This video explains SFDA’s medical device regulations, the role of an Authorized Representative (AR), and the steps foreign manufacturers must take to gain market access. Learn how Pure Global streamlines compliance and helps you scale across the Middle East.
This video gives medical device manufacturers a clear roadmap for entering Saudi Arabia, he largest medical-device market in the Middle East. With a population of more than 35 million, universal healthcare coverage, and an ambitious Vision 2030 agenda, the Kingdom is investing heavily in advanced technologies to transform its healthcare system. The market is currently valued at USD 2.11 billion (2023) and is expected to grow at 6% CAGR through 2032, making Saudi Arabia a priority launch destination for global innovators.
Topics covered in this video include:
Regulatory oversight is managed by the Saudi Food and Drug Authority (SFDA), which enforces strict, risk-based rules to ensure safety and effectiveness. Devices are classified into Classes A, B, and C, with higher-risk products subject to more stringent scrutiny and documentation. For foreign manufacturers, understanding these classifications and preparing compliant technical files are essential first steps toward successful market entry.
Need help with SFDA approval?
Pure Global simplifies the regulatory journey with AI-enabled workflows, local subsidiaries, and in-house experts who specialize in SFDA requirements. From device classification and technical documentation to AR services and post-market surveillance, our process reduces risk and accelerates compliance. With one engagement, we can help you expand not only in Saudi Arabia but also across the wider Middle East, aligning your regulatory strategy with your global growth ambitions. Learn more about SFDA Saudi Arabia Medical Device Registration.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us