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

Guidance Notes

Technical References

Code of Practice

Application for Listing of In-Vitro Diagnostic Medical Device

Application Form

Guidance Notes

Technical References

Code of Practice

Application for Change(s) of Listing

Application Form

Application for Renewal of Listing

Application Form

Post-Market Surveillance Report

Report Form

For other documents related to the Medical Device Administrative Control System, please refer to the Issue Document Page.