Singapore HSA updated “GN-17 R3 Guidance on Preparation of a Product Registration Submission for GMD” and “GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD” for Software Medical Device Registration.
The following information are required as part of the product registration submission of a software medical device:
– Summary of software development life cycle process including processes in place to manage the various life cycle activities.
– Software Requirements Specification documenting functional, performance, interface, design, developmental, and other requirements for the software.
– Traceability Analysis linking product design requirements, design specifications, and testing requirements. Identified hazards should be tied to implementation and testing of the mitigations. (Only applicable to device registration via the full evaluation route)
Updated guidance document GN-17 and GN-18 can be found at the following link: https://www.hsa.gov.sg/medical-devices/guidance-documents