COFEPRIS vs AGES: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of COFEPRIS (Mexico) vs AGES (Austria).
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 …
Class I, II, III
COFEPRIS sanitary registration
- ▸Sanitary registration
- ▸FDA/EU recognition pathway
- ▸GMP compliance
- ▸Import permits
- ▸Vigilance reporting
AGES
AGES — Austria Medical Device Regulatory Authority
Austria
AGES is the national regulatory authority responsible for medical device oversight in Austria. It manages device registration, market surveillance, and adverse event reporting within the Europe regula…
EU MDR classes
AGES registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
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