COFEPRIS
Commission fédérale de protection contre les risques sanitaires (Mexique)
Mexico
Last reviewed 2026-06-21
COFEPRIS réglemente les dispositifs médicaux au Mexique selon la loi générale de santé avec un système à trois classes.
CLASSES DE DISPOSITIFS
Class I, II, III
VOIE D'APPROBATION
COFEPRIS sanitary registration
FONCTIONS RÉGLEMENTAIRES CLÉS
- ▸Enregistrement sanitaire
- ▸Voie de reconnaissance FDA/EU
- ▸Conformité BPF
- ▸Permis d'importation
- ▸Déclarations de vigilance
SITE OFFICIEL
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.
MedFlux surveille les changements réglementaires, alertes de sécurité et signaux de marché de COFEPRIS en temps réel.
SURVEILLER {abbr} GRATUITEMENT →