Medical Device Listing Application

Medical Device Listing Application

(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.)

The Medical Device Division has introduced a new Medical Device Information System (MDIS) on 2 April 2024, which will offer a one-stop e-service for the industry to submit online applications for listing of medical devices (MDs) and traders under the Medical Device Administrative Control System (MDACS), as well as to report safety alerts and adverse events related to MDs.

To facilitate smooth transition from paper-based to online submission of the application, the key dates of rollout of e-services of MDIS and ceasing to accept paper-based submissions are set out in the MDIS theme page.

 

Application for Listing of General Medical Device

Application Form

Application for the Listing of Class II/III/IV General Medical Devices (MD101) (via MDIS)
WEB
Essential Principles Conformity Checklist (MD-CCL)
PDF
Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA)(MD111)
PDF

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) (MD102) (via MDIS)
WEB
Essential Principles Conformity Checklist for In Vitro Diagnostic Medical Devices (MDIVD-CCL)
PDF
Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA)(MD111)
PDF

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 Application Form for Listed Medical Devices (MD105) (via MDIS)

 

Application for Renewal of Listing

Application Form

Renewal Form for Listed Medical Devices (via MDIS)

 

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.