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 episode, we dissect the critical details of this new resolution. We explore the updated risk classification system, the surprising new requirements for local clinical data, and the stringent cybersecurity mandates that now apply. This is a must-listen for any manufacturer or investor who wants to understand the new cost, timeline, and strategic implications of launching a digital health product in Brazil.

**Case Study Spotlight:** Imagine your AI-powered diagnostic tool, previously on a straightforward path to market as a Class II device, is suddenly reclassified as high-risk Class III by the new ANVISA rules. This shift instantly triggers the need for expensive, time-consuming local clinical trials, potentially delaying your launch by more than a year. We unpack how to navigate this exact scenario and what it means for your budget and global strategy.

**Key Takeaways:**

* What are the three most critical changes in ANVISA's new SaMD framework?

* How do the new cybersecurity requirements differ from FDA or CE standards?

* Is my existing telehealth platform now considered a regulated medical device in Brazil?

* What is the single biggest mistake foreign companies make when submitting AI-based digital health dossiers to ANVISA now?

* How does this regulatory shift in Brazil impact future trends in Colombia and Mexico?

* Are there any new fast-track approval pathways for certain types of SaMD under this resolution?

* What kind of local partnerships have become essential for ensuring compliance with these new rules?

At Pure Global, we specialize in demystifying complex regulatory landscapes like this. Our integrated approach combines local, in-country experts with advanced AI and data tools to deliver end-to-end solutions—from initial market strategy and technical dossier submission to post-market surveillance. We act as your local representative, ensuring you not only enter the market but thrive in it. To streamline your entry into Brazil or over 30 other markets, contact us at [email protected] or visit https://pureglobal.com/.

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 surface. While alignment with international standards simplifies dossier preparation, ANVISA has embedded stringent local requirements for cybersecurity and data privacy, directly linked to Brazil's powerful General Data Protection Law (LGPD). This creates a new hybrid regulatory landscape where a simple copy-paste of your global submission is a recipe for rejection.

A real-world case illustrates the challenge. A MedTech company with an FDA-cleared AI diagnostic tool gets its Brazilian application rejected. Their critical mistake was assuming their HIPAA-compliant cybersecurity protocols would satisfy the LGPD-specific requirements now hardwired into ANVISA's SaMD rules, leading to costly delays and rework.

Key Takeaways for This Episode:

- Is Brazil's new SaMD regulation an open door or a hidden trap for global innovators?

- How does the new IMDRF alignment truly impact your existing technical dossier?

- What are the most common cybersecurity and data privacy mistakes companies make when entering Brazil?

- How could your SaMD's risk classification change under ANVISA's new framework versus the FDA or EU?

- Beyond the device itself, what new software validation and lifecycle management proofs are now required?

- How can you leverage Brazil's strict LGPD data law as a competitive advantage?

- What are the hidden costs of non-compliance with these new localized requirements?

Navigating this new environment requires deep local expertise combined with a global perspective. At Pure Global, we offer end-to-end regulatory consulting for MedTech and IVD companies, using our local experts in Brazil and advanced AI tools to streamline market access. We turn regulatory complexity into your competitive advantage. To learn more about our services, contact us at [email protected] or visit us at https://pureglobal.com/.

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 comes with a significant catch. The new regulation includes a strict data privacy addendum linked to Brazil's LGPD law. This creates a critical new set of challenges for foreign manufacturers, focusing on algorithmic bias and data sovereignty. We explore how this seemingly minor detail could derail market entry plans and add unexpected costs and delays.

A prime example is a European AI diagnostics firm, poised for rapid entry into Brazil's market. They are now facing unexpected delays and significant costs due to unforeseen local data hosting and algorithmic bias validation requirements. Their initial strategy, built on leveraging their existing FDA clearance, is now obsolete, forcing a costly scramble to meet local data compliance.

Key Takeaways:

- What is Brazil's new fast-track pathway for AI-powered medical devices?

- How could ANVISA's new data privacy rules unexpectedly block your market entry?

- Why is proving your AI is free from demographic bias now a regulatory requirement in Brazil?

- Are you prepared for mandatory local data handling protocols and their hidden costs?

- How can a regulation designed to speed up approvals actually slow you down?

- What steps can you take to turn Brazil's complex LGPD rules into a competitive advantage?

- Is your existing technical dossier sufficient for this new, data-centric review process?

Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI to streamline global market access. We act as your local representative, develop efficient regulatory strategies, and use advanced AI to compile and submit technical documents, ensuring you can navigate complex challenges like Brazil's new AI regulations. To prepare your market access strategy, contact us at [email protected] or visit https://pureglobal.com/.

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, risk management, and technical documentation.

