HSA vs ANSM: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of HSA (Singapore) vs ANSM (France).
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
ANSM
ANSM — France Medical Device Regulatory Authority
France
ANSM is the national regulatory authority responsible for medical device oversight in France. It manages device registration, market surveillance, and adverse event reporting within the Europe regulat…
EU MDR classes
ANSM registration
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
MedFlux monitors both HSA and ANSM in real time — every regulatory change, safety alert, and market signal delivered in under 90 seconds.
COMPARE LIVE DATA FREE →