Saudi Arabia
Saudi Arabia is the largest medical device market in the Middle East region, supported by substantial government investments in the healthcare sector.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Saudi Food and Drug Authority (SFDA).
Device Classification:
- Class A: Low risk
- Class B: Moderate risk
- Class C: High risk
- Class D: Very high risk
Specific Local Requirements
| Language | Documentation in English or Arabic. |
| Local Representative (Authorized Representative - AR) | Required for foreign manufacturers. |
| Certifications | ISO 13485. CE Certificate, FDA, and Certificate of Free Sale facilitate the process. |
Challenges and Operational Advice
- Strict regulations: SFDA enforces tight controls on all medical devices.
- Bureaucratic process: The registration process may be subject to administrative delays.
Why Choose ISEMED
- GCC Experience
Full support for registration in Saudi Arabia. - Online Management
Assistance with the GHAD system for registration.
FAQ
- Is a local representative required? Yes, AR.
- Documentation language? English or Arabic.
- License duration? For Class I devices, the MDMA registration is valid for 3 years. For higher-risk devices, the validity matches the approval certificate from the country of origin (IMDRF member), or 3 years if the original certificate has no expiry date.