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

Regulation	Year
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

Document	Year
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

Document	Year
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

Document	Year
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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