The United Arab Emirates (UAE) stands as a lucrative and strategic hub for the MedTech industry in the Middle East. However, accessing this market requires navigating a complex regulatory framework managed by the Ministry of Health and Prevention (MOHAP). This episode breaks down the essential steps for successful market entry.

From appointing a mandatory local representative to understanding the nuances of the device classification system and compiling a perfect technical dossier, we provide a clear roadmap for foreign manufacturers. Learn how to leverage your existing international approvals and avoid common pitfalls that can lead to costly delays.

Consider the case of a US-based diagnostics company with an FDA-approved device. They attempted to enter the UAE market independently, underestimating the importance of the local representative's role. Their application was stalled for months because their chosen partner lacked the proper licenses and experience in handling MOHAP's specific queries, jeopardizing their entire regional launch strategy.

Key questions answered in this episode:

* Why is appointing a licensed UAE Local Representative the first and most critical step?

* What are the four risk-based device classes in the UAE, and how do they affect your registration pathway?

* How can your existing CE marking or FDA approval accelerate your UAE submission, and what are its limitations?

* What are the most common documentation errors that lead to rejection by MOHAP?

* What is the typical timeline for device registration, and what factors can cause significant delays?

* How can AI and data tools streamline the creation and management of your technical dossier?

* What post-market surveillance activities are required to maintain your product's registration in the UAE?

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