Quick Answer
Medical products entering Saudi Arabia are regulated by the Saudi Food and Drug Authority (SFDA), with medical devices going through the SALEEM program for registration and conformity. SASO/SABER may also apply to certain products. Registration can take time and must be planned before importing.
Saudi Medical Import Requirements
- SFDA regulates medical devices, drugs, and health products
- Medical devices use the SALEEM registration program
- SASO/SABER conformity for certain product categories
- Plan registration well ahead — timelines can be long
SFDA/SALEEM is the core requirement for medical devices. See our importing to Saudi Arabia guide and SASO.
Key Takeaways
- SFDA regulates medical products in Saudi Arabia.
- Devices use the SALEEM program.
- SASO/SABER may also apply.
- Plan registration well ahead.
Frequently Asked Questions
Who regulates medical products in Saudi Arabia?
The Saudi Food and Drug Authority (SFDA) regulates medical devices, drugs, and health products, with medical devices going through the SALEEM registration and conformity program.
What is the SALEEM program?
SALEEM is the SFDA's medical device regulatory program covering registration and conformity for devices entering Saudi Arabia. Devices must be registered through it.
Does SASO apply to medical products?
SASO/SABER conformity applies to many product categories; medical devices are primarily handled through SFDA/SALEEM. Confirm which apply to your specific product.
How long does SFDA registration take?
Medical device registration through SFDA/SALEEM can take significant time depending on device class, so it must be planned well before importing.
Can Plutonia help with Saudi medical imports?
Yes. Plutonia advises on SFDA/SALEEM and SASO requirements and works with local regulatory consultants for medical imports. Submit your product details to start.