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
PDF
[GN-01] Overview of the Medical Device Administrative Control System
PDF
[GN-02] Guidance Notes for Listing Class II, III & IV Medical Devices
PDF
[GN-03] Guidance Notes for Adverse Event Reporting by Local Responsible Persons
PDF
[GN-04] Conformity Assessment Framework and Conformity Assessment Bodies
PDF
[GN-06] Guidance Notes for Listing In Vitro Diagnostic (IVD) Medical Devices
PDF
[GN-07] Guidance Notes for Listing of Importers of Medical Devices
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[GN-08] Guidance Notes for Listing of Local Manufacturers
PDF
[GN-09] Guidance Notes for Listing of Distributors
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[GN-10] Guidance Notes for Changes of Listed Medical Devices
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Technical References

[TR-001] Principles of Conformity Assessment for Medical Devices
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[TR-002] Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
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[TR-003] Classification of General Medical Devices
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[TR-004] Essential Principles of Safety and Performance of Medical Devices
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[TR-005] Additional Medical Device Labelling Requirements
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[TR-006] Classification of In Vitro Diagnostic Medical Devices (IVDMDs)
PDF
[TR-007] Software Medical Devices and Cybersecurity
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[TR-008] Artificial Intelligence Medical Devices (AI-MD)
PDF

 

Code of Practice

[COP-01] Code of Practice for Local Responsible Persons
PDF
[COP-02] Code of Practice for Conformity Assessment Bodies
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[COP-03] Code of Practice for Listed Local Manufacturers of Medical Devices
PDF
[COP-04] Code of Practice for Listed Importers of Medical Devices
PDF
[COP-05] Code of Practice for Listed Distributors of Medical Devices
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Other Documents

Quick Guide - Submitting COVID-19 Rapid Antigen Test (RAT) Applications
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[RS-01] List of Recognised Standards for Medical Devices
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Note for Expedited Approval Scheme of Class II/III/IV General Medical Device Listing Applications
PDF