Pure Global's MENA MedTech Insights: The Hidden Technical File Trap for Class A Medical Devices in Dubai, UAE & Saudi Arabia

This episode of MENA MedTech Insights tackles a crucial question for manufacturers entering the UAE market: Is a full technical file needed to register a Class A medical device in Dubai? While the initial submission process seems straightforward, a common misunderstanding can lead to severe compliance issues and market access withdrawal. We explore the critical difference between what you must submit versus what you must have ready for regulators at all times.

Discover the real-world implications through the case of a surgical instrument company that faced a surprise audit from the UAE's Ministry of Health and Prevention (MOHAP). Their simple Declaration of Conformity put them on the market, but their failure to have a complete, audit-ready technical file on hand resulted in a suspended license and a damaged reputation. This story highlights the hidden risks of assuming low-risk device registration is just a paperwork exercise.

In this episode, you will learn:
- What does the UAE's MOHAP officially require for Class A device submissions?
- Why is a Declaration of Conformity much more than just a simple signature?
- What are the hidden risks if you don't have a complete technical file ready for an audit?
- How does the Saudi FDA's approach compare to Dubai's for low-risk devices?
- What specific documents must be audit-proof for your Class A device in the MENA region?
- Why is referencing EU regulations a critical strategy for successful UAE market access?
- What happens when a distributor, not the manufacturer, is asked for technical proof during an inspection?

At Pure Global, we specialize in navigating these complexities. We offer end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise in the UAE, Saudi Arabia, and across the MENA region with advanced AI tools to streamline your global market access. Don't let a documentation oversight put your business at risk. Contact us for a consultation at [email protected] or visit https://pureglobal.com/.