24 February 2026
Pure Global: Brazil's New Device Regs & The Risk Management Blind Spot.
LATAM MedTech Insights
About
This week, we dive into a critical regulatory update from Brazil. ANVISA has just rolled out a new resolution that reshapes the essential safety and performance requirements for medical devices, placing a heavy new emphasis on lifecycle risk management and international harmonization. This change impacts everything from technical file preparation to post-market surveillance.
We explore the specific new requirements for high-risk devices, software, and the increased demand for locally relevant clinical data. This episode is essential for any MedTech company currently in or planning to enter the Brazilian market, as non-compliance with these new rules could lead to significant delays and rejections.
**Case Study:** A European MedTech company, confident with their CE-marked cardiac monitoring software, submits to ANVISA. They are unexpectedly rejected. The reason? Their risk management file, which was perfectly acceptable for the EU, failed to meet Brazil's new, stringent requirements for post-market data collection and cybersecurity vulnerability monitoring. Their market entry is now delayed by at least a year, forcing a costly overhaul of their compliance documentation.
**What You'll Learn:**
- What specific event triggered ANVISA's major regulatory overhaul last week?
- How does the new 'lifecycle' approach to risk management change your submission strategy?
- Are your existing international clinical studies still valid under the new rules?
- What are the three new documentation requirements for Software as a Medical Device (SaMD)?
- Why might your current Quality Management System be non-compliant in Brazil right now?
- What is the single biggest mistake foreign manufacturers are making in their new ANVISA submissions?
At Pure Global, we specialize in navigating these complex regulatory landscapes. We offer end-to-end solutions, from market access strategy to local representation, using advanced data tools to streamline your path to compliance in over 30 markets, including Brazil. Don't let regulatory hurdles block your expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can help.
We explore the specific new requirements for high-risk devices, software, and the increased demand for locally relevant clinical data. This episode is essential for any MedTech company currently in or planning to enter the Brazilian market, as non-compliance with these new rules could lead to significant delays and rejections.
**Case Study:** A European MedTech company, confident with their CE-marked cardiac monitoring software, submits to ANVISA. They are unexpectedly rejected. The reason? Their risk management file, which was perfectly acceptable for the EU, failed to meet Brazil's new, stringent requirements for post-market data collection and cybersecurity vulnerability monitoring. Their market entry is now delayed by at least a year, forcing a costly overhaul of their compliance documentation.
**What You'll Learn:**
- What specific event triggered ANVISA's major regulatory overhaul last week?
- How does the new 'lifecycle' approach to risk management change your submission strategy?
- Are your existing international clinical studies still valid under the new rules?
- What are the three new documentation requirements for Software as a Medical Device (SaMD)?
- Why might your current Quality Management System be non-compliant in Brazil right now?
- What is the single biggest mistake foreign manufacturers are making in their new ANVISA submissions?
At Pure Global, we specialize in navigating these complex regulatory landscapes. We offer end-to-end solutions, from market access strategy to local representation, using advanced data tools to streamline your path to compliance in over 30 markets, including Brazil. Don't let regulatory hurdles block your expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can help.