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Medical Device Administrative Control System

Guidance Notes for the Medical Device Administrative Control System

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] 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.)
[PDF]
 
[GN-01S] Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System [PDF]
 
[GN-02] Guidance Notes for Listing Class II, III & IV Medical Devices (Jul 2011 Edition) [PDF]
 
[GN-03] Guidance Notes for Adverse Incident Reporting by Local Responsible Persons [PDF]
 
[GN-04] Conformity Assessment Framework and Conformity Assessment Bodies [PDF]
 
[GN-06] Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices (Jan 2019 Edition) [PDF]
 
[GN-07] Guidance Notes for Listing of Importers of Medical Devices (Apr 2018 Edition) [PDF]
 
[GN-08] Guidance Notes for Listing of Local Manufacturers [PDF]
 
[GN-09] Guidance Notes for Listing of Distributors [PDF]

Technical References

[TR-001] Principles of Conformity Assessment for Medical Devices [PDF]
 
[TR-002] Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) [PDF]
 
[TR-003] Classification Rules for Medical Devices [PDF]
 
[TR-004] Essential Principles of Safety and Performance of Medical Devices [PDF]
 
[TR-005] Additional Medical Device Labelling Requirements [PDF]
 
[TR-006] Principles of In Vitro Diagnostic (IVD) Medical Devices Classification [PDF]

Code of Practice

[COP-01] Code of Practice for Local Responsible Persons [PDF]
 
[COP-02] Code of Practice for Conformity Assessment Bodies [PDF]
 
[COP-03] Code of Practice for Listed Local Manufacturers [PDF]
 
[COP-04] Code of Practice for Listed Importers of Medical Devices (Apr 2018 Edition) [PDF]

Others

[RS-01] List of Recognised Standards for Medical Devices [PDF]
 

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Last Revision Date : 23 January 2019