This episode of MedTech Global Insights delves into the specifics of the United Arab Emirates' medical device classification system, a critical hurdle for any company looking to enter this lucrative market. We explore the four-tiered, risk-based framework set by the UAE's Ministry of Health and Prevention (MOHAP) and uncover the hidden complexities that often surprise foreign manufacturers. We move beyond the basics to discuss the common pitfalls that can lead to costly delays and rejections. Learn why your existing CE or FDA approval is not a golden ticket and how local requirements, such as mandatory in-country representation and market-specific clinical data, can make or break your market entry strategy. **Case Study Spotlight:** Imagine your innovative Class C IVD, fully approved in Europe, faces unexpected registration delays in the UAE. Your submission is stalled because you lack a registered local Marketing Authorization Holder, a non-negotiable prerequisite from MOHAP. This common scenario can cost months of lost revenue and create significant regulatory hurdles that could have been easily prevented with proper local strategy. **What You'll Learn:** - Why is the UAE's device classification system more complex than it first appears? - How do the four risk classes for devices and IVDs directly impact your submission strategy? - What is the single most common administrative mistake that leads to application rejection in the UAE? - Why might your existing clinical data be deemed insufficient by MOHAP? - How does the requirement for a local representative affect your entire market access plan? - What are the key differences in documentation for a Class II versus a Class III device submission in the UAE? - How can you leverage your existing international approvals to streamline, but not replace, the UAE registration process? - What are the financial implications of underestimating MOHAP's regulatory requirements? For more information, contact us at [email protected] or visit https://pureglobal.com/