We explore the hidden complexities that are tripping up even experienced regulatory affairs teams. We break down the specific areas where ANVISA is focusing its attention, from demanding localized clinical evidence to flagging minor inconsistencies in product labeling. This episode is essential for any MedTech company looking to enter or maintain its presence in the Brazilian market.

**What You'll Learn:**

- Why is Brazil's RDC 751 proving to be more than just a document reformatting exercise?

- What is the single biggest mistake foreign manufacturers are making in their new ANVISA submissions?

- How can your existing CE-marked or FDA-approved clinical data lead to a rejection in Brazil?

- Are you correctly understanding the difference between device 'grouping' (agrupamento) and 'kits' (conjunto)?

- What are the unwritten expectations from ANVISA reviewers when they examine your technical dossier?

- How can you avoid a six-month delay by getting your Instructions for Use and labeling right the first time?

- How can you transform the challenges of RDC 751 into a strategic advantage for market entry?

Navigating global markets requires deep local expertise and cutting-edge tools. Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, leveraging local experts in Brazil and advanced AI to streamline market access. From initial regulatory strategy to post-market surveillance, we act as your local representative to ensure your success. To learn how we can help you conquer the Brazilian market, contact us at [email protected] or visit https://pureglobal.com/.

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 behind this push for harmonization with global standards and contrast it with the immediate, resource-intensive hurdles companies must overcome. This episode is essential listening for any MedTech professional with stakes in the Brazilian market.

For example, consider a successful US-based IVD manufacturer whose product has been on the Brazilian market for years. Under RDC 751, their device is now in a higher risk class and their existing technical file is obsolete. How can they possibly compile, translate, and submit a completely new dossier that meets the stringent new structure before their current license expires and their multi-million dollar revenue stream is cut off?

What You'll Learn:

- What are the three most common deficiencies ANVISA is finding in new RDC 751 submissions?

- How does the new technical file structure differ from the US FDA 510(k) or EU MDR requirements?

- Is your current Brazil Registration Holder (BRH) equipped to handle these complex new requirements?

- What's the biggest mistake companies make when updating their risk management files for ANVISA?

- Could this regulatory challenge actually be a strategic opportunity to leapfrog competitors?

- How will Brazil's alignment with the IMDRF framework impact your expansion plans in other LATAM countries?

At Pure Global, we specialize in transforming regulatory complexity into market opportunity. Our team of local experts in Brazil, combined with our AI-powered data tools, provides end-to-end solutions for MedTech and IVD companies. Whether it's conducting a gap analysis for RDC 751, managing technical dossier submissions, or acting as your official local representative, we streamline your path to market. Don't let regulatory changes disrupt your business. Contact us for a consultation at [email protected] or visit https://pureglobal.com/ to learn more.

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 device, the pain point is immediate. Your existing FDA or CE Mark clinical data might no longer be enough to secure or maintain your registration in Brazil. You're now facing the challenge of generating local Real-World Evidence, a potentially costly and complex process. But the attraction is clear: successfully navigating these new requirements unlocks continued access to one of the world's most lucrative and rapidly growing healthcare markets.

Key Takeaways:

- How will ANVISA's new agenda impact your 2026 product registration timeline?

- Is your Software as a Medical Device prepared for Brazil's new cybersecurity standards?

- What now constitutes acceptable Real-World Evidence for the Brazilian population?

- Could a new fast-track process for low-risk devices actually increase your compliance burden?

- How does ANVISA's focus on lifecycle management affect your post-market responsibilities?

- Are your global clinical studies designed to meet Brazil's new data expectations?

- What changes do you need to make to your quality management system right now?

At Pure Global, we specialize in turning these regulatory shifts into strategic advantages. With our local expertise in Brazil and advanced AI tools, we develop efficient pathways for regulatory approval, manage technical dossier submissions, and act as your local representative to ensure you not only enter the market but thrive in it. Don't let regulatory changes disrupt your plans. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.

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 documentation, especially for AI- and machine learning-driven software.

This change means the old way of registering your SaMD product in Brazil is no longer valid. Consider a European startup with an innovative AI diagnostic tool that analyzes patient data to predict disease progression. Under the previous, more ambiguous rules, they were preparing for a mid-tier regulatory process. Now, their product is definitively classified as high-risk, requiring extensive new evidence on clinical validation, data privacy, and cybersecurity that they hadn't budgeted for, potentially delaying their market entry by months.

Key questions from this episode:

- How does ANVISA's new risk classification system impact your AI-powered diagnostic tool?

- What specific cybersecurity and data privacy documents are now mandatory for your submission?

- How has the definition of a medical device been expanded to include your wellness or diagnostic app?

- What are the new, stringent requirements for clinical validation for high-risk SaMD?

- How can you perform a gap analysis between your existing technical file and the new Brazilian requirements?

