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HSA Guidance Documents — by Topic

Finding HSA guidance​

All current HSA guidance documents for medical devices are published on the HSA website:

hsa.gov.sg/medical-devices/guidance-documents

Guidance documents are updated periodically. Always use the current version from the HSA website — do not rely on downloaded copies that may be outdated.

Guidance by topic area​

Registration and classification​

  • Quick Guide to Medical Device Registration and Licensing (April 2026)
  • Risk classification guidance documents
  • Registration guides by class and route (see Registration Guides)

Device grouping​

  • Guidance on grouping types (Family, System, Group, Single)
  • Dental Grouping Terms (DGT)
  • IVD grouping guidance

Clinical evidence​

  • Clinical evidence requirements for medical device registration
  • Guidance on clinical investigations

Quality management systems​

  • QMS requirements for dealer's licences
  • GDP guidance for importers and wholesalers

Post-market​

  • Adverse event reporting guidance
  • FSCA reporting guidance
  • Change notification guidance

Digital health and SaMD​

Labelling and advertising​

  • Labelling guidance for medical devices
  • Advertising guidelines for medical devices

Specific device types​

  • Custom-made medical devices
  • Guidance for specific device categories as published by HSA

Official sources​