity of 2 years. This ends the old practice under which spare parts travelled automatically with the main equipment, and it turns spare parts into a compliance item that must be planned independently — with its own form, its own applicant, and its own renewal calendar running on a different clock from the certificate itself.

2. Legal basis

Practical estimate: the restriction of the applicant to the certificate-holding establishment, the required documentation (manufacturer declaration, spare parts list, proforma invoice, sworn statement, and a copy of the registration certificate), and the 2-year validity come from public information published by the Moroccan competent authority. GRZAN marks these points as a practical estimate; before formal submission, the text of the decision should be checked with AMMPS or the certificate-holding establishment.

3. Expert insights

Insight 1: Spare parts no longer clear customs automatically with the main device. Previously, spare parts could be imported together with the equipment or in subsequent shipments; now a separate authorisation is required. This directly affects the logistics design of the after-sales system: the spare parts package in the first shipment and every subsequent spare parts consignment must travel under this authorisation. Companies that planned spares as incidental accessories of equipment shipments must rebuild their shipping calendar around the authorisation’s validity periods and coverage list, or risk detention of service-critical consignments.

Insight 2: The applicant is limited to the certificate-holding establishment; the manufacturer cannot apply itself. This mirrors the logic of Article 12, second paragraph: the spare parts authorisation attaches to the registration certificate, and only the certificate-holding establishment can apply. The Chinese manufacturer’s spare parts supply plan must therefore be bound to its Moroccan partner. Service commitments made to hospital customers ultimately depend on a document that the manufacturer cannot request in its own name, which makes the partner’s responsiveness on renewals a genuine service-continuity variable worth contracting for explicitly.

Insight 3: The requirement that the spare parts list match the registered device is the easiest point to fail. The authorisation documentation requires the spare parts list to be consistent with the spare parts of the registered device. This means manufacturers should incorporate the spare parts list into dossier planning at the registration stage; parts added afterwards may fall outside the scope of the authorisation. The practical consequence is that the registration dossier is not only about the device itself but also seeds the future after-sales chain, and any post-registration parts changes require reconciling the list before the next shipment.

Insight 4: The 2-year validity is not synchronised with the 5-year certificate cycle. The spare parts authorisation is valid for 2 years (practical estimate), while the registration certificate runs for 5 years. Within one certificate cycle the spare parts authorisation must be renewed at least twice, and the two calendars must be tracked separately. A single combined expiry log that treats certificate and spare parts authorisation as one item will systematically mislead service planning; GRZAN recommends dedicated entries with their own reminder dates and renewal owners.

Insight 5: The authorisation answers the continuity-of-maintenance duty of Article 10. Article 10, third paragraph, requires operators to guarantee the continuity of device maintenance under contract. The spare parts authorisation regime in effect provides the import channel that makes this duty feasible: with an authorisation, spare parts can be lawfully imported, and with spare parts, maintenance continuity can be sustained. The two regimes should be read together, and the maintenance contract’s term should be planned against the authorisation calendar rather than assumed to align with the certificate cycle.

4. Practical recommendations

1. Build the spare parts list into registration planning. Compile a complete spare parts list at the dossier stage so it can serve as the basis for the later spare parts authorisation.
2. Have the certificate-holding establishment lead the application. The Chinese manufacturer supplies the manufacturer declaration, spare parts list, and proforma invoice; the holder submits.
3. Keep a separate ledger for spare parts authorisations. Record the authorisation number, covered parts scope, issue date, and expiry date, with a 2-year expiry reminder.
4. Re-sequence after-sales logistics. Ensure that first-shipment spare parts packages and every later consignment fall within the authorisation’s validity and scope, checking each against the covered list.
5. Align with the maintenance contract. Match the term of the maintenance contract under Article 10 with the spare parts authorisation validity to avoid a situation of contract without parts.

5. Verification checklist

• □ Confirmed that spare parts imports require a separate authorisation (DE RD DM/10)
• □ The application has been made by the Moroccan establishment holding the device’s registration certificate
• □ The spare parts list has been reconciled with the spare parts of the registered device
• □ The manufacturer declaration, proforma invoice, sworn statement, and registration certificate copy are complete
• □ The authorisation validity (2 years) has been entered in the ledger with an expiry reminder
• □ The after-sales logistics plan has been re-sequenced against the authorisation scope and validity
• □ The spare parts authorisation has been aligned with the term of the Article 10 maintenance contract

Regulatory information verified as of 30 October 2026

GRZAN supports medical device manufacturers entering the Moroccan market with spare parts authorisation filings, after-sales logistics planning, maintenance contract alignment, and cost budgeting for registration and service obligations. For support on the requirements described above, contact info@grzanglobal.com.