Medical Device Control Office

Guidance Notes for the Medical Device Administrative Control System

Guidance documents for the Medical Device Administrative Control System
are available in pdf format:

	Overview of the Medical Device Administrative Control System (GN-01)

	Guidance Notes for Listing Class IV Medical Devices (GN-02)

	Guidance Notes for Adverse Incident Reporting by Local Responsible Persons (GN-03)

	Conformity Assessment Framework and Conformity Assessment Bodies (GN-04)

	Guidance Notes for Listing Class II/III Medical Devices (GN-05)

	Guidance Notes for Listing of Importers of Medical Devices (GN-07)

	Guidance Notes for Listing of Local Manufacturers (GN-08)

	Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System

	Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices (GN-06)

	Proposed Document - Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device

	Guidance Notes for Definitions and Abbreviations for Medical Device Administrative System (GN-00)

Technical References

	Principles of Conformity Assessment for Medical Devices (TR-001)

	Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) (TR-002)

	Principles of In Vitro Diagnostic (IVD) Medical Devices Classification (TR-006)

	Classification Rules for Medical Devices (TR-003)

Code of Practice

	Code of Practice for Local Responsible Persons (COP-01)

	Code of Practice for Conformity Assessment Bodies (COP-02)

	Code of Practice for Listed Local Manufacturers (COP-03)

	Code of Practice for Listed Importers of Medical Devices (COP-04)