United Arab Emirates
The United Arab Emirates is a strategic hub for the healthcare sector in the Middle East, with growing demand for high-quality medical devices, also driven by the expansion of medical tourism.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authorities are the Ministry of Health and Prevention (MOHAP) and the Dubai Health Authority (DHA) for the Emirate of Dubai.
Device Classification:
- Class I: Low risk
- Class II, III: Moderate risk
- Class IV: High risk
Specific Local Requirements
| Language | Documentation in English or Arabic. |
| Local Representative | Mandatory for foreign manufacturers. |
| Certifications | ISO 13485. CE Certificate, FDA, and Certificate of Free Sale facilitate the process. |
Challenges and Operational Advice
- Bureaucratic process: Potential delays; it is essential to monitor application status.
- Market access: Identifying qualified partners/distributors is key.
Why Choose ISEMED
- GCC Expertise
Specialized support for registrations in Gulf countries. - End-to-End Assistance
Full management from document submission to communication with authorities.
FAQ
- Is a local representative required? Yes.
- Documentation language? English or Arabic.
- License duration? 5 years.