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