Strengthening Health in Latin America: Brazil and Mexico Join Forces in Historic Agreements
In a strategic move to strengthen public health in Latin America, Brazil and Mexico are advancing negotiations to sign important bilateral agreements. Preliminary discussions, which took place in August, involved a Brazilian delegation led by Vice President Geraldo Alckmin and the Mexican government, led by President Claudia Sheinbaum. The main focus of these agreements is cooperation in key areas such as vaccines, medicines, and regulatory harmonization. The final agreements are expected to be signed in 2026.
ANVISA explains how drug safety is assessed in the pharmacovigilance cycle
Pharmacovigilance is essential to ensure that medicines marketed in Brazil continue to be safe and effective over time. Even after approval and market entry, these products continue to be monitored through a structured cycle that involves detecting adverse events, analyzing risks and adopting corrective measures. In this blog, you will understand how this process coordinated by ANVISA works, what the roles of each agent involved are and why the participation of society is so important.
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.
Cosmetic Safety Dossier: Navigating Regulatory and International Convergence
Building a cosmetic safety dossier is no longer just a local requirement. With increasing alignment to international standards, ANVISA now demands a well-structured set of documents proving product and ingredient safety — especially for functional cosmetics. In this blog, we’ll show you how to create a robust dossier based on Brazilian regulations and global benchmarks such as ISO 16128, EU CosIng, and SCCS guidance.
Cosmetic or Grade 2: Understand the Categories and Avoid Rework
Before launching a cosmetic product in the Brazilian market, companies must identify whether it falls under Grade 1 or Grade 2 classification by Anvisa, Brazil’s health regulatory agency. This classification directly affects whether the product requires notification or full registration, which in turn impacts timelines, documentation, and compliance risks. In this Blog, we explain the difference between the two categories and how to ensure the correct classification to avoid costly rework.
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.
The end of paper at Anvisa! Electronic Protocol is the future of Health Surveillance
The Brazilian Health Surveillance Agency (ANVISA) will fully adopt the electronic document protocol from March 13, 2025, as established by RDC 947/2024. This change will eliminate the need for paper documents, promoting greater agility in document analysis, modernizing processes and reducing operating costs, especially those related to digitization and physical storage.
RDC 954/2024 -Comprehending the Highlights and Impacts on Drug Registration
The National Health Surveillance Agency (ANVISA) has launched Collegiate Board Resolution, RDC 954/2024 introduces several updates to make the drug registration process more agile and in line with international standards. .
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 RDC 936/2024: New Guidelines for Health Products and Their Implications for Medicine
The National Health Surveillance Agency (ANVISA) has launched Collegiate Board Resolution (RDC) 936/2024, which establishes new guidelines for the regulation of health products. These changes aim to improve the safety and efficacy of products used in medicine, directly impacting health professionals and patients.