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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 regulatory framework.
DEVICE CLASSES
EU MDR classes
APPROVAL PATHWAY
AEMPS registration
KEY REGULATORY FUNCTIONS
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
OFFICIAL WEBSITE
https://www.aemps.gob.es →MedFlux monitors AEMPS regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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