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Medical Device Global Market Access

Medical Device Global Market Access

Von: Pure Global
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 Navigate every market. Accelerate every launch. Medical Device Global Market Access by Pure Global is the audio briefing that turns the world’s most confusing regulatory pathways into clear, actionable roadmaps. If you’re a MedTech founder, RA/QA leader, product manager, or investor who needs to get devices cleared anywhere from Austin to Abu Dhabi, this show is your shortcut. Why listen? • Step-by-step playbooks – We decode EU MDR, U.S. 510(k), Brazil’s ANVISA, China’s NMPA, and 25 + other regimes, showing exactly how long each milestone really takes and where companies get stuck. • First-hand war stories – Hear candid interviews with regulatory veterans who have shepherded implants, software, wearables, diagnostics, and AI algorithms to market—and lived to tell the tale. • Real-time intelligence – Every episode covering the week’s new guidances, standards, and enforcement trends so you’re always ahead of the curve. • Actionable templates – From clinical evaluation checklists to technical-file skeletons, we break down the documents you’ll need and the pitfalls reviewers love to flag. • AI-powered insights – Because Pure Global mines millions of public filings, tenders, and recalls, we surface data-backed best practices you won’t hear at conferences—or from competitors. What you’ll hear • Launching SaMD under multiple risk classes in parallel • Surviving an unannounced ISO 13485 audit • Building a “reg-first” QMS that scales • Mastering Latin-American registrations without endless language cycles • Leveraging real-world evidence to shorten clinical timelines • Aligning cybersecurity, privacy, and post-market surveillance rules across regions Whether you’re plotting first entry, managing lifecycle expansions, or rescuing a delayed submission, subscribing could shave months—and millions—off your path to revenue. ⸻ Brought to you by Pure Global – the AI-native consultancy that already guides MedTech innovators through regulatory and market-access hurdles in 30 + countries. Ready for expert help on your next submission? Visit https://pureglobal.com or email info@pureglobal.com to start accelerating today.Copyright 2026 Pure Global
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  • MFDS to COFEPRIS: Why Your Korean Medical Device Classification is Invalid in Mexico

    MFDS to COFEPRIS: Why Your Korean Medical Device Classification is Invalid in Mexico
    Jan 23 2026
    This episode details the critical error of applying South Korea's four-tier MFDS medical device classification directly to Mexico's three-tier COFEPRIS registration system. We explain why the differing regulatory frameworks, classification rules, and risk criteria make a direct transfer impossible and discuss the severe consequences of such a mistake, including immediate rejection, costly delays, and reputational damage with the regulatory authority. - Why is it a mistake to use a Korean device classification for a Mexican market submission? - What are the primary differences between the MFDS and COFEPRIS classification systems? - How many risk classes for medical devices exist in South Korea versus Mexico? - What are the consequences of submitting a device to COFEPRIS with the wrong classification? - Can a device's risk level change when moving from the Korean to the Mexican market? - How do different national regulations impact global market access strategy? - What is the first step to ensure a smooth registration process in Mexico? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. Our experts develop efficient regulatory strategies, leveraging a single registration process to access over 30 markets, including Mexico and South Korea. We use advanced AI and data tools to compile technical dossiers, manage submissions, and provide continuous regulatory monitoring, ensuring your products meet local standards from initial strategy to post-market surveillance. Let us handle the complexities of COFEPRIS and MFDS regulations. Visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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    3 Min.
  • Korean Devices in Mexico: Mastering COFEPRIS Classification and Grouping

    Korean Devices in Mexico: Mastering COFEPRIS Classification and Grouping
    Jan 22 2026
    This episode focuses on the critical regulatory hurdles Korean medical device companies face when entering the Mexican market. We delve into the specifics of COFEPRIS's three-tier classification system, highlighting its key differences from Korea's four-class MFDS framework. Listeners will learn why misclassification is a primary cause of submission rejections and how a strategic approach to device grouping can significantly reduce registration costs and timelines, ensuring a smoother and more efficient market entry into Mexico. Key Questions: - How does Mexico's COFEPRIS device classification differ from Korea's MFDS system? - What are the most common reasons for COFEPRIS submission rejections? - Why is a device grouping strategy essential for entering the Mexican market? - How can you minimize costs and delays when registering multiple devices in Mexico? - What international frameworks influence Mexico's medical device regulations? - Are there specific nuances Korean manufacturers must know before submitting to COFEPRIS? Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining your path to international markets. Our experts develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers for markets like Mexico. We act as your local representative in over 30 countries, ensuring your products achieve and maintain compliance. Whether you are a startup or a multinational, our technology-driven solutions accelerate your global expansion. For a consultation, contact info@pureglobal.com or visit https://pureglobal.com. Explore our free regulatory AI tools and database at https://pureglobal.ai.
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    3 Min.
  • COFEPRIS & MFDS: A New 30-Day Fast-Track for Korean MedTech in Mexico

    COFEPRIS & MFDS: A New 30-Day Fast-Track for Korean MedTech in Mexico
    Jan 21 2026
    This episode explores the transformative Abbreviated Regulatory Pathway being launched by Mexico's COFEPRIS in September 2025. We detail how this new 30-day process specifically benefits Korean medical device manufacturers holding MFDS approval, outlining the immense opportunity for accelerated market entry. The discussion also covers critical challenges, such as proving product equivalency and navigating submission requirements, to help companies leverage this shortcut effectively. - What is Mexico's new Abbreviated Regulatory Pathway for medical devices? - When does the new COFEPRIS 30-day approval process take effect? - How can Korean companies leverage their existing MFDS approval for faster market access in Mexico? - What are the key requirements for proving product equivalency between Korean and Mexican submissions? - How can you avoid common pitfalls when using this new expedited pathway? - What does this regulatory change mean for the Latin American MedTech market? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies seeking to accelerate global market entry. Our experts specialize in developing efficient regulatory strategies, like leveraging Mexico's new 30-day abbreviated pathway for MFDS-approved devices. We act as your local representative in over 30 markets, using advanced AI to compile and submit technical dossiers that minimize rejections. Whether you are a startup or a multinational, Pure Global provides the local expertise and technology-driven solutions needed to navigate complex regulatory environments. Visit us at https://pureglobal.com, contact info@pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.
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    3 Min.
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