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Adopting a Life Cycle Approach to Software Medical Devices: Regulatory Guidelines by Singapore HSA


Quality Management System (QMS) For Software Medical Devices

Pre-Market Product Registration Requirements

Product registration applications for medical devices submitted to HSA must conform to the format specified in the ASEAN Common Submission Dossier Template (CSDT) document. This format can be adapted from the International Medical Device Regulators Forum (IMDRF) Non-in Vitro Diagnostic Medical Device Market Authorization Table of Contents (nIVD MA ToC). The mapping between the pertinent sections in the IMDRF ToC dossier and CSDT is available at

Software Manufacturers and Distributors: Activity Controls

Changes to A Registered Software: Change Notification

Post-Market Management of Software Medical Devices

Software with Multiple Functions


  1. A secure device design
  2. Having proper customer security documentation
  3. Conduct cyber risk management
  4. Conduct verification and validation testing and
  5. Having an on-going plan for surveillance and timely detection of emerging threats

Artificial Intelligence Medical Devices (AI-MD)

Figure 1: Typical illustration of an AI model