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

DocumentLanguageNumberPublished
Classification Rules for Medical Devicesen TR-0031/2010
Overview of the Hong Kong Medical Device Administrative Control Systemen GN-019/2005
Principles of Conformity Assessment for Medical Devicesen TR-001 10/2006

General Guidance Documents

DocumentLanguageNumberPublished
Additional Medical Device Labelling Requirementsen TR-0054/2010
Code of Practice for Listed Local Manufacturersen COP-038/2007
Code of Practice for Local Responsible Personsen COP-019/2005
Essential Principles of Safety and Performance of Medical Devicesen TR-0044/2010
Guidance Notes for Listing of Importers of Medical Devicesen GN-077/2007
STED Format for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)en TR-00210/2006
[COP-02] Code of Practice for Conformity Assessment Bodiesen COP-023/2007

Specific Guidance Documents

DocumentLanguageNumberPublished
Code of Practice for Listed Importers of Medical Devicesen COP-049/2007
Guidance Notes for Listing Class II, III & IV Medical Devices (Jul 2011 Edition)en GN-027/2011
Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices (Jul 2011 Edition)en GN-067/2011
Guidance Notes for Listing of Local Manufacturers en GN-083/2007
Principles of In Vitro Diagnostic (IVD) Medical Devices Classificationen TR-00612/2009

Additional Information

DocumentLanguageNumberPublished
Guidance Notes for Definitions and Abbreviations for Medical Device Administrative System.en GN-001/2010
Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System en GN-01S12/2009