ANVISA Opens Public Consultation on New Regulatory Framework for Medical Devices in Brazil

Brazil Anvisa

Brazil’s national health surveillance agency, ANVISA, has launched a targeted public consultation as part of its effort to revise and modernize the regulatory framework for medical devices. This initiative aims to align Brazilian regulations with international best practices, enhance patient safety, and foster innovation. Stakeholders across the health and regulatory sectors are invited to submit their contributions and insights.

Brazil Discusses Revisions to Allergen Labeling on Food Products

Clear and accurate food labeling is essential for protecting consumers, especially those with food allergies. To improve transparency and safety, ANVISA recently held a virtual sectoral dialogue to discuss the revision of Brazil’s allergen labeling regulations. The initiative aims to update current standards, improve clarity for consumers, and align Brazilian practices with international regulatory trends.

Brazil Approves New Composition for Seasonal Influenza Vaccines

Anvisa

Annual influenza vaccination is one of the most effective strategies for preventing respiratory complications and reducing hospitalizations caused by the flu virus. Each year, the vaccine composition must be updated based on the most recent circulating strains. In 2025, ANVISA approved a new regulation defining the composition of seasonal influenza vaccines to be used in Brazil, aligning the country with World Health Organization (WHO) recommendations.

US-FDA TRANSITION PLAN FOR MEDICAL DEVICE UNDER EUA IN USA

On December 31st, 2021, the US Food and Drug Administration (FDA) published the draft of new guidance that outlines the transition plan for devices granted and marketed in USA under EUA designation during the coronavirus pandemic.