LATAM MedTech Insights

In this episode of LATAM MedTech Insights, we demystify the medical device registration process in Peru by taking a close look at the foundational regulation: Supreme Decree Nº 016-2011-SA. We explore how the national authority, DIGEMID, uses a risk-based classification system and what this means for your specific device. We break down the critical requirements that often create barriers for forei...

In this episode of LATAM MedTech Insights, we provide a detailed analysis of Chile's Resolution Exenta No. 1618/2020, a landmark regulation that established a strict technovigilance framework for medical devices. We dissect the specific reporting obligations, mandatory timelines, and the critical role of the in-country legal representative. This session moves beyond theory to explore the practical...

In this episode of LATAM MedTech Insights, we dissect the crucial updates to Brazil's medical device regulations, specifically ANVISA's RDC 497/2021 and the recent amendment RDC 850/2024. We explore how these resolutions have fundamentally changed the administrative process for obtaining and renewing the essential Brazilian Good Manufacturing Practice (B-GMP) certificate. We uncover why the recent...

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This episode of LATAM MedTech Insights offers a detailed guide to registering your medical device in Colombia, focusing on the foundational regulation, Decree 4725 of 2005. We break down the essential requirements set by Colombia's regulatory authority, INVIMA, providing manufacturers with a clear roadmap for successful market entry into one of Latin America's most dynamic healthcare markets. Imag...

In this episode of LATAM MedTech Insights, we demystify the seemingly simple but highly nuanced process of renewing medical device registrations in Argentina. We take a close look at the specific requirements outlined in ANMAT's Disposition 2318/2002, focusing on the critical 90-day submission deadline and the legally binding "sworn declaration." We explore the common pitfalls that can lead to cos...

This episode of LATAM MedTech Insights provides a detailed analysis of Mexico's mandatory Good Manufacturing Practices (GMP) standard, NOM-241-SSA1-2021. We explore the critical requirements for medical device manufacturers, importers, and distributors operating in Mexico, focusing on the pillars of a compliant Quality Management System (QMS), risk management, and supply chain control. We break do...

In this episode of LATAM MedTech Insights, we explore the intricate details of Mexico's medical device labeling standard, NOM-137-SSA1-2008. As one of Latin America's largest MedTech markets, Mexico presents a huge opportunity, but access is strictly controlled by its regulatory body, COFEPRIS. We break down the most common mistakes foreign manufacturers make, from language requirements to the spe...

In this episode of LATAM MedTech Insights, we demystify the mandatory INMETRO certification for electro-medical devices in Brazil. We break down the critical requirements of Ordinance 384/2020, a regulation that serves as a vital gatekeeper to one of Latin America's most significant markets. We'll guide you through the conformity assessment process, from selecting a Certification Body to undergoin...

This episode of LATAM MedTech Insights unpacks the significant changes introduced by Brazil's new medical device regulation, ANVISA RDC 751/2022. We explore how this new framework moves Brazil towards harmonization with international standards, particularly the EU MDR, and what this means for global MedTech companies. We break down the practical impact of the updated risk classification system and...

Brazil's MedTech market is one of the largest in Latin America, but its regulatory landscape, governed by ANVISA, can seem complex. Many SaMD companies overestimate the time and difficulty of market entry, missing out on significant opportunities. This episode demystifies the process for Class II Software as a Medical Device. We reveal the streamlined 'notificação' pathway, a simplified notificati...

Colombia's MedTech market is one of the fastest-growing in Latin America, offering significant opportunities for global manufacturers. However, navigating its regulatory landscape, managed by INVIMA, presents a unique challenge that can make or break your market entry strategy: the mandatory local legal representative. This episode of LATAM MedTech Insights unpacks this critical requirement. We ex...

In this episode of LATAM MedTech Insights, we explore the essential labeling and language regulations for Software as a Medical Device (SaMD) in Mexico. We unpack the specific requirements set by the national regulatory body, COFEPRIS, and highlight the critical importance of Spanish language localization for a successful market entry. We discuss a common pitfall through a case study: an innovativ...

