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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

03:16

Unlocking LATAM's MedTech Potential: Pure Global's...

LATAM MedTech Insights ·

2025/09/29

In this episode of LATAM MedTech Insights, we explore the lucrative yet complex market for infusion pumps in Latin America. As hospitals across the region upgrade their technology for better patient outcomes, the demand for advanced medication delivery systems is at an all-time high. However, gaining market access is a formidable challenge, with each country's regulatory agency—from Brazil's ANVISA to Mexico's COFEPRIS—imposing unique and stringent requirements.We uncover the specific hurdles

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02:54

LATAM's New Breath: Navigating Brazil's Ventilator...

LATAM MedTech Insights ·

2025/09/28

In this episode of LATAM MedTech Insights, we move beyond the headlines of the pandemic to uncover the real state of the respiratory device market in Latin America. The urgent rush for ventilators has subsided, leaving behind a complex landscape of equipment surplus, shifting clinical needs, and formidable regulatory barriers. We explore how the focus is moving from emergency ICU equipment to long-term solutions for chronic conditions like COPD and sleep apnea, creating new opportunities for agile

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02:53

Navigating Brazil & Mexico's Hemodialysis Market: A...

LATAM MedTech Insights ·

2025/09/27

In this episode of LATAM MedTech Insights, we explore the rapidly growing but complex market for hemodialysis machines and dialyzers in Latin America. We uncover the key drivers behind the region's multi-billion dollar renal care industry, focusing on the specific regulatory, logistical, and commercial hurdles in key countries like Brazil, Mexico, and Colombia.We examine real-world scenarios where manufacturers have faced significant delays and strategic pivots. For example, a European dialyzer

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05:01

Cracking the Code of LATAM MedTech with Pure Global:...

LATAM MedTech Insights ·

2025/09/26

In this episode of LATAM MedTech Insights, we demystify the medical device registration process in Peru by taking a close look at the foundational regulation: Supreme Decree Nº 016-2011-SA. We explore how the national authority, DIGEMID, uses a risk-based classification system and what this means for your specific device.We break down the critical requirements that often create barriers for foreign manufacturers, including the mandatory appointment of a Peruvian Registration Holder (PRH) and the

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03:51

Navigating Chile's Technovigilance Maze: A Pure...

LATAM MedTech Insights ·

2025/09/25

In this episode of LATAM MedTech Insights, we provide a detailed analysis of Chile's Resolution Exenta No. 1618/2020, a landmark regulation that established a strict technovigilance framework for medical devices. We dissect the specific reporting obligations, mandatory timelines, and the critical role of the in-country legal representative.This session moves beyond theory to explore the practical challenges and common mistakes foreign manufacturers face when dealing with the Chilean health

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03:32

Pure Global's MedTech Guide: Mastering Brazil's...

LATAM MedTech Insights ·

2025/09/24

In this episode of LATAM MedTech Insights, we dissect the crucial updates to Brazil's medical device regulations, specifically ANVISA's RDC 497/2021 and the recent amendment RDC 850/2024. We explore how these resolutions have fundamentally changed the administrative process for obtaining and renewing the essential Brazilian Good Manufacturing Practice (B-GMP) certificate.We uncover why the recent extension of B-GMP validity from two to four years makes a flawless submission more critical than

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00:24

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LATAM MedTech Insights ·

2025/09/23

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03:09

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

LATAM MedTech Insights ·

2025/09/22

This episode of LATAM MedTech Insights offers a detailed guide to registering your medical device in Colombia, focusing on the foundational regulation, Decree 4725 of 2005. We break down the essential requirements set by Colombia's regulatory authority, INVIMA, providing manufacturers with a clear roadmap for successful market entry into one of Latin America's most dynamic healthcare markets.Imagine your company has developed an innovative Class IIb diagnostic device. You are ready to tap into the

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05:56

LATAM MedTech Insights by Pure Global: Mastering...

LATAM MedTech Insights ·

2025/09/21

In this episode of LATAM MedTech Insights, we demystify the seemingly simple but highly nuanced process of renewing medical device registrations in Argentina. We take a close look at the specific requirements outlined in ANMAT's Disposition 2318/2002, focusing on the critical 90-day submission deadline and the legally binding "sworn declaration."We explore the common pitfalls that can lead to costly delays and even market withdrawal. A minor change in your product's documentation or manufacturing

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03:58

Pure Global Presents LATAM MedTech Insights:...

LATAM MedTech Insights ·

2025/09/20

This episode of LATAM MedTech Insights provides a detailed analysis of Mexico's mandatory Good Manufacturing Practices (GMP) standard, NOM-241-SSA1-2021. We explore the critical requirements for medical device manufacturers, importers, and distributors operating in Mexico, focusing on the pillars of a compliant Quality Management System (QMS), risk management, and supply chain control. We break down what COFEPRIS, Mexico's health authority, looks for during an audit and why simply being ISO 13485

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03:00

Cracking the Code of Mexican MedTech: Pure Global's...

LATAM MedTech Insights ·

2025/09/19

In this episode of LATAM MedTech Insights, we explore the intricate details of Mexico's medical device labeling standard, NOM-137-SSA1-2008. As one of Latin America's largest MedTech markets, Mexico presents a huge opportunity, but access is strictly controlled by its regulatory body, COFEPRIS.We break down the most common mistakes foreign manufacturers make, from language requirements to the specific data that must be present on your packaging. Learn how to navigate the nuances of primary versus

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04:01

LATAM MedTech Insights: A Pure Global Guide to...

LATAM MedTech Insights ·

2025/09/18

In this episode of LATAM MedTech Insights, we demystify the mandatory INMETRO certification for electro-medical devices in Brazil. We break down the critical requirements of Ordinance 384/2020, a regulation that serves as a vital gatekeeper to one of Latin America's most significant markets. We'll guide you through the conformity assessment process, from selecting a Certification Body to undergoing factory audits and product testing.We explore the distinct roles of ANVISA and INMETRO, clarifying

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03:20

Pure Global's Deep Dive into ANVISA RDC 751/2022:...

LATAM MedTech Insights ·

2025/09/17

This episode of LATAM MedTech Insights unpacks the significant changes introduced by Brazil's new medical device regulation, ANVISA RDC 751/2022. We explore how this new framework moves Brazil towards harmonization with international standards, particularly the EU MDR, and what this means for global MedTech companies.We break down the practical impact of the updated risk classification system and the new technical dossier structure. This shift is a game-changer for manufacturers, promising to

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03:27

LATAM MedTech Insights: Pure Global's Guide to...

LATAM MedTech Insights ·

2025/09/16

Brazil's MedTech market is one of the largest in Latin America, but its regulatory landscape, governed by ANVISA, can seem complex. Many SaMD companies overestimate the time and difficulty of market entry, missing out on significant opportunities. This episode demystifies the process for Class II Software as a Medical Device.We reveal the streamlined 'notificação' pathway, a simplified notification process that can lead to market approval in as little as 30 days. We walk through a real-world

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02:54

Navigating Colombia's MedTech Market with Pure...

LATAM MedTech Insights ·

2025/09/15

Colombia's MedTech market is one of the fastest-growing in Latin America, offering significant opportunities for global manufacturers. However, navigating its regulatory landscape, managed by INVIMA, presents a unique challenge that can make or break your market entry strategy: the mandatory local legal representative. This episode of LATAM MedTech Insights unpacks this critical requirement. We explore why simply appointing your in-country distributor can be a catastrophic mistake, leading to a

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03:10

Cracking COFEPRIS: Pure Global's Essential Guide to...

LATAM MedTech Insights ·

2025/09/14

In this episode of LATAM MedTech Insights, we explore the essential labeling and language regulations for Software as a Medical Device (SaMD) in Mexico. We unpack the specific requirements set by the national regulatory body, COFEPRIS, and highlight the critical importance of Spanish language localization for a successful market entry.We discuss a common pitfall through a case study: an innovative SaMD company faces a costly six-month delay in their COFEPRIS application. The reason? While all

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03:21

Unlocking Brazil's SaMD Market: Why ISO 13485 Isn't...

LATAM MedTech Insights ·

2025/09/13

In this episode of LATAM MedTech Insights, we dissect the complex world of SaMD registration in Brazil. We go beyond the surface-level question of certifications and explore the strategic nuances that can define your success in Latin America's largest market. We explain why simply having an ISO 13485 certificate, the global standard for quality management, is not enough to get your software approved by ANVISA. We uncover the critical role of Brazilian Good Manufacturing Practices (BGMP) and reveal

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03:27

Pure Global's Insider Guide: Fast-Tracking Foreign AI...

LATAM MedTech Insights ·

2025/09/12

In this episode of LATAM MedTech Insights, we demystify the process of registering a foreign-made AI medical device in Mexico. As one of Latin America's largest and most promising markets, Mexico presents a significant opportunity for MedTech innovators. However, its regulatory body, COFEPRIS, has unique requirements that can stall market entry if not navigated correctly.We explore why COFEPRIS treats AI and Software as a Medical Device (SaMD) differently than other global agencies and reveal the

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02:53

Unlocking Brazil: Pure Global's Guide to ANVISA's...

LATAM MedTech Insights ·

2025/09/11

This episode of LATAM MedTech Insights dives deep into the complex world of clinical data requirements for Software as a Medical Device (SaMD) seeking approval from Brazil's regulatory body, ANVISA. We unpack the critical regulation RDC 657/2022 and explain how ANVISA's risk-based classification system directly dictates the level of clinical evidence your company must provide.We explore the specific pathways for both low-risk and high-risk SaMD. Learn what kind of evidence can be used for simpler

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04:35

Navigating ANMAT's Stance on AI Medical Devices in...

LATAM MedTech Insights ·

2025/09/10

This episode of LATAM MedTech Insights dives into a critical question for innovators: How does Argentina's regulatory authority, ANMAT, handle artificial intelligence and machine learning in medical devices? We cut through the ambiguity to reveal that while there isn't a specific AI-only regulation, these products are actively regulated under the existing robust framework for Software as a Medical Device (SaMD).We explore the practical steps for registering an AI-powered device in Argentina, from

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