LATAM MedTech Insights

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 for lower-risk devices, aiming to cut review times by more than half and reshape the market access landscape. This move signals a major shift, potentially transforming Brazil from one of the most challenging LATAM markets into a hub for MedTech innovation. This episode unpacks the details of the AnvisAI project, exploring what it means for manufacturers' regulatory strategies and the immediate opportunities it creates for faster market entry. We...

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 traceability regulations. This move promises to cut costs and streamline logistics for manufacturers but introduces a new host of digital compliance and supply chain challenges. We explore how this digital-first policy impacts a device manufacturer's entire operational playbook overnight. Imagine being able to update a user manual with a single click instead of recalling thousands of product kits. This episode details the immediate opportunities and...

Brazil's MedTech landscape is buzzing as its regulatory agency, ANVISA, puts Software as a Medical Device (SaMD) back under the microscope. In its newly released 2024-2025 agenda, ANVISA has signaled major revisions to the existing framework, a move that comes sooner than many in the industry expected. This suggests that the initial guidelines are already being outpaced by rapid advancements in digital health, especially in AI and machine learning. This episode dives deep into the implications for MedTech manufacturers. While Brazil's alignment with international standards has created opportunities, navigating the specifics of its regulatory environment remains a complex challenge. For...

Brazil's regulatory agency, ANVISA, is updating its rules for Software as a Medical Device (SaMD) as a key priority for 2025. This major overhaul will align Brazil’s digital health landscape with global standards like the EU MDR, introducing stricter requirements for cybersecurity, interoperability, and technical documentation. This change presents a critical challenge for MedTech innovators. For example, a US-based AI diagnostics company eager to enter the lucrative Brazilian market now faces new, complex questions. How can they ensure their existing cybersecurity protocols meet ANVISA's new, currently undefined standards? The fear of a delayed or rejected submission due to non-compliance with th...

Last week, Brazil's ANVISA implemented a sudden and strict new regulation for cybersecurity in connected medical devices. This unexpected move introduces mandatory data localization, forcing companies to store Brazilian patient data on servers within the country, creating significant technical and financial hurdles for global manufacturers. This episode of LATAM MedTech Insights unpacks the immediate impact of this new rule. We explore the specific technical requirements, the short 90-day compliance window, and what this means for companies with existing products in the market or those planning to enter Brazil's lucrative MedTech space. Imagine your state-of-the-art, cloud-powered diagnostic device, already approved in...

Brazil's regulatory agency, ANVISA, has just redefined the future of digital health in Latin America with its new, comprehensive framework for AI-powered Software as a Medical Device (SaMD). This landmark regulation introduces a stricter risk classification system and new requirements for algorithm validation and cybersecurity, directly impacting any MedTech company looking to enter or grow in the region's largest market. This episode of LATAM MedTech Insights provides a crucial analysis of these changes. We uncover what the new four-tiered risk system means for your product, how to manage the lifecycle of your AI algorithms under the new rules, and why...

This week on LATAM MedTech Insights, we're diving into a groundbreaking regulatory shift in Brazil. For years, launching a clinical trial in Latin America's largest market was a high-risk gamble due to unpredictable and lengthy approval processes. Now, everything has changed. A new Clinical Research Statute is dismantling these old barriers, aiming to slash approval times and make Brazil a global hub for MedTech innovation. We explore the concrete changes to the ethics review system and what this means for international companies that had previously put their Brazilian market entry plans on hold. A U.S. MedTech startup with a...

This episode of LATAM MedTech Insights dives deep into the most significant regulatory shift in the region's largest market: Brazil. We explore ANVISA's new regulations, RDC 751/2022 for medical devices and RDC 830/2023 for IVDs, which align Brazil's framework more closely with international standards like the EU MDR. This is a critical update for any MedTech company looking to enter or expand its footprint in Latin America. We unpack what this harmonization means in practical terms. Consider this: a medical device company with CE marking for its product previously faced a complex, 18-month process to reformat its entire technical dossier for Brazil...

In this episode of LATAM MedTech Insights, we explore why a one-size-fits-all approach to entering the Latin American medical technology market is a recipe for failure. The region is not a monolith but a collection of unique countries, each with its own distinct regulatory, economic, and healthcare systems. Success depends on moving beyond surface-level data and leveraging deep market intelligence. We dissect how granular market briefs provide the critical insights needed to build a winning go-to-market strategy. We contrast the opportunities in a market like Colombia, which heavily relies on imports, with the complex regulatory hurdles of a giant like...

