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.
Mexico’s Modernized GMP Guidelines: Advancing Pharmaceutical Regulation
On March 20, 2025, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) implemented revisions to its Good Manufacturing Practice (GMP) guidelines to align with international regulatory standards and enhance global recognition. These updates are designed to optimize compliance processes, reduce administrative burdens, and strengthen the efficiency and competitiveness of Mexico’s pharmaceutical sector in the global market.
Mexico’s COFEPRIS Enhances New Molecules Committee to Accelerate Pharmaceutical Innovation
Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) has strengthened the expertise of its New Molecules Committee, a key regulatory body responsible for evaluating novel pharmaceutical agents. This initiative aims to enhance evidence-based decision-making, expedite drug approval processes, and expand public access to cutting-edge treatments. By integrating specialized experts, COFEPRIS seeks to streamline regulatory reviews and reinforce Mexico’s role as a leading hub for pharmaceutical research and innovation.
“The inclusion of these specialists will significantly enhance evidence-based decision-making with the highest scientific rigor,” stated COFEPRIS Commissioner Armida Zúñiga Estrada in a 14 March announcement. Furthermore, their work will have a direct impact on the availability of innovative treatments.
Mexico’s Patent Office, COFEPRIS Sign Agreement on Drug Patents
Officials with Mexico’s patent office and its pharmaceutical regulator have signed a new agreement aimed at preemptively clarifying patent protections for drugs in hopes of speeding the review process.