LATAM MedTech Insights

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/.

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 critical changes: a complete overhaul of the rules for Software as a Medical Device (SaMD) and the game-changing proposal to make MDSAP audits mandatory for all manufacturers. We break down the immediate operational and strategic impact these changes will have on your business.

A US-based digital health startup just received FDA clearance for its AI-powered diagnostic tool. They saw Brazil as their next big market, but the planned revision of RDC 657 means their existing validation data might be insufficient for ANVISA. They now face a potential rework of their entire technical file, delaying market entry by over a year and adding unexpected six-figure costs. We discuss how to avoid this trap.

This Episode's Key Questions:
- How will ANVISA's new SaMD regulation impact AI and machine learning devices?
- Is mandatory MDSAP participation a certainty for Brazil, and what is the deadline to prepare?
- What are the three key documents you need to update in your technical file for the new software rules?
- How can you leverage your existing certifications to streamline the new Brazilian requirements?
- What is the number one mistake foreign manufacturers make when interpreting ANVISA's agenda?
- Will the validity of Good Manufacturing Practices certificates finally be extended to align with product registrations?

At Pure Global, we specialize in turning these regulatory challenges into market opportunities. With our local experts in Brazil and advanced AI tools, we streamline the entire market access process, from regulatory strategy and technical dossier preparation to acting as your official in-country representative. Don't let regulatory hurdles block your entry into one of the world's largest MedTech markets. Contact us at [email protected] or visit https://pureglobal.com to secure your market presence.

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 repositions Mexico as a more attractive market within the LATAM region. We also uncover the potential challenges and new expectations this places on companies, particularly regarding long-term post-market surveillance and compliance. This isn't just a simple extension; it's a strategic move that requires a new way of thinking about your market presence in Mexico.

**Key Takeaways:**
* What specific change in Mexico's General Health Law doubles the life of a device registration?
* How does the new 10-year renewal period impact the long-term cost and strategy for my products in Mexico?
* Are all classes of medical devices eligible for this new extension?
* With a longer registration, what are COFEPRIS's new expectations for post-market surveillance?
* Should this regulatory shift in Mexico cause me to reconsider my expansion plans in other LATAM countries like Brazil or Colombia?
* What steps should I take now to prepare my existing registrations for this new ten-year cycle?

At Pure Global, we offer end-to-end regulatory consulting solutions to help MedTech and IVD companies navigate exactly these kinds of changes. We combine local expertise with advanced AI and data tools to streamline global market access, manage your technical dossiers, and ensure continuous compliance. Let us help you turn regulatory changes into strategic advantages. Contact us at [email protected] or visit https://pureglobal.com/.

Brazil's regulatory agency, ANVISA, has just released a surprise draft guidance for personalized, 3D-printed medical devices, sending shockwaves through the MedTech industry. With a very short 30-day window for public feedback, international companies are now scrambling to understand the complex new rules for software validation and data privacy that could disrupt their market access strategies.

This episode dives deep into the specific challenges and hidden opportunities within this proposal. We analyze the potential requirement for Brazil-specific software validation, which may conflict with existing FDA or CE Mark approvals. We also unpack the ambiguous data localization clauses that could threaten the global operational models of many manufacturers.

**Case Study Spotlight:** Imagine your company has perfected a workflow for creating patient-specific implants in a central European facility. You're on the verge of expanding into Brazil, but ANVISA's new rules could suddenly make your data transfer processes non-compliant, forcing a multi-million dollar investment in local infrastructure. Is your current regulatory strategy agile enough to handle this?

**Key Questions Answered:**
* Is ANVISA's 30-day feedback window a genuine consultation or a new barrier to entry?
* What are the specific cybersecurity and data privacy risks hidden in the new draft?
* How can you effectively challenge a proposed regulation that conflicts with your global model?
* What are the unwritten rules for submitting feedback to ANVISA that actually gets considered?
* Could Brazil's new framework for personalized devices set a new, complex standard for all of LATAM?

Pure Global offers end-to-end regulatory consulting to help MedTech innovators navigate precisely these kinds of challenges. We combine local, in-country expertise with advanced AI tools to streamline global market access and ensure you're always ahead of regulatory changes. Don't let surprise regulations derail your expansion. Contact us at [email protected] or visit us at https://pureglobal.com/.

In this episode of LATAM MedTech Insights, we dissect the critical regulatory updates from Brazil's ANVISA that are reshaping the landscape for Software as a Medical Device (SaMD). This is not a minor tweak; it's a fundamental shift demanding that foreign manufacturers, especially in the AI and digital health sectors, rethink their entire market entry strategy.

We explore the immediate implications of these new clarifications, focusing on the heightened demands for localized clinical data and the stringent requirements of Brazil's data privacy laws. This episode provides essential insights for any company looking to stay compliant and competitive in Latin America's largest and most complex market.

**A Real-World Challenge:** Imagine you are a US-based scale-up with a revolutionary AI diagnostic tool, poised to enter the Brazilian market. Suddenly, you discover your extensive US and EU clinical data is deemed insufficient by ANVISA. You are now facing an unexpected, year-long delay to conduct local studies, jeopardizing your funding and first-mover advantage. How do you navigate this without derailing your entire LATAM launch?

**Key Takeaways From This Episode:**
* What specific clinical evidence is ANVISA now demanding for foreign SaMD?
* How does Brazil's data privacy law (LGPD) impact your software's architecture?
* Why is the risk classification for your AI-driven device more complex than you think?
* What is the biggest mistake companies make when interpreting these new guidelines?
* Could these stricter regulations hide unforeseen opportunities for well-prepared companies?
* How can you leverage regulatory reliance pathways to potentially streamline this process?
* What are the three essential questions to ask your local regulatory partner today?

Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies, combining local expertise with advanced AI and data tools to streamline global market access. We help you turn regulatory hurdles into market opportunities. To learn more about navigating Brazil's evolving landscape or expanding into over 30 other global markets, contact us at [email protected] or visit https://pureglobal.com/.