LATAM MedTech Insights
Ran Chen
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Recent Episodes
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…
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…
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…
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…
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…
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.…
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…
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…
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…
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…
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…
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…
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…
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),…
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…
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…
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.…
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,…
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…
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…
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LATAM MedTech Insights has published 188 episodes since August 2025, covering topics in Business, Life Sciences.
LATAM MedTech Insights is currently dormant with new episodes daily. Average episode length is 2m.
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