『MENA MedTech Insights』のカバーアート

MENA MedTech Insights

MENA MedTech Insights

著者： 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 生物科学 科学 経済学
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  • Pure Global's MENA MedTech Insights: Why Your CE Mark Isn't a Golden Ticket for Medical Device Registration in Saudi Arabia, UAE, and Egypt

    Pure Global's MENA MedTech Insights: Why Your CE Mark Isn't a Golden Ticket for Medical Device Registration in Saudi Arabia, UAE, and Egypt
    2025/08/28
    In this episode of MENA MedTech Insights, we debunk the common myth that a CE mark is an all-access pass to the Middle East and North Africa's booming medical device market. While essential, it's only the first step. We explore the nuanced "CE-plus" regulatory models in key jurisdictions that often surprise even experienced manufacturers. We break down the specific requirements for market entry into powerhouse markets like Saudi Arabia and the United Arab Emirates. Learn why local representation, country-specific registration portals like the SFDA's GHAD system, and tailored post-market surveillance plans are non-negotiable, even for devices with full European approval. This episode provides the practical, on-the-ground intelligence you need to avoid costly delays and build a successful MENA expansion strategy. Here are some of the key takeaways from this episode: * Why is my CE-marked device not automatically approved for sale in Saudi Arabia? * What is a Medical Device Marketing Authorization (MDMA) and how does it differ from a CE certificate? * Is it possible to enter the UAE market without a local Authorized Representative? * How do you navigate the SFDA’s GHAD portal for a successful submission? * What are the most common reasons for registration delays in the MENA region? * How are regulations in countries like Egypt evolving beyond reference country approval? * What specific labeling and post-market requirements do I need to be aware of in the Gulf? * How can I leverage my existing CE technical file to speed up registration in MENA? Struggling to get your MedTech or IVD products into complex markets like the Middle East? At Pure Global, we transform regulatory hurdles into market opportunities. We offer end-to-end solutions, combining local expertise in over 30 countries with advanced AI tools to streamline your global market access. Let us be your local representative and manage your entire registration lifecycle. Contact us to build your global expansion strategy today at info@pureglobal.com or visit us at https://pureglobal.com/.
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    3 分
  • Pure Global's MENA MedTech Insights: A Step-by-Step Guide to Class II Medical Device Registration in Jordan and Navigating JFDA Requirements

    Pure Global's MENA MedTech Insights: A Step-by-Step Guide to Class II Medical Device Registration in Jordan and Navigating JFDA Requirements
    2025/08/27
    This episode of MENA MedTech Insights provides a detailed guide to registering a Class II medical device in Jordan. We explore the critical role of the Jordan Food and Drug Administration (JFDA) and break down the essential steps for foreign manufacturers, from appointing a local representative to compiling a compliant technical dossier. We delve into the specific documentation required, including the importance of prior approval from reference markets like the EU or USA. Learn about common pitfalls, such as translation requirements and the complex process of document legalization, which can cause significant delays if not handled correctly. **Key Takeaways From This Episode:** * Why is appointing a registered Authorized Representative your non-negotiable first step in Jordan? * Does the JFDA accept FDA 510(k) clearance, or is a CE mark mandatory for Class II devices? * What is the single most common documentation error that stalls applications with the JFDA? * Are English-only labels and Instructions for Use (IFU) sufficient for the Jordanian market? * How can improper document legalization at the embassy level halt your entire market entry strategy? * What is the realistic timeline for approval, from submission to receiving your registration certificate? * How can you leverage your existing regulatory approvals to fast-track your entry into Jordan? At Pure Global, we offer end-to-end regulatory consulting to help MedTech and IVD companies seamlessly access over 30 global markets, including Jordan. Our combination of local expertise and advanced AI tools ensures your submission is efficient and compliant. Let us be your strategic partner in global expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn more.
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    3 分
  • 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)
    2025/08/26
    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 分
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