Hong Kong Medical Device Regulations
All documents were published by the Medical Device Control Office (MDCO) in Hong Kong and are in PDF format.
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Principles of Conformity Assessment for Medical Devices | TR-001 | 10/2006 | English |
| Download | Overview of the Hong Kong Medical Device Administrative Control System | GN-01 | 9/2005 | English |
| Download | Classification Rules for Medical Devices | TR-003 | 1/2010 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Additional Medical Device Labelling Requirements | TR-005 | 4/2010 | English |
| Download | Essential Principles of Safety and Performance of Medical Devices | TR-004 | 4/2010 | English |
| Download | Guidance Notes for Listing of Importers of Medical Devices | GN-07 | 7/2007 | English |
| Download | Code of Practice for Listed Local Manufacturers | COP-03 | 8/2007 | English |
| Download | [COP-02] Code of Practice for Conformity Assessment Bodies | COP-02 | 3/2007 | English |
| Download | Code of Practice for Local Responsible Persons | COP-01 | 9/2005 | English |
| Download | STED Format for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) | TR-002 | 10/2006 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Principles of In Vitro Diagnostic (IVD) Medical Devices Classification | TR-006 | 12/2009 | English |
| Download | Guidance Notes for Listing of Local Manufacturers | GN-08 | 3/2007 | English |
| Download | Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices (Jul 2011 Edition) | GN-06 | 7/2011 | English |
| Download | Guidance Notes for Listing Class II, III & IV Medical Devices (Jul 2011 Edition) | GN-02 | 7/2011 | English |
| Download | Code of Practice for Listed Importers of Medical Devices | COP-04 | 9/2007 | English |
| Document | Number | Published | Language | |
|---|---|---|---|---|
| Download | Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System | GN-01S | 12/2009 | English |
| Download | Guidance Notes for Definitions and Abbreviations for Medical Device Administrative System. | GN-00 | 1/2010 | English |
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Hong Kong Medical Device Regulations
All documents were published by the Medical Device Control Office (MDCO) in Hong Kong and are in PDF format.
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MDCO - Hong Kong Medical Device Control Office
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