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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

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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