Pre-Market Overview
Overview of Mexico's medical device pre-market authorisation system — sanitary registration, registration routes, and what happens before a device can be sold in Mexico.
Standard Registration Route
The full COFEPRIS standard registration route for medical devices — when it applies, dossier contents, timelines, and practical tips.
Equivalency (Abbreviated) Route
Mexico's fast-track registration pathway for devices already approved by an IMDRF or MDSAP-recognised authority — how it works, who qualifies, and what to submit.
Technical Dossier Requirements
What to include in a COFEPRIS medical device technical dossier for the standard registration route — documentation requirements by device class.
Clinical Evidence Requirements
What clinical data COFEPRIS expects for medical device registration in Mexico, how to use foreign clinical data, and clinical investigation requirements.
Registration Fees & Timelines
COFEPRIS government fees for medical device sanitary registration and renewal by device class, and review timelines for standard and equivalency routes.
Special Device Types
Regulatory pathways in Mexico for special device categories — combination products, custom devices, single-use devices, SaMD, IVDs, and export-only devices.