Hong Kong Medical Device Regulations
Hong Kong Medical Device Regulations
All documents were published by the Medical Device Control Office (MDCO) in Hong Kong and are in PDF format.
Major Regulations
| 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 |
General Guidance Documents
| 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 |
Specific Guidance Documents
| 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 |
Additional Information
| 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 |