Navigate SFDA Regulations
with Confidence

The SFDA regulates all food products, drugs (prescription and over-the-counter), medical devices (Class I through Class III), cosmetics, pesticides, and animal feed entering or manufactured in Saudi Arabia. Any company selling these products in the Kingdom must obtain SFDA approval before market entry.

Registration timelines vary by product category. Food products typically take 30-90 days for standard registration. Medical devices range from 90 days for Class I to 6-12 months for Class III devices. Pharmaceutical registration can take 12-18 months including clinical review. Our reports provide detailed timelines and strategies to avoid common delays.

Yes, for medical devices, an Authorized Representative (AR) based in Saudi Arabia is mandatory. The AR acts as the legal point of contact between your company and the SFDA. For food products, you need a local importer with a valid SFDA establishment license. Our reports include vetted AR and importer contacts for each category.

Rasad is the SFDA's track-and-trace system for pharmaceutical products. It requires all drugs sold in Saudi Arabia to carry unique serialization codes that enable end-to-end supply chain tracking from manufacturer to patient. Compliance with Rasad is mandatory and non-negotiable for pharmaceutical market entry.

LinkSaudi provides comprehensive market intelligence reports that cover SFDA regulatory requirements, step-by-step registration roadmaps, and verified local partner contacts. Each report includes a regulatory compliance checklist, common pitfalls to avoid, and 25+ pre-vetted distributor contacts. You also get 30 days of expert support to help interpret the data and plan your market entry.