LATAM MedTech Insights

This week, we dissect the groundbreaking new cybersecurity resolution from Brazil's ANVISA that is sending ripples through the MedTech world. The new rules for Software as a Medical Device (SaMD) go far beyond international standards, demanding a proactive, localized approach to cybersecurity and data validation that presents both challenges and opportunities. We explore how this regulation transf...

This week on LATAM MedTech Insights, we dissect the groundbreaking new Software as a Medical Device (SaMD) regulation just released by Brazil's ANVISA. This isn't just another update; it's a complete strategic reset for any digital health company targeting the Brazilian market. We explore the critical changes in risk classification for AI-driven software and the stringent new cybersecurity mandate...

This week, we dissect the groundbreaking new resolution from Brazil's ANVISA that's set to revolutionize the AI-powered medical device landscape. We explore how this regulatory shift dramatically accelerates market access for Software as a Medical Device (SaMD) companies. Learn what this means for startups and established players eyeing the largest MedTech market in Latin America, and how the rule...

Brazil's medical device market has undergone its most significant regulatory overhaul in two decades with the full implementation of RDC 751/2022. This new framework replaces the long-standing RDC 185/2001, introducing a new risk classification system and technical documentation structure that aligns more closely with global standards like the EU MDR. While this harmonization presents long-term be...

This week on LATAM MedTech Insights, we dissect the immediate impact of a surprise guidance note issued by Brazil's ANVISA. This new clarification on regulation RDC 751 is tightening the screws on foreign medical device manufacturers, especially those in the digital health and SaMD space. We explore the heightened requirements for technical dossiers and clinical data that are catching companies of...

Brazil's digital health market is booming, but a recent regulatory update from its agency, ANVISA, has changed the rules of the game for 2026. The new guidance for Software as a Medical Device (SaMD) goes far beyond basic registration, introducing stringent cybersecurity and lifecycle management requirements that are catching many international companies off guard. In this episode, we break down w...

This episode of LATAM MedTech Insights dives into the critical new regulatory guidance from Brazil's ANVISA for Software as a Medical Device (SaMD). As Brazil doubles down on localized requirements, we explore why simply having FDA or CE approval is no longer enough to guarantee market access. We uncover the hidden complexities of ANVISA's risk classification and the growing importance of local da...

Brazil's regulatory landscape for AI and software medical devices just got a lot more complex. In this episode, Pure Global dives into ANVISA's latest unspoken rules that demand localized clinical data and stricter adherence to Brazil's data privacy laws, moving beyond simple acceptance of FDA or CE marks. We explore why your existing global dossiers might now be insufficient for the Brazilian mar...

This week, we dive into a sudden and impactful regulatory shift in Brazil. ANVISA, the country's health agency, released a new resolution last week that specifically targets Software as a Medical Device (SaMD), creating significant new hurdles for manufacturers, especially those using AI and machine learning. This update introduces stringent cybersecurity protocols, challenging data localization l...

In this episode, we dissect the breaking news from Brazil where the regulatory agency, ANVISA, has just rolled out a comprehensive and stricter framework for AI-powered Software as a Medical Device (SaMD). This sudden move creates significant new barriers to entry in Latin America's most lucrative MedTech market. We explore the immediate and costly implications for international manufacturers, who...

Mexico just opened a new door for MedTech companies. Last week, the country's health authority, COFEPRIS, launched an accelerated approval pathway for devices with existing FDA or CE credentials. This could slash market entry timelines from years to months, but it comes with a catch. This episode dives deep into the opportunities and the hidden compliance traps of this new regulation. We uncover t...

This week, we dive into a major regulatory shift in Latin America's largest MedTech market. Brazil's agency, ANVISA, has just released new, stringent guidance for AI-powered Software as a Medical Device (SaMD). This development creates significant new barriers for foreign manufacturers, moving beyond simple acceptance of international certifications and demanding a highly localized compliance stra...

This week, we dive into a major regulatory shift in Brazil that is catching international MedTech companies off guard. ANVISA's RDC 751/2022 is entering a critical new phase, and the latest clarifications on technical dossier requirements are creating significant hurdles for manufacturers seeking market access. We break down what these changes mean and why your existing FDA or CE mark documentatio...

