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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

01:49

Pure Global: Brazil's AI MedTech Fast-Track, Decoding...

LATAM MedTech Insights ·

2026/04/25

This week, we dissect the seismic news from Brazil. ANVISA just launched an accelerated approval pathway for AI-powered medical devices, creating a potential gold rush for MedTech innovators. This episode explores the immense opportunity for rapid market entry and the critical, hidden compliance challenges that come with it.We uncover the stringent new post-market surveillance and data reporting requirements that could trap unprepared manufacturers. Imagine securing a landmark approval for your

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01:58

Pure Global: Brazil's AI Software Gambit - Decoding...

LATAM MedTech Insights ·

2026/04/24

Brazil's health regulator, ANVISA, has just shaken up the digital health landscape. A new draft resolution brings critical clarifications for AI-powered medical software, creating a clearer but much stricter pathway to Latin America's largest market. This move could accelerate innovation for some, while creating major new hurdles for others.This episode unpacks the critical details of this regulatory shift. We explore the dilemma facing manufacturers of AI-driven diagnostics: the new rules provide

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01:44

Pure Global: Costa Rica's MedTech Gambit - The New...

LATAM MedTech Insights ·

2026/04/23

This week, we dive into a game-changing development out of Costa Rica. Long known as a premier manufacturing hub for MedTech, the country just launched the "Medical Device Innovation Pathway" (MDIP), a new accelerated registration process exclusively for locally manufactured devices. This move could redefine market entry strategies across Latin America, offering unprecedented speed but with significant new hurdles.We unpack what the MDIP truly entails, moving beyond the headlines to analyze the

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01:52

Pure Global: Brazil's ANVISA Shift – Cracking the...

LATAM MedTech Insights ·

2026/04/22

This week, we dissect the latest critical guidance from Brazil's ANVISA on RDC 751, a regulation that aligns the country's medical device framework with the EU's MDR. This is more than a policy update. it's a strategic shift that redefines the requirements for market access in Latin America's powerhouse. We explore the immediate impact on technical dossiers, post-market surveillance, and the newly empowered role of the Brazil Registration Holder.This episode is for any MedTech manufacturer eyeing

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02:22

Brazil's AI MedTech Surprise: Pure Global on ANVISA's...

LATAM MedTech Insights ·

2026/04/21

This week on LATAM MedTech Insights, we dissect the groundbreaking new regulatory framework released by Brazil's ANVISA for AI-powered medical devices. Announced just last week, this move positions Brazil as a leader in digital health regulation in Latin America, but it also creates significant new hurdles for innovators looking to enter the market.We explore the specific requirements of the new resolution, including the critical and non-negotiable need for clinical data from the local Brazilian

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02:06

Pure Global: Brazil's MedTech Renewal Riddle -...

LATAM MedTech Insights ·

2026/04/20

This week on LATAM MedTech Insights, we dissect a game-changing update from Brazil's regulatory agency, ANVISA. The validity for medical device registrations has been doubled from five to ten years. This sounds like great news, but it comes with a significant new hurdle: a mandatory mid-cycle compliance review that could catch unprepared companies off guard. We break down what this shift means for your long-term strategy in Latin America's biggest market. We explore the opportunities for reduced

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02:07

Pure Global: Brazil's ANVISA Deadline Chaos - A...

LATAM MedTech Insights ·

2026/04/19

Last week, Brazil's ANVISA sent shockwaves through the MedTech industry by announcing a hard deadline for transitioning all medical device registrations to the new RDC 751 framework. In this episode, we break down what this sudden enforcement means for foreign manufacturers, moving beyond the headlines to reveal the hidden complexities and strategic risks. We explore why existing international dossiers, like those for CE marking, may not be enough and what specific gaps ANVISA is targeting, putting

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01:51

Mexico's Digital Gate: Pure Global on COFEPRIS's...

LATAM MedTech Insights ·

2026/04/18

Mexico's regulatory authority, COFEPRIS, has just launched its mandatory all-digital submission platform, DigiPRIS. While this move promises to streamline market access, the initial rollout has created significant and unexpected challenges for medical device manufacturers, leading to submission errors, delays, and uncertainty. This episode of LATAM MedTech Insights unpacks the chaotic first week of the new system. We share a real-world case study of a cardiovascular device company whose complete

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01:52

Pure Global's Brazil Brief: Decoding ANVISA's New AI...

LATAM MedTech Insights ·

2026/04/17

In this episode, we dive into a critical regulatory update from Brazil that is sending shockwaves through the digital health community. Last week, ANVISA unexpectedly released a new instruction specifically targeting AI and Software as a Medical Device (SaMD), creating immediate hurdles for foreign manufacturers.We break down the three core changes involving clinical data, cybersecurity, and algorithm updates. This shift presents a major challenge for companies relying on international data and

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01:54

Pure Global: Brazil's New ANVISA Gambit - Cracking...

LATAM MedTech Insights ·

2026/04/16

This week, we dive into a sudden and pivotal regulatory shift in Brazil. ANVISA has just launched a new fast-track approval pathway for medium-risk medical devices, a move that could dramatically accelerate market entry. But this opportunity comes with a complex new requirement that is already tripping up unprepared manufacturers.In this episode, we break down exactly what ANVISA's new resolution entails. We explore the case of a German MedTech firm whose attempt to leverage this new fast-track

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01:55

Pure Global: Brazil's AI MedTech Rules – Decoding...

