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 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
General Guidance Documents
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
Specific Guidance Documents
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
Additional Information
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