Saudi Arabia's Vision 2030 has created a surge of opportunity for digital health and AI-driven medical devices. However, the Saudi Food and Drug Authority (SFDA) maintains one of the region's most rigorous regulatory frameworks. This episode provides a detailed walkthrough of the SFDA's requirements for Software as a Medical Device (SaMD) and AI-based technologies, focusing on the practical challenges and strategic steps manufacturers must take to gain market access. We break down the critical guidance document MDS-G010, explaining the risk-based classification system, the extensive technical documentation needed, and why your existing clinical data from other markets might not be enough. We also explore the non-negotiable role of a local Authorized Representative and the common pitfalls that can lead to costly delays. This is an essential guide for any MedTech company looking to enter the lucrative Saudi market. A compelling case involves a US-based company with a groundbreaking AI algorithm for early disease detection. Despite having FDA clearance, they faced unexpected delays in Saudi Arabia. The SFDA questioned the validity of their training data for the local population, forcing them into a lengthy and expensive local clinical validation study they hadn't budgeted for. This episode explores how to anticipate and avoid such pitfalls. What You'll Learn: * What is the SFDA's key guidance document for AI and machine learning devices? * How does the SFDA classify Software as a Medical Device based on risk? * What are the critical components the SFDA expects in your technical dossier for an AI model? * Why might your existing clinical data from the US or Europe be insufficient for the Saudi market? * What are the specific cybersecurity and data privacy expectations for SaMD in Saudi Arabia? * Why is appointing a local Authorized Representative a non-negotiable first step for registration? * What is the most common mistake that leads to SFDA application delays for foreign SaMD manufacturers? * How can you prepare your Quality Management System for SFDA compliance? Navigating the SFDA's evolving digital health landscape requires specialized expertise. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies, combining local experts in Saudi Arabia with advanced AI tools to streamline your market access. Don't let regulatory hurdles block your entry into one of the most promising MedTech markets. Contact us for a consultation at [email protected] or visit our website at https://pureglobal.com/ to learn how we can be your partner in the MENA region.