Medical Device Trader Listing Application
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 Inclusion on the List of Importers / Distributors of Medical Devices
Application Form
Application for Inclusion on the List of Importers / Distributors (MD-IP+D) (via MDIS)
Guidance Notes
[GN-07] Guidance Notes for Listing of Importers of Medical Devices
[GN-09] Guidance Notes for Listing of Distributors of Medical Devices
Code of Practice
[COP-04] Code of Practice for Listed Importers of Medical Devices
Application for Listing of Local Manufacturers of