HSA vs AEMPS: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of HSA (Singapore) vs AEMPS (Spain).
HSA
Health Sciences Authority (Singapore)
Singapore
Singapore's HSA regulates medical devices using a four-class risk-based system (A, B, C, D). HSA accepts conformity assessment from recognized bodies and is a founding member of IMDRF. Singapore serve…
Class A, B, C, D
HSA registration
- ▸Device registration (Class B-D)
- ▸Class A dealer license
- ▸GN-13 guidance compliance
- ▸Adverse event reporting
- ▸IMDRF participation
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
MedFlux monitors both HSA and AEMPS in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
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