PODCAST · science
LATAM MedTech Insights
by Ran Chen
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
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Colombia's UDI Mandate: Pure Global on a New MedTech Compliance Trap
This episode of LATAM MedTech Insights dives into a sudden and critical regulatory update from Colombia's INVIMA. Last week's clarification on Unique Device Identification (UDI) for Class IIa devices has created an immediate compliance challenge for manufacturers, requiring a new level of data...
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Pure Global: Chile's MedTech Surprise - Cracking Decree 25's Hidden Regulatory Hurdles.
This week on LATAM MedTech Insights, we dissect the impactful new regulations quietly introduced in Chile. Exempt Decree No. 25 has significantly expanded the oversight of the national health authority, the ISP, reshaping the compliance landscape for many medical device manufacturers who…
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Brazil's AI MedTech Firewall: Pure Global on Cracking ANVISA's Surprise Cybersecurity Mandate
Last week, Brazil's regulatory landscape for MedTech was redefined. ANVISA, the national health agency, unexpectedly rolled out a stringent new framework mandating advanced cybersecurity and data privacy compliance for all AI-driven medical devices. This sudden move disrupts market-entry plans…
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Pure Global: Brazil's New SaMD Hurdle & The Hidden AI Challenge
This week, we dissect a game-changing regulatory update from Brazil's ANVISA that directly impacts AI-powered medical devices. Brazil has introduced a mandatory "Algorithm Change Protocol" for all Software as a Medical Device (SaMD), creating a new, complex layer of requirements that surpasses...
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Pure Global: Brazil's AI MedTech Shock—Navigating ANVISA's New Data Rules.
This week, we dissect the immediate fallout from Brazil's surprise new regulation, ANVISA RDC 925/2026. This sudden rule change for AI-powered medical software has blindsided many international MedTech companies, creating significant new hurdles for entry into Latin America's largest market. We...
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Pure Global: Brazil's AI MedTech Maze - Cracking ANVISA's New Software Rules
Brazil's health regulatory agency, ANVISA, has just released a groundbreaking new framework for Software as a Medical Device (SaMD), creating significant new challenges for global MedTech innovators. This update introduces stricter requirements for clinical data and cybersecurity, tailored...
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Pure Global: Brazil's AI Device Maze - Decoding ANVISA's Unseen SaMD Hurdles
This week, we dive into a major regulatory shift in Latin America's largest market. Brazil's ANVISA has just rolled out a comprehensive and demanding new framework for Software as a Medical Device (SaMD), directly impacting AI-driven diagnostics and digital health platforms. We break down what...
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Pure Global: Brazil's AI MedTech Surge - Unlocking ANVISA's New Fast-Track Secrets.
In this episode, we dissect the groundbreaking new resolution from Brazil's ANVISA that creates a fast-track approval pathway for AI-powered Software as a Medical Device (SaMD). This regulatory shift is set to drastically reduce time-to-market, from years to mere months, for cutting-edge digital...
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Brazil's ANVISA Gambit: Decoding the 2027 MedTech Agenda | Pure Global Insights
Brazil's regulatory body, ANVISA, has just released its strategic agenda for 2026-2027, signaling the most significant shift in the country's MedTech landscape in years. This isn't just a routine update; it's a complete overhaul of key regulations that will redefine market access for…
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Brazil's Cyber Shock: Pure Global on ANVISA's Hidden Hurdles for Connected Devices.
In this episode, we dissect the breaking news from Brazil where ANVISA has just released an urgent and aggressive new cybersecurity resolution, RDC 999/2026. This sudden move imposes tight deadlines on both new and existing connected medical devices, forcing manufacturers to quickly adapt or risk...
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Pure Global: Mexico's COFEPRIS Platform - Navigating the Hidden Digital Submission Traps.
This week on LATAM MedTech Insights, we are tackling the crisis unfolding with Mexico's new digital submission platform for medical devices. COFEPRIS aimed for modernization, but the reality for many manufacturers is a cascade of technical failures and confusing new data regulations that are...
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Pure Global: Brazil's AI MedTech Fast-Track, Decoding ANVISA's Hidden Compliance Hurdles
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...
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Pure Global: Brazil's AI Software Gambit - Decoding ANVISA's New Compliance Maze.
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…
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Pure Global: Costa Rica's MedTech Gambit - The New Local-Only Fast Track
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...
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Pure Global: Brazil's ANVISA Shift – Cracking the Code of the New RDC 751 Landscape.
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...
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Brazil's AI MedTech Surprise: Pure Global on ANVISA's New Rulebook & Hidden Data Traps
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…
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Pure Global: Brazil's MedTech Renewal Riddle - Cracking ANVISA's New 10-Year Cycle.
