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PODCAST

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.

science life sciences

All Episodes

03:47

Unlocking Colombia's MedTech Market: A Pure Global...

LATAM MedTech Insights ·

2025/09/09

As Colombia's healthcare market embraces digital transformation, understanding the regulatory pathway for Software as a Medical Device (SaMD) is crucial for innovators. This episode of LATAM MedTech Insights demystifies the INVIMA registration process, revealing that SaMD is not regulated under a separate framework, but through the country's existing medical device decrees. We provide a clear, step-by-step guide for manufacturers looking to enter this promising market.We break down the essential

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03:17

Pure Global's LATAM MedTech Insights: Decoding...

LATAM MedTech Insights ·

2025/09/08

In this episode of LATAM MedTech Insights, we explore the significant regulatory shift in Mexico concerning AI-powered medical software. Mexico's health authority, COFEPRIS, has updated its framework, moving away from treating software as a simple accessory to classifying it as a regulated medical device in its own right. This change is crucial for any MedTech company aiming to penetrate the vibrant Mexican market. We break down the new risk-based classification system—Class I, II, and III—and

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03:09

Pure Global Presents: Decoding ANVISA's AI & SaMD...

LATAM MedTech Insights ·

2025/09/07

This week on LATAM MedTech Insights, we demystify the regulatory maze of Brazil's ANVISA for companies developing AI and Software as a Medical Device (SaMD). As the largest market in Latin America, Brazil presents a massive opportunity, but its regulatory agency, ANVISA, has specific and stringent requirements that can stall market entry if you're unprepared. We explore the cornerstone regulation, RDC 657/2022, and how it interacts with the broader medical device framework. We break down the

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03:21

Navigating ANVISA in Brazil: Pure Global Explains the...

LATAM MedTech Insights ·

2025/09/06

This episode of LATAM MedTech Insights tackles a critical question for manufacturers entering Brazil: Is a Good Manufacturing Practice (GMP) certificate really required for low-risk, Class I medical devices? We explore the common misconceptions surrounding ANVISA's RDC 751/2022 regulation and the simplified *notificação* registration pathway. Many companies assume the lack of an upfront certificate submission means compliance is optional. This can be a costly mistake. We reveal how ANVISA's

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03:21

Pure Global Presents: The LATAM Labeling Labyrinth -...

LATAM MedTech Insights ·

2025/09/05

This episode of LATAM MedTech Insights dives deep into the often-underestimated challenge of labeling requirements for low-risk medical devices in Latin America. We uncover the fragmented regulatory landscape and reveal why a one-size-fits-all approach is doomed to fail. We explore the specific, nuanced requirements of key markets including Brazil (ANVISA), Mexico (COFEPRIS), Colombia (INVIMA), and Argentina (ANMAT), moving beyond simple language translation to discuss the critical data points that

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02:56

Unlocking Brazil's MedTech Market: The Critical Role...

LATAM MedTech Insights ·

2025/09/04

This episode of LATAM MedTech Insights dives into a critical, often misunderstood, aspect of entering the Brazilian market: the requirement of a Brazil Registration Holder (BRH) for low-risk, Class I medical devices. While these devices follow a simplified "notificação" process instead of a full registration, foreign manufacturers are still legally required to have a local entity representing them before the regulatory body, ANVISA.We explore why this requirement exists and the significant risks

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06:02

Unlocking MedTech in Colombia: A Pure Global Guide to...

LATAM MedTech Insights ·

2025/09/03

In this episode of LATAM MedTech Insights, we demystify the "automatic" registration process for low-risk medical devices in Colombia. We explore the requirements set by the national regulatory body, INVIMA, for Class I and IIa devices, detailing the specific documentation needed for a successful and speedy market entry.We break down why this streamlined pathway is a major advantage for MedTech manufacturers targeting the Colombian market. Learn how to leverage your existing approvals and what

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03:23

Cracking the ANMAT Code with Pure Global: The...

LATAM MedTech Insights ·

2025/09/02

Entering Argentina's lucrative MedTech market presents a huge opportunity, but it's filled with regulatory complexities. A common and costly mistake manufacturers make is assuming that low-risk, Class I medical devices are exempt from registration with the national authority, ANMAT. This single misunderstanding can lead to product seizures at customs, unexpected costs, and a complete halt to your market entry strategy.In this episode, we uncover the truth behind this myth. We explore a real-world

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03:14

Cracking the COFEPRIS Code for LATAM Expansion: Pure...

LATAM MedTech Insights ·

2025/09/01

In this episode of LATAM MedTech Insights, we demystify the process of registering a low-risk (Class I) medical device in Mexico. Don't let the "low-risk" classification fool you; navigating the requirements of COFEPRIS, Mexico's health authority, is a complex journey filled with potential pitfalls that can delay your market entry indefinitely. We break down the essential steps, from appointing a legally required Mexico Registration Holder (MRH) to compiling a flawless technical dossier. We uncover

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04:11

Brazil's MedTech Maze: A Pure Global Guide to...

LATAM MedTech Insights ·

2025/08/31

This episode of LATAM MedTech Insights tackles the common misconceptions surrounding the registration of Class I medical devices in Brazil. We move beyond the outdated term "cadastro" to provide a detailed breakdown of the current "notificação" (notification) pathway managed by ANVISA. Learn why this simplified, faster route to market is often misunderstood by foreign manufacturers. We explore the critical, non-negotiable requirements that are often overlooked. From the strategic importance of

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03:36

The Mercosur MedTech Myth: Is a Single Device...

LATAM MedTech Insights ·

2025/08/30

Many MedTech companies dream of a single registration process for the entire Mercosur market, including giants like Brazil and Argentina. Is this a reality, or just a regulatory myth? This episode of LATAM MedTech Insights dives deep into the current state of regulatory harmonization in the region. We uncover the practical challenges and strategic opportunities that exist today.While Mercosur is moving towards a unified framework, the reality on the ground is a complex patchwork of national

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03:10

Colombia's INVIMA Timelines: A Pure Global Deep Dive...

LATAM MedTech Insights ·

2025/08/29

Colombia is one of Latin America's most promising MedTech markets, but gaining access requires navigating the complex regulatory landscape of its authority, INVIMA. While official timelines suggest a straightforward process, the reality on the ground can be quite different, with unexpected delays impacting launch plans and revenue forecasts.In this episode, we uncover the real-world timelines for medical device registration in Colombia. We explore a case study of a European orthopedic company that

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03:34

Cracking the Code of Brazil's BGMP: A LATAM MedTech...

LATAM MedTech Insights ·

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

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03:17

Unlocking the Peruvian MedTech Market: A Pure Global...

LATAM MedTech Insights ·

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

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03:24

LATAM MedTech Insights by Pure Global: Leveraging FDA...

LATAM MedTech Insights ·

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

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03:40

Navigating INVIMA: A Guide to Colombia's Spanish...

LATAM MedTech 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

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10:15

Pure Global's Guide to ANMAT: Why Your Choice of...

LATAM MedTech Insights ·

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

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03:22

Navigating MedTech in LATAM: A Pure Global Deep Dive...

LATAM MedTech Insights ·

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

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03:36

From FDA to LATAM: How Pure Global Helps Navigate the...

LATAM MedTech Insights ·

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

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08:17

LATAM MedTech Insights by Pure Global: A Strategic...

LATAM MedTech Insights ·

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

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81 results

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