MENA MedTech Insights Podcast Por Ran Chen arte de portada

MENA MedTech Insights

MENA MedTech Insights

De: 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 2025 Ran Chen Ciencia Ciencias Biológicas Economía
Episodios
  • Saudi MedTech's New Rules: Pure Global on The Localization Mandate.

    Saudi MedTech's New Rules: Pure Global on The Localization Mandate.
    Dec 17 2025
    This week, we dive deep into a seismic shift in Saudi Arabia's MedTech market. Recent regulatory updates are aggressively prioritizing local manufacturing, creating new, complex challenges for international medical device companies wanting to enter or stay in the Kingdom. We explore what these changes mean on the ground and how firms can turn this potential barrier into a strategic advantage. We unpack a real-world scenario where a leading European IVD manufacturer's multi-million dollar tender was jeopardized by new local content requirements. Discover the hidden complexities they faced, from vetting local partners to navigating the SFDA's evolving procurement landscape, and the strategic pivot required to stay in the game. Key questions answered in this episode: - What specific SFDA rules are now favoring local MedTech manufacturers? - Is a local joint venture the only pathway to winning government tenders in Saudi Arabia? - How do you perform due diligence on a potential local partner to ensure compliance and quality? - What are the real costs and risks associated with technology transfer for localization? - Can establishing a Saudi manufacturing base unlock access to other GCC markets? - What are the most common mistakes foreign companies make when entering this evolving market? - How can you leverage regulatory intelligence to anticipate these market shifts? 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. If you're looking to navigate the complexities of the MENA market, contact us at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 m
  • Riyadh's AI MedTech Rush: Unpacking the SFDA's Fast-Track Hurdles with Pure Global.

    Riyadh's AI MedTech Rush: Unpacking the SFDA's Fast-Track Hurdles with Pure Global.
    Dec 16 2025
    This week on MENA MedTech Insights, we dissect the groundbreaking news from Saudi Arabia. The SFDA has just launched a new accelerated approval pathway for AI-driven medical devices, promising to slash market entry timelines. But is this new "golden ticket" too good to be true? We explore the fine print behind this opportunity, revealing the stringent new post-market surveillance and data localization demands that are catching many international companies off guard. This is a must-listen for any MedTech innovator, scaleup, or enterprise with their eyes on the lucrative Saudi market. A German MedTech company celebrated their rapid SFDA approval for an AI diagnostic tool, only to face a potential market withdrawal. Their challenge? They were unprepared for the mandate to produce localized clinical performance data within 180 days, a hurdle that now threatens their entire market presence. Key Questions for This Episode: 1. What specific types of AI devices qualify for the SFDA's new fast-track? 2. Why are the post-market surveillance requirements now more demanding than the pre-market submission? 3. What are the top data localization mistakes foreign companies make in Saudi Arabia? 4. How does this new pathway align with Saudi Vision 2030's healthcare goals? 5. Can you leverage your existing EU or US approvals for this new accelerated track? 6. What is the single biggest risk of rushing a submission under these new guidelines? 7. How can you build a compliant post-market surveillance plan before you even submit your dossier? Navigating these rapid regulatory shifts is where Pure Global excels. We provide end-to-end regulatory consulting for MedTech companies, combining deep local expertise in markets like Saudi Arabia with advanced AI tools to streamline global market access. From developing a robust regulatory strategy to managing post-market surveillance and acting as your local representative, we ensure your path to the MENA market is both fast and compliant. Don't let regulatory surprises derail your launch. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your market access.
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    2 m
  • Pure Global: Decoding Riyadh's New MedTech Rules & SFDA's Hidden Hurdles

    Pure Global: Decoding Riyadh's New MedTech Rules & SFDA's Hidden Hurdles
    Dec 15 2025
    This week, MENA MedTech Insights dives into the seismic regulatory shifts in Saudi Arabia. The SFDA's new product safety framework is reshaping the market access landscape for medical device manufacturers, demanding a higher standard of clinical evidence and post-market surveillance that catches many international companies off guard. We break down what these enhanced requirements for technical documentation and vigilance mean for your business, and why the old methods of entering the lucrative Saudi market are no longer viable. We explore a real-world case where a US-based AI software company faced significant delays due to the SFDA's new demands for localized clinical data, a costly lesson in the importance of proactive compliance. Key Takeaways: - What are the three biggest changes in the SFDA's new technical regulations for 2025? - How does Saudi Vision 2030 directly connect to these stricter MedTech import rules? - Why might your existing EU MDR or FDA technical file now be rejected by the SFDA? - What are the new mandatory post-market surveillance obligations you cannot afford to ignore? - How can you turn these regulatory hurdles into a powerful competitive advantage in KSA? - Is a local clinical investigation now required for your high-risk device? - What is the single most common mistake companies are making when submitting their new dossiers? - How have the requirements for appointing an Authorized Representative in KSA changed? At Pure Global, we specialize in transforming these complex regulatory challenges into clear market access strategies. With our end-to-end solutions, local expertise in Riyadh, and advanced AI tools, we streamline your journey into the most demanding markets. Ready to secure your place in the new Saudi MedTech landscape? Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    2 m
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