← All regulators
§ LATIN AMERICA
COFEPRIS
Federal Commission for Protection against Health Risks (Mexico)
Mexico
COFEPRIS regulates medical devices in Mexico under the General Health Law. Mexico uses a three-class system (I, II, III). A sanitary registration (registro sanitario) is required for Class II and III devices. Mexico has mutual recognition pathways for devices approved by FDA or EU.
DEVICE CLASSES
Class I, II, III
APPROVAL PATHWAY
COFEPRIS sanitary registration
KEY REGULATORY FUNCTIONS
- ▸Sanitary registration
- ▸FDA/EU recognition pathway
- ▸GMP compliance
- ▸Import permits
- ▸Vigilance reporting
OFFICIAL WEBSITE
https://www.gob.mx/cofepris →MedFlux monitors COFEPRIS regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
MONITOR {abbr} FREE →