In this episode of MENA MedTech Insights, we dissect the UAE's transformative Cabinet Decision No. 58 of 2022. This new regulation is a critical hurdle for any MedTech or IVD company looking to enter or remain in this key Middle Eastern market. We provide a clear, actionable breakdown of the most significant changes you need to be aware of. We explore the three core pillars of the new legislation: the mandatory implementation of the Unique Device Identification (UDI) system, the heightened requirements for proactive Post-Market Surveillance (PMS), and the expanded legal responsibilities of the in-country Authorized Representative. We go beyond the theory to discuss the real-world operational impact these changes have on manufacturers, from labeling and data submission to clinical data collection. A European manufacturer with a CE-marked device thought entering the UAE would be straightforward. They were wrong. The new UDI requirements and stringent post-market surveillance rules under Cabinet Decision No. 58 created unexpected six-month delays and significant costs when their technical file was rejected for non-compliance. Find out how you can avoid their critical mistakes and streamline your path to market. **In this Episode:** * How does the UAE's new UDI system differ from the EU and US models, and what does it mean for your labeling process? * What are the three most common mistakes companies make when updating their Post-Market Surveillance plans for the UAE? * Is your current Authorized Representative truly compliant with the stricter legal liabilities under Decision 58? * Why might your existing CE-marked technical file be rejected by the UAE authorities? * What are the specific upcoming deadlines you absolutely cannot miss for UDI implementation? * How can you leverage the new regulation to gain a competitive advantage in the MENA region? At Pure Global, we transform these regulatory hurdles into market opportunities. Our end-to-end solutions combine local UAE expertise with advanced AI tools to streamline your market access. Don't let regulatory complexity slow your growth. Contact us at [email protected] or visit https://pureglobal.com/ to learn how we can accelerate your entry into the UAE market.