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

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

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.
Brazil’s Anvisa authorizes Remdesivir for Pediatric- Use in the treatment of Covid-19

Anvisa approved, on Monday (11/21), the extension of use of the antiviral drug Remdesivir for pediatric use in the treatment of Covid-19.
Brazil Authorizes Emergency-use of Molecular kits for Monkeypox Diagnosis

Anvisa Authorizes the immediate and emergency use of 24,000 units of Monkeypox diagnostic reagents, comprising two molecular kits produced by BioManguinhos/Fiocruz.
Brazil’s Anvisa approves new Remdesivir indication for Covid-19

The new indication is for adult patients who do not require supplemental oxygen and who are at risk of progressing to a severe case.
Brazil’s Anvisa approves Anvisa regulates the use of self-tests for Covid-19

Brazil’s Anvisa approves resolution establishing requirements for registration, distribution, commercialization, and use of covid-19 self-tests.
Brazil’s Anvisa approves Rules for travelers entering Brazil

Foreign and Brazilian travelers abroad must present the Negative PCR exam to the airline company responsible for the flight, before boarding
Brazil’s Anvisa approves extending the use of CoronaVac to children and adolescents aged 6 to 17 years

The emergency use authorization granted this Thursday (01/20) is valid only for the age group 6 to 17 years old.
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.
Brazil’s Anvisa Updates the List of Brazilian Common Appellations

The Resolution RDC No. 590/2021 published on December 29th, 2021, the List of Brazilian Common Denominations (DCBs). The regulation included 28 new designations and changed two.
Brazil’s Anvisa identifies positive Covid-19 case in Brazilian passenger from South Africa

The Ordinance No.660/2021 It would impose restrictions on exceptional and specific restrictions, measures and requirements for entry into the country, due to the risks of contamination and dissemination of the SARS-CoV-2 coronavirus (covid-19).