Pharma & Medical Clearance
SFDA is the strictest regulator in the region — and OBOOR masters its rules
A Sector That Allows No Mistakes
The Saudi Food & Drug Authority (SFDA) is recognized as the strictest regulator in the MENA region. It became a full member of the International Council for Harmonisation (ICH) in 2021.
Importing medical products requires:
- SFDA establishment license
- Product registration (MDMA or eSDR)
- Authorized legal representative in the Kingdom
- Licensed medical warehouse
- GMP certificates from the manufacturer
Relevant Regulators
We deal with all of them on your behalf
Pharmaceuticals
Registered via the eSDR (Saudi Drug Registration) system — covers innovative drugs, generics, biologics, and veterinary drugs.
Medical Devices
Require an MDMA (Medical Device Marketing Authorization) certificate.
Medical Supplies
Some devices may be exempt from MDMA and require an MDIL (Medical Device Import License).
Mandatory Requirements
What every shipment needs
Product Types We Handle
Comprehensive sector experience
Human pharmaceuticals
Veterinary drugs
Medical devices
Medical supplies
Cosmetics
Lab & diagnostics
What We Provide
End-to-end solutions in one package
Frequently Asked Questions
What is the difference between MDMA and MDIL?
MDMA = Marketing Authorization — required for any medical device to be marketed in Saudi Arabia. MDIL = Import License — for devices exempt from registration (e.g., demo or training devices).
How long does MDMA take?
The process ranges from 3–12 months depending on the device class and risk level.
Do I need a legal representative?
Yes — mandatory. Any foreign manufacturer wanting to register a product with SFDA must have an authorized legal representative in the Kingdom.
Do pharma shipments require refrigeration?
Many drugs require specific temperatures (2–8°C for cold-chain, below -20°C for frozen).
How are drug registration fees calculated?
SFDA updated its fees in 2021, including fees on eSDR system templates. We clarify the exact cost during the consultation.
Your medical shipment deserves specialized expertise
Our team understands SFDA complexity and accelerates your procedures