Singapore HSA reviewed several Medical Device Guidance Documents which were not updated since June 2018, and confirmed that the content for these guidance documents remain valid on 1 Nov 2022.
Below are the list of guidance documents reviewed by HSA:
GN-05: Guidance on the Reporting of Adverse Events for Medical Devices, Revision 2.1
GN-07: Guidance on Complaint Handling of Medical Devices, Revision 2.2
GN-11: Guidance on the Declaration of Conformity, Revision 1.3
GN-33: Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices, Revision 1.2