LATAM MedTech Insights ·

2026/04/15

This week, we dissect the critical new amendment to Brazil's RDC 657 software regulations, a move by ANVISA that specifically targets AI and machine learning devices. The update introduces complex new requirements for clinical validation, post-market changes, and cybersecurity, significantly raising the bar for market entry.We explore what these changes mean for MedTech manufacturers, why Brazil is becoming one of the most demanding markets for digital health, and how companies can adapt their

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01:44

Brazil's AI MedTech Shortcut: Cracking ANVISA's New...

LATAM MedTech Insights ·

2026/04/14

This week, we dissect breaking news from Brazil. ANVISA, the national health regulatory agency, has just launched a new fast-track pilot program for AI-powered medical software. This move could slash market entry timelines in half, but it comes with a host of new, complex requirements that could trap unprepared companies.We explore the specific opportunities this creates for MedTech innovators in the diagnostic space and the hidden challenges in clinical data and cybersecurity compliance that lie

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01:56

Pure Global: Brazil's AI MedTech Gambit - Navigating...

LATAM MedTech Insights ·

2026/04/13

Brazil's ANVISA just launched a new fast-track approval process for AI medical software, a huge opportunity for MedTech innovators. However, this golden ticket comes with a major catch: a strict data localization law that could derail market entry plans for unprepared international companies. This episode of LATAM MedTech Insights unpacks the new resolution and explores the critical strategic decisions that foreign device manufacturers now face.We delve into the dual nature of this regulation. It

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01:54

Pure Global: Brazil's Sudden MedTech Shift - Decoding...

LATAM MedTech Insights ·

2026/04/12

This week on LATAM MedTech Insights, we dissect the seismic shift in Brazil's regulatory landscape. Last week, ANVISA issued an unexpected technical note on clinical evaluation requirements under RDC 751, fundamentally altering the path to market for many international device manufacturers. We explore the end of the 'easy' equivalence route based on CE or FDA clearance and what this means for your technical dossier, budget, and timeline. This isn't just a minor update; it's a strategic challenge

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02:04

Pure Global: Brazil's AI Diagnostic Boom & The New...

LATAM MedTech Insights ·

2026/04/11

Brazil's ANVISA just opened a fast-track approval process for AI medical devices, creating a huge opportunity for MedTech innovators. But this incredible speed comes with a hidden challenge: a new set of ultra-stringent cybersecurity regulations that are catching many companies off guard and threatening to derail their launch plans. Imagine a US-based scaleup, CardioVision AI, ready to enter Brazil with their FDA-cleared diagnostic software. They see ANVISA's new fast-track and are excited for a

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01:35

Brazil's AI MedTech Gambit: Pure Global Decodes...

LATAM MedTech Insights ·

2026/04/10

This week on LATAM MedTech Insights, we dissect the groundbreaking new regulations for AI-powered medical devices just announced by Brazil's ANVISA. This move positions Brazil at the forefront of digital health governance in Latin America, but it also creates a complex new landscape for manufacturers to navigate.We break down what these changes mean, from updated cybersecurity mandates to new requirements for algorithmic transparency. We also explore the immediate impact on MedTech innovators who

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01:39

Brazil's New Data Maze: Pure Global on Unseen Traps...

LATAM MedTech Insights ·

2026/04/09

In this episode, we dissect the immediate impact of Brazil's new ANVISA resolution, RDC 848/2024. This isn't just another regulatory update; it's a fundamental shift in how Brazil evaluates the safety and performance of medical devices, with a sharp new focus on lifecycle risk management and cybersecurity.We explore how this change disrupts the conventional market entry strategy for international MedTech companies. A previously straightforward submission process now requires a new level of

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01:56

Brazil's New MedTech Shortcut: Pure Global on...

LATAM MedTech Insights ·

2026/04/08

This week, we dive into a game-changing regulatory shift in Latin America's largest MedTech market. Brazil's ANVISA has just launched a new "reliance pathway," promising to dramatically accelerate market access for high-risk medical devices that have already been approved by authorities like the US FDA. This could slash years off of registration timelines.In this episode, we unpack the reality behind the hype. We explore the massive opportunities this creates for international manufacturers and

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02:13

Pure Global: Brazil's New SaMD Rules, Unlocking the...

LATAM MedTech Insights ·

2026/04/07

Brazil just rewrote the rules for digital health. Last week, ANVISA published its new regulatory framework for Software as a Medical Device (SaMD), creating an urgent new landscape for MedTech companies. This update introduces a new risk classification system, expedited pathways for some devices, and significant new hurdles for high-risk AI and machine learning technologies. This episode of LATAM MedTech Insights unpacks the critical details of this regulatory shift. We explore the specific

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01:58

Pure Global: Brazil's New AI Rules - A Stifling...

LATAM MedTech Insights ·

2026/04/06

This week, we dissect a major regulatory shift in Brazil's MedTech landscape. ANVISA has just rolled out its new strategic framework for Software as a Medical Device (SaMD) and AI, aiming to align with global standards. But what does this mean for the innovators on the ground?.While harmonization promises safer and more effective digital health tools, the new requirements could inadvertently create significant barriers for local startups. This episode explores how the heightened demands for

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