In this episode of MENA MedTech Insights, we explore the booming market for Continuous Glucose Monitoring (CGM) devices across the Middle East and North Africa. Driven by some of the world's highest diabetes rates, countries like Saudi Arabia and the UAE represent a massive opportunity for MedTech manufacturers, but also a significant regulatory challenge. We break down the specific requirements of key health authorities, including the Saudi Food and Drug Authority (SFDA) and the UAE's Ministry of Health and Prevention (MoHAP). Learn about the common pitfalls that can delay your market entry by months, if not years, and discover the strategies needed to succeed in this unique healthcare ecosystem. **Case Study In Focus:** A promising European CGM company entered the Saudi market with full EU certification, expecting a quick approval. They were instead met with a nine-month delay that cost them critical first-mover advantage and significant unplanned expenses. Their mistake? Underestimating the SFDA's stringent requirements for Arabic language localization and local clinical usability data, a detail their standard global dossier completely missed. **Key Takeaways From This Episode:** - Why is the MENA region considered the next major frontier for CGM device manufacturers? - What are the most common submission mistakes that lead to SFDA rejection in Saudi Arabia? - How does the UAE's regulatory pathway differ from Saudi Arabia's, and what does this mean for your go-to-market timeline? - Is your existing CE Mark or FDA approval sufficient for entry into the Gulf markets? - Why is a local authorized representative a non-negotiable asset for success in the UAE? - How is the market's shift from hospital to direct-to-consumer models changing regulatory strategy? - What specific documentation details does the SFDA scrutinize that other global agencies might overlook? - Can advanced AI tools genuinely accelerate your technical dossier preparation for MENA submissions? At Pure Global, we provide end-to-end regulatory consulting to help MedTech innovators navigate these complexities. We combine deep local expertise with advanced AI and data tools to streamline market access in over 30 countries, including Saudi Arabia and the UAE. Don't let regulatory hurdles block your growth. Contact us for a consultation at [email protected] or visit https://pureglobal.com/.