Medical Device Listing Application
Medical Device Listing Application
(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.)
Application for Listing of General Medical Device
Application Form
Application for the Listing of Class II/III/IV General Medical Devices (MD-C2&3&4)
Essential Principles Conformity Checklist (MD-CCL)
Guidance Notes
[GN-02] Guidance Notes for Listing Class II, III & IV General Medical Devices
Technical References
[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
Code of Practice
[COP-01] Code of Practice for Local Responsible Persons
Application for Listing of In-Vitro Diagnostic Medical Device
Application Form
Application for the Listing of In-Vitro Diagnostic Medical Devices (IVDMD) (MD-IVD)
Essential Principles Conformity Checklist for In Vitro Diagnostic Medical Devices (MDIVD-CCL)
Guidance Notes
[GN-06] Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Device
Quick Guide - Submitting COVID-19 Rapid Antigen Test (RAT) Applications
Technical References
[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 (IVD) Medical Devices
Code of Practice
[COP-01] Code of Practice for Local Responsible Persons
Application for Change(s) of Listing
Application Form
Change Form for Listed Medical Devices
Update Information for Listed Traders and Conformity Assessment Bodies (CAB) under Medical Device Administrative Control System (MDACS)
Application for Renewal of Listing
Application Form
Renewal Form for Listed Medical Devices
Post-Market Surveillance Report
Report Form
Post-Market Surveillance Report Form (MD108)
For other documents related to the Medical Device Administrative Control System, please refer to the Issue Document Page.
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Only submissions with duly completed application forms and required documents will be processed. Materials provided with any submission will not be returned.