Hong Kong Regulatory Framework Medical Device registration

Hong Kong Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Hong Kong market:

Major Regulations

RegulationYear
Classification Rules for Medical Devices 2010
Overview of the Hong Kong Medical Device Administrative Control System 2005
Principles of Conformity Assessment for Medical Devices 2006

General Guidance Documents

DocumentYear
Additional Medical Device Labelling Requirements 2010
Code of Practice for Listed Local Manufacturers 2007
Code of Practice for Local Responsible Persons 2005
Essential Principles of Safety and Performance of Medical Devices 2010
Guidance Notes for Listing of Importers of Medical Devices 2007
STED Format for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) 2006
[COP-02] Code of Practice for Conformity Assessment Bodies 2007

Specific Guidance Documents

DocumentYear
Code of Practice for Listed Importers of Medical Devices 2007
Guidance Notes for Listing Class II, III & IV Medical Devices  2011
Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices 2011
Guidance Notes for Listing of Local Manufacturers 2007
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification 2009

Additional Information

DocumentYear
Guidance Notes for Definitions and Abbreviations for Medical Device Administrative System 2010
Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System 2009

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