ISP vs AEMPS: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of ISP (Chile) vs AEMPS (Spain).
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
AEMPS
AEMPS — Spain Medical Device Regulatory Authority
Spain
AEMPS is the national regulatory authority responsible for medical device oversight in Spain. It manages device registration, market surveillance, and adverse event reporting within the Europe regulat…
EU MDR classes
AEMPS registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
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