UAE MedTech Market Entry: A Guide to Timelines and Costs
Medical Device Global Market Access · Pure Global
September 23, 20252m 44s
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Show Notes
This episode provides a detailed breakdown of the timelines and costs associated with registering a medical device in the United Arab Emirates. We explore the two main regulatory pathways, the specific government fees in AED, and the often-overlooked indirect costs like translation and notarization that manufacturers must budget for. We also break down the review timelines based on MOHAP’s risk classification system.
Key Questions:
• What is the first step for any manufacturer entering the UAE market?
• How does the device risk class affect the MOHAP review timeline?
• What are the specific government fees in Emirati Dirhams for device registration?
• Are there different regulatory pathways for professional-use versus home-use devices?
• What are the "hidden costs" that can impact your budget?
• How long is a medical device registration certificate valid for in the UAE?
• Who is the primary regulatory authority for medical devices 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.