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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
  • Navigating INVIMA: A Guide to Colombia's Spanish Medical Device Labeling Requirements with Pure Global's Expert Insights

    Navigating INVIMA: A Guide to Colombia's Spanish Medical Device Labeling Requirements with Pure Global's Expert Insights
    2025/08/25
    In this episode of LATAM MedTech Insights, we explore the non-negotiable Spanish labeling requirements for medical devices in Colombia. We delve into INVIMA's regulations under Decree 4725 and explain why simply having FDA or CE approval isn't enough to guarantee a smooth market entry. We’ll walk through a real-world case study of a US company whose launch was delayed by six months due to overlooked translation of their device's software and manual. This costly mistake highlights the critical importance of a localized approach and the severe commercial impact of non-compliance. Learn what "labeling" truly covers and how to avoid common pitfalls. Key Questions Answered in This Episode: - What specific Colombian decree mandates Spanish for medical device labels? - Does "labeling" include just the box, or also the software and user manual? - Can I use a simple sticker with Spanish translation over my original English label? - What are the real business costs of getting the language requirement wrong in Colombia? - Why is a direct machine translation of my IFU a high-risk strategy? - How early in my product development should I plan for multi-language labeling? - What's the best practice for designing packaging for both US and Colombian markets? At Pure Global, we specialize in navigating these complex regulatory landscapes. We provide end-to-end solutions, from local representation to AI-powered technical dossier preparation, ensuring your MedTech and IVD products meet all local requirements in over 30 countries. Don't let language be a barrier to your success. Contact us for a consultation at info@pureglobal.com or visit https://pureglobal.com/.
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    4 分
  • Pure Global's Guide to ANMAT: Why Your Choice of Medical Device Registration Holder in Argentina Can Make or Break Your LATAM Market Access.

    Pure Global's Guide to ANMAT: Why Your Choice of Medical Device Registration Holder in Argentina Can Make or Break Your LATAM Market Access.
    2025/08/24
    In this episode of LATAM MedTech Insights, we dive into one of the most critical and often misunderstood aspects of entering the Argentine medical device market: the role of the local registration holder. While ANMAT's requirement for a local representative seems straightforward, the legal implications of who you choose can have massive consequences for your business. We explore why appointing your commercial distributor as your registration holder can be a high-risk strategy. This episode uncovers how this common practice can lead to a complete loss of market access, forcing companies to restart the costly and time-consuming registration process from zero. We detail the strategic advantages of separating your regulatory representation from your commercial partnerships to ensure business continuity and protect your investment. **What You'll Learn:** - Why is ANMAT's requirement for a local registration holder more than just an administrative step? - What are the hidden risks of appointing your distributor as your registration holder in Argentina? - Who legally owns your medical device registration in Argentina, and why does it matter? - If you split with your local partner, what happens to your hard-won market approval? - How can an independent representative provide business continuity and control over your assets? - Is this registration ownership model unique to Argentina, or is it a common theme in LATAM? - What key criteria should you use when selecting a local registration holder in Argentina? At Pure Global, we specialize in providing independent, expert local representation to safeguard your market access. We act as your registration holder across Latin America, ensuring you maintain full control over your assets while having the flexibility to build the best commercial strategy. Ready to secure and streamline your entry into Argentina? Contact us at info@pureglobal.com or visit https://pureglobal.com/ for a strategic consultation.
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    10 分
  • Navigating MedTech in LATAM: A Pure Global Deep Dive into Medical Device Classification Rules in Brazil, Mexico, and Colombia

    Navigating MedTech in LATAM: A Pure Global Deep Dive into Medical Device Classification Rules in Brazil, Mexico, and Colombia
    2025/08/23
    In this episode of LATAM MedTech Insights, we demystify the complex web of medical device classification rules across Latin America's key markets. While most countries use a risk-based system, the specific requirements of agencies like Brazil's ANVISA, Mexico's COFEPRIS, and Colombia's INVIMA present unique challenges that can derail market entry for unprepared companies. We explore how seemingly minor details in documentation, translation, and local procedural norms can lead to major delays. This episode provides essential insights for any MedTech company looking to expand into this dynamic but demanding region, moving beyond the regulations to discuss real-world examples and common pitfalls. For example, consider a European MedTech company with a CE-marked Class IIa device. They targeted Colombia, assuming a smooth registration process due to the similar classification system. However, they faced a six-month delay because their technical dossier, while compliant in the EU, lacked specific local declarations and formatting required by INVIMA. This small oversight cost them a critical sales season and highlighted the importance of localized expertise. Key questions answered in this episode: - Why isn't there a single classification system for all of Latin America? - What's the crucial difference between Brazil's `Cadastro` and `Registro` pathways? - How can a reference country approval from the FDA help in Mexico, and what is the most common mistake companies make in the process? - Why does Colombia's EU-like system still catch experienced European manufacturers by surprise? - What are the top three documentation details that lead to registration rejection in these key markets? - How do device grouping or family definitions differ between ANVISA, COFEPRIS, and INVIMA? At Pure Global, we specialize in turning these regulatory challenges into market opportunities. Our combination of local experts in over 30 markets and advanced AI-powered data tools ensures your path to registration is clear and efficient. Don't let regulatory details derail your LATAM expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can accelerate your market access.
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    3 分
  • From FDA to LATAM: How Pure Global Helps Navigate the COFEPRIS Medical Device Pathway in Mexico for Faster Market Access

