,"The Questions and Answers – RDC No. 894/2024 (4th edition, October 2025) is an official guidance document published by Anvisa to assist in implementing RDC 894/2024, which establishes the Good Cosmetovigilance Practices for holders of cosmetic product registrations in Brazil.
This document provides regulatory clarification and practical guidance on setting up and maintaining a cosmetovigilance system, including procedures for adverse event monitoring, risk management, notification deadlines, and data handling. Structured in a question-and-answer format, it reflects the main chapters of the regulation, covering definitions, organizational responsibilities, training requirements, signal detection, audits, and enforcement measures.
The Q&A includes more than 60 practical examples addressing companies’ operational and compliance questions. It highlights the importance of a designated cosmetovigilance officer, proper staff qualification, documentation control, and continuous monitoring of product safety in the post-market phase. RDC 894/2024 enters into force on August 28, 2025, allowing a one-year transition period. The document reinforces Anvisa’s goal of promoting transparency, regulatory consistency, and consumer protection in the cosmetics sector."