MENA MedTech Insights by Pure Global: Navigating CT Scanner Regulations and SFDA Market Access in Saudi Arabia & the UAE

MENA MedTech Insights

The market for CT imaging systems in the MENA region is booming, fueled by ambitious healthcare projects and substantial government investment. For global MedTech manufacturers, this translates into a massive opportunity. However, the path to market is paved with complex and varied regulatory requirements that can easily derail even the most prepared companies. This episode of MENA MedTech Insights dives deep into the practical challenges and strategic solutions for launching CT scanners in key markets like Saudi Arabia and the UAE. We uncover the critical differences between the SFDA and MOHAP approval processes and illustrate how a single misstep in documentation or local representation can lead to significant delays and financial losses. **In this episode, you will discover:** - What are the crucial differences between the SFDA's MDMA process and the UAE MOHAP's registration system for a CT scanner? - Why was a European company's SFDA submission for their CT system rejected despite having a CE mark? - What is the one license manufacturers often forget when importing heavy medical equipment into the UAE? - How do local representation requirements in Saudi Arabia and the UAE impact your business strategy? - What specific post-market surveillance data do MENA authorities demand? - How can Saudi Vision 2030 accelerate your product's adoption if you navigate the regulations correctly? - How can you leverage a single technical file across multiple MENA countries to save time and resources? Unlock the MENA market's potential without the regulatory headaches. 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 local representative and guide your strategy from submission to post-market surveillance. Contact us to learn more at [email protected] or visit our website at https://pureglobal.com/.