Singapore HSA revised GN-05: Guidance on the Reporting of Adverse Events for Medical Devices with the following update:
– Included new section regarding Adverse Event Investigation
– Listed regulatory actions that HSA may take upon reviewing the adverse event
Please refer to the following for the updated guideline: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-05-r3-guidance-on-the-reporting-of-adverse-events-(2023-sep)-pub.pdf