Lebanon
Lebanon is a key market in the Middle East for the distribution of medical devices. Despite political instability, it remains relevant due to its advanced healthcare facilities and the presence of international operators.
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Regulatory Framework
The competent authority is the Ministry of Public Health (MOPH).
Device Classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation in English, French, or Arabic. |
| Local Representative | Required for foreign manufacturers. |
| Certifications | CE, FDA, and ISO 13485 facilitate the approval process. |
Challenges and Operational Advice
- Political scenario: Political instability may cause delays in processes.
- Local partners: It is essential to rely on experienced distributors.
Why Choose ISEMED
- Middle East Experience
Support in dealings with local authorities. - Tailored Assistance
Complete management of registration and selection of commercial partners.
FAQ
- Is a local representative required? Yes.
- Documentation language? English, French, or Arabic.
- License duration? 5 years.