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