ANVISA Launches Public Consultation to Review the Regulatory Framework for Medical Device Vigilance
The Brazilian Health Regulatory Agency (ANVISA) has published Public Call No. 4/2026, inviting medical device registration and notification holders to contribute to the revision of Brazil's regulatory framework for Medical Device Vigilance (Tecnovigilância).
According to the notice, the initiative forms part of ANVISA's 2026–2027 Regulatory Agenda and aims to gather stakeholder feedback to support the review of the current post-market surveillance framework applicable to medical devices marketed in Brazil.
Revision of the Medical Device Vigilance Framework
According to ANVISA, the objective of the public call is to collect contributions from companies holding medical device registrations or notifications regarding the future revision of the national Medical Device Vigilance regulatory framework.
The document explains that post-market surveillance plays a key role throughout the lifecycle of medical devices by monitoring their safety and performance after they have been placed on the market.
According to ANVISA, information collected during the post-market phase supports ongoing risk management activities and may lead to manufacturing improvements or market actions when necessary.
Post-Market Surveillance as a Lifecycle Activity
The document highlights that risk management should not be regarded as a one-time activity but as a continuous process throughout the product lifecycle.
ANVISA explains that Medical Device Vigilance relies on the collection and analysis of information relating to:
Adverse events;
Technical complaints;
Safety and performance data;
Trends identified through post-market reports.
The agency notes that this information contributes to monitoring device performance under real-world conditions and supports regulatory actions intended to protect public health.
Need to Update the Existing Regulatory Framework
According to ANVISA, the current Medical Device Vigilance requirements are established under RDC 67/2009 and RDC 551/2021, which were developed between 2008 and 2012.
The agency states that post-market surveillance practices have evolved significantly in both Brazil and internationally since those regulations were introduced, creating the need to review and update the existing regulatory framework.
The document also highlights the growing challenges associated with innovative technologies, including:
Software as a Medical Device (SaMD);
Artificial Intelligence (AI).
Stakeholder Participation
The public call is specifically addressed to companies holding medical device registrations or notifications in Brazil.
According to the notice, interested parties may submit their contributions through an electronic questionnaire within 30 calendar days, beginning on the first business day following publication of the notice.
ANVISA states that only contributions submitted within the established timeframe and within the scope of the consultation will be considered during its internal review process.
Relevance for Medical Device and IVD Manufacturers
The public consultation is directly relevant to medical device and IVD manufacturers placing products on the Brazilian market, particularly organisations holding product registrations or notifications with ANVISA.
Topics of particular interest include:
Medical Device Vigilance (Tecnovigilância);
Post-market surveillance;
Risk management throughout the product lifecycle;
Adverse event and technical complaint reporting;
Emerging technologies, including Software as a Medical Device (SaMD) and Artificial Intelligence;
Future revisions to Brazil's post-market surveillance requirements.
The publication provides manufacturers with an opportunity to contribute to the future development of Brazil's Medical Device Vigilance framework and offers insight into the regulatory priorities identified by ANVISA for post-market surveillance.
