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UAE MedTech Approval: Decoding the MOHAP Process
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?…
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