Brazil's MedTech market offers immense opportunity, but its regulatory body, ANVISA, demands flawless execution. A fragmented approach, where different teams handle registration and post-market compliance, often leads to costly delays and strategic dead ends. This episode explores why an integrated strategy is non-negotiable for success. We break down the four pillars of Brazilian MedTech regulation: correct device classification, meticulous technical documentation in Portuguese, the critical choice of a Brazil Registration Holder (BRH), and robust post-market surveillance. Learn how these elements are interconnected and why managing them under one expert team provides a significant competitive advantage in this complex market. **A...

In this episode of LATAM MedTech Insights, we dive deep into the unique regulatory landscape of Colombia, a pivotal market for any device manufacturer looking to enter Latin America. We uncover how INVIMA's dual-track system offers a strategic gateway for MedTech companies that know how to leverage it. We explore the powerful "automatic registration" pathway for low-risk devices that can get your product to market and generating revenue faster than you think. We also break down the complexities and extended timelines associated with the rigorous pre-approval process for high-risk technologies, and how to plan for them effectively. A Case for...

In this episode of LATAM MedTech Insights, we demystify the complex process of medical device registration in Argentina. We provide a detailed guide on navigating the requirements of the national regulatory authority, ANMAT, from appointing a local registration holder to preparing a compliant technical dossier in Spanish. We break down the critical steps and common pitfalls that can lead to costly delays and rejections. Learn why your choice of a local partner can make or break your market access strategy and how your existing international approvals, like CE or FDA, fit into the Argentinian framework. We share a real-world case...

Peru's MedTech market offers immense growth opportunities, but entry is strictly controlled by its regulatory authority, DIGEMID. A critical step for any foreign manufacturer is appointing a local representative, known as a Peru Registration Holder. This isn't just a formality—it's a foundational strategic decision that dictates your control over your own products in the country. In this episode, we explore why the common shortcut of letting a distributor hold your product registration can lead to significant business risks, including a complete loss of market access. We'll walk through the strategic advantages of appointing an independent, professional representative to ensure yo...

This episode of LATAM MedTech Insights dives into one of the most stable and attractive regulatory environments in Latin America: Colombia. We explore how INVIMA, the national regulatory authority, offers a clear and predictable pathway for medical device manufacturers, standing in contrast to the complexities found elsewhere in the region. We specifically focus on the significant strategic advantage of Colombia's ten-year registration validity for most medical devices. This episode unpacks how this long-term approval cycle can reduce administrative burdens, lower costs, and enable companies to focus on sustainable market growth instead of constant regulatory upkeep. A real-world pain point we...

Brazil, Latin America's largest MedTech market, is implementing a mandatory Unique Device Identification (UDI) system, with a critical deadline for high-risk devices looming in mid-2025. This change, mandated by ANVISA's RDC 591/2021, requires immediate action from manufacturers to ensure their products remain on the market. This episode of LATAM MedTech Insights breaks down the essential steps for preparing for Brazil's UDI rollout. We explore the unique challenge where device labeling is required before the official government database (SIUD) is fully active, creating significant operational hurdles. We'll provide a clear roadmap for what your company needs to do right now to avoid...

In this episode of LATAM MedTech Insights, we demystify the complex world of Brazil's medical device regulations under ANVISA. We explore the critical differences between the faster 'Notificação' pathway for low-risk devices and the intensive 'Registro' full-review process for high-risk products, revealing why your strategy for one won't work for the other. This episode is for any MedTech company that sees Brazil as a key market but is concerned about the regulatory hurdles. We break down the real-world implications of each pathway, from documentation requirements to the formidable challenge of the Brazilian Good Manufacturing Practices (BGMP) audit, ensuring you un...

In this episode of LATAM MedTech Insights, we explore the groundbreaking regulatory reforms in Mexico that are set to accelerate market access for medical device manufacturers. We break down the new COFEPRIS abbreviated pathway, which leverages approvals from other international regulatory bodies to streamline the registration process. This shift marks a significant opportunity for MedTech and IVD companies to enter one of Latin America's largest markets faster than ever before. We discuss the practical implications of these homologation reforms, detailing how leveraging existing clearances from authorities like the European Union can drastically cut down approval timelines and costs, turning a...

Mexico presents a golden opportunity for MedTech companies, but its regulatory body, COFEPRIS, has a critical requirement: all foreign manufacturers must appoint a local Mexico Registration Holder (MRH). This entity doesn't just submit your paperwork; they legally own your product registration, a detail that can make or break your business in the region. This episode of LATAM MedTech Insights dives deep into the strategic importance of this decision. We explore the significant risks of appointing a distributor as your MRH and how this can lead to a loss of market control, and we outline the powerful advantages of partnering with...

