Guidance Notes

Guidance Notes

(Note: The Medical Device Control Office has been renamed as the Medical Device Division with effect from 1 October 2019. Please refer to Contact Us page for updates in contact information and contact our office for enquiry, if necessary.)

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