『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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  • Cracking the Code of Brazil's BGMP: A LATAM MedTech Insight from Pure Global on Navigating ANVISA Inspections for Market Success.

    Cracking the Code of Brazil's BGMP: A LATAM MedTech Insight from Pure Global on Navigating ANVISA Inspections for Market Success.
    2025/08/28
    Entering the Brazilian MedTech market is a massive opportunity, but it comes with a critical gatekeeper: the ANVISA Brazilian Good Manufacturing Practice, or BGMP, inspection. This episode of LATAM MedTech Insights demystifies this complex process for foreign manufacturers. We break down the step-by-step journey, from the initial application submitted by your Brazil Registration Holder to the intense, on-the-ground audit by ANVISA inspectors. We explore the nuances that go beyond standard ISO or MDSAP certifications and delve into the specific expectations of Brazilian regulators. This is your essential guide to understanding what it truly takes to get your manufacturing site approved for one of Latin America's most lucrative healthcare markets. Consider this common scenario: A U.S.-based device company, fully MDSAP certified, waited 18 months for their ANVISA inspection. They believed they were perfectly prepared, but the audit resulted in a critical non-conformity. Why? The inspectors discovered a subtle gap in their post-market surveillance data collection process that didn't align with Brazil's specific reporting requirements. This oversight led to a costly six-month delay and a complete re-submission, a frustrating setback that local expertise could have prevented. Key questions answered in this episode: 1. Why is your choice of a Brazil Registration Holder the most critical first step? 2. What are the three key documents ANVISA will scrutinize before they even schedule your visit? 3. How does an MDSAP audit differ from what a Brazilian inspector looks for on your factory floor? 4. What is the single most common reason foreign manufacturers fail their first BGMP inspection? 5. How can you prepare your shop-floor team for the detailed questions they will face? 6. What are ANVISA's expectations for traceability records, from raw material to finished device? 7. Are there new risk-based approaches that could help you bypass a physical inspection? At Pure Global, we specialize in turning these regulatory hurdles into market access pathways. We offer end-to-end regulatory consulting, acting as your local representative and leveraging AI-driven tools to ensure your submission is flawless. Don't navigate the complexities of ANVISA alone. Contact us for a strategic consultation at info@pureglobal.com or learn more by visiting https://pureglobal.com/.
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    4 分
  • Unlocking the Peruvian MedTech Market: A Pure Global Breakdown of Medical Device Registration Costs and Hidden Fees in LATAM

    Unlocking the Peruvian MedTech Market: A Pure Global Breakdown of Medical Device Registration Costs and Hidden Fees in LATAM
    2025/08/27
    This episode of LATAM MedTech Insights dives deep into the real costs of registering a medical device in Peru. We uncover why the official DIGEMID government fees are just the tip of the iceberg and explore the significant hidden expenses in local representation, technical dossier translation, and costly time delays that can derail your market entry strategy. We break down the critical strategic decision of appointing a Peru Registration Holder (PRH). Imagine a medical device scaleup, excited to enter the Peruvian market. They budget for the official fees but are blindsided when their registration is tied to a single distributor who holds their market access hostage. This common pitfall prevents them from expanding their commercial network and costs them a year in lost revenue to fix. This episode teaches you how to avoid this and other costly mistakes. Key Takeaways: * Why are official government fees only 10% of your total registration cost in Peru? * What is a Peru Registration Holder (PRH), and why is choosing the wrong one a critical strategic mistake? * How can simple Spanish translation errors lead to a complete dossier rejection by DIGEMID? * What are the hidden operational costs associated with preparing a technical file for the Peruvian market? * How can you leverage existing approvals like an FDA 510(k) or a CE Mark to potentially speed up your process? * What is the true opportunity cost of a 12-month registration delay, and how can you mitigate it? * Why is an independent local representative often a better long-term investment than your distributor? At Pure Global, we provide end-to-end regulatory consulting to help MedTech companies navigate complex markets like Peru. Our integrated approach combines local, in-country expertise with advanced AI tools to streamline dossier preparation, manage submissions, and act as your independent local representative. We turn regulatory hurdles into market opportunities. To secure and accelerate your market access in Latin America, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    3 分
  • LATAM MedTech Insights by Pure Global: Leveraging FDA Approval & CE Marks for Medical Device Registration in Chile's Evolving Market

    LATAM MedTech Insights by Pure Global: Leveraging FDA Approval & CE Marks for Medical Device Registration in Chile's Evolving Market
    2025/08/26
    Many MedTech innovators see their FDA approval or CE mark as a golden ticket to Latin America, often targeting Chile first due to its reputation as an accessible market. However, the ground rules are changing fast. What was once a largely voluntary system is now shifting to a mandatory registration framework for all medical devices, creating new hurdles for unprepared companies. This episode of LATAM MedTech Insights dives into the reality of entering the Chilean market today. We uncover why your existing certifications are not a direct passport for sales but are the critical foundation for a successful regulatory submission to Chile's health authority, the ISP. What you'll learn in this episode: - Why was Chile historically considered an "easy" market in LATAM, and why is this no longer true? - Is registration with the ISP now mandatory for all medical devices? - Can I sell my device directly in Chile if it has FDA 510(k) clearance? - What is the role of a Certificate of Free Sale (CFS) in the Chilean registration process? - How does the ISP review technical dossiers based on CE marking or FDA approval? - What are the biggest mistakes companies make when entering the Chilean MedTech market? - Do I need a local legal representative or registration holder in Chile? - How long does the registration process typically take for a device with prior CE/FDA approval? Navigating the nuances of market access in Chile and across Latin America requires local expertise and a strategic approach. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, acting as your local representative and using advanced AI tools to streamline global market access. Let us help you turn your existing approvals into successful registrations. Contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    3 分
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