(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:
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[GN-00] Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System |

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| [GN-01] Overview of the Medical Device Administrative
Control System
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[GN-01S] Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System |
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[GN-02] Guidance Notes for Listing Class
II, III & IV Medical Devices (Jul 2011 Edition) |
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[GN-03] Guidance Notes for Adverse Incident
Reporting by Local Responsible Persons |
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[GN-04] Conformity Assessment Framework and Conformity Assessment Bodies |
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[GN-06] Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices (Jan 2019 Edition) |

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[GN-07] Guidance Notes for Listing of Importers of Medical Devices (Apr 2018 Edition) |
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[GN-08] Guidance Notes for Listing of Local Manufacturers |
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[GN-09] Guidance Notes for Listing of Distributors |
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