LATAM MedTech Insights

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.

Episodes

LATAM MedTech Insights by Pure Global: Leveraging FDA Approval & CE Marks for Medical Device Registration in Chile's Evolving Market

August 26, 2025 • 3 mins

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 th...

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

August 25, 2025 • 3 mins

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 s...

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Pure Global's Guide to ANMAT: Why Your Choice of Medical Device Registration Holder in Argentina Can Make or Break Your LATAM Market Access.

August 24, 2025 • 10 mins

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 r...

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Navigating MedTech in LATAM: A Pure Global Deep Dive into Medical Device Classification Rules in Brazil, Mexico, and Colombia

August 23, 2025 • 3 mins

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, tr...

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From FDA to LATAM: How Pure Global Helps Navigate the COFEPRIS Medical Device Pathway in Mexico for Faster Market Access

August 22, 2025 • 3 mins

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 resourc...

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LATAM MedTech Insights by Pure Global: A Strategic Guide to ANVISA Medical Device Registration in Brazil

August 21, 2025 • 8 mins

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 ...

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Unlocking Brazil's MedTech Market: A Pure Global Deep Dive on ANVISA Medical Device Registration for Your LATAM Strategy

August 19, 2025 • 3 mins

Brazil represents the largest MedTech market in Latin America, but its regulatory landscape, governed by the agency ANVISA, is one of the most demanding in the world. This episode breaks down the essential steps and common pitfalls companies face when seeking medical device approval in this complex market. We provide a clear overview of the multi-layered process, from initial facility certification to final product registration.

We ...

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LATAM MedTech Insights

Episodes

.css-14f5ked{margin:0;word-break:break-word;display:-webkit-box;-webkit-box-orient:vertical;box-orient:vertical;-webkit-line-clamp:2;overflow:hidden;}LATAM MedTech Insights by Pure Global: Leveraging FDA Approval & CE Marks for Medical Device Registration in Chile's Evolving Market

.css-r6mb8g{margin:0;word-break:break-word;display:-webkit-box;-webkit-box-orient:vertical;box-orient:vertical;-webkit-line-clamp:1;overflow:hidden;}Navigating INVIMA: A Guide to Colombia's Spanish Medical Device Labeling Requirements with Pure Global's Expert Insights

Pure Global's Guide to ANMAT: Why Your Choice of Medical Device Registration Holder in Argentina Can Make or Break Your LATAM Market Access.

Navigating MedTech in LATAM: A Pure Global Deep Dive into Medical Device Classification Rules in Brazil, Mexico, and Colombia

From FDA to LATAM: How Pure Global Helps Navigate the COFEPRIS Medical Device Pathway in Mexico for Faster Market Access

LATAM MedTech Insights by Pure Global: A Strategic Guide to ANVISA Medical Device Registration in Brazil

Unlocking Brazil's MedTech Market: A Pure Global Deep Dive on ANVISA Medical Device Registration for Your LATAM Strategy

Popular Podcasts

LATAM MedTech Insights by Pure Global: Leveraging FDA Approval & CE Marks for Medical Device Registration in Chile's Evolving Market

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