Singapore HSA Reviewed and Validated Medical Device Guidance Document Remains Valid

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

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