The Health Sciences Authority (HSA) of Singapore made several key updates to align with current International Medical Device Regulators Forum (IMDRF) regulatory recommendations regarding software/programmed or programmable medical devices. Product owners that are involved in Software as a Medical Device (SaMD) either being standalone or embedded within the Medical Device are highly suggested to be aware of the following updates:
| Updated Regulation | Key Update | Link to Update |
|---|---|---|
| Revision 3 of GN-17 Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT | Under Product Description shall include a summary of Software Development Life Cycle (SDLC). and Software Requirements Specification documents. Under Design Verification and Validation, Traceability Analysis and hazard identifications tied to testing and mitigations of software should be provided. | View update |
| Revision 3 of TR-01 Contents of a Product Registration Submission for General Medical Devices using the ASEAN CSDT | Under Design Verification and Validation, Traceability Analysis and hazard identifications tied to testing and mitigations of software should be provided. | View update |
| Revision 3 of E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS | Under Product Description shall include a summary of Software Development Life Cycle (SDLC) and Software Requirements Specification documents. | View update |
| Revision 3 of GN-18 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT | Under Product Description shall include a summary of Software Development Life Cycle (SDLC) and Software Requirements Specification documents. | View update |
| Revision 3 of TR-02 Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT | Summary of SDLC, processes, software configuration management and problem resolution during SDLC. In addition, the Software Requirement Specification (SRS) documentation, which describes what the software is supposed to do should be provided. | View update |
| Revision 3 of E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS | Under Product Description shall include a summary of Software Development Life Cycle (SDLC) and Software Requirements Specification documents. | View update |
| Revision 11 of GN-15 Guidance on Medical Device Product Registration | Under the Verification and Validation documents to include traceability analysis (only for full evaluation route) | View update |
| Revision 3 of GL-04 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach | Traceability Studies that relates to product design requirements, design specification and testing requirements, together with hazards identifications should be provided | View update |
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