Singapore HSA: A Guide to Medical Device Risk Classification (Class A-D)

Medical Device Global Market Access · Feb 21, 2026 · 3m

This episode provides a detailed guide to Singapore's Health Sciences Authority (HSA) medical device risk classification system. We explore the four-tier structure (Class A to Class D), explain how it aligns with international GHTF/IMDRF principles, and discuss how factors like intended use and invasiveness determine a device's class. Understanding this foundational step is crucial as it dictates the entire regulatory pathway for market access in Singapore. Key Questions: - What are the four risk classes for medical devices in Singapore? - How does the HSA classify a device based on its…