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Artwork for LATAM MedTech Insights

LATAM MedTech Insights

Ran Chen
ANVISA
Brazil
Cofepris
Medical Device Registration
Invima
Anmat
Colombia
Argentina
Mexico
Medical Devices
Spanish Medical Device Labeling Requirements
Peru
Medical Device Classification
Class 1 Devices
Class 1 Medical Devices
Brazil Registration Holder
Class I Devices
FDA Approval
CE Mark
RDC 751 2022

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.

PublishesDailyEpisodes72Founded4 months ago
Number of ListenersCategories
Life SciencesScienceTechnology

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Artwork for LATAM MedTech Insights

Latest Episodes

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, att... more

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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 connecte... more

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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 alread... more

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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 ... more

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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 ... more

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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... more

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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 f... more

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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 traceabi... 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?

This podcast serves as a critical resource for professionals interested in the Latin American medical technology and digital health sector. It covers significant trends, regulatory developments, and investment opportunities across the region, particularly highlighting markets like Brazil, Mexico, and Colombia. Each episode features detailed discussions and interviews with industry innovators, investors, and policymakers that shed light on the complex landscape of healthcare within Latin America. Unique elements include a focus on regulatory frameworks, referencing specific agencies like ANVISA and COFEPRIS, making it an invaluable tool for understanding market entry strategies in Latin American countries.

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How many episodes of LATAM MedTech Insights are there?

LATAM MedTech Insights launched 4 months ago and published 72 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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