- Will your existing ISO 13485 certification be enough to meet the new quality management system expectations for software?

- How will these changes affect registration timelines and costs for entering the Brazilian market?

At Pure Global, we specialize in navigating these complex regulatory landscapes. We provide end-to-end regulatory consulting for MedTech and IVD companies, using local expertise and advanced AI tools to streamline your market access. Whether you're a startup or a multinational, we can help you adapt your strategy, update your technical dossiers, and ensure a successful launch in Brazil and over 30 other markets. Contact us at [email protected] or visit https://pureglobal.com/.

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 development, it also introduces a new paradigm of compliance. With a decade-long gap between renewals, the focus intensifies on continuous post-market surveillance and vigilance. We explore the strategic pivot required for companies to thrive in this new environment, moving from a short-term renewal sprint to a long-term compliance marathon.

A Case to Consider: Imagine your company has just secured a 10-year registration for its flagship diagnostic device in Mexico. The immediate cost savings are clear. But the real challenge is ensuring your vigilance and quality systems are robust enough to stand up to a decade of scrutiny from COFEPRIS without the regular check-in of a 5-year renewal. How do you maintain perfect compliance over such a long period?

Key Takeaways:

- What specific article of Mexico's General Health Law has changed for medical devices?

- How does a 10-year registration cycle fundamentally alter a manufacturer's financial planning?

- Why might this change make Mexico a more attractive long-term investment than other LATAM markets?

- What are the hidden compliance risks of having a longer period between renewal submissions?

- How must companies adapt their post-market surveillance strategies for this new "marathon"?

- Could this strategic move by COFEPRIS influence regulators like ANVISA or INVIMA?

- What kind of local operational support becomes critical for maintaining a 10-year registration?

At Pure Global, we specialize in navigating these complex regulatory landscapes. Our end-to-end solutions, combining local expertise with advanced AI tools, streamline global market access. We handle everything from initial strategy to post-market surveillance, ensuring your innovation reaches the market and stays there. Don't let regulatory hurdles slow you down. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.

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 on the new risk classifications and the intensified requirements for local clinical data. This episode is essential for any MedTech manufacturer, investor, or regulatory professional looking to understand the evolving landscape in Brazil and what it takes to succeed there now.

**Case Study Spotlight:** Imagine your company has an innovative AI tool for detecting diabetic retinopathy, ready for Brazilian launch with a Class II strategy. Suddenly, new ANVISA guidance reclassifies your product to high-risk Class III, demanding extensive local clinical trials and delaying your launch by over a year. We discuss the strategic pivot required to overcome this exact challenge.

**In this episode, you will learn:**

- What are the key differences in ANVISA's new SaMD classification system for AI?

- How do the new Brazilian guidelines align with international standards like the EU MDR?

- What specific clinical evidence is now required for a high-risk SaMD submission in Brazil?

- Does this new framework create more barriers or opportunities for foreign developers?

- What are the most common pitfalls to avoid when submitting your AI SaMD for approval under the new rules?

- How can you leverage existing global data while satisfying the new local requirements?

- What does this mean for the future of digital health investment in Latin America?

Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies. We combine local expertise with advanced AI to streamline market access in complex, evolving markets like Brazil. Facing challenges with the new SaMD regulations? Contact Pure Global at [email protected] or visit us at https://pureglobal.com/ for a strategic consultation.

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 risks. We explore the hidden compliance traps, the increased importance of post-market surveillance, and why this regulatory gift could become a major liability for businesses that fail to adapt their operational mindset from cyclical renewals to continuous vigilance.

A real-world example of the risk is a company that secures a 10-year registration for its Class II device. In year four, COFEPRIS issues a new guidance on cybersecurity reporting for software-enabled devices. The company, focused on other market entries and no longer preparing for a renewal, misses the update. In year seven, a minor audit reveals this non-compliance, leading to fines and a potential suspension of their registration, jeopardizing a decade of projected revenue.

Key questions from this episode:

- Why does a 10-year approval cycle demand more vigilance, not less?

- How will COFEPRIS likely shift its enforcement focus now?

- What is the biggest mistake a company can make after securing a 10-year registration in Mexico?

- How does this regulatory change impact your long-term budget planning?

- Is your current post-market surveillance system robust enough for this new paradigm?

- What tools can ensure your technical file remains a 'living document' for a full decade?

- How can you turn this regulatory change into a competitive advantage?

Navigating the complexities of long-term market access requires local expertise and global strategic oversight. Pure Global offers end-to-end regulatory consulting for MedTech companies, using advanced AI and data tools to streamline global market access and ensure continuous compliance. Let us help you build a robust, decade-long regulatory strategy. Contact us at [email protected] or visit https://pureglobal.com/.