UAE Medical Device Registration – MOHAP & EDE

A European orthopedic implant manufacturer engaged LIS Consulting to support its expansion into the UAE market and navigate the country’s multi-authority regulatory framework. Challenge: Securing registrations across MOHAP & EDE, appointing a local authorised representative, and managing differing documentation, portal, and compliance requirements. Our Approach: LIS Consulting defined the optimal market access strategy, supported the appointment of a UAE authorised representative, prepared and submitted registration dossiers, managed authority queries, and coordinated registration timelines. Outcome: Full market access was achieved across MOHAP & EDE, enabling nationwide distribution and establishing a sustainable framework for future product registrations and renewals.