Hong Kong Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for Hong Kong.

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Major Regulations
Document Number Published Language
Log in Classification Rules for Medical Devices TR-003 1/2010 English
Log in Overview of the Hong Kong Medical Device Administrative Control System GN-01 9/2005 English
General Guidance Documents
Document Number Published Language
Log in Conformity Assessment Framework and Conformity Assessment Bodies GN-04 2006 English
Log in Code of Practice for Local Responsible Persons COP-01 9/2005 English
Log in STED Format for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) TR-002 10/2006 English
Log in Additional Medical Device Labelling Requirements TR-005 4/2010 English
Specific Guidance Documents
Document Number Published Language
Log in Guidance Notes for Adverse Incident Reporting by Local Responsible Persons (LRP) GN-03 2021 English
Log in Principles of In Vitro Diagnostic (IVD) Medical Devices Classification TR-006 12/2009 English
Log in Guidance Notes for Listing Class B, C, and D In Vitro Diagnostic (IVD) Medical Devices GN-06 2021 English
Log in Guidance Notes for Listing Class II-III-IV Medical Devices GN-02 2021 English