Episode Details

This episode delves into the essential requirement for medical device manufacturers to appoint a Marketing Authorization Holder (MAH) or Local Authorized Representative to enter the United Arab Emirates market. We explore the role and responsibilities of this local partner as mandated by the Ministry of Health and Prevention (MOHAP), the strategic implications of choosing a distributor versus an independent representative, and the key functions they perform in device registration and post-market surveillance. • What is a Marketing Authorization Holder in the UAE? • Why is appointing a local representative mandatory for foreign medical device manufacturers? • What are the core responsibilities of a UAE-based authorized representative? • Should you appoint your distributor or an independent third party as your local agent? • How does this choice impact your long-term market strategy and flexibility? • What key documentation is managed by the local representative during registration with MOHAP? • How long is a typical medical device registration valid in the UAE? • What role does the representative play in post-market surveillance and vigilance? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.