『LATAM MedTech Insights』のカバーアート

LATAM MedTech Insights

LATAM MedTech Insights

著者： Ran Chen
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 Welcome to LATAM MedTech Insights, your essential guide to the booming medical technology and digital health sector across Latin America. Each episode, we dissect the key trends, investment opportunities, and regulatory news shaping the industry. Join us for in-depth interviews with the innovators, investors, and policymakers driving the future of healthcare from Mexico to Brazil.Copyright 2025 Ran Chen 生物科学 科学 経済学
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  • Navigating Brazil's ANVISA RDC 751 & RDC 830: A Pure Global Guide to LATAM MedTech & IVD Market Access Success

    Navigating Brazil's ANVISA RDC 751 & RDC 830: A Pure Global Guide to LATAM MedTech & IVD Market Access Success
    2025/10/17
    This episode of LATAM MedTech Insights dives deep into the most significant regulatory shift in the region's largest market: Brazil. We explore ANVISA's new regulations, RDC 751/2022 for medical devices and RDC 830/2023 for IVDs, which align Brazil's framework more closely with international standards like the EU MDR. This is a critical update for any MedTech company looking to enter or expand its footprint in Latin America. We unpack what this harmonization means in practical terms. Consider this: a medical device company with CE marking for its product previously faced a complex, 18-month process to reformat its entire technical dossier for Brazil. Today, that same dossier can be leveraged to gain market access in a fraction of the time and cost. This episode explains how you can capitalize on this change and avoid common pitfalls during the transition. Key Takeaways: * How does Brazil's new RDC 751/2022 fundamentally change the market entry strategy for your medical device? * What is the critical June 1, 2024 deadline for IVD manufacturers under RDC 830/2023 and what must be done? * Can your existing EU or FDA technical documentation be used for a submission in Brazil now? * How does Brazil's regulatory shift compare to changes happening in Mexico and Colombia? * What are the key differences between the old 'cadastro' system and the new 'notificação' pathway? * Why is having an expert local representative in Brazil more crucial than ever under these new rules? * What are the most common mistakes companies make when transitioning their legacy products to the new regulations? Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies. We combine local expertise with advanced AI and data tools to streamline your global market access, from initial strategy to post-market surveillance. To navigate the complexities of the LATAM market, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分
  • Unlocking LATAM MedTech: How Pure Global Leverages Market Intelligence on Colombia and Brazil for Strategic Entry

    Unlocking LATAM MedTech: How Pure Global Leverages Market Intelligence on Colombia and Brazil for Strategic Entry
    2025/10/16
    In this episode of LATAM MedTech Insights, we explore why a one-size-fits-all approach to entering the Latin American medical technology market is a recipe for failure. The region is not a monolith but a collection of unique countries, each with its own distinct regulatory, economic, and healthcare systems. Success depends on moving beyond surface-level data and leveraging deep market intelligence. We dissect how granular market briefs provide the critical insights needed to build a winning go-to-market strategy. We contrast the opportunities in a market like Colombia, which heavily relies on imports, with the complex regulatory hurdles of a giant like Brazil. This episode will show you how the right data can illuminate your path, save you from costly mistakes, and give you a decisive competitive advantage. A Tale of Two Markets: Imagine targeting Colombia, where an 80% import dependency for medical devices signals a ready-made demand for your product. Now, picture Brazil, where your market entry is halted before it begins because you were unaware of the mandatory pre-submission GMP inspection by ANVISA. This single regulatory detail could delay your launch by over a year and add tens of thousands to your budget. Which path would you rather take? Key Takeaways: * Why is treating LATAM as a single market the most common strategic error? * What does Colombia's 80% import dependency really mean for your sales strategy? * How can Brazil's ANVISA pre-registration requirements completely alter your budget and timeline? * Beyond market size, what are the most critical data points a market brief must contain? * How does deep market intelligence inform your choice between direct entry and a distributor model? * What hidden regulatory hurdles could derail your launch in promising markets? * How can you leverage existing international approvals to potentially fast-track your LATAM entry? * What economic indicators should you monitor that directly impact medical device reimbursement? At Pure Global, we transform this critical data into actionable strategy. We offer end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline your global market access. Stop guessing and start strategizing. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can help you succeed in Latin America and beyond.
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    2 分
  • Pure Global's Deep Dive into Brazil: Mastering ANVISA MedTech Regulations with an Integrated Registration & PMS Strategy

    Pure Global's Deep Dive into Brazil: Mastering ANVISA MedTech Regulations with an Integrated Registration & PMS Strategy
    2025/10/15
    Brazil's MedTech market offers immense opportunity, but its regulatory body, ANVISA, demands flawless execution. A fragmented approach, where different teams handle registration and post-market compliance, often leads to costly delays and strategic dead ends. This episode explores why an integrated strategy is non-negotiable for success. We break down the four pillars of Brazilian MedTech regulation: correct device classification, meticulous technical documentation in Portuguese, the critical choice of a Brazil Registration Holder (BRH), and robust post-market surveillance. Learn how these elements are interconnected and why managing them under one expert team provides a significant competitive advantage in this complex market. **A cautionary tale:** Imagine spending over a year and thousands of dollars to prepare your device registration, only to discover that the distributor you appointed as your local representative (BRH) has decided to partner with a competitor. Because they legally own your registration license, you have completely lost market access and must start the entire process from scratch, giving your competition a two-year head start. **In this episode, you will learn:** * Why is Brazil's four-class risk system more nuanced than it appears? * What are the most common documentation mistakes that lead to ANVISA rejections? * How can the choice of your Brazil Registration Holder (BRH) make or break your entire LATAM strategy? * Are you truly in control of your device registration if your distributor is your BRH? * What specific post-market surveillance activities does ANVISA require beyond simple adverse event reporting? * Why is having a single, integrated team for registration and post-market support a competitive advantage in Brazil? * What is BGMP certification and why is it non-negotiable for higher-risk devices? At Pure Global, we offer end-to-end regulatory solutions for MedTech and IVD companies. Our integrated approach combines local Brazilian expertise with advanced AI tools to streamline market access, from initial strategy to post-market surveillance. Contact us to learn how our unified team can de-risk and accelerate your entry into the Brazilian market. Email us at info@pureglobal.com or visit https://pureglobal.com/.
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    2 分
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