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MENA MedTech Insights

MENA MedTech Insights

Von: Ran Chen
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 Welcome to MENA MedTech Insights, the definitive podcast for professionals in the Middle East and North Africa's rapidly growing medical technology sector. Each episode, we explore the latest innovations, market trends, and regulatory landscapes, featuring exclusive interviews with the founders, investors, and leaders who are shaping the future of healthcare in the region.Copyright 2026 Ran Chen Wissenschaft Ökonomie
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  • Pure Global: Saudi AI MedTech's New Rules & The Hidden Fast-Track to Market Access

    Pure Global: Saudi AI MedTech's New Rules & The Hidden Fast-Track to Market Access
    Feb 22 2026
    Saudi Arabia has just opened a new fast-track regulatory pathway for AI-powered medical software. In this episode, we break down the new SFDA guidelines released last week that are set to revolutionize market access for MedTech innovators in the Kingdom. While this new framework promises to slash approval times for devices already cleared in Europe or the US, it is filled with hidden complexities. We explore the massive opportunities for SaMD companies and reveal the critical pitfalls related to local representation and post-market surveillance that could derail your market entry strategy. Case Study: A US-based startup with an FDA-cleared diagnostic AI is thrilled about the news, believing they can now launch in Saudi Arabia in under six months. They are completely unaware that their failure to appoint a local Authorized Representative before submission will lead to an automatic rejection, wasting valuable time and resources. This week's key takeaways: - What specific clause in the new SFDA guideline creates this "fast-track" for AI software? - Why is having a prior FDA or CE approval now a strategic key for Saudi market entry? - What is the single most common mistake that will get your application rejected despite the new rules? - How do Saudi Arabia's local representation requirements differ from those in the UAE? - What are the three most critical post-market surveillance duties you cannot ignore? - Can you simply reuse your existing technical file, or does it need a significant overhaul? - How does this new policy fit into Saudi Arabia's broader Vision 2030 health strategy? At Pure Global, we turn regulatory complexity into your competitive advantage. Our local experts in Riyadh, combined with advanced AI tools, provide end-to-end support for MedTech and IVD companies. We handle market strategy, local representation, technical dossier submissions, and post-market surveillance. Don't let regulatory hurdles block your access to the booming MENA market. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to streamline your success.
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    2 Min.
  • Riyadh's AI MedTech Maze: Pure Global on SFDA's Sudden Regulatory Shift.

    Riyadh's AI MedTech Maze: Pure Global on SFDA's Sudden Regulatory Shift.
    Feb 21 2026
    This week on MENA MedTech Insights, we dissect the game-changing news from the Saudi Food and Drug Authority (SFDA). The Kingdom is not just adopting AI in healthcare; it's embedding AI into the very core of its regulatory review process. This signals a new era for MedTech approvals, demanding a higher standard of data, security, and performance from manufacturers. We explore what this AI-driven oversight means for your business. From the need for localized clinical data to new cybersecurity mandates, we uncover the hidden requirements that could make or break your market entry strategy in Saudi Arabia. We present a case study of a European AI diagnostic firm, whose successful product faces unexpected hurdles in Riyadh, highlighting the critical pain points and strategic pivots now required. **Key Takeaways:** * Why is the SFDA's new AI-powered review process more than just a simple guideline update? * What specific questions will the SFDA's new systems ask about your AI algorithm's training data? * How can you prove your device is effective and unbiased for the MENA population? * Are your current cybersecurity protocols strong enough to pass this new regulatory scrutiny? * What is "algorithm drift," and why must you have a post-market plan for it in Saudi Arabia? * How can you turn these new, complex requirements into a significant competitive advantage? Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies. We combine local expertise with advanced AI and data tools to streamline your global market access, helping you navigate complex environments like Saudi Arabia. Get in touch to prepare your products for the future of regulation. Contact us at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 Min.
  • Riyadh's UDI Deadline: Pure Global on Dodging the MedTech Scramble

    Riyadh's UDI Deadline: Pure Global on Dodging the MedTech Scramble
    Feb 20 2026
    This episode of MENA MedTech Insights dives into the final, critical phase of Saudi Arabia's Unique Device Identification (UDI) system rollout. With the September 1st deadline for low-risk Class A devices fast approaching, we unpack the strategic complexities and hidden challenges that MedTech manufacturers are facing right now. We move beyond the regulations themselves to discuss the real-world consequences of failure to comply. We explore the data management hurdles, the risk of system overloads based on past deadlines, and the severe impact on supply chains and revenue if your products are not fully compliant in time. This is a must-listen for any regulatory professional or business leader with stakes in the Saudi market. A Practical Case: Imagine your container of high-volume, low-risk medical devices is detained at Jeddah port. The reason? A mismatch between your submitted data and the physical labeling, flagged during a random inspection, all because your team rushed the Saudi-DI submission in the final weeks leading to the deadline. This episode provides the strategic foresight to prevent this exact scenario. Key questions answered in this episode: * What was the number one lesson learned from the SFDA's previous UDI deadlines for higher-risk devices? * Why is the data required for the Saudi-DI database more complex than you might expect? * Can you leverage your existing EU or FDA UDI data, or is a complete rework required for Saudi Arabia? * What are the most common labeling mistakes that lead to shipment rejections at the Saudi border? * How can you pressure-test your local authorized representative's readiness for the UDI submission process? * What is the true 'last responsible moment' to begin your Class A device compliance project to avoid the last-minute rush? * Are there any exemptions or expedited pathways that manufacturers are overlooking? Navigating complex regulatory landscapes like the SFDA's UDI implementation is what we do at Pure Global. We offer end-to-end regulatory consulting, combining deep local expertise in Saudi Arabia with advanced AI tools to streamline your global market access. From developing your regulatory strategy and managing technical dossier submissions to acting as your local representative, we ensure your products reach the market efficiently and remain compliant. Don't let regulatory hurdles block your growth in the MENA region. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    2 Min.
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