In this episode of LATAM MedTech Insights, we dissect the complex regulatory pathways for two key medical device categories in Latin America: surgical instrument sets and electrosurgical units. We explore the fragmented nature of LATAM regulations, moving beyond generalities to offer specific, actionable insights. We delve into the critical "family grouping" strategies required by Brazil's ANVISA for large instrument sets and contrast them with the requirements of Mexico's COFEPRIS. For active devices, we uncover the often-overlooked mandatory electrical safety certifications, like INMETRO in Brazil, that can halt a product launch in its tracks, even after clinical approval seems within reach. ...

The Latin American market for anesthesia machines and equipment is expanding rapidly, driven by significant investments in both public and private healthcare infrastructure. This growth presents a massive opportunity for MedTech manufacturers, but it comes with a formidable challenge: a highly complex and fragmented regulatory environment that can stop even the most prepared companies in their tracks. In this episode, we unpack the practical realities of entering this lucrative market. We go beyond the surface-level data to explore the specific, detailed requirements of key regulatory bodies like Brazil's ANVISA and Mexico's COFEPRIS. We'll discuss the critical differences in procurement strategies...

In this episode of LATAM MedTech Insights, we explore the immense opportunities and significant regulatory challenges of bringing blood glucose monitoring devices to the Latin American market. We uncover the specific demands of key regulatory bodies like Brazil's ANVISA, Mexico's COFEPRIS, and Argentina's ANMAT. We break down the complex, country-specific requirements that often trip up manufacturers. Imagine launching your state-of-the-art continuous glucose monitor in Brazil, only to be rejected by ANVISA after a year-long review because of an overlooked electrical safety certification. This common pitfall highlights the critical need for local expertise, a topic we dissect with real-world examples to...

In this episode of LATAM MedTech Insights, we delve into the booming orthopedic surgical implant market across Latin America. We uncover why a successful market-entry strategy requires more than just a great product and existing international approvals. We explore the complex and fragmented regulatory landscapes of key countries like Brazil, Mexico, and Colombia, highlighting the critical differences that can make or break your expansion plans. We share a cautionary tale of a premier German knee implant company, holding a valid CE mark, that faced a two-year delay in entering the Mexican market. Their mistake was assuming their European clinical data...

In this episode of LATAM MedTech Insights, we delve into the rapidly expanding but notoriously complex market for cardiac monitoring and ECG devices in Latin America. We uncover why the region's high demand, fueled by demographic shifts and a growing healthcare sector in countries like Brazil, Mexico, and Argentina, presents both a massive opportunity and a significant challenge for global MedTech manufacturers. We explore the fragmented regulatory maze, moving beyond theory to discuss the practical realities of dealing with powerful agencies like Brazil's ANVISA and Mexico's COFEPRIS. We share a detailed case study of a European company whose launch of...

In this episode of LATAM MedTech Insights, we delve into the burgeoning market for digital X-ray and radiographic equipment in Latin America. We explore the powerful growth drivers, from government healthcare modernization projects in Brazil to the booming private medical sector in Mexico, revealing why this region is a key target for global MedTech innovators. However, this opportunity is guarded by a maze of complex and fragmented regulations. We uncover the specific challenges of navigating distinct regulatory bodies like Brazil's ANVISA, Mexico's COFEPRIS, and Argentina's ANMAT. Imagine your company has a groundbreaking portable X-ray device ready to launch. You target...

In this episode of LATAM MedTech Insights, we dissect the burgeoning market for endoscopic imaging systems in Latin America. We explore the massive opportunities in key countries and expose the intricate regulatory hurdles that often lead to costly delays and market access failures for international MedTech companies. We move beyond theory to discuss the practical realities of registering advanced medical devices in this high-growth region. From Brazil's demanding ANVISA documentation and INMETRO certification to Mexico's unique COFEPRIS requirements and the critical need for a local legal representative, we provide actionable insights for manufacturers. Learn how to avoid common pitfalls and...

In this episode of LATAM MedTech Insights, we explore the lucrative yet complex market for infusion pumps in Latin America. As hospitals across the region upgrade their technology for better patient outcomes, the demand for advanced medication delivery systems is at an all-time high. However, gaining market access is a formidable challenge, with each country's regulatory agency—from Brazil's ANVISA to Mexico's COFEPRIS—imposing unique and stringent requirements. We uncover the specific hurdles manufacturers face, from lengthy manufacturing audits to critical translation errors that can derail a product launch. For instance, a leading MedTech company faced a nine-month delay in Mexi...

