HSA has specified “ISO 14155 – Clinical Investigation of Medical Devices for Human Subjects” in GN-20: Guidance on Clinical Evaluation, as a benchmark to the industry that clinical investigations are generally expected to be designed, conducted and reported in accordance with ISO 14155, or to a comparable standard, and in compliance with local regulations.
For more details, please refer to updated GN-20 at the following link: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-20-r2-guidance-on-clinical-evaluation(2022-nov)_pub.pdf