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MENA MedTech Insights

MENA MedTech Insights

Written by: 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 Biological Sciences Economics Science
Episodes
  • Riyadh's Digital Mandate: Pure Global on the MedTech Scramble for SFDA's New Rules

    Riyadh's Digital Mandate: Pure Global on the MedTech Scramble for SFDA's New Rules
    Jan 26 2026
    In this episode, we dissect the sudden and mandatory shift by Saudi Arabia's SFDA to its new GHAD digital platform. This move has created significant operational challenges for international MedTech companies, freezing submissions and jeopardizing market access for those with unprepared local representatives. We explore the immediate consequences and the long-term strategic implications of this digital-first regulatory enforcement. This isn't a theoretical problem. Consider a real-world scenario where a leading European diagnostics company, which has operated in the Kingdom for years, suddenly has its new product launch pipeline frozen. Their chosen local representative, a large logistics partner, lacks the regulatory expertise to manage the new GHAD system, turning a routine submission into a major business crisis and threatening to concede a multi-million dollar contract to a more compliant competitor. Key questions answered in this episode: - What is the SFDA's new GHAD platform and why was its launch so disruptive? - Why are traditional distributor-as-representative models failing under the new digital rules? - What are the three critical capabilities your Saudi authorized representative must have now? - How does this regulatory shift connect to Saudi Arabia's Vision 2030 goals? - What are the immediate steps to take if your product submissions are currently stalled? - Could this digital-first enforcement model be adopted by the UAE next? - What are the hidden costs of choosing the wrong local partner in this new environment? Navigating complex regulatory shifts in the MENA region requires specialized, on-the-ground expertise. Pure Global offers end-to-end regulatory consulting, acting as your local, digitally proficient representative to ensure seamless market access and compliance. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to secure your position in the evolving Saudi market.
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    2 mins
  • Saudi AI MedTech: Pure Global on Cracking the SFDA's New Data Localization Code

    Saudi AI MedTech: Pure Global on Cracking the SFDA's New Data Localization Code
    Jan 25 2026
    Saudi Arabia's new SFDA 'Digital Health Innovation Track' promises to slash approval times for AI medical devices, opening a lucrative door to one of the largest markets in the Middle East. This accelerated pathway is designed to attract cutting-edge technology and align with the ambitious goals of Vision 2030. However, this golden opportunity comes with a significant challenge: a strict new mandate for data localization. Global MedTech companies, accustomed to using international data sets for validation, now face the complex task of sourcing and utilizing local Saudi patient data. This creates a critical hurdle that could delay or even derail market entry for those unprepared to navigate the specific clinical and regulatory landscape of the Kingdom. **Key Takeaways:** - Is Saudi Arabia's new AI fast-track a real game-changer or a regulatory mirage? - What are the top three data localization mistakes foreign companies make when entering the Gulf? - How can you leverage existing EU or FDA approvals to your advantage under the new SFDA rules? - Beyond AI, which other digital health sectors are next for deregulation in the Kingdom? - What's the one critical piece of documentation that most companies forget in their SFDA submission? - How does the data mandate affect cybersecurity protocols for your device? - Could this new policy position Saudi Arabia as the top MedTech hub in MENA? Navigating complex market shifts like this is what we do best. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, combining local expertise in markets like Saudi Arabia with advanced AI tools to streamline global market access. We help you turn regulatory challenges into market opportunities. Contact us at info@pureglobal.com or visit us at https://pureglobal.com/.
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    2 mins
  • Riyadh's New MedTech Gambit: Pure Global on SFDA's Hidden Fast-Track Rules

    Riyadh's New MedTech Gambit: Pure Global on SFDA's Hidden Fast-Track Rules
    Jan 24 2026
    This week on MENA MedTech Insights, we delve into the game-changing new "Medical Industry Localization Fast-Track" program just rolled out by the Saudi Food and Drug Authority (SFDA). This strategic initiative, a core component of Saudi Vision 2030, is set to drastically alter the landscape for medical device registration in the Kingdom, linking faster market access directly to local investment. We uncover the critical details of the program, from the promise of 60-day approval timelines to the specific device categories being targeted. We analyze the tiered eligibility requirements and what a "localization plan" truly means for international manufacturers, exploring both the immense opportunities for rapid growth and the hidden complexities of navigating this new regulatory and business environment. A real-world example: Consider a European orthopedic device manufacturer. They have a best-in-class product perfect for the Saudi market but have been hesitant due to the unpredictable, year-long registration delays. The new fast-track program seems like a golden ticket, but it requires a partnership with a local entity for finishing and assembly. Can they find a partner that meets their stringent quality standards, and how do they structure a deal that protects their IP while satisfying the SFDA's requirements? Key questions for your team: 1. Which specific cardiovascular and diabetic devices are prioritized in the SFDA's new fast-track program? 2. What are the minimum requirements for a "localization plan" to be accepted by the SFDA? 3. How does this new program affect medical devices that have already received CE marking or FDA approval? 4. What are the key legal pitfalls to avoid when structuring a joint venture with a Saudi partner for local assembly? 5. How will the SFDA monitor and enforce the localization commitments made by manufacturers after approval? 6. Does this program apply to In-Vitro Diagnostics (IVDs) in the same way it applies to medical devices? 7. What are the unwritten rules for negotiating with potential local partners in the Kingdom? Navigating these shifts 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, using local experts and advanced AI to streamline market access in Saudi Arabia and over 30 other countries. Don't let regulatory complexity be a barrier to entry. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can accelerate your growth.
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    2 mins
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