Federal Commission for Protection against Sanitary Risks (COFEPRIS)

What is COFEPRIS? The Federal Commission for Protection against Sanitary Risks, known as COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), is Mexico’s primary federal authority overseeing the regulation of products and services that impact public health. It operates as a decentralized entity under the Secretariat of Health with administrative, technical, and operational autonomy, led by a commissioner appointed by the President of Mexico. COFEPRIS’s jurisdiction spans medical devices and in vitro diagnostics (IVDs), pharmaceuticals, biological products, foods and beverages, cosmetics, sanitizing agents, pesticides, tobacco products, organ and blood transplants, and advertising related to health products. What does COFEPRIS do? COFEPRIS ensures that regulated products circulating in Mexico meet rigorous safety, efficacy, and quality standards throughout their life cycle. This includes evaluating technical documentation to grant marketing authorizations for medical devices and health products, applying risk-based classification systems, and overseeing compliance with Good Manufacturing Practices—specifically NOM‑241‑SSA1‑2012, which aligns with ISO 13485 for device manufacturing oversight. Once authorized, the agency maintains post-market vigilance, managing adverse event reporting, product recalls, labelling enforcement, and technology-enabled risk management systems. COFEPRIS also supervises the import, export, and advertising of health products and regulates clinical trials and transfers of rights for registered products.