The New Digital Frontier of Health: Understanding SaMD (Software as Medical Device) Regulation by ANVISA
The advance of technology has turned applications, platforms, and Artificial Intelligence (AI) into essential tools for diagnosis and treatment. ANVISA (Brazil’s National Health Surveillance Agency) is updating its rules to keep pace with this evolution. The focus is on RDC 657/2022, which establishes the foundation for the regulation of Software as a Medical Device (SaMD), ensuring that these digital innovations are safe and effective for the patient. The recent expansion of the target audience for the Agency’s inspection course reinforces its commitment to training and oversight in this sector.
COFEPRIS: Self-Verification Guide for Warehouses Storing and Distributing Medicines and Other Health Supplies
Mexico’s health regulatory authority, COFEPRIS, has published a Self-Verification Guide designed for companies operating warehouses that store and distribute medicines and other health-related supplies. This initiative aims to strengthen compliance with sanitary regulations, standardize procedures, and help businesses identify nonconformities—ultimately improving safety and traceability across the supply chain.
Brazil Approves New Composition for Seasonal Influenza Vaccines
Annual influenza vaccination is one of the most effective strategies for preventing respiratory complications and reducing hospitalizations caused by the flu virus. Each year, the vaccine composition must be updated based on the most recent circulating strains. In 2025, ANVISA approved a new regulation defining the composition of seasonal influenza vaccines to be used in Brazil, aligning the country with World Health Organization (WHO) recommendations.
New Guidance on Forced Degradation Studies for Medicines in Brazil
The stability of medicines is one of the fundamental pillars to ensure their efficacy, safety, and quality throughout their shelf life. In this context, forced degradation studies are essential tools for drug development and stability assessment. Recently, Anvisa published new guidance establishing clear directives for conducting these studies in Brazil, providing greater consistency and transparency for the pharmaceutical industry.
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.
COFEPRIS x FDA: What Are the Key Differences in Medical Device Regulatory Pathways?
Companies looking to commercialize medical devices internationally often target two major markets: the United States and Mexico. These countries are regulated by two robust authorities — the FDA (Food and Drug Administration) in the U.S. and COFEPRIS (Federal Commission for Protection against Sanitary Risks) in Mexico — each with distinct regulatory frameworks.
Understanding the differences between FDA and COFEPRIS approval processes is essential for planning efficient market entry, minimizing risks, and reducing time-to-market. In this blog post, we provide a clear comparison of both regulatory systems, including requirements, timelines, and strategic advantages.
Medical Device Registration at Cofepris: Everything You Need to Know in 2025
How to register medical devices with Cofepris in Mexico. This Blog explains risk classification, documentation, timelines, and tips for national and international companies.
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.
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.