Department of Health | Medical Device Division - Issued Documents under Medical Device Administrative Control System (MDACS)

Issued Documents under Medical Device Administrative Control System (MDACS)

(Note: The Chinese name of the Medical Device Division will be renamed with effect from 21 January 2025 while the English name remains unchanged. All issued listing certificates shall remain valid until their expiry date. For enquiry, please contact the Medical Device Division.)

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