Algeria
Algeria is one of the main medical device markets in North Africa, with growing demand for healthcare products and a high percentage of imported devices.
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Regulatory Framework
The competent authority is the Direction de la Pharmacie et du Médicament (DPM) under the Ministry of Health, Population and Hospital Reform.
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 | Required for foreign manufacturers. |
| Certifications | CE, FDA, and ISO 13485 facilitate the process. |
Challenges and Operational Advice
- Complex procedures: Processes may be subject to bureaucratic delays.
- Regulated market: Continuous monitoring of regulatory updates is necessary.
Why Choose ISEMED
- North Africa Expertise
Support with registration and regulatory compliance. - Comprehensive Assistance
From dossier preparation to handling local procedures.
FAQ
- Is a local representative required? Yes.
- Documentation language? French or Arabic.
- License duration? 3 years.