This week on MENA MedTech Insights, we dissect the groundbreaking new regulatory framework for Digital Therapeutics (DTx) just launched by the UAE's Ministry of Health and Prevention (MOHAP). This policy creates a dedicated, clear approval pathway for software-based treatments, ending the uncertainty that previously stalled market access for this innovative class of MedTech.

This episode is essential for any digital health innovator targeting the Gulf. We analyze the specific requirements of the new framework, from clinical evidence standards to the critical cybersecurity and data privacy mandates. We also explore the commercial implications, including the major hurdle of securing reimbursement and the strategic advantage this gives the UAE in attracting global DTx investment.

**Key Takeaways:**

1. How does the UAE's new framework classify different types of Digital Therapeutics?

2. What level of clinical evidence is MOHAP now requiring for DTx registration?

3. Are international clinical studies accepted, or is local data a mandatory requirement?

4. What are the new data residency and privacy rules for DTx apps in the UAE?

5. How can companies navigate the yet-to-be-defined reimbursement landscape with local insurers?

6. What is the most critical difference between the UAE's DTx framework and Europe's MDR for software?

7. Which therapeutic areas, such as mental health or chronic disease, are being prioritized by MOHAP for these new DTx solutions?

Navigating these shifts requires specialized expertise. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies, combining local knowledge with AI-driven tools to streamline your market access. Whether you're a startup or a multinational, we build the most efficient pathway for your innovation. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.