Sign up to save your podcasts
Or
Share Pure Global's Ultimate Guide to UAE MOHAP: How to Successfully Register Your Software as a Medical Device (SaMD) in the MENA MedTech Market
Share to email
Share to Facebook
Share to X
Share to email
Share to Facebook
Share to X
Or
Pure Global's Ultimate Guide to UAE MOHAP: How to Successfully Register Your Software as a Medical Device (SaMD) in the MENA MedTech Market
Thinking of launching your Software as a Medical Device (SaMD) in the United Arab Emirates? The path to approval from the Ministry of Health and Prevention (MOHAP) is filled with unique challenges specific to the MENA region. This episode of MENA MedTech Insights breaks down the essential steps, common pitfalls, and insider strategies for a successful SaMD registration in the UAE, one of the most dynamic markets in the Middle East.
We explore a real-world scenario where a promising AI diagnostic tool faced a nine-month delay. The manufacturer misclassified its risk level and lacked the specific cybersecurity documentation MOHAP required, a costly mistake that stalled their market entry and could have been avoided with proper local guidance.
Key Takeaways From This Episode:
* Is a local UAE representative truly necessary for my software-only medical device?
* How does MOHAP classify SaMD, and what does it mean for my submission timeline and cost?
* Can my existing FDA clearance or European CE Marking speed up the approval process in the UAE?
* What specific cybersecurity and data privacy documents do I absolutely need to prepare for MOHAP?
* What are the most common and easily avoidable reasons for MOHAP rejecting an SaMD application?
* How critical is ISO 13485 certification for a software company targeting the UAE market?
* What post-market surveillance obligations apply to my software once it's approved?
Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. Let us be your partner in navigating the complexities of the MENA market. Contact us today at [email protected] or visit https://pureglobal.com/ to learn more.
View all episodes
By Ran ChenThinking of launching your Software as a Medical Device (SaMD) in the United Arab Emirates? The path to approval from the Ministry of Health and Prevention (MOHAP) is filled with unique challenges specific to the MENA region. This episode of MENA MedTech Insights breaks down the essential steps, common pitfalls, and insider strategies for a successful SaMD registration in the UAE, one of the most dynamic markets in the Middle East.
We explore a real-world scenario where a promising AI diagnostic tool faced a nine-month delay. The manufacturer misclassified its risk level and lacked the specific cybersecurity documentation MOHAP required, a costly mistake that stalled their market entry and could have been avoided with proper local guidance.
Key Takeaways From This Episode:
* Is a local UAE representative truly necessary for my software-only medical device?
* How does MOHAP classify SaMD, and what does it mean for my submission timeline and cost?
* Can my existing FDA clearance or European CE Marking speed up the approval process in the UAE?
* What specific cybersecurity and data privacy documents do I absolutely need to prepare for MOHAP?
* What are the most common and easily avoidable reasons for MOHAP rejecting an SaMD application?
* How critical is ISO 13485 certification for a software company targeting the UAE market?
* What post-market surveillance obligations apply to my software once it's approved?
Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. Let us be your partner in navigating the complexities of the MENA market. Contact us today at [email protected] or visit https://pureglobal.com/ to learn more.