FDA vs HSA: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of FDA (United States) vs HSA (Singapore).
FDA
U.S. Food and Drug Administration
United States
The FDA is the primary regulatory authority for medical devices in the United States. Its Center for Devices and Radiological Health (CDRH) oversees premarket review, postmarket surveillance, and enfo…
Class I, II, III
510(k), PMA, De Novo, HDE
- ▸510(k) clearance and PMA approval
- ▸MAUDE adverse event database
- ▸FDA Enforcement Reports and recalls
- ▸De Novo classification
- ▸Breakthrough Device Designation
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
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