Anvisa Launches Public Consultation on UDI Data Requirements for Medical Devices
Brazil’s National Health Surveillance Agency (Anvisa) has opened Public Consultation No. 1,313, seeking public input on a proposed Normative Instruction that defines how companies must transmit and manage data under the Unique...
Read MoreBrazil's CONASQ Endorses Proposal to Limit Hazardous Substances in Electronics
The Brazilian National Commission on Chemical Safety (CONASQ) has approved a proposal to restrict the use of hazardous substances in electronic and electrical products. This decision was reached during a meeting,...
Read MoreBrazil Launches Environmental Monitoring Strategy for PFOS and Pesticides
On February 20, 2025, Brazil officially launched the "Environmental Monitoring Strategy for PFOS and Pesticides," a groundbreaking initiative to track pesticide contamination and enhance public health. This strategic program is a...
Read MoreANVISA Updates Regulations on Plastic Packaging and Equipment in Contact with Food
The National Health Surveillance Agency (ANVISA) has published on the 6th of February 2025, Resolution RDC No. 961/2025, amending Resolution RDC No. 56/2012 regarding the list of authorized monomers, initiator substances, and...
Read MoreBrazil: Anvisa updates toxicological evaluation guides for pesticides
Feb-12-2025
The Brazilian Health Regulatory Agency (Anvisa) has revised its pesticide evaluation guidance for mutagenicity, carcinogenesis, neurotoxicity, and reproductive toxicity. Purpose of the Updated Guidelines These guides are critical resources for assessing...
Read MoreBrazil - Key Regulatory Insights 2024
Jan-22-2025
On November 13, 2024, Brazilian President Lula sanctioned Law 15.022/24, previously known as PL 6120/24, establishing the National Inventory of Chemical Substances. This law establishes a comprehensive framework for effective risk...
Read MoreANVISA Issues Comprehensive Guidelines for Toxicological Classification of Formulated Products
Jan-20-2025
On 26 December 2024, the Brazilian Health Regulatory Agency (ANVISA) issued a technical note detailing the toxicological classification process for formulated products derived from equivalent technical products. The guidelines aim to...
Read MoreBrazilian Public Consultations No. 1304 and 1305/2024: Major Updates to Cosmetic Substance Regulations
On December 27, 2024, ANVISA announced two critical public consultations—No. 1,304 and No. 1,305—aimed at revising regulations for substances used in personal hygiene products, cosmetics, and perfumes. These updates are set...
Read MoreLaw No. 15070: Brazil’s New Regulatory Framework for Sustainable Bioinputs
Jan-16-2025
Enacted on December 23, 2024, Law No. 15,070 establishes a comprehensive regulatory framework for bioinputs in Brazil, covering their production, import, export, registration, commercialization, and use. This landmark legislation integrates sustainability...
Read MoreAnvisa Launches Public Consultations to Revise Herbal Medicines Regulatory Framework
The Brazilian Health Regulatory Agency (Anvisa) has announced the launch of three public consultations (CPs) to revise the regulatory framework for herbal medicines. This initiative, announced on November 27, 2024, also...
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