Inspections and Enforcement Procedures for Medical Devices in Morocco

1. Key takeaways

Article 38 of Law No. 84-12 authorizes duly commissioned and sworn officials to carry out periodic inspections of the manufacturing, import, export, distribution and maintenance establishments declared under Article 7 and Article 10. Article 39 prohibits officials with conflicting interests from acting as inspectors. Article 40 provides that when an inspection reveals infringements or anomalies, the competent authority issues a formal notice (mise en demeure) to the head of the establishment; if the situation is not remedied within the deadline, the case may be referred to the King’s Prosecutor (procureur du Roi) for judicial proceedings; where public health is endangered, the authority may ask the court to order the provisional closure of the establishment. The architecture is deliberately graduated: inspection, then correction, then prosecution, with closure reserved for the courts. Companies that understand each rung of this ladder can usually resolve findings long before they reach the prosecutor. Conversely, an establishment that treats the first inspection as an isolated event, rather than as the opening of a file that will be revisited, tends to accumulate findings that later justify harsher measures.

2. Legal basis

3. Expert insights

Insight 1: the first paragraph of Article 38 opens with “without prejudice to the provisions of Law No. 17-04”. This shows that inspection powers are cumulative across the two laws: the pharmacist-inspector regime under Law 17-04 runs in parallel with the commissioned inspectors under Law 84-12. In addition, Decree No. 2.18.878 (published in September 2021) governs the methods by which pharmacist inspectors conduct inspections; this citation is a practical estimate, as the bulletin issue number was not obtained in this verification. An establishment may therefore face inspectors from more than one legal basis. For preparation purposes this means the document set must satisfy the expectations of both regimes, and the practical estimate on the methods used by pharmacist inspectors should be confirmed directly with the authority or counsel before relying on it.

Insight 2: obstructing an inspection is an independent penalty ground. Article 43 lists “obstructing the inspection operations provided for in Article 38” among the punishable acts: Class I and Class IIA devices face fines of MAD 200,000 to 500,000, and Class IIB and Class III devices face 2% to 5% of turnover (floor of MAD 500,000). Refusing access to premises or delaying the production of documents can both be qualified as obstruction, which means conduct during the visit itself carries its own financial risk, separate from any underlying finding. Even a cooperative establishment can breach this clause accidentally if staff on the ground do not know who is authorized to release records and how quickly.

Insight 3: the Article 40 procedure is progressive. The sequence is: an infringement or anomaly is found → a formal notice is issued with a remediation deadline set according to the importance of the corrections required → the deadline (which may be extended) expires without remediation → referral to the King’s Prosecutor. The company has at least one opportunity to remedy on this chain, and the key is to take the formal notice seriously rather than treating it as routine correspondence. The deadline in the notice is set according to the importance of the required corrections, which means the authority has already formed a view of severity — and the remediation response should visibly match that view.

Insight 4: provisional closure is a judicial measure, not an administrative one. The third paragraph provides that where the anomalies or infringements found are liable to endanger public health, the competent authority requests the president of the competent court to order the closure of the establishment on the basis of the record of findings, pending the outcome of the substantive judicial proceedings. The involvement of a court shows how cautious the legislator was about closure powers — but also that the ultimate sanction on the table is existential for the business. Since the request is grounded in the record of findings, the quality of what is written into that record during the visit is directly relevant to whether the authority could ever credibly make such a request.

Insight 5: the recusal rule of Article 39 protects inspection independence. The provision prohibits designating as inspector any official who holds, directly or indirectly, an interest in such establishments capable of compromising his independence. This gives companies a documented basis to challenge an inspector’s qualification where a genuine conflict exists — to be raised through proper channels, not at the inspection door. The challenge should be factual and specific, since a baseless objection made in the heat of a visit would itself damage the establishment’s standing with the authority.

4. Practical recommendations

1. Treat inspections as a routine preparedness item. The establishment’s declaration dossier, good-practice records, traceability data, vigilance log and recall drill records should be retrievable at any time.
2. Designate inspection contacts. Define who receives the inspectors, who produces documents and who signs the record, to avoid confusion on the day. A short internal briefing held before any announced visit — covering the document pack, the contacts and the record of findings — costs little and prevents the accidental statements that later appear in enforcement files.
3. Start remediation the moment a formal notice arrives. Work backwards from the deadline set in the notice, and apply early for an extension where one is needed.
4. Keep remediation evidence complete. Submit evidence of the corrections to the competent authority once done, so the case never enters the judicial referral stage.
5. Challenge an inspector’s qualification where justified. If an interest-based conflict under Article 39 exists, raise it through the license-holding establishment by lawful means.

5. Verification checklist

• □ A compliance document pack, retrievable at any time, is in place at the establishment
• □ Inspection contacts and their responsibilities are defined
• □ Good-practice records (Article 11) are archived by category
• □ The vigilance log and recall drill records can be produced on demand
• □ A formal-notice response workflow exists, including the extension request path
• □ The mechanism for submitting remediation evidence is defined
• □ The penalty risk for obstructing inspections (Article 43) has been assessed

Regulatory information verified as of October 30, 2026

Post-market support from GRZAN. GRZAN supports medical device manufacturers and importers in the Moroccan market with post-market compliance, including inspection preparation and accompaniment, responses to formal notices, remediation evidence management, and enforcement-defense coordination. If you want your establishment inspection-ready before the inspectors arrive, or you are facing a mise en demeure, contact info@grzanglobal.com.