COFEPRIS
Federal Commission for Protection against Health Risks (Mexico)
Mexico
Last reviewed 2026-06-21
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 →§ FAQ
What is COFEPRIS medical device registration?
COFEPRIS (Federal Commission for Protection against Health Risks) manages medical device registration in Mexico through a sanitary registration (registro sanitario) system. Class II and III devices require formal registration. Mexico offers expedited pathways for devices already approved by FDA, EU, or other reference authorities through mutual recognition agreements.
What is the COFEPRIS device classification system?
Mexico uses a three-class system: Class I (lowest risk), Class II (moderate risk, requires sanitary registration), and Class III (highest risk, requires sanitary registration with additional clinical evidence). Classification is determined by the General Health Council and aligns broadly with international standards.
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