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 System |

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[GN-01] Overview of the Medical Device Administrative
Control System
(Note: The "Classification Rules for Medical Devices" given in Appendix 1 of this guidance document may be updated from time to time. You may wish to refer to the most updated version included in the Technical Reference [TR-003] Classification Rules for Medical Devices published by Department of Health.) |
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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 (Jul 2011 Edition) |

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[GN-07] Guidance Notes for Listing of Importers of Medical Devices |
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[GN-08] Guidance Notes for Listing of Local Manufacturers |
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