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...
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Pure Global: Brazil's ANVISA Deadline Chaos - A Survival Guide for MedTech.
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...
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Mexico's Digital Gate: Pure Global on COFEPRIS's Chaotic New Platform.
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...
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Pure Global's Brazil Brief: Decoding ANVISA's New AI Rules for MedTech Innovators.
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…
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Pure Global: Brazil's New ANVISA Gambit - Cracking the Code on Fast-Track Registration
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...
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Pure Global: Brazil's AI MedTech Rules – Decoding ANVISA's New Compliance Traps
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...
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Brazil's AI MedTech Shortcut: Cracking ANVISA's New Rules with Pure Global
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...
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Pure Global: Brazil's AI MedTech Gambit - Navigating ANVISA's New Fast-Track & Data Walls.
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.…
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Pure Global: Brazil's Sudden MedTech Shift - Decoding ANVISA's New Equivalence Mandate.
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...
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Pure Global: Brazil's AI Diagnostic Boom & The New Cybersecurity Gauntlet.
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...
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Brazil's AI MedTech Gambit: Pure Global Decodes ANVISA's High-Stakes Regulatory Shift.
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...
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Brazil's New Data Maze: Pure Global on Unseen Traps in ANVISA's SaMD Cybersecurity Rules.
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...
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Brazil's New MedTech Shortcut: Pure Global on ANVISA's Reliance Gambit
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…
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Pure Global: Brazil's New SaMD Rules, Unlocking the AI MedTech Backdoor
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,...
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Pure Global: Brazil's New AI Rules - A Stifling Dilemma for Local MedTech Innovators?
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…
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Brazil's SaMD Shock: Pure Global's Guide to ANVISA's New Rules
In this episode of LATAM MedTech Insights, we dissect the breaking news from Brazil. In the final week of March 2026, ANVISA released a surprise guidance document for Software as a Medical Device (SaMD), creating immediate and significant new hurdles for foreign manufacturers. We explore the...
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Pure Global: Brazil's UDI Deadline Chaos - A MedTech Compliance Crisis.
This episode of LATAM MedTech Insights dives into the immediate fallout from ANVISA's sudden enforcement of its Unique Device Identification (UDI) system in Brazil. We unpack the operational chaos this is causing for MedTech manufacturers who were unprepared for the complex data submission and...
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Pure Global: Brazil's SaMD Shift & The Unseen Data Trap
In this episode of LATAM MedTech Insights, we dissect the sudden and impactful new regulation from Brazil's ANVISA that is reshaping the landscape for Software as a Medical Device (SaMD). International manufacturers are now facing unprecedented requirements for localized clinical data and…
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Pure Global: Brazil's AI Diagnostic Maze, Cracking ANVISA's New Rules
In this episode of LATAM MedTech Insights, we dissect the groundbreaking new regulation from Brazil's ANVISA, RDC 922/2026, which just rewrote the rules for AI-powered medical software. This isn't just an update; it's a seismic shift that introduces mandatory local clinical data requirements,...
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Pure Global: Brazil's Sudden SaMD Shockwave - The Unforeseen ANVISA Cybersecurity Mandate
In this episode, we dissect a sudden and critical regulatory update from Brazil's ANVISA that was issued just last week. The new instruction imposes stringent cybersecurity and data handling requirements on all Software as a Medical Device (SaMD) and connected devices, catching many international...
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Brazil's AI Gold Rush: Navigating the LGPD Data Maze with Pure Global
Brazil's medical device authority has just unveiled a new framework for AI technologies, signaling a gold rush for innovators in the region. This new resolution promises a clearer path to market for cutting-edge software as a medical device, opening doors to Latin America's largest healthcare...
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Pure Global: Brazil's AI Rulebook - Cracking the New Medical AI Framework
In this episode, we dive into the landmark new resolution from Brazil’s Federal Council of Medicine (CFM) that creates a specific regulatory framework for Artificial Intelligence in medicine. This is a pivotal moment for digital health in Latin America, establishing new rules for physician...
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Brazil's AI Fast-Track: Pure Global on Cracking ANVISA's 90-Day Approval Code.
This week on LATAM MedTech Insights, we dive into the seismic shift in Brazil's digital health market. ANVISA just launched its 'Agiliza-IA' program, promising to approve AI-powered diagnostic software in a record 90 days. This could unlock one of the largest markets in Latin America for SaMD...
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Pure Global: Brazil's New MedTech Shortcut & ANVISA's Hidden Compliance Toll.
