Medical Device Administrative Control System

Guidance Notes

(Note: The Medical Device Control Office has been renamed as the Medical Device Division with effect from 1 October 2019. Please refer to Contact Us page for updates in contact information and contact our office for enquiry, if necessary.)

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

	[GN-00] Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System
	[GN-01] Overview of the Medical Device Administrative Control System (Note: The "Classification Rules for Medical Devices" given in Appendix 1 of this guidance document may be updated from time to time.  You may wish to refer to the most updated version included in the Technical Reference [TR-003] Classification Rules for Medical Devices published by Department of Health.)
	[GN-01S] Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System
	[GN-02] Guidance Notes for Listing Class II, III & IV Medical Devices (Jul 2011 Edition)
	[GN-03] Guidance Notes for Adverse Incident Reporting by Local Responsible Persons
	[GN-04] Conformity Assessment Framework and Conformity Assessment Bodies
	[GN-06] Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices (Jan 2019 Edition)
	[GN-07] Guidance Notes for Listing of Importers of Medical Devices (Apr 2018 Edition)
	[GN-08] Guidance Notes for Listing of Local Manufacturers
	[GN-09] Guidance Notes for Listing of Distributors

Technical References

	[TR-001] Principles of Conformity Assessment for Medical Devices
	[TR-002] Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
	[TR-003] Classification Rules for Medical Devices
	[TR-004] Essential Principles of Safety and Performance of Medical Devices
	[TR-005] Additional Medical Device Labelling Requirements
	[TR-006] Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Code of Practice

	[COP-01] Code of Practice for Local Responsible Persons
	[COP-02] Code of Practice for Conformity Assessment Bodies
	[COP-03] Code of Practice for Listed Local Manufacturers
	[COP-04] Code of Practice for Listed Importers of Medical Devices (Apr 2018 Edition)

Others

	[RS-01] List of Recognised Standards for Medical Devices

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