Registration of Medical Devices in Brazil: Understanding Risk Classes and Regulatory Requirements

To market medical devices in Brazil — from surgical materials to diagnostic equipment — companies must register them with Anvisa, the National Health Surveillance Agency. Brazil classifies these products into four risk classes (I to IV), which determine the level of regulatory control and documentation required. In this article, you’ll learn how Brazil defines medical device risk classes and what is required to bring each type to market.

Registering Cosmetics with Anvisa: Practice Guide for 2025

The regularization of cosmetics in Brazil goes through specific processes defined by Anvisa. With the entry into force of RDC 752/2022, the procedures have become clearer and more digital, but still require attention to detail. This updated guide for 2025 presents a step-by-step process for registration (or notification), explains the risk categories and provides essential tips for avoiding rework.

Toxicology and Safety in Cosmetics: Current Regulatory Requirements

The safety of cosmetics is a growing priority for both regulators and consumers. In Brazil, Anvisa establishes clear guidelines on toxicological evaluation and safety requirements for ingredients and finished products. This article explores what is currently required, with a focus on RDC 752/2022, addressing critical points for companies and professionals working in the sector.

ANVISA’s New Rules for Post-Market Monitoring of Cosmetics: The Impact of RDC 894/2024

ANVISA's New Rules for Post-Market Monitoring of Cosmetics: The Impact of RDC 894/2024

The National Health Surveillance Agency (ANVISA) has published two documents on the new rules for post-market monitoring of cosmetics. The Inspection Manual for Good Cosmetic Surveillance Practices and the Questions and Answers on RDC 894/2024 will support the implementation of the new regulatory guidelines and strengthen the safety of cosmetic products in Brazil.

ANVISA Publishes Database for Clinical Investigations into Medical Devices

ANVISA Publishes Database for Clinical Investigations into Medical Devices

The National Health Surveillance Agency (ANVISA) has announced the launch of a database aimed at clinical investigations related to medical devices. This initiative represents an important milestone in the health sector, promoting greater transparency, efficiency and safety in research carried out in Brazil.