FDA vs AEMPS: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of FDA (United States) vs AEMPS (Spain).
FDA
U.S. Food and Drug Administration
United States
The FDA is the primary regulatory authority for medical devices in the United States. Its Center for Devices and Radiological Health (CDRH) oversees premarket review, postmarket surveillance, and enfo…
Class I, II, III
510(k), PMA, De Novo, HDE
- ▸510(k) clearance and PMA approval
- ▸MAUDE adverse event database
- ▸FDA Enforcement Reports and recalls
- ▸De Novo classification
- ▸Breakthrough Device Designation
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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