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Artwork for LATAM MedTech Insights

LATAM MedTech Insights

Ran Chen
Anvisa
Brazil
Cofepris
Medical Device Registration
Invima
Anmat
Colombia
Argentina
Medical Devices
Spanish Medical Device Labeling Requirements
Peru
Mexico
Medical Device Classification
Class 1 Devices
Class 1 Medical Devices
Brazil Registration Holder
Class I Devices
CE Mark
FDA Approval
BRH

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.

PublishesDailyEpisodes135Founded7 months ago
Number of ListenersCategories
TechnologyScienceLife Sciences

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Latest Episodes

This week, we dissect a game-changing announcement from Brazil's ANVISA: a new "fast-track" approval process for AI-powered medical devices. While it promises rapid market access, it hides significant challenges beneath the surface that could derail ... more

Last week, Brazil's regulatory agency, ANVISA, issued an unexpected technical guidance that reclassifies certain Software as a Medical Device (SaMD) products. This move has sent shockwaves through the digital health sector, pushing many devices that ... more

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This week on LATAM MedTech Insights, we dive into the significant new regulatory guidance from Brazil's ANVISA that is reshaping the landscape for Software as a Medical Device (SaMD). This update brings Brazil closer to global standards but introduce... more

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This week, we dive into a major regulatory shift in Brazil that just went live on March 1st, 2026. ANVISA's new Normative Instruction N°426/2026 activates the national UDI (Unique Device Identification) database, requiring manufacturers to submit det... more

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This episode of LATAM MedTech Insights, brought to you by Pure Global, dives into the landmark regulatory shift just implemented by Brazil's ANVISA. We unpack the new RDC 830/2023 resolution for In-Vitro Diagnostic (IVD) devices, a critical update th... more

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A seismic regulatory shift is underway in Brazil, Latin America's biggest MedTech market. ANVISA's new Unique Device Identification (UDI) system, detailed in Normative Instruction 426/2026, is now being implemented. This isn't just a new labeling rul... more

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Brazil's MedTech market just experienced a seismic shift. ANVISA, the national regulatory agency, has rolled out its new comprehensive framework, RDC 751, fundamentally changing the rules for medical device registration and market access. This move a... more

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This week, we dissect the groundbreaking new resolution from Brazil's ANVISA, RDC 989, which establishes a new fast-track approval pathway for AI-driven diagnostic software. This is a pivotal moment for the MedTech industry in Latin America, promisin... more

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Frequently Asked Questions About LATAM MedTech Insights

What is LATAM MedTech Insights about and what kind of topics does it cover?

LATAM MedTech insights cover the intersection of medical technology, digital health, and regulatory changes across Latin America, with a strong emphasis on Brazil and regulatory developments that impact market access. Episodes frequently dissect new rules, lifecycle risk management, cybersecurity requirements, and fast-track pathways for AI-enabled and software-driven medical devices, highlighting practical implications for market entry, compliance costs, and post-market obligations. The showoften features case studies and real-world timelines that illustrate how regulators, manufacturers, and investors navigate Latin America's evolving MedTech landscape. It's particularly valuable for founders, regulatory professionals, and venture and cor... more

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How many episodes of LATAM MedTech Insights are there?

LATAM MedTech Insights launched 7 months ago and published 135 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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