Mexico's Health Authority ( COFEPRIS)

COFEPRIS or the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios is a decentralized and autonomous body run by a commissioner appointed by the President of Mexico and regulates health facilities, advertising activities, and the manufacturing, import, or export of health products.

Document Number Document Title Issued by Description Available Languages Download
NOM-059-SSA1-2015 Good Manufacturing Practices of Medicines Ministry of Health The regulation lays down the minimum requirements necessary for the manufacturing process of medicines for human use marketed in Mexico and/or for research purposes. English For Sale
NOM-241-SSA1-2012 Good Manufacturing Practices for establishments dedicated to the manufacture of Medical Devices Ministry of Health The regulation lays down the requirements that processes must meet, from the design of the installation, development, obtaining, preparation, mixing, production, assembly, handling, packaging, conditioning, stability, analysis, control, storage and distribution of medical devices marketed in Mexico. English For Sale
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