This episode of MENA MedTech Insights dives into the critical regulatory nuances for medical device companies expanding into the MENA region, particularly those with existing EU supply chains and approvals. We uncover why a CE mark is only the beginning of the journey and explore the growing divergence between EU standards, like EUDAMED, and the specific requirements of key markets like Saudi Arabia and the UAE. We break down the common assumption that EU compliance guarantees smooth entry into the Gulf. Learn how local data requirements, mandatory labeling laws, and the crucial choice of an in-country representative can make or break your market access strategy. This is essential listening for any regulatory affairs professional or business leader looking to capture the immense opportunity in the region without falling into common regulatory traps. A European MedTech firm secured a major distribution deal for their innovative cardiovascular stent in the Gulf, contingent on a 6-month launch timeline. They submitted their CE-marked technical file to the Saudi authorities, assuming a quick approval. However, their launch was halted for over a year because their EUDAMED-formatted UDI data was incompatible with the Saudi UDI system, and their chosen distributor lacked the regulatory expertise to resolve the issue, jeopardizing the entire commercial partnership. Key Takeaways: • Is your CE mark still a golden ticket for market access in Saudi Arabia and the UAE? • How can you leverage your EUDAMED preparation for faster entry into MENA markets instead of seeing it rejected? • What are the hidden risks of appointing a commercial distributor as your sole legal representative? • Are your labeling and technical documents truly compliant with local Arabization and data requirements? • How is the rise of national UDI databases in the Gulf impacting your global supply chain? • What steps should you take today to future-proof your regulatory strategy for the entire MENA region? At Pure Global, we specialize in turning these complex regulatory challenges into streamlined market access. Our integrated approach allows you to use a single, efficient process to enter multiple global markets, including the EU and key MENA countries. With local experts on the ground in over 30 markets, we manage everything from regulatory strategy and dossier submission to acting as your independent legal representative. Don’t let regulatory hurdles slow your growth. Contact us at [email protected] or visit https://pureglobal.com to learn how we can accelerate your global expansion.