Pure Global's Guide to UAE MOHAP Approval: Navigating the Authorized Representative Requirement for MedTech Market Access

MENA MedTech Insights

The UAE's MedTech market is booming, but a key MOHAP regulation can stop foreign companies in their tracks: the requirement of a local Authorized Representative. Many manufacturers default to appointing their distributor, a decision that can lead to significant business risks and loss of market control. This episode explores the strategic importance of separating your regulatory and commercial functions. We uncover the hidden dangers of tying your device registration to a distributor and lay out the benefits of using an independent Authorized Representative. Learn how to maintain control over your assets, ensure long-term compliance, and build a flexible, resilient market strategy for the UAE and beyond. Imagine this: Your company’s innovative surgical device is gaining traction in the UAE, but your relationship with your distributor, who is also your Authorized Representative, has soured. When you decide to terminate the commercial agreement, you discover they refuse to transfer the product registration. Your market access is now completely blocked, and you face a lengthy and expensive re-registration process with a new partner, all while your competitors seize the opportunity. Key Takeaways: * What are the three core responsibilities of an Authorized Representative under UAE MOHAP? * Why is appointing your distributor as your AR considered a high-risk strategy? * How does an independent AR give you more commercial flexibility in the market? * What happens to your device registration if your distributor-AR partnership ends abruptly? * What are the key differences between a commercial agent and a regulatory representative? * How can you vet a potential Authorized Representative to ensure they are qualified? * What specific steps are involved in transferring a registration from a distributor to an independent AR? At Pure Global, we provide professional, independent Authorized Representative services in the UAE and over 30 markets worldwide. We act as your local regulatory partner, managing the entire product lifecycle while you retain full control of your commercial strategy. Our end-to-end solutions, powered by local expertise and advanced AI tools, streamline your global market access. Contact us at [email protected] or visit https://pureglobal.com/ to secure your market presence.