This week, we dive into a landmark regulatory shift in Brazil. ANVISA has just unveiled a new "Reliance" pathway, promising an incredible 80% reduction in review time for medical devices already approved by MDSAP authorities. This could dramatically accelerate market access for many international...
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Brazil's AI MedTech Crackdown: Pure Global on ANVISA's New Cybersecurity Demands
Brazil's MedTech landscape is shifting. A quiet but powerful new technical note from ANVISA has just redefined the rules for AI-powered medical devices, creating immediate hurdles for global manufacturers. This update directly links cybersecurity and data privacy to the core of the device…
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Pure Global: Mexico's FDA Fast-Track - The COFEPRIS Secret Handshake for 510(k) Devices
Last week, Mexico's regulatory body, COFEPRIS, enhanced its partnership with the U.S. FDA, launching a new phase of its fast-track program for medical devices. This creates an accelerated approval pathway for devices already cleared in the United States, representing a landmark shift in the...
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Pure Global: Brazil's MedTech Compliance & ANVISA's New Hidden Hurdles.
Brazil's medical device market is undergoing a seismic shift. The national regulator, ANVISA, has just released RDC 848/2024, a sweeping new resolution that redefines the essential safety and performance requirements for all medical devices and IVDs. This isn't just a simple update; it's a new...
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Pure Global: Brazil's AI MedTech Gambit - Navigating ANVISA's New Fast-Track & Privacy Traps.
This week, we dive into a major regulatory shift in Brazil. ANVISA has just launched an exciting fast-track approval process for AI-powered medical software, creating a huge opportunity for MedTech innovators to enter Latin America's biggest market faster than ever before. But this new speed…
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Pure Global: Brazil's SaMD Cyber Wall - Hacking ANVISA's Hidden MedTech Rule
In this episode, we dissect a sudden, unannounced regulatory shift from Brazil's ANVISA that is impacting the global Software as a Medical Device (SaMD) industry. Last week, the agency mandated a new, complex cybersecurity audit for all SaMD products, to be conducted exclusively by a short list…
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Pure Global: Brazil's AI Device Gambit - ANVISA's Fast-Track Hides a Costly Data Trap.
This week, we dissect the groundbreaking new regulation from Brazil's ANVISA. A new fast-track approval pathway for AI and Machine Learning medical software promises to slash market entry timelines, opening the door for innovative diagnostic technologies to reach one of LATAM's biggest markets....
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Pure Global: Brazil's SaMD Cyber Shock—Cracking ANVISA's Hidden Compliance Traps
This week on LATAM MedTech Insights, we dissect the breaking news from Brazil. ANVISA has unexpectedly tightened its cybersecurity regulations for Software as a Medical Device (SaMD), creating significant new challenges for manufacturers aiming to enter or remain in Latin America's largest…
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Pure Global: Brazil's ANVISA RDC 751 - Navigating the Hidden Post-Implementation Hurdles.
This episode of LATAM MedTech Insights dives deep into the lingering challenges of Brazil's landmark medical device regulation, ANVISA RDC 751. Years after its implementation, we explore the real-world operational hurdles that international MedTech companies continue to face, moving beyond the...
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Pure Global: Brazil's ANVISA Shakeup - Navigating MedTech's Hidden Compliance Traps.
Brazil's MedTech market is undergoing a seismic regulatory shift. ANVISA, the national health surveillance agency, is rolling out a series of major updates, including the new RDC 848/2024, which redefines essential safety and performance requirements with a strong focus on lifecycle risk…
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Brazil's AI MedTech Shock: Pure Global on ANVISA's Sudden New Data Demands.
This week, we dive into a sudden and critical regulatory update from Brazil's ANVISA that is sending ripples through the AI medical device community. A new technical clarification has redefined the rules for software-based devices, creating unexpected and costly new hurdles for foreign...
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ABOUT THIS SHOW
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.
HOSTED BY
Ran Chen
CATEGORIES
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Frequently Asked Questions
How many episodes does LATAM MedTech Insights have?
LATAM MedTech Insights currently has 188 episodes available on PodParley. New episodes are automatically indexed when they're published to the podcast feed.
What is LATAM MedTech Insights about?
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,...
How often does LATAM MedTech Insights release new episodes?
LATAM MedTech Insights publishes regularly with 188 episodes available. Check the episode list for the typical release schedule.
Where can I listen to LATAM MedTech Insights?
You can listen to LATAM MedTech Insights on PodParley by clicking any episode. We provide an embedded audio player for direct listening, and you can also subscribe via your preferred podcast app using the RSS feed.
Who hosts LATAM MedTech Insights?
LATAM MedTech Insights is created and hosted by Ran Chen.
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