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§ ASIA-PACIFIC
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 serves as a regulatory gateway to Southeast Asian markets.
DEVICE CLASSES
Class A, B, C, D
APPROVAL PATHWAY
HSA registration
KEY REGULATORY FUNCTIONS
- ▸Device registration (Class B-D)
- ▸Class A dealer license
- ▸GN-13 guidance compliance
- ▸Adverse event reporting
- ▸IMDRF participation
OFFICIAL WEBSITE
https://www.hsa.gov.sg →MedFlux monitors HSA regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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