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.
Brazil Regulatry Breakdown: Food supplement or specific medicine?
The food supplement category was created in Brazil in 2018 to ensure the population’s access to safe and quality products. However, there is still confusion about the framing and registering the products in brazil ; is it a Food Supplement or is its a specific medicine?