    From FDA to LATAM: How Pure Global Helps Navigate the COFEPRIS Medical Device Pathway in Mexico for Faster Market Access
    2025/08/22
    This episode of LATAM MedTech Insights dives deep into the medical device approval process in Mexico, governed by the regulatory body COFEPRIS. We demystify the requirements, from device classification to the critical role of a local registration holder, providing a clear roadmap for international MedTech companies looking to enter this lucrative market. We explore the strategic pathways that can save you valuable time and resources. Discover how leveraging your existing approvals from bodies like the US FDA or Health Canada can dramatically accelerate your journey to market, transforming a potentially lengthy process into a streamlined and predictable one. A US-based scaleup with a novel Class II device faced this exact scenario. Their initial submission was stalled for over a year due to documentation errors and a lack of a clear strategy, costing them valuable time and market opportunity. This episode reveals how leveraging an often-overlooked equivalency pathway could have cut their approval time in half and avoided costly mistakes. Key Takeaways from this episode: 1. What are the four main risk classifications for medical devices in Mexico? 2. How can you use your existing FDA or Health Canada approval to speed up COFEPRIS registration? 3. What is a Mexican Registration Holder (MRH), and why is choosing the right one critical to your business's future? 4. What common documentation mistakes lead to costly delays with COFEPRIS? 5. How does the new "Abbreviated Pathway" coming in 2025 change the game for manufacturers? 6. Is it better to use your distributor as your MRH, or an independent third party? 7. What are the specific post-market surveillance requirements you must meet in Mexico? At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. We act as your local representative in over 30 markets, including Mexico, to get your product approved and maintain compliance. Contact us to learn how we can accelerate your entry into the LATAM market at info@pureglobal.com or visit us at https://pureglobal.com/.
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    4 分
  • LATAM MedTech Insights by Pure Global: A Strategic Guide to ANVISA Medical Device Registration in Brazil

    LATAM MedTech Insights by Pure Global: A Strategic Guide to ANVISA Medical Device Registration in Brazil
    2025/08/21
    Brazil's MedTech market is a massive opportunity, but ANVISA's complex and unique regulatory requirements can be a significant barrier for foreign manufacturers. This episode provides a clear, step-by-step guide to navigating the medical device registration process, breaking down everything from initial classification to post-market responsibilities. We uncover the critical decisions and common pitfalls that can delay your market entry by years and cost you millions. Learn the strategic importance of every step, from selecting a local partner to preparing for rigorous facility audits, and discover how to leverage recent regulatory changes to your advantage. **Featured Case:** Imagine spending two years and hundreds of thousands of dollars to get your innovative medical device approved in Brazil, only to realize your distributor legally owns your registration. When you decide to switch to a better partner, you're forced to start the entire lengthy and expensive process all over again. This episode explains how this common and costly trap occurs and provides a clear strategy to avoid it from day one. **Key Questions Answered:** - Why is choosing your Brazil Registration Holder (BRH) the single most critical decision for market access? - What is the difference between a Cadastro and a Registro submission, and which path does your device need to follow? - Can my existing FDA clearance or CE Mark help fast-track my ANVISA application? - What specific preparations are needed to pass the mandatory Brazilian Good Manufacturing Practice (BGMP) audit? - Is it possible for a foreign company to register a device without a physical office in Brazil? - How do you avoid the common pitfall of losing your device registration when you change local distributors? - What are the latest regulatory updates from ANVISA that can accelerate your approval timeline? - Why must all technical documentation be submitted in Brazilian Portuguese, and what's the best way to manage this? At Pure Global, we offer end-to-end regulatory solutions to streamline your global market access. We act as your independent local representative in Brazil and over 30 other markets, ensuring you always maintain full control of your assets. Our team combines local expertise with advanced AI tools to efficiently manage technical dossiers, navigate complex submissions, and monitor regulatory changes. Don’t let regulatory hurdles block your entry into LATAM's most promising market. Contact us today at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can accelerate your path to market.
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    8 分