Unlocking the UAE MedTech Market: A Deep Dive into the MOHAP Classification Letter and How Pure Global Streamlines Your Entry

This episode of MedTech Global Insights dives deep into a crucial, often underestimated step for entering the UAE's medical device market: obtaining a MOHAP classification letter. We explore why this document is more than just a bureaucratic formality and how it dictates the entire regulatory pathway, from documentation and fees to timelines for approval.

We break down the common pitfalls manufacturers face, from assuming their existing EU or FDA classification will carry over, to being unprepared for MOHAP's specific local interpretations and precedents. Learn why getting this initial classification wrong can lead to months of delays and unforeseen costs, and how proactive, localized strategy is key to success.

A real-world pain point. Imagine your innovative Software as a Medical Device, already holding a CE mark, is suddenly elevated to a higher risk class by UAE authorities. This decision demands unexpected clinical data and a complete overhaul of your registration timeline and budget. This all stems from one document: the MOHAP classification letter.

Key takeaways from this episode:
- Why is the UAE’s device classification system often different from that of the EU or the FDA?
- What are the most common and costly mistakes companies make when applying for a MOHAP classification letter?
- How can you determine if your novel technology will face extra scrutiny from MOHAP reviewers?
- Is a local authorized representative required just to obtain a classification letter, even before full registration?
- What really happens if your device is misclassified, and what are the steps to correct it?
- Which specific documents are non-negotiable for a successful and swift classification submission?
- How do local precedents in the UAE market influence the classification of a new device?

For more information, contact us at [email protected] or visit https://pureglobal.com/.