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MENA MedTech Insights

MENA MedTech Insights

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 2025 Ran Chen
Episodes
  • Beyond the Fees: Pure Global Reveals the True Cost of Medical Device Registration in MENA's GCC Markets (Saudi Arabia & UAE)

    Beyond the Fees: Pure Global Reveals the True Cost of Medical Device Registration in MENA's GCC Markets (Saudi Arabia & UAE)
    Aug 26 2025
    This episode of MENA MedTech Insights dives deep into the true cost of medical device registration in the GCC, moving beyond the well-known government fees. We uncover the various hidden expenses that can surprise manufacturers, including mandatory local representation, document translation, and embassy legalization costs, providing a realistic financial picture for entering key markets like Saudi Arabia and the UAE. Imagine a European stent manufacturer budgeting $4,000 for SFDA fees in Saudi Arabia, only to discover their total out-of-pocket cost is nearly triple that amount. This episode reveals the hidden expenses they faced, from mandatory representative fees to document legalization, that can derail market entry plans and timelines. We explain how to avoid these surprises. What You'll Learn: - Why is the official government registration fee just the tip of the iceberg? - What are the mandatory "hidden costs" for market access in Saudi Arabia and the UAE? - How much should you budget for a local authorized representative, and is it a one-time fee? - Do you need to translate your entire technical dossier into Arabic? - How do registration costs fundamentally differ between a low-risk and a high-risk device? - What are the annual fees you must plan for *after* your initial registration is approved? - How can embassy legalization requirements impact your submission timeline and budget? - Can a single regulatory strategy effectively cover the entire GCC region? At Pure Global, we transform these challenges into opportunities. We offer end-to-end regulatory consulting for MedTech and IVD companies, using local expertise and advanced AI to streamline your access to over 30 global markets, including the entire GCC. Stop guessing your budget and start building a predictable market entry strategy. Contact us today at info@pureglobal.com or visit our website at https://pureglobal.com/ to learn more.
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    3 mins
  • Pure Global Presents: Decoding Egypt's Arabic Labeling Requirements for Medical Devices – Your SEO Guide to MENA MedTech Market Entry

    Pure Global Presents: Decoding Egypt's Arabic Labeling Requirements for Medical Devices – Your SEO Guide to MENA MedTech Market Entry
    Aug 25 2025
    This episode of MENA MedTech Insights dives deep into a crucial, and often underestimated, aspect of entering the Egyptian medical device market: the strict Arabic labeling requirements set by the Egyptian Drug Authority (EDA). We explore the dual-language mandate and uncover the common pitfalls that can lead to significant delays and financial losses for manufacturers. Imagine your company has spent millions on product development and is ready to launch in Egypt, a key MENA market. Your shipment arrives but is held indefinitely at customs. The reason is a simple oversight where the device's instructions for use and outer packaging are only in English. This single compliance failure forces a complete repackaging effort, delaying your market entry by months and giving your competitors a critical advantage. This episode will help you avoid that exact scenario. Key Takeaways: - Why is dual-language labeling in both Arabic and English an absolute necessity for the Egyptian market? - What specific information must be translated on the primary label, the packaging, and the Instructions For Use (IFU)? - How do the Egyptian Drug Authority's UDI requirements integrate with existing labeling rules? - What are the most common mistakes foreign manufacturers make when designing their labels for Egypt? - Are internationally recognized symbols sufficient, or do they require an explanation in Arabic? - Beyond translation, what are the EDA’s expectations for the physical quality and design of the packaging itself? - How can a seemingly minor labeling error lead to major consequences like shipment rejection or product recalls? At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and IVD companies. We combine local expertise in over 30 markets, including Egypt, with advanced AI and data tools to streamline your global market access and ensure you get every detail right, from technical dossiers to local labeling. Contact us to ensure your product launch is a success at info@pureglobal.com or visit https://pureglobal.com/.
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    3 mins
  • Pure Global MENA MedTech Insights: Choosing Your Saudi Arabia Authorized Representative - The Critical SFDA Decision Between a Distributor and an Independent AR

    Pure Global MENA MedTech Insights: Choosing Your Saudi Arabia Authorized Representative - The Critical SFDA Decision Between a Distributor and an Independent AR
    Aug 24 2025
    In this episode of MENA MedTech Insights, we tackle a critical strategic decision for any medical device manufacturer looking to enter the Kingdom of Saudi Arabia: choosing your Authorized Representative (AR). This SFDA requirement is more than a formality; it's a choice that can define your operational freedom and long-term success in the market. We explore the two main pathways: appointing your distributor versus partnering with an independent, third-party AR. While naming your distributor seems convenient, it can lead to significant conflicts of interest and lock you into a single commercial partner, jeopardizing your market access if the relationship changes. This episode breaks down the risks and reveals why an independent AR provides the control and flexibility essential for sustainable growth. Imagine this: your MedTech product is gaining traction in Saudi Arabia, but your relationship with your distributor-AR sours. You try to switch partners, only to find your market registration is held hostage, forcing a costly and lengthy re-approval process. This episode explores how to avoid that exact scenario. What you'll learn in this episode: 1. What are the SFDA's core requirements for a medical device Authorized Representative? 2. Why might appointing your distributor as your AR create a major conflict of interest? 3. How can your choice of AR lock you into a single commercial partner and block your market flexibility? 4. What happens to your device registration (MDMA) if you part ways with your distributor-AR? 5. What are the strategic benefits of using an independent AR for long-term market control? 6. How does a neutral AR allow you to manage multiple distributors seamlessly? 7. What key questions should you ask before signing any AR agreement in Saudi Arabia? At Pure Global, we provide end-to-end regulatory consulting and act as your independent Authorized Representative in Saudi Arabia and over 30 markets worldwide. We combine local expertise with advanced AI to secure and maintain your market access, giving you full control over your commercial strategy. To learn more about how we can help you succeed in the MENA region, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    3 mins
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