Tunisia
Tunisia is a strategic market for medical devices, with a growing economy and increasing demand for advanced healthcare equipment.
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Regulatory Framework
The regulatory authority is the Direction de la Pharmacie et du Médicament (DPM), responsible for the registration and oversight of medical devices.
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in French or Arabic. |
| Local Representative | Mandatory for non-Tunisian companies. |
| Certifications | Compliance with ISO standards and local regulations is required. |
Challenges and Operational Advice
- Flexible timelines: The process may exceed 12 months for high-risk devices.
- Regulatory updates: DPM regularly updates registration requirements.
- Language barriers: Documentation must meet local language requirements.
Why Choose ISEMED
- Local Experience
Support with registration through DPM. - Comprehensive Assistance
Full regulatory process management to reduce waiting times. - Local Partners
Collaboration with Tunisian entities to streamline the process.
FAQ
- Is a local representative required? Yes.
- Documentation language? French or Arabic.
- License duration? Varies depending on the device class.