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
  • 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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  • 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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  • Riyadh's MedTech Revolution: Pure Global on Saudi's New Manufacturing Game

    Riyadh's MedTech Revolution: Pure Global on Saudi's New Manufacturing Game
    Dec 14 2025
    Saudi Arabia is rewriting its MedTech rulebook. Driven by Vision 2030, the Saudi Food and Drug Authority (SFDA) is rolling out new regulations and incentives designed to shift the country from a top medical device importer to a powerful local manufacturing hub. This move creates immense opportunities for innovators but presents complex strategic challenges for established international companies. This episode of MENA MedTech Insights dives deep into these changes. We analyze how the new push for local production, aligned with global standards like ISO 13485, is creating a new competitive landscape. Consider a global IVD manufacturer that has long profited from Saudi Arabia's high demand for diabetic testing supplies. Now, with new incentives favoring local production, they face a critical choice: invest millions in a local facility to protect their market share, or risk being outmaneuvered by emerging, government-backed local players. We unpack this high-stakes dilemma. What you will learn in this episode: - What specific SFDA changes are driving the "Made in Saudi" medical device initiative? - How does the mandatory alignment with ISO 13485 impact foreign companies? - Is local manufacturing becoming a prerequisite for winning major government tenders? - What are the hidden risks and opportunities in partnering with local Saudi entities? - How can companies leverage these new regulations to potentially fast-track approvals? - What are the real financial incentives being offered for local MedTech production? - How will this strategic pivot in Saudi Arabia impact supply chains across the wider MENA region? Navigating this complex regulatory shift requires a partner with on-the-ground expertise and a global perspective. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining local experts with advanced AI tools to streamline market access in Saudi Arabia and over 30 markets worldwide. To build your winning strategy, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 m
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