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