Health Products Act — AI-Medical Device (AI-MD) Regulation

The Health Products Act 2007 is Singapore's core law for medical devices, administered by the Health Sciences Authority (HSA). Medical devices containing AI components (AI-Medical Devices, AI-MD) — whether standalone Software as a Medical Device (SaMD) or algorithms embedded in hardware — must be registered with HSA according to risk class before they can be marketed or used clinically in Singapore. Supporting regulation includes the Regulatory Guidelines for Software Medical Devices (revised 2022), which contains a dedicated section on AI-MD covering training data quality, change-control plans for model updates, the special requirements for continuous-learning systems, levels of clinical evidence, cybersecurity, and data protection. AI-MDs are also expected to follow Good Machine Learning Practice (GMLP) principles, aligned with the multilateral framework agreed with the US FDA and Health Canada. This is one of the two pieces of pre-existing legislation that the W&C tracker singles out as AI-relevant — a concrete illustration of what "Singapore has no dedicated AI law" actually means: AI is brought into hard-law regulation through modernised sector statutes, not through a horizontal AI act.