ISP vs AIFA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of ISP (Chile) vs AIFA (Italy).
ISP
ISP — Chile Medical Device Regulatory Authority
Chile
ISP is the national regulatory authority responsible for medical device oversight in Chile. It manages device registration, market surveillance, and adverse event reporting within the Latin America re…
Class I, II, III, IV
ISP registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
AIFA
AIFA — Italy Medical Device Regulatory Authority
Italy
AIFA is the national regulatory authority responsible for medical device oversight in Italy. It manages device registration, market surveillance, and adverse event reporting within the Europe regulato…
EU MDR classes
AIFA registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
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