Subcontracting and Delegation of Operations under Article 10

1. Key takeaways

Article 10 of Law No. 84-12 allows establishments declared under Article 7 to delegate, through subcontracting (sous-traitance), one or more operations in manufacture, export, distribution, or maintenance to another establishment, subject to three conditions: the arrangement must be based on a specification document (cahier des charges), it must comply with the good practices of Article 11, and the competent authority must be notified in the manner set by regulation. In addition, device operators must guarantee the continuity of device maintenance under a contract concluded with the manufacturer or a qualified maintenance establishment. Subcontracting is therefore lawful in Morocco, but only inside a defined compliance frame.

For a Chinese manufacturer, the significance of Article 10 is that it legitimises operational models that would otherwise be impossible: a Moroccan certificate-holding establishment can delegate manufacturing work back to the foreign factory, or route distribution and maintenance through specialised local operators. But the same provision also means that every delegation must leave a documentary trail — the cahier des charges, the notification receipt, and the qualification file of the delegate. A partnership that runs on informal arrangements, however smooth commercially, is invisible to the regulation and will be treated as unnotified delegation when examined.

2. Legal basis

3. Expert insights

Insight 1: Subcontracting is legalised, but notification is mandatory. The provision permits subcontracting while simultaneously requiring the head of the establishment to notify the competent authority in the manner prescribed by regulation. Unnotified subcontracting falls under Article 43, which punishes the delegation of one or more manufacture, distribution, or export operations to another establishment without notifying the authority under Article 10: for Class I and Class IIA devices, a fine of MAD 200,000 to MAD 500,000. The notification is not a courtesy step; it is a condition of legality, and its absence converts a permissible arrangement into a punishable one regardless of the subcontract’s technical quality.

Insight 2: Delegating to an unqualified establishment is a separate, distinct ground of liability. Article 43 separately lists the delegation of one or more manufacture, export, distribution, or maintenance operations to an unqualified domestic or foreign establishment. Note that the text expressly says domestic or foreign — offshore delegates are equally bound. If a Chinese manufacturer accepts subcontracted manufacturing work from a Moroccan establishment, its own qualifications will be evaluated within this framework. The reputational and financial exposure therefore travels across the border with the work, and qualification evidence should be exchanged before the subcontract is signed, not during an inspection.

Insight 3: Continuity of maintenance is an independent obligation of the operator. Article 10, third paragraph, requires device operators (exploitants) to guarantee the continuity of device maintenance under a contract concluded with the manufacturer or a qualified maintenance establishment; the list of devices subject to mandatory maintenance is set separately by regulation. Article 43 imposes penalties on operators that fail to ensure maintenance continuity. This means the maintenance obligation is not absorbed by the subcontracting arrangement — it stands alongside it and must be resourced explicitly, with a contracting counterparty capable of servicing the devices in Morocco.

Insight 4: The cahier des charges is the technical foundation of the subcontract. The provision requires subcontracting to be based on a specification document. This is not a simple commercial contract: it is the document that defines the scope of the delegated operations, the technical requirements, and the allocation of responsibilities, and it will be requested during inspections. Treating it as a purchase-order attachment is a mistake; GRZAN recommends drafting it as a controlled technical document with version history, because inspectors judge the compliance of the arrangement largely through this document.

Insight 5: Good practices propagate through the subcontract. Article 10 requires subcontracting to be carried out in compliance with the good practices of Article 11, and Article 11 binds both the establishments referred to in Article 7 and their delegates. Subcontracting does not sever the compliance chain: the delegate is bound by the same good-practice requirements covering manufacture, transport, storage, distribution, and performance evaluation. In contract terms, this means the good-practice obligations must be flowed down explicitly, with audit rights attached, so that the chain remains demonstrable end to end.

4. Practical recommendations

1. Complete the notification before work starts and retain the receipt. Notify the competent authority of the subcontracting arrangement in the prescribed manner and archive the acknowledgment in the compliance file.
2. Draft the cahier des charges as a technical document. Define the scope of operations, technical standards, quality responsibilities, and documentation deliverables, rather than relying on a purely commercial contract.
3. Verify the delegate’s qualifications. Whether the delegate is inside Morocco or abroad, evaluate its qualifications and keep the assessment on file to avoid the ground of delegation to an unqualified establishment.
4. Cover the mandatory maintenance list in the maintenance contract. Agree maintenance responsibilities with healthcare customers and guarantee continuity in line with the regulatory list.
5. Flow good-practice requirements into the subcontract. Transmit the Article 11 requirements for manufacture, transport, storage, distribution, and performance evaluation clause by clause to the delegate.

5. Verification checklist

• □ The subcontracting arrangement is based on a cahier des charges
• □ Notification has been made to the competent authority under Article 10 and the receipt retained
• □ The qualifications of the delegate, including any foreign delegate, have been assessed and archived
• □ The good-practice requirements of Article 11 are written into the subcontract
• □ The duty of maintenance continuity is expressly defined in the contract
• □ The list of devices subject to mandatory maintenance has been checked
• □ The penalty risks of unnotified subcontracting and delegation to unqualified establishments have been assessed

Regulatory information verified as of 30 October 2026

GRZAN supports medical device manufacturers entering the Moroccan market with subcontracting documentation, cahier des charges drafting, delegate qualification audits, and cost budgeting for registration and maintenance obligations. For support on the requirements described above, contact info@grzanglobal.com.