The Saudi Food and Drug Authority (SFDA) was established by a Royal Decree in 2003 (1424H) under the Council of Ministers’ Resolution No. 1, dated 07/01/1424H (March 8, 2003).

🔹 It was established as an independent body reporting directly to the Council of Ministers.
🔹 The main goal was to ensure the safety, efficacy, and quality of food, drugs, and medical devices in the Kingdom of Saudi Arabia.

Saudi Food and Drug Authority (SFDA) Objectives,

• Setting and enforcing standards for food, drugs, medical devices, cosmetics, and tobacco products
• Licensing and auditing establishments and manufacturers
• Ensuring public health and safety in KSA through science-based regulatory practices

At Medical Regulation Gate (MRG), we proudly serve as your dedicated partner in navigating the complex and ever-evolving regulatory framework governed by the Saudi Food and Drug Authority (SFDA). With unmatched expertise across medical devices, pharmaceuticals, cosmetics, and non-medical imports, our services are tailored to ensure full compliance with SFDA requirements at every stage — from product classification, licensing, and registration to post-market surveillance, advertising approvals, and strategic market access. Whether you’re entering the Saudi market for the first time or managing a robust product portfolio, MRG empowers you with intelligent regulatory solutions that uphold safety, efficiency, and market success — always in alignment with the regulatory excellence of the Saudi Food and Drug Authority (SFDA).