In this episode of LATAM MedTech Insights, we dissect the complex world of SaMD registration in Brazil. We go beyond the surface-level question of certifications and explore the strategic nuances that can define your success in Latin America's largest market. We explain why simply having an ISO 13485 certificate, the global standard for quality management, is not enough to get your software approv...

In this episode of LATAM MedTech Insights, we demystify the process of registering a foreign-made AI medical device in Mexico. As one of Latin America's largest and most promising markets, Mexico presents a significant opportunity for MedTech innovators. However, its regulatory body, COFEPRIS, has unique requirements that can stall market entry if not navigated correctly. We explore why COFEPRIS t...

This episode of LATAM MedTech Insights dives deep into the complex world of clinical data requirements for Software as a Medical Device (SaMD) seeking approval from Brazil's regulatory body, ANVISA. We unpack the critical regulation RDC 657/2022 and explain how ANVISA's risk-based classification system directly dictates the level of clinical evidence your company must provide. We explore the speci...

This episode of LATAM MedTech Insights dives into a critical question for innovators: How does Argentina's regulatory authority, ANMAT, handle artificial intelligence and machine learning in medical devices? We cut through the ambiguity to reveal that while there isn't a specific AI-only regulation, these products are actively regulated under the existing robust framework for Software as a Medical...

As Colombia's healthcare market embraces digital transformation, understanding the regulatory pathway for Software as a Medical Device (SaMD) is crucial for innovators. This episode of LATAM MedTech Insights demystifies the INVIMA registration process, revealing that SaMD is not regulated under a separate framework, but through the country's existing medical device decrees. We provide a clear, ste...

In this episode of LATAM MedTech Insights, we explore the significant regulatory shift in Mexico concerning AI-powered medical software. Mexico's health authority, COFEPRIS, has updated its framework, moving away from treating software as a simple accessory to classifying it as a regulated medical device in its own right. This change is crucial for any MedTech company aiming to penetrate the vibra...

This week on LATAM MedTech Insights, we demystify the regulatory maze of Brazil's ANVISA for companies developing AI and Software as a Medical Device (SaMD). As the largest market in Latin America, Brazil presents a massive opportunity, but its regulatory agency, ANVISA, has specific and stringent requirements that can stall market entry if you're unprepared. We explore the cornerstone regulation,...

This episode of LATAM MedTech Insights tackles a critical question for manufacturers entering Brazil: Is a Good Manufacturing Practice (GMP) certificate really required for low-risk, Class I medical devices? We explore the common misconceptions surrounding ANVISA's RDC 751/2022 regulation and the simplified *notificação* registration pathway. Many companies assume the lack of an upfront certificat...

This episode of LATAM MedTech Insights dives deep into the often-underestimated challenge of labeling requirements for low-risk medical devices in Latin America. We uncover the fragmented regulatory landscape and reveal why a one-size-fits-all approach is doomed to fail. We explore the specific, nuanced requirements of key markets including Brazil (ANVISA), Mexico (COFEPRIS), Colombia (INVIMA), an...

This episode of LATAM MedTech Insights dives into a critical, often misunderstood, aspect of entering the Brazilian market: the requirement of a Brazil Registration Holder (BRH) for low-risk, Class I medical devices. While these devices follow a simplified "notificação" process instead of a full registration, foreign manufacturers are still legally required to have a local entity representing them...

In this episode of LATAM MedTech Insights, we demystify the "automatic" registration process for low-risk medical devices in Colombia. We explore the requirements set by the national regulatory body, INVIMA, for Class I and IIa devices, detailing the specific documentation needed for a successful and speedy market entry. We break down why this streamlined pathway is a major advantage for MedTech m...

Entering Argentina's lucrative MedTech market presents a huge opportunity, but it's filled with regulatory complexities. A common and costly mistake manufacturers make is assuming that low-risk, Class I medical devices are exempt from registration with the national authority, ANMAT. This single misunderstanding can lead to product seizures at customs, unexpected costs, and a complete halt to your...