Brazil's national health agency, ANVISA, has just launched a new, comprehensive regulatory framework for Software as a Medical Device (SaMD), with a major focus on AI and digital health technologies. This pivotal update ends years of uncertainty but introduces stricter rules that are reshaping the market entry strategy for all MedTech innovators targeting Latin America's biggest economy. In this e...

In this episode, we dissect the groundbreaking new regulation from Brazil's ANVISA for Software as a Medical Device (SaMD). The country has officially aligned its framework with the global IMDRF standards, a move that promises to streamline market access for international manufacturers. But this harmonization comes with a uniquely Brazilian twist. We explore the hidden complexities beneath the sur...

This week on LATAM MedTech Insights, we dissect the breaking news from Brazil. ANVISA has just launched a new "Agile Approval Program" promising rapid, sub-90-day registration for AI-powered medical software. This move is designed to attract top-tier global technology and accelerate innovation within Latin America's largest market. While the fast-track approval sounds like a golden ticket, it come...

This episode of LATAM MedTech Insights dives into the critical challenges emerging from Brazil's new medical device regulation, RDC 751/2022. As of last week, an increasing number of international manufacturers are facing surprising rejections from ANVISA. The issue goes far beyond simple paperwork; it reflects a fundamental misunderstanding of the heightened scrutiny now applied to clinical data,...

This week on LATAM MedTech Insights, we dissect the ongoing regulatory shake-up in Brazil. ANVISA's RDC 751/2022 is now in full force, and medical device manufacturers are facing a complex new reality. We unpack the critical changes, moving beyond the headlines to explore the on-the-ground impact of the new technical dossier structure and reclassification rules. We explore the long-term vision beh...

Brazil's health agency, ANVISA, just dropped its regulatory agenda for 2026-2027, and it’s set to reshape the landscape for medical device manufacturers. This new roadmap signals a major pivot from one-time market approval to a continuous, full-lifecycle approach to regulation, with big implications for SaMD, clinical data, and post-market surveillance. For any MedTech company with a high-risk dev...

A major regulatory shift just hit Brazil, Latin America's top MedTech market. Last week, the national agency ANVISA rolled out a completely new framework for Software as a Medical Device (SaMD), creating urgent challenges and new opportunities for digital health companies worldwide. This update introduces a stricter, four-tiered risk classification system and demands more rigorous technical docume...

In this episode, we dissect a major regulatory shift in Mexico. A new reform to the General Health Law has extended medical device registration renewals to a 10-year cycle, a significant jump from the previous five years. This change presents a massive opportunity for manufacturers, offering long-term market stability and reduced administrative burdens. While this extension is a welcome developmen...

This week, we dive into a critical regulatory shift in Latin America's largest MedTech market. Brazil's ANVISA has just issued new, stringent guidelines for Software as a Medical Device (SaMD), specifically targeting the booming field of AI-powered diagnostics. This update reshapes the pathway to market for innovators both inside and outside Brazil. We break down exactly what has changed, focusing...

In this episode, we dissect the breaking news from Mexico's health authority, COFEPRIS. A new reform extends medical device registration renewals from five years to a full decade. This change is poised to reshape market strategy for all MedTech companies in the region. While this extension appears to be a major win by reducing administrative burdens, it introduces subtle but significant long-term...

Brazil's health agency, ANVISA, has just unveiled its ambitious 2026-2027 regulatory agenda, signaling one of the most significant shifts in the Latin American MedTech landscape in years. This isn't just a minor update; it's a fundamental move towards stricter, globally harmonized standards that will redefine market access. This episode of LATAM MedTech Insights dives deep into the two most critic...

In this episode, we dive into a major regulatory shift that just happened in Mexico. Last week, COFEPRIS officially extended the renewal period for medical device registrations from five to ten years. This change presents a massive opportunity for MedTech manufacturers, reducing long-term costs and administrative burdens. We explore the practical implications of this reform, discussing how it repo...