Guidance Notes

Guidance Notes

(Note: The Chinese name of the Medical Device Division will be renamed with effect from 21 January 2025 while the English name remains unchanged. All issued listing certificates shall remain valid until their expiry date. For enquiry, please contact the Medical Device Division.)

Guidance documents for the Medical Device Administrative Control System are available in pdf format:

[GN-00] Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System
[GN-01] Guidance Notes for Overview of the Medical Device Administrative Control System
[GN-02] Guidance Notes for Listing Class II, III & IV General Medical Devices
[GN-03] Guidance Notes for Adverse Event Reporting by Local Responsible Persons
[GN-04] Guidance Notes for Conformity Assessment Framework and Conformity Assessment Bodies
[GN-06] Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Device
[GN-07] Guidance Notes for Listing of Importers of Medical Devices
[GN-08] Guidance Notes for Listing of Local Manufacturers of Medical Devices
[GN-09] Guidance Notes for Listing of Distributors of Medical Devices
[GN-10] Guidance Notes for Changes of Listed Medical Devices