Mexico's Medical Device Regulations

Medical Devices are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios). All medical devices imported into or distributed within Mexico must first undergo registration with COFEPRIS.

Good Manufacturing Practices (GMP)
Document Number Document Title Issued by Description Available Languages Download
NOM-241-SSA1-2012 Good Manufacturing Practices for establishments dedicated to the manufacture of Medical Devices Mexico Ministry of Health This standard 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 the country. English For Sale