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Medical Device Administrative Control System > Issued Documents
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Guidance Notes for the Medical Device Administrative
Control System |
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Guidance documents for the Medical Device Administrative Control
System
are available in pdf format:
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Overview of the Medical Device Administrative
Control System (GN-01) |
[PDF ] |
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Guidance Notes for Listing Class
IV Medical Devices (GN-02) |
[PDF ] |
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Guidance Notes for Adverse Incident
Reporting by Local Responsible Persons (GN-03) |
[PDF ] |
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Conformity Assessment Framework and Conformity Assessment Bodies (GN-04) |
[PDF ] |
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Guidance Notes for Listing Class II/III Medical Devices (GN-05) |
[PDF ] |
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Guidance Notes for Listing of Importers of Medical Devices (GN-07) |
[PDF ] |
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Guidance Notes for Listing of Local Manufacturers (GN-08) |
[PDF ] |
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Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System |
[PDF ]
[NEW! ] |
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Technical References |
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Principles of Conformity Assessment for Medical Devices (TR-001) |
[PDF ] |
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Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) (TR-002) |
[PDF ] |
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Code of Practice |
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Code of Practice for Local Responsible
Persons (COP-01) |
[PDF ] |
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Code of Practice for Conformity Assessment Bodies (COP-02) |
[PDF ] |
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Code of Practice for Listed Local Manufacturers (COP-03) |
[PDF ] |
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Public Consultation on Regulation of Medical Devices
(July to September 2003) |
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Consultation Document |
[PDF ] |
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Pamphlet for the Consultation |
[PDF ] |
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2005 copyright | Important
notices
Last revision date: 14 November 2008