COFEPRIS (Federal Commission for Protection against Sanitary Risks)

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. COFEPRIS’s jurisdiction covers 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.  

COFEPRIS ensures that regulated products in Mexico meet 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 according to NOM-241-SSA1-2025. COFEPRIS also enforces post-market monitoring to ensure products maintain compliance and remain safe and effective.

‍Website: COFEPRIS
Address: Oklahoma 14 Col. Nápoles, Demarcación Territorial Benito Juárez, Ciudad de México, C.P. 03810.
Phone: 800 033 5050
Email: contactociudadano@cofepris.gob.mxdf