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Department of Health

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Code of Practice COP-01: Code of Practice for Local Responsible Person Code of Practice COP-02: Code of Practice for Conformity Assessment Bodies Code of Practice COP-03: Code of Practice for Listed Local Manufacturers Code of Practice COP-04: Code of Practice for Listed Importers of Medical Devices Guidance Notes GN-00: Definitions and Abbreviations for Medical Device Administrative System Guidance Notes GN-01: Overview of the Medical Device Administrative Control System Guidance Notes GN-01S: Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System Guidance Notes GN-02: Guidance Notes for Listing Class IV Medical Devices Guidance Notes GN-03: Guidance Notes for Adverse Incident Reporting by Local Responsible Person Guidance Notes GN-04: Conformity Assessment Framework and Conformity Assessment Bodies Guidance Notes GN-05: Guidance Notes for Listing Class II/III Medical Devices Guidance Notes GN-06: Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices Guidance Notes GN-07: Guidance Notes for Listing of Importers of Medical Devices Guidance Notes GN-08: Guidance Notes for Listing of Local Manufacturers Hong Kong Chinese Materia Medica Standards (Volume 1) Hong Kong Chinese Materia Medica Standards (Volume 2) Hong Kong Good Manufacturing Practice Guidelines for Proprietary Chinese Medicines Practising Guidelines for Manufactuurers of Proprietary Chinese Medicines Practising Guidelines for Retailers of Chinese Herbal Medicines Practising Guidelines for Wholesalers of Chinese Herbal Medicines Practising Guidelines for Wholesalers of Proprietary Chinese Medicines Smoke-free Workplace Implementation Manual Technical Reference TR-002: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) Technical Reference TR-003: Classification Rules for Medical Devices Technical Reference TR-004: Essential Principles of Safety and Performance of Medical Devices Technical Reference TR-005: Additional Medical Device Labelling Requirements Technical Reference TR-006: Principles of In Vitro Diagnostic (IVD) Medical Devices Classification Technical References TR-001: Principles of Conformity Assessment for Medical Devices