Brazil ANVISA’s New e-Notivisa System: A major shift in medical device vigilance

By Luiz Levy Cruz Martins

Brazilian medical device market regulator ANVISA is deploying a new post-market surveillance (PMS) and technovigilance framework for medical devices featuring more advanced adverse event reporting capabilities.

Background on ANVISA PMS requirements

ANVISA’s previous PMS system, NOTIVISA, permitted users (professionals within hospital or clinic environments or end users) to report medical device technical complaints and adverse events to the regulator. The technical complaints and adverse events would then be forwarded to Brazil Registration Holders (BRH) for further investigation.

ANVISA is replacing the traditional NOTIVISA system with e‑Notivisa (link in Portuguese).  Manufacturers and BRHs have started to receive complaints in e-Notivisa with a new level of transparency, traceability and global alignment. 

• e-Notivisa collects more detailed data
  e‑Notivisa captures comprehensive medical device, usage and patient context and profile data, helping improve root cause investigations.
• e-Notivisa permits direct communication with complainants
  BRHs can now interact directly with users through a chat feature to clarify issues, request additional details, confirm whether devices are available for investigation and provide feedback. This strengthens the investigation process compared to the previous NOTIVISA system.

e-Notivisa is aligned with IMDRF adverse event coding

The new system incorporates International Medical Device Regulators Forum (IMDRF) codes, enabling global comparison of vigilance and better signal detection. With improved usability, the system supports faster and more robust vigilance processes to drive more consistent safety monitoring in Brazil.

What does this mean for manufacturers and BRHs?

From a regulatory perspective, e-Notivisa presents more than a system upgrade -- it’s a cultural shift toward more data-driven technovigilance in Brazil. These improved features can help organizations better manage challenges such as:

• Increased regulatory expectations from ANVISA
• Needs for QMS updates
• Stronger demands for traceability and compliance 
• More structured PMS systems

Important note: While users can now report adverse event information using the new e-Notivisa system, BRHs and manufacturers should continue submitting reports through NOTIVISA until such functionality is fully built out in the e-Notivisa system.

Benefits of early preparation 

Manufacturers that develop robust PMS systems and adapt early will be better positioned for inspections, adverse event management and global integration.

Emergo by UL serves as a BRH and provides global vigilance consulting support.