COFEPRIS
Bundeskommission zum Schutz vor Gesundheitsrisiken (Mexiko)
Mexico
Last reviewed 2026-06-21
COFEPRIS reguliert Medizinprodukte in Mexiko unter dem Allgemeinen Gesundheitsgesetz mit einem Drei-Klassen-System.
GERÄTEKLASSEN
Class I, II, III
ZULASSUNGSWEG
COFEPRIS sanitary registration
WICHTIGE REGULIERUNGSFUNKTIONEN
- ▸Sanitäre Registrierung
- ▸FDA/EU-Anerkennungsweg
- ▸GMP-Konformität
- ▸Importgenehmigungen
- ▸Vigilanzmeldungen
OFFIZIELLE 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.
MedFlux überwacht COFEPRIS regulatorische Änderungen, Sicherheitswarnungen und Marktsignale in Echtzeit.
{abbr} KOSTENLOS ÜBERWACHEN →