In this episode of LATAM MedTech Insights, we move beyond the headlines of the pandemic to uncover the real state of the respiratory device market in Latin America. The urgent rush for ventilators has subsided, leaving behind a complex landscape of equipment surplus, shifting clinical needs, and formidable regulatory barriers. We explore how the focus is moving from emergency ICU equipment to long-term solutions for chronic conditions like COPD and sleep apnea, creating new opportunities for agile MedTech companies. Imagine you are a MedTech innovator with a cutting-edge respiratory device, ready to tap into the burgeoning Brazilian market. Your launch...

In this episode of LATAM MedTech Insights, we explore the rapidly growing but complex market for hemodialysis machines and dialyzers in Latin America. We uncover the key drivers behind the region's multi-billion dollar renal care industry, focusing on the specific regulatory, logistical, and commercial hurdles in key countries like Brazil, Mexico, and Colombia. We examine real-world scenarios where manufacturers have faced significant delays and strategic pivots. For example, a European dialyzer company with full CE marking was stalled for over a year trying to enter Brazil, simply because they were unprepared for the mandatory in-person ANVISA inspection of their overseas...

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 foreign manufacturers, including the mandatory appointment of a Peruvian Registration Holder (PRH) and the specific documentation needed for your submission dossier. This episode provides essential, practical insights for any MedTech company considering Peru as their next market. A Real-World C...

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 challenges and common mistakes foreign manufacturers face when dealing with the Chilean health authority (ISP). We unpack the nuances of identifying trends from seemingly minor incidents and explain how failure to comply can lead to significant regulatory penalties and loss of market access. **What You’ll...

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 extension of B-GMP validity from two to four years makes a flawless submission more critical than ever. We'll walk you through a real-world case study of a diagnostic device manufacturer that faced a three-month market lockout due to minor administrative errors in their renewal application, highlighting the...

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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. Imagine your company has developed an innovative Class IIb diagnostic device. You are ready to tap into the Colombian market, but your submission is rejected by INVIMA. The reason is a failure to properly appoint a local legal representative and your Instructions for Use (IFU...

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 costly delays and even market withdrawal. A minor change in your product's documentation or manufacturing process, considered insignificant in other markets like the EU or USA, could completely invalidate your renewal application in Argentina, forcing you into a lengthy and expensive new...

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 down what COFEPRIS, Mexico's health authority, looks for during an audit and why simply being ISO 13485 certified is not enough. This episode is essential for any MedTech company looking to leverage Mexico's manufacturing advantages and access one of the largest markets in Latin America. We...

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 specific data that must be present on your packaging. Learn how to navigate the nuances of primary versus secondary labels, the correct way to use supplementary stickers, and why your local distributor's information is a critical component for avoiding customs delays. ...

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 undergoing factory audits and product testing. We explore the distinct roles of ANVISA and INMETRO, clarifying how they work together and what manufacturers must do to satisfy both. We highlight common pitfalls, such as assuming your existing FDA or CE mark documentation is sufficient...

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 the new technical dossier structure. This shift is a game-changer for manufacturers, promising to reduce complexity, time, and cost when entering Latin America's largest market. **Case Study:** Imagine a US-based MedTech scale-up with an innovative patient monitoring system that has already achieved CE...

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 notification process that can lead to market approval in as little as 30 days. We walk through a real-world example of a dermatology AI app, detailing how proper preparation of the technical dossier and leveraging local expertise led to a rapid and su...

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 explore why simply appointing your in-country distributor can be a catastrophic mistake, leading to a loss of control over your own product registration and effectively locking you out of the market. We'll detail the precise role of a legal representative and how choosing an independent partner...

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 innovative SaMD company faces a costly six-month delay in their COFEPRIS application. The reason? While all their documents were translated, the software's user interface, including simple menus and error messages, was left in English—a critical oversight that made their pr...

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 approved by ANVISA. We uncover the critical role of Brazilian Good Manufacturing Practices (BGMP) and reveal how the Medical Device Single Audit Program (MDSAP) can be your most powerful tool. Learn how leveraging MDSAP can slash your time-to-market from...

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 treats AI and Software as a Medical Device (SaMD) differently than other global agencies and reveal the single most effective strategy for expedited approval: the Equivalency Agreement. Learn how leveraging your existing FDA, Health Canada, or Japan MHLW clearance can cut...

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 specific pathways for both low-risk and high-risk SaMD. Learn what kind of evidence can be used for simpler devices and understand the rigorous demands for more complex, high-impact software. We highlight common pitfalls and strategic considerations that can make or break your market...

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 Device (SaMD). We explore the practical steps for registering an AI-powered device in Argentina, from the crucial risk classification process to the detailed requirements for your technical dossier. Using the example of an AI tool for diagnostic imaging, we illustrate the challenges...

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, step-by-step guide for manufacturers looking to enter this promising market. We break down the essential requirements, from the critical first step of risk classification to the mandatory appointment of a local legal representative. We detail the specific documentation needed for your technical dossier, including software...

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 vibrant Mexican market. We break down the new risk-based classification system—Class I, II, and III—and discuss how the intended use of your AI software determines its regulatory pathway. This episode provides essential information for developers and manufacturers, ensuring they...

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, RDC 657/2022, and how it interacts with the broader medical device framework. We break down the crucial four-tier risk classification system and explain how it dictates your entire path to market, from a simple notification for low-risk software to a full...

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 certificate submission means compliance is optional. This can be a costly mistake. We reveal how ANVISA's post-market surveillance can place your market access at risk if you're not prepared, and discuss how programs like MDSAP can be a strategic asset for demonstrating compliance. **A Case Study in Ri...

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), and Argentina (ANMAT), moving beyond simple language translation to discuss the critical data points that regulators are looking for. Imagine this scenario. A promising European startup ships its innovative Class I diagnostic device to Colombia. They've secured the "automatic" INVIMA registration and applied a Spanish-language sticker...

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 before the regulatory body, ANVISA. We explore why this requirement exists and the significant risks of appointing a commercial distributor as your BRH. This common mistake can lead to a loss of market access, create conflicts of interest, and severely limit yo...

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 manufacturers targeting the Colombian market. Learn how to leverage your existing approvals and what common administrative errors can cause significant delays, turning a fast-track process into a frustrating roadblock. Consider the case of a scale-up company with an innovative...

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 market entry strategy. In this episode, we uncover the truth behind this myth. We explore a real-world case of a surgical instrument company whose first major shipment was impounded at the border. They faced mounting demurrage charges and a frantic search for a...

In this episode of LATAM MedTech Insights, we demystify the process of registering a low-risk (Class I) medical device in Mexico. Don't let the "low-risk" classification fool you; navigating the requirements of COFEPRIS, Mexico's health authority, is a complex journey filled with potential pitfalls that can delay your market entry indefinitely. We break down the essential steps, from appointing a legally required Mexico Registration Holder (MRH) to compiling a flawless technical dossier. We uncover the most common mistakes foreign manufacturers make, such as improper document legalization and translation errors, which lead to costly rejections and wasted time. This episode is...

This episode of LATAM MedTech Insights tackles the common misconceptions surrounding the registration of Class I medical devices in Brazil. We move beyond the outdated term "cadastro" to provide a detailed breakdown of the current "notificação" (notification) pathway managed by ANVISA. Learn why this simplified, faster route to market is often misunderstood by foreign manufacturers. We explore the critical, non-negotiable requirements that are often overlooked. From the strategic importance of selecting the right Brazil Registration Holder (BRH) to the necessity of a complete technical dossier that ANVISA can audit at any time, we cover the essential groundwork. We share a...

Many MedTech companies dream of a single registration process for the entire Mercosur market, including giants like Brazil and Argentina. Is this a reality, or just a regulatory myth? This episode of LATAM MedTech Insights dives deep into the current state of regulatory harmonization in the region. We uncover the practical challenges and strategic opportunities that exist today. While Mercosur is moving towards a unified framework, the reality on the ground is a complex patchwork of national adoptions and lingering local requirements. We break down why you can't use a single dossier and what this means for your market access...

Colombia is one of Latin America's most promising MedTech markets, but gaining access requires navigating the complex regulatory landscape of its authority, INVIMA. While official timelines suggest a straightforward process, the reality on the ground can be quite different, with unexpected delays impacting launch plans and revenue forecasts. In this episode, we uncover the real-world timelines for medical device registration in Colombia. We explore a case study of a European orthopedic company that planned for an 8-month approval for their Class IIb device, only to be delayed by an additional five months due to a request for information regarding the...

Entering the Brazilian MedTech market is a massive opportunity, but it comes with a critical gatekeeper: the ANVISA Brazilian Good Manufacturing Practice, or BGMP, inspection. This episode of LATAM MedTech Insights demystifies this complex process for foreign manufacturers. We break down the step-by-step journey, from the initial application submitted by your Brazil Registration Holder to the intense, on-the-ground audit by ANVISA inspectors. We explore the nuances that go beyond standard ISO or MDSAP certifications and delve into the specific expectations of Brazilian regulators. This is your essential guide to understanding what it truly takes to get your manufacturing site approved...

This episode of LATAM MedTech Insights dives deep into the real costs of registering a medical device in Peru. We uncover why the official DIGEMID government fees are just the tip of the iceberg and explore the significant hidden expenses in local representation, technical dossier translation, and costly time delays that can derail your market entry strategy. We break down the critical strategic decision of appointing a Peru Registration Holder (PRH). Imagine a medical device scaleup, excited to enter the Peruvian market. They budget for the official fees but are blindsided when their registration is tied to a single distributor...

Many MedTech innovators see their FDA approval or CE mark as a golden ticket to Latin America, often targeting Chile first due to its reputation as an accessible market. However, the ground rules are changing fast. What was once a largely voluntary system is now shifting to a mandatory registration framework for all medical devices, creating new hurdles for unprepared companies. This episode of LATAM MedTech Insights dives into the reality of entering the Chilean market today. We uncover why your existing certifications are not a direct passport for sales but are the critical foundation for a successful regulatory submission...

In this episode of LATAM MedTech Insights, we explore the non-negotiable Spanish labeling requirements for medical devices in Colombia. We delve into INVIMA's regulations under Decree 4725 and explain why simply having FDA or CE approval isn't enough to guarantee a smooth market entry. We’ll walk through a real-world case study of a US company whose launch was delayed by six months due to overlooked translation of their device's software and manual. This costly mistake highlights the critical importance of a localized approach and the severe commercial impact of non-compliance. Learn what "labeling" truly covers and how to avoid common pi...

In this episode of LATAM MedTech Insights, we dive into one of the most critical and often misunderstood aspects of entering the Argentine medical device market: the role of the local registration holder. While ANMAT's requirement for a local representative seems straightforward, the legal implications of who you choose can have massive consequences for your business. We explore why appointing your commercial distributor as your registration holder can be a high-risk strategy. This episode uncovers how this common practice can lead to a complete loss of market access, forcing companies to restart the costly and time-consuming registration process from zero...

In this episode of LATAM MedTech Insights, we demystify the complex web of medical device classification rules across Latin America's key markets. While most countries use a risk-based system, the specific requirements of agencies like Brazil's ANVISA, Mexico's COFEPRIS, and Colombia's INVIMA present unique challenges that can derail market entry for unprepared companies. We explore how seemingly minor details in documentation, translation, and local procedural norms can lead to major delays. This episode provides essential insights for any MedTech company looking to expand into this dynamic but demanding region, moving beyond the regulations to discuss real-world examples and common pitfalls. ...

This episode of LATAM MedTech Insights dives deep into the medical device approval process in Mexico, governed by the regulatory body COFEPRIS. We demystify the requirements, from device classification to the critical role of a local registration holder, providing a clear roadmap for international MedTech companies looking to enter this lucrative market. We explore the strategic pathways that can save you valuable time and resources. Discover how leveraging your existing approvals from bodies like the US FDA or Health Canada can dramatically accelerate your journey to market, transforming a potentially lengthy process into a streamlined and predictable one. A US-based...

Brazil's MedTech market is a massive opportunity, but ANVISA's complex and unique regulatory requirements can be a significant barrier for foreign manufacturers. This episode provides a clear, step-by-step guide to navigating the medical device registration process, breaking down everything from initial classification to post-market responsibilities. We uncover the critical decisions and common pitfalls that can delay your market entry by years and cost you millions. Learn the strategic importance of every step, from selecting a local partner to preparing for rigorous facility audits, and discover how to leverage recent regulatory changes to your advantage. **Featured Case:** Imagine spending two years...

Brazil represents the largest MedTech market in Latin America, but its regulatory landscape, governed by the agency ANVISA, is one of the most demanding in the world. This episode breaks down the essential steps and common pitfalls companies face when seeking medical device approval in this complex market. We provide a clear overview of the multi-layered process, from initial facility certification to final product registration.

We explore the critical requirements that every MedTech manufacturer must meet, including the often-underestimated B-GMP certification, the different registration pathways based on device risk class, and the strategic importance of selecting the...