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MENA MedTech Insights

MENA MedTech Insights

Auteur(s): Ran Chen
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À propos de cet audio

 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 Science Sciences biologiques Économie
Épisodes
  • MENA MedTech Insights: Pure Global's Guide to Navigating Regulatory Strategy in Saudi Arabia and the UAE

    MENA MedTech Insights: Pure Global's Guide to Navigating Regulatory Strategy in Saudi Arabia and the UAE
    Oct 18 2025
    The MENA region is a goldmine for MedTech innovation, but its complex and fragmented regulatory landscape can be a major barrier to entry. This episode of MENA MedTech Insights dives deep into the two largest markets: Saudi Arabia and the United Arab Emirates. We uncover the most common pitfalls companies face, from underestimating the SFDA's unique documentation demands to misunderstanding the critical role of a local Authorized Representative in the UAE. This is a practical guide for any MedTech company looking to succeed in this lucrative but challenging region. Case Highlight: Imagine your CE-marked device, a leader in Europe, gets stuck in regulatory limbo for 18 months in Saudi Arabia. This is a real scenario we explore, where a German company's failure to localize its technical dossier for the SFDA cost them critical time and market share, allowing a competitor to get ahead. Learn how to avoid this costly mistake. What You'll Learn: - Why is a CE mark or FDA approval not a golden ticket for market access in Saudi Arabia? - What are the specific documentation pitfalls that lead to SFDA submission rejections? - What is the true legal responsibility of an Authorized Representative in the UAE, and why can't your distributor always fill this role? - How can a unified regulatory strategy help you enter multiple MENA markets like the UAE, Saudi Arabia, and Egypt more efficiently? - What role does AI and technology play in accelerating dossier preparation for the MENA region? - How do post-market surveillance requirements differ between key MENA countries? - What are the first steps to building a robust market entry plan for the Gulf? At Pure Global, we transform these regulatory hurdles into clear pathways for market access. Our team combines local, in-country expertise with advanced AI tools to offer end-to-end regulatory consulting for MedTech and IVD companies. From initial strategy and dossier submission to acting as your legal representative, we streamline your global expansion. Ready to unlock the MENA market? Contact our experts at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    2 min
  • Pure Global's MENA MedTech Playbook: Navigating Saudi Arabia & UAE Regulations with Your EU EUDAMED Strategy.

    Pure Global's MENA MedTech Playbook: Navigating Saudi Arabia & UAE Regulations with Your EU EUDAMED Strategy.
    Oct 17 2025
    This episode of MENA MedTech Insights dives into the critical regulatory nuances for medical device companies expanding into the MENA region, particularly those with existing EU supply chains and approvals. We uncover why a CE mark is only the beginning of the journey and explore the growing divergence between EU standards, like EUDAMED, and the specific requirements of key markets like Saudi Arabia and the UAE. We break down the common assumption that EU compliance guarantees smooth entry into the Gulf. Learn how local data requirements, mandatory labeling laws, and the crucial choice of an in-country representative can make or break your market access strategy. This is essential listening for any regulatory affairs professional or business leader looking to capture the immense opportunity in the region without falling into common regulatory traps. A European MedTech firm secured a major distribution deal for their innovative cardiovascular stent in the Gulf, contingent on a 6-month launch timeline. They submitted their CE-marked technical file to the Saudi authorities, assuming a quick approval. However, their launch was halted for over a year because their EUDAMED-formatted UDI data was incompatible with the Saudi UDI system, and their chosen distributor lacked the regulatory expertise to resolve the issue, jeopardizing the entire commercial partnership. Key Takeaways: • Is your CE mark still a golden ticket for market access in Saudi Arabia and the UAE? • How can you leverage your EUDAMED preparation for faster entry into MENA markets instead of seeing it rejected? • What are the hidden risks of appointing a commercial distributor as your sole legal representative? • Are your labeling and technical documents truly compliant with local Arabization and data requirements? • How is the rise of national UDI databases in the Gulf impacting your global supply chain? • What steps should you take today to future-proof your regulatory strategy for the entire MENA region? At Pure Global, we specialize in turning these complex regulatory challenges into streamlined market access. Our integrated approach allows you to use a single, efficient process to enter multiple global markets, including the EU and key MENA countries. With local experts on the ground in over 30 markets, we manage everything from regulatory strategy and dossier submission to acting as your independent legal representative. Don’t let regulatory hurdles slow your growth. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn how we can accelerate your global expansion.
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    2 min
  • MENA MedTech Strategy: Why Saudi Arabia & UAE Demand Regulatory Clarity Before Budgeting | A Pure Global Insight

    MENA MedTech Strategy: Why Saudi Arabia & UAE Demand Regulatory Clarity Before Budgeting | A Pure Global Insight
    Oct 16 2025
    In this episode of MENA MedTech Insights, we explore the number one reason why medical device companies fail when entering markets like Saudi Arabia and the UAE: a lack of upfront regulatory clarity. We break down why a detailed understanding of the authorities, device classifications, and submission mechanics is non-negotiable *before* a single dollar of the budget is spent. Discover the common pitfalls that lead to massive budget overruns and months of delays. We use the real-world example of a company with a CE-marked device that plans for a simple registration in Saudi Arabia, only to be blindsided by the complex requirements of appointing a local Authorized Representative and navigating the SFDA's specific GHAD submission portal, costing them dearly in both time and money. Key Takeaways: * What is the single biggest mistake companies make before budgeting for MENA market entry? * Why is knowing the specific submission portal, like Saudi's GHAD system, critical *before* you start? * How can prerequisite requirements in the UAE, such as manufacturer registration, completely halt your market access plan? * Are you accounting for the hidden costs and timelines of appointing a local in-country representative? * Why is your CE mark or FDA approval just a starting point, not a free pass, in the MENA region? * How can a consolidated "regulatory intelligence report" de-risk your entire market entry strategy? * What specific questions should you ask to ensure your budget is realistic and defensible? At Pure Global, we provide this critical upfront clarity. Our end-to-end regulatory consulting, powered by local expertise and advanced AI tools, helps you build a predictable and successful market access strategy for the MENA region and beyond. Don't gamble with your global expansion. Contact us for a strategic consultation at info@pureglobal.com or visit https://pureglobal.com/.
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    2 min
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