All documents were published by the Medical Device Control Office (MDCO) in Hong Kong and are in PDF format.
| Document | Language | Number | Published |
|---|---|---|---|
| Classification Rules for Medical Devices | en | TR-003 | 1/2010 |
| Overview of the Hong Kong Medical Device Administrative Control System | en | GN-01 | 9/2005 |
| Principles of Conformity Assessment for Medical Devices | en | TR-001 | 10/2006 |
| Document | Language | Number | Published |
|---|---|---|---|
| Additional Medical Device Labelling Requirements | en | TR-005 | 4/2010 |
| Code of Practice for Listed Local Manufacturers | en | COP-03 | 8/2007 |
| Code of Practice for Local Responsible Persons | en | COP-01 | 9/2005 |
| Essential Principles of Safety and Performance of Medical Devices | en | TR-004 | 4/2010 |
| Guidance Notes for Listing of Importers of Medical Devices | en | GN-07 | 7/2007 |
| STED Format for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) | en | TR-002 | 10/2006 |
| [COP-02] Code of Practice for Conformity Assessment Bodies | en | COP-02 | 3/2007 |
| Document | Language | Number | Published |
|---|---|---|---|
| Code of Practice for Listed Importers of Medical Devices | en | COP-04 | 9/2007 |
| Guidance Notes for Listing Class II, III & IV Medical Devices (Jul 2011 Edition) | en | GN-02 | 7/2011 |
| Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices (Jul 2011 Edition) | en | GN-06 | 7/2011 |
| Guidance Notes for Listing of Local Manufacturers | en | GN-08 | 3/2007 |
| Principles of In Vitro Diagnostic (IVD) Medical Devices Classification | en | TR-006 | 12/2009 |
| Document | Language | Number | Published |
|---|---|---|---|
| Guidance Notes for Definitions and Abbreviations for Medical Device Administrative System. | en | GN-00 | 1/2010 |
| Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System | en | GN-01S | 12/2009 |
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
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