In Mexico, medical devices and in-vitro diagnostic devices are regulated by COFEPRIS, a division of the Mexican Ministry of Health. The regulatory process involves classifying the device, appointing a Mexico Registration Holder representative, preparing a registration dossier in Spanish including documentation of quality management and technical specifications, and submitting the application to COFEPRIS for review. Approval time ranges from 1-10 months depending on the device class and review process. Registrations are valid for 5 years and must be renewed in advance of the expiration date.