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Reforms Tracker

This page tracks significant regulatory reforms to Singapore's medical device framework. For the most current information, always refer to official HSA announcements.

Framework​

Singapore's medical device regulatory framework has been broadly stable since the HP(MD) Regulations 2010. Significant updates have occurred in:

  • QMS requirements: periodic updates to QMS and auditor requirements for dealer's licences
  • Digital health: development of the dedicated digital health/SaMD guidance framework
  • SHARE portal: transition from the legacy PRISM portal to SHARE for all regulatory submissions
  • Quick Guide updates: HSA's Quick Guide to Registration and Licensing updated April 2026
  • ASEAN harmonisation: ongoing updates aligned with AMDC/AMDD developments

Anticipated areas of development​

Based on international trends and IMDRF/AMDC workstreams, future areas of regulatory development in Singapore may include:

  • AI/ML medical devices: further guidance on adaptive AI algorithms and post-market change management for AI SaMD
  • Cybersecurity: updated cybersecurity requirements for connected devices
  • UDI: potential expansion of UDI requirements
  • ASEAN CSDT updates: continued alignment with ASEAN dossier harmonisation

This tracker is maintained on a best-efforts basis. Always verify against official HSA communications.