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 (PMS)

 

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.