Brazil's New e-Notivisa System: ANVISA's Overhaul of Medical Device Adverse Event Reporting

from Medical Device Global Market Access

On July 1, 2026, Brazil's ANVISA mandated the use of its new e-Notivisa system for all medical device adverse event reporting, replacing the legacy NOTIVISA platform. This episode details the critical changes, including the adoption of the International Medical Device Regulators Forum (IMDRF) adverse event coding, which aligns Brazil's technovigilance requirements with global standards. We discuss the implications for manufacturers and Brazil Registration Holders (BRHs) and provide practical steps for updating quality systems, training teams, and ensuring compliance with the new structured data requirements. Key Questions: - What is the new e-Notivisa system launched by Brazil's ANVISA? - When did the e-Notivisa system become mandatory for adverse event reporting? - How does e-Notivisa change technovigilance requirements in Brazil? - What are the key differences between e-Notivisa and the old NOTIVISA system? - How does the adoption of IMDRF adverse event codes impact manufacturers? - Why is this new system important for global regulatory harmonization? - What immediate actions should manufacturers and Brazil Registration Holders take? - How should quality and regulatory teams update their procedures for the new system? Sources: - https://www.emergobyul.com/news/brazil-anvisas-new-e-notivisa-system-major-shift-medical-device-vigilance How Pure Global can help: Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in Brazil and over 30 other markets, managing post-market surveillance and ensuring compliance with evolving regulations like ANVISA's e-Notivisa system. Our experts can help update your QMS, train your team on IMDRF coding, and manage all submissions to keep your products on the market. Leverage our local expertise and advanced AI tools to navigate complex regulatory landscapes efficiently. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.

NOW PLAYING

0:00 4:55

1×

No transcript for this episode yet

We transcribe on demand. Request one and we'll notify you when it's ready — usually under 10 minutes.

Share this episode

Similar Episodes

No similar episodes found.

Similar Podcasts

Breaking News Show | eTurboNews Juergen Thomas Steinmetz News is relevant to the global travel and tourism industry, human rights and global issues.Breaking news when it happens and only from the source. Solving for Change MOBIA Technology Innovations Solving for Change welcomes business and technology leaders to share stories of bold business transformation within complex organizations. In an era when technology and markets are changing around businesses, the key to staying competitive is to evolve in response to those changes. MOBIA’s Mike Reeves and Marc LeBlanc investigate business transformation, deconstructing the challenges, ambitions, and market disruptions that drive companies to embark on transformation journeys, and exploring their unique approaches to achieving meaningful outcomes. What sparks leaders to pursue business transformation? How do they overcome the challenges along the way? What are the keys to creating enduring change? Through in-depth conversations with business and technology leaders, Mike and Marc answer these questions and explore how businesses evolve by pulling four key transformation levers: people, process, technology, and culture. Critical Conversations by Mind the Frontline Chris Smetana Welcome to ”Critical Conversations by Mind the Frontline,” your ultimate source for in-depth discussions on first responder mental health, wellness, and recovery.Our vodcast is dedicated to providing crucial insights for police, fire, EMS, allied health workers, dispatchers, air medical, military personnel, and their families.In each episode, we tackle essential topics, including mental health strategies, recovery methods, treatment options, the latest research, and professional development opportunities.Join us as we come together to foster resilience within the entire first responder community. Don’t miss out – subscribe now and be part of this vital mission.Find out more at www.mindthefrontline.org#CriticalConversations #MindTheFrontline #FirstResponderMentalHealth #WellnessJourney #CommunitySupport Take Me Off Your List Pitchfire Ryan O'Hara, CEO and founder of Pitchfire dives into the wild world of B2B marketing, demand generation, sales, and all things go-to-market with the help of some friends. Sponsored by Pitchfire. Sign up for free: https://www.pitchfire.com

Frequently Asked Questions

How long is this episode of Medical Device Global Market Access?

This episode is 4 minutes long.

When was this Medical Device Global Market Access episode published?

This episode was published on July 10, 2026.

What is this episode about?

Can I download this Medical Device Global Market Access episode?

Yes, you can download this episode by clicking the download button on the episode player, or subscribe to the podcast in your preferred podcast app for automatic downloads.

URL copied to clipboard!