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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 System PDF
[GN-01] Overview of the Medical Device Administrative Control System 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 IV Medical Devices 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-05] Guidance Notes for Listing Class II/III Medical Devices PDF
[GN-06] Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices PDF
[GN-07] Guidance Notes for Listing of Importers of Medical Devices PDF
[GN-08] Guidance Notes for Listing of Local Manufacturers 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 PDF
   
 
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Medical Device Control Office
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image 2005 copyright logo | Important notices Last revision date: 26 April 2010