In this episode of MENA MedTech Insights, we provide a deep dive into the Saudi Food and Drug Authority's (SFDA) Unique Device Identification (UDI) system. We explore the critical requirements of guidance MDS-G34, a non-negotiable for medical technology companies operating in Saudi Arabia, a key market in the Middle East. Understanding this framework is essential for ensuring device traceability, patient safety, and uninterrupted market access. We break down the core components of the SFDA UDI, from the structure of the UDI-DI and UDI-PI to the specific labeling rules and the mandatory registration process in the Saudi-DI database. This episode also clarifies the critical, risk-based compliance deadlines, highlighting the dates that have passed for higher-risk devices and the upcoming deadline for Class A devices. A European manufacturer, fully compliant with EU regulations, had its first major shipment to Saudi Arabia detained by customs for weeks. Their mistake. They had perfect UDI labels but failed to complete one crucial, country-specific step: registering the device information in the SFDA's database through their local representative. This oversight cost them revenue, time, and damaged a key business relationship from the very start. What You'll Learn: - What are the two key components of a UDI number under SFDA's MDS-G34 guidance? - Why is simply having a US FDA or EU MDR compliant UDI not enough for the Saudi market? - What is the mandatory first step before your UDI-labeled device can be legally placed on the Saudi market? - What was the critical compliance deadline for medium and high-risk medical devices? - What is the final upcoming UDI deadline for low-risk devices that all manufacturers must meet? - How does the SFDA require the UDI to be physically presented on device packaging? - What common oversight leads to shipments being detained at Saudi customs, even with correct labeling? Navigating the complexities of market access in the MENA region requires more than just global compliance; it demands specialized local knowledge. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise in Saudi Arabia with advanced AI tools to streamline market access. From acting as your official local representative to managing your Saudi-DI database submissions, we ensure your path to compliance is clear and efficient. Contact Pure Global at [email protected] or visit us at https://pureglobal.com/ to secure your market presence.