『Pure Global's Expert Guide to UAE Medical Device Approval: How to Navigate MOHAP Regulations in Dubai and Abu Dhabi for Fast Market Access.』のカバーアート

Pure Global's Expert Guide to UAE Medical Device Approval: How to Navigate MOHAP Regulations in Dubai and Abu Dhabi for Fast Market Access.

Pure Global's Expert Guide to UAE Medical Device Approval: How to Navigate MOHAP Regulations in Dubai and Abu Dhabi for Fast Market Access.

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 The UAE boasts one of the most advanced healthcare systems in the MENA region, but accessing this lucrative market requires a deep understanding of the Ministry of Health and Prevention (MOHAP) regulations. This episode provides a practical, step-by-step guide for MedTech manufacturers aiming for successful market entry, transforming complex regulatory hurdles into a clear path to approval. We break down the entire process, from the non-negotiable first step of appointing a local Authorized Representative to leveraging your existing international approvals from bodies like the FDA or the EU. Learn how to prepare a compliant technical dossier, navigate the e-submission portal, and avoid the common pitfalls that delay market access for even the most innovative devices. **This Episode's Key Insights:** * Why is appointing a local Authorized Representative your absolute first step for UAE market entry? * How can your existing CE Mark or FDA approval dramatically accelerate your MOHAP submission? * What are the most common documentation mistakes that lead to rejection by the UAE authorities? * Is your device classification in the EU guaranteed to be the same in the UAE? * What are the hidden costs in the registration process beyond the official government fees? * How do you manage post-market surveillance and reporting once your device is approved? * What specific labeling and language requirements must be met for the UAE market? At Pure Global, we specialize in turning regulatory complexities into market opportunities. With our end-to-end solutions, local expertise, and advanced AI tools, we streamline global market access for MedTech and IVD companies. Let us be your partner in navigating the path to success in the UAE and beyond. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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