Medical Device Global Market Access Podcast Por Pure Global arte de portada

Medical Device Global Market Access

Medical Device Global Market Access

De: 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
Episodios
  • ANVISA's Gateway to Brazil: Why Korean MFDS Approval is Non-Negotiable

    ANVISA's Gateway to Brazil: Why Korean MFDS Approval is Non-Negotiable
    Jan 14 2026
    This episode delves into the single most critical requirement for Korean medical device manufacturers entering the Brazilian market: providing proof of country of origin market authorization. We explain why Brazil's ANVISA requires official approval from Korea's Ministry of Food and Drug Safety (MFDS) and how this documentation serves as vital evidence of a device's safety and efficacy. We also explore the direct impact that your domestic regulatory timeline in Korea has on your ability to access the Brazilian market, highlighting the need for a coordinated global registration strategy. Key Questions: - What is the most important document for a Korean MedTech company entering Brazil? - How does Brazil's ANVISA verify the safety of foreign medical devices? - Why is your Korean MFDS approval critical for Brazilian market entry? - Can you register a device in Brazil without approval in its home country? - How can delays in your Korean registration impact your global expansion plans? - What strategic considerations must Korean manufacturers make when planning for Brazilian market access? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies seeking to access new international markets like Brazil. Our experts develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers for ANVISA registration, ensuring your Korean MFDS approval is leveraged effectively. We act as your local representative, managing the entire process to get your product approved faster. Explore our free regulatory AI tools and database at https://pureglobal.ai, or contact us at info@pureglobal.com and visit https://pureglobal.com to accelerate your global expansion.
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    3 m
  • Brazil's INMETRO Certification: A Guide for Korean Electro-Medical Device Manufacturers

    Brazil's INMETRO Certification: A Guide for Korean Electro-Medical Device Manufacturers
    Jan 13 2026
    This episode focuses on a critical regulatory hurdle for Korean medical device companies entering the Brazilian market: the mandatory INMETRO certification for electro-medical devices. We break down why this certification, which requires local testing in Brazil, is often an unexpected challenge for manufacturers accustomed to the MFDS system. We cover the specific devices affected, the typical timelines of three to twelve months, and the ongoing costs associated with maintenance audits, providing a clear overview of this significant market access barrier. Key Questions: - What is INMETRO certification and why is it mandatory for certain medical devices in Brazil? - How does Brazil's local testing requirement differ from the process recognized by Korea's MFDS? - Which international standard, IEC 60601, triggers the need for INMETRO certification? - What is the expected timeline for achieving this certification, from start to finish? - Are there ongoing costs and audits required to maintain INMETRO certification after approval? - Why must Korean companies budget for this as a separate, significant market access expense? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with local expertise and advanced AI. Whether you're navigating Brazil's INMETRO certification or entering any of our 30+ markets, our team provides comprehensive support from regulatory strategy and technical dossier submission to post-market surveillance. We act as your local representative, ensuring a smooth path to market. To accelerate your global expansion and leverage our powerful AI and data tools, contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free resources at https://pureglobal.ai.
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    3 m
  • Cracking the Code: Brazil's Complex Import Taxes for Korean MedTech

    Cracking the Code: Brazil's Complex Import Taxes for Korean MedTech
    Jan 12 2026
    This episode delves into the single most significant barrier for Korean medical device manufacturers entering the Brazilian market: the intricate and burdensome import taxation system. We break down the multiple federal and state-level taxes—including II, IPI, PIS, COFINS, and ICMS—that can collectively exceed 60% of a product's value, and explain why a nuanced understanding of landed costs and product classification is essential for success. - Why is Brazil's import tax system so challenging for Korean MedTech companies? - What are the five key taxes levied on imported medical devices in Brazil? - How can the total tax burden impact the competitiveness of your product? - Why does the importing state in Brazil change the final cost of your device? - What is a 'landed cost' and why is it critical to calculate it accurately? - How does Brazil's tax structure differ from Korea's import duties? - What strategic adjustments must Korean companies make to their pricing for the Brazilian market? Pure Global provides end-to-end regulatory consulting for MedTech and IVD firms, streamlining global market access with local expertise and advanced AI. We help you develop efficient regulatory strategies, manage technical dossier submissions, and navigate complex markets like Brazil. Our services include acting as your local representative in over 30 countries and ensuring continuous regulatory monitoring. By integrating technology and deep market knowledge, we help you overcome barriers and accelerate your entry into new territories. For a strategic partner in your global expansion, contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools at https://pureglobal.ai.
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    3 m
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