UAE MedTech Approval: Decoding the MOHAP Process
Medical Device Global Market Access · Pure Global
September 25, 20252m 40s
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Show Notes
This episode demystifies the medical device approval process in the United Arab Emirates. We explain the central role of the Ministry of Health and Prevention (MOHAP), the mandatory manufacturer registration, and how the formal risk-based classification system (Classes I-IV) dictates your entire path to market, from evidence requirements to review timelines.
Key Questions:
• Who is the single regulatory authority for medical devices in the UAE?
• What is the first step a manufacturer must take before submitting a product for approval?
• How does the UAE classify medical devices based on risk?
• Why is receiving a formal risk classification from MOHAP so critical for your submission strategy?
• What does your device's classification determine about your evidence and documentation requirements?
• How do international approvals like CE marking influence the UAE process?
• What is the typical validity period for a medical device registration certificate in the UAE?
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 [email protected] for tailored support.