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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.

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All Episodes

02:03

Brazil's AI MedTech Gold Rush: ANVISA's Hidden Rules...

LATAM MedTech Insights ·

2026/01/11

This week, we dissect the groundbreaking news from Brazil's ANVISA: a new fast-track approval pathway for AI-powered medical devices. This move promises to slash approval times and revolutionize the digital health landscape, but the opportunities are wrapped in complex new challenges.We go beyond the headlines to explore the intricate new requirements for clinical data, cybersecurity, and local data privacy laws that could derail even the most prepared global companies. Discover why this

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02:08

Brazil's AI MedTech Shake-Up: Pure Global on Cracking...

LATAM MedTech Insights ·

2026/01/09

This week, we dive into a major regulatory shift in Brazil that's sending shockwaves through the digital health sector. ANVISA, the national health surveillance agency, has just released RDC 899, a groundbreaking resolution that imposes stringent new cybersecurity and data privacy rules for all Software as a Medical Device (SaMD).This update creates immediate challenges for MedTech companies, especially those leveraging AI and machine learning. The resolution requires deep integration with

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01:58

Pure Global: Brazil's ANVISA 2025 Regs - Navigating...

LATAM MedTech Insights ·

2026/01/08

This week on LATAM MedTech Insights, we dissect the latest 2025 medical device registration guidance from Brazil's ANVISA. While the new framework aims to streamline market access, it has introduced a host of undocumented challenges that are causing significant delays for international manufacturers. We explore the gap between the official regulations and the practical hurdles companies are facing right now.From the specific demands of the new digital submission portal to the increased technical

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01:45

Pure Global: Decoding Brazil's Shock ANVISA Shift on...

LATAM MedTech Insights ·

2026/01/07

This week, we dissect the surprise technical note from Brazil's ANVISA that just reshaped the rules for market entry. This clarification to RDC 751 demands more stringent, localized clinical evidence for high-risk devices, creating a significant new hurdle for international MedTech manufacturers looking to enter Latin America's largest market.We explore the immediate impact on companies that have long relied on their FDA or CE Marking data for Brazilian submissions. This isn't just a new piece of

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02:15

Pure Global | Brazil's MedTech Shift: Cracking...

LATAM MedTech Insights ·

2026/01/06

Brazil's health agency, ANVISA, has just launched a new digital portal, ending weeks-long delays for essential medical device certificates. This major shift from paper to a fully online system promises to accelerate market access, enhance transparency, and slash the administrative burden that has long frustrated manufacturers trying to enter Latin America's largest market.This episode breaks down what this digital transformation truly means for the industry. Consider a company whose multi-million

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01:41

Pure Global: Mexico's DigiReg Shift - Navigating...

LATAM MedTech Insights ·

2026/01/03

In this episode of LATAM MedTech Insights, we dissect the chaotic rollout of COFEPRIS's new mandatory digital platform, 'DigiReg'. Launched in the last week of December 2025, this platform was meant to be the final step in simplifying medical device registration in Mexico. Instead, it has created a maze of technical glitches and undocumented requirements.We explore how this "simplification paradox" is catching foreign manufacturers off guard. For instance, a leading European diagnostics firm found

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01:52

Pure Global: Mexico's MedTech Shift - Unseen Hurdles...

LATAM MedTech Insights ·

2026/01/02

This episode dives into the most overlooked but critical MedTech trend in Latin America as of late 2025: the dramatic tightening of post-market surveillance rules. While most companies focus on getting their device approved, regulatory bodies like Mexico's COFEPRIS and Brazil's ANVISA have shifted their focus to what happens *after* a product hits the market. We uncover the new requirements for faster reporting, real-world evidence, and data transparency that are creating major compliance risks for

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02:25

Mexico's Fast-Track Trap: Pure Global on AI MedTech's...

LATAM MedTech Insights ·

2025/12/21

Mexico's MedTech market is buzzing with the news of COFEPRIS's new fast-track approval pathway, promising quicker market access for devices with existing international approvals. This move positions Mexico as a key entry point into Latin America, attracting significant global interest. However, beneath this promising headline lies a complex new reality.The updated regulations include stringent new requirements for AI-driven software and connected devices, focusing heavily on cybersecurity and

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02:05

Argentina's SaMD Data Tango: Pure Global on ANMAT's...

LATAM MedTech Insights ·

2025/12/20

This week, we dive into a sudden and seismic regulatory shift in Argentina. ANMAT's newly issued Resolution 785/2025 has introduced strict data localization and cybersecurity audit requirements for all Software as a Medical Device (SaMD) and connected devices, sending shockwaves through the industry. This episode breaks down the immediate implications for foreign manufacturers, who now face a tight 180-day deadline to overhaul their data infrastructure. We explore the strategic challenges posed by

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02:03

Pure Global: Brazil's AI Device Gambit—ANVISA's New...

LATAM MedTech Insights ·

2025/12/19

This week, we dissect a game-changing regulatory shift in Latin America's largest market. Brazil's ANVISA has just proposed a new fast-track approval process for AI-driven medical software, promising to slash market entry timelines for devices already approved by agencies like the FDA. But a closer look reveals a complex new challenge that could catch even the most prepared companies off guard.Imagine you're a global MedTech company with an FDA-cleared diagnostic AI. You see the 'fast-track' news

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02:24

Brazil's SaMD Gambit: Unlocking ANVISA's New...

LATAM MedTech Insights ·

2025/12/18

This week, we dissect a game-changing regulatory shift in Latin America's largest market. Brazil's ANVISA has just launched a new resolution for Software as a Medical Device (SaMD), creating an unprecedented fast-track pathway for innovative digital health products. This move promises to slash approval times and attract global investment.But there's a catch. While the new "fast-track" leverages existing international approvals, it also imposes stricter, more sophisticated requirements on technical

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02:12

Brazil's SaMD Cybersecurity Shockwave: Pure Global on...

LATAM MedTech Insights ·

2025/12/17

Last week, Brazil's ANVISA unleashed a pivotal update for Software as a Medical Device (SaMD) with its new resolution, RDC 992/2025. While appearing to align with international standards, this new regulation introduces complex cybersecurity and data privacy requirements tied specifically to Brazil's LGPD law, creating unexpected hurdles for global manufacturers. In this episode of LATAM MedTech Insights, we dissect the fine print of ANVISA's new rules. We explore the immediate operational impacts,

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01:51

Brazil's MDR Surprise: ANVISA's Hidden Clause for...

LATAM MedTech Insights ·

2025/12/16

This week, we dissect the immediate fallout from ANVISA's surprise regulatory shift in Brazil. While the move towards EU MDR alignment was expected, a hidden clause mandating local usability studies for high-risk devices has caught many international MedTech firms by surprise, threatening to delay launches and inflate budgets.We explore the specifics of the new RDC 987/2025 resolution and what it means for companies who previously relied on their CE marking for a smoother entry into Latin

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02:05

Brazil's ANVISA AI Gambit: Pure Global on Hacking the...

LATAM MedTech Insights ·

2025/12/15

Last week, Brazil's regulatory agency, ANVISA, unveiled a groundbreaking 2025 plan to tackle its notorious medical device approval backlogs. The initiative, named "AnvisAI," leverages artificial intelligence to create an automated fast-track system for lower-risk devices, aiming to cut review times by more than half and reshape the market access landscape. This move signals a major shift, potentially transforming Brazil from one of the most challenging LATAM markets into a hub for MedTech

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02:04

Pure Global: Brazil's MedTech Leap to Digital - The...

LATAM MedTech Insights ·

2025/12/14

This week, we dissect a major regulatory shake-up in Latin America's largest MedTech market: Brazil. ANVISA, the national health surveillance agency, has just initiated a pivotal shift from paper to digital, while simultaneously revoking its traceability regulations. This move promises to cut costs and streamline logistics for manufacturers but introduces a new host of digital compliance and supply chain challenges.We explore how this digital-first policy impacts a device manufacturer's entire

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02:41

São Paulo SaMD Shake-Up: Pure Global on ANVISA’s...

LATAM MedTech Insights ·

2025/12/13

Brazil's MedTech landscape is buzzing as its regulatory agency, ANVISA, puts Software as a Medical Device (SaMD) back under the microscope. In its newly released 2024-2025 agenda, ANVISA has signaled major revisions to the existing framework, a move that comes sooner than many in the industry expected. This suggests that the initial guidelines are already being outpaced by rapid advancements in digital health, especially in AI and machine learning. This episode dives deep into the implications for

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02:05

Pure Global LATAM Insights: Brazil's SaMD Shakeup -...

LATAM MedTech Insights ·

2025/12/12

Brazil's regulatory agency, ANVISA, is updating its rules for Software as a Medical Device (SaMD) as a key priority for 2025. This major overhaul will align Brazil’s digital health landscape with global standards like the EU MDR, introducing stricter requirements for cybersecurity, interoperability, and technical documentation. This change presents a critical challenge for MedTech innovators. For example, a US-based AI diagnostics company eager to enter the lucrative Brazilian market now faces new,

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02:09

Pure Global: Brazil's MedTech Data Shock - ANVISA's...

LATAM MedTech Insights ·

2025/12/11

Last week, Brazil's ANVISA implemented a sudden and strict new regulation for cybersecurity in connected medical devices. This unexpected move introduces mandatory data localization, forcing companies to store Brazilian patient data on servers within the country, creating significant technical and financial hurdles for global manufacturers. This episode of LATAM MedTech Insights unpacks the immediate impact of this new rule. We explore the specific technical requirements, the short 90-day

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02:03

Brazil's AI MedTech Leap: Pure Global on Cracking...

LATAM MedTech Insights ·

2025/12/10

Brazil's regulatory agency, ANVISA, has just redefined the future of digital health in Latin America with its new, comprehensive framework for AI-powered Software as a Medical Device (SaMD). This landmark regulation introduces a stricter risk classification system and new requirements for algorithm validation and cybersecurity, directly impacting any MedTech company looking to enter or grow in the region's largest market. This episode of LATAM MedTech Insights provides a crucial analysis of these

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02:18

Pure Global: Brazil's Clinical Trial Overhaul - The...

LATAM MedTech Insights ·

2025/12/09

This week on LATAM MedTech Insights, we're diving into a groundbreaking regulatory shift in Brazil. For years, launching a clinical trial in Latin America's largest market was a high-risk gamble due to unpredictable and lengthy approval processes. Now, everything has changed. A new Clinical Research Statute is dismantling these old barriers, aiming to slash approval times and make Brazil a global hub for MedTech innovation. We explore the concrete changes to the ethics review system and what this

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