Issued Documents under Medical Device Administrative Control System (MDACS)

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Issued Documents under Medical Device Administrative Control System (MDACS)

Issued Documents under Medical Device Administrative Control System (MDACS)

(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 Notes

[GN-00] Guidance Notes for Definitions and Abbreviations for Medical Device Administrative Control System
[GN-01] Overview of the Medical Device Administrative Control System
[GN-02] Guidance Notes for Listing Class II, III & IV Medical Devices
[GN-03] Guidance Notes for Adverse Event 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
[GN-07] Guidance Notes for Listing of Importers of Medical Devices
[GN-08] Guidance Notes for Listing of Local Manufacturers
[GN-09] Guidance Notes for Listing of Distributors
[GN-10] Guidance Notes for Changes of Listed Medical Devices

 

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 of General Medical Devices
[TR-004] Essential Principles of Safety and Performance of Medical Devices
[TR-005] Additional Medical Device Labelling Requirements
[TR-006] Classification of In Vitro Diagnostic Medical Devices (IVDMDs)
[TR-007] Software Medical Devices and Cybersecurity
[TR-008] Artificial Intelligence Medical Devices (AI-MD)

 

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 of Medical Devices
[COP-04] Code of Practice for Listed Importers of Medical Devices
[COP-05] Code of Practice for Listed Distributors of Medical Devices

 

Other Documents

Quick Guide - Submitting COVID-19 Rapid Antigen Test (RAT) Applications
[RS-01] List of Recognised Standards for Medical Devices
Notes for the Expedited Approval Scheme for Medical Device Listing Applications
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