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

- Date: 2007
- Who: MOH
- Source: https://www.hsa.gov.sg/medical-devices/regulatory-overview
- sgai: https://sgai.md/policies/health-products-act-ai-medical-devices/
- License: sgai-authored content (summaries, translations, analysis) is CC BY 4.0 — attribute and link to sgai.md. Verbatim source text (Hansard, speeches, transcripts, policy documents) remains © its original rights holders and is reproduced for reference only. Terms: https://github.com/meltflake/sgai/blob/main/DATA-LICENSE.md

## Why it matters

HSA brought AI-MD under regulation using 2007 legacy law, confirming Singapore's approach of amending existing law rather than enacting dedicated AI legislation for high-risk scenarios

## Summary

AI-containing medical devices must be registered with HSA — the hard-law gate for healthcare AI market access.
