Morocco
Morocco is an emerging market for medical devices, with growing demand for healthcare products and government investments aimed at modernizing the healthcare sector.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The regulatory authority is the Direction du Médicament et de la Pharmacie (DMP) under the Ministry of Health.
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in French and/or Arabic. |
| Local Representative | Required for foreign manufacturers. |
| Certifications | Compliance with ISO 13485 and Moroccan requirements. CE and FDA certifications facilitate the process. |
Challenges and Operational Advice
- Bureaucratic process: Potential delays due to administrative complexity.
- Language barriers: It is essential to submit accurate documentation in French and/or Arabic.
Why Choose ISEMED
- Local Expertise
Experience with Moroccan authorities. - Tailored Assistance
Support in preparing dossiers and managing local communications.
FAQ
- Is a local representative required? Yes.
- Documentation language? French and/or Arabic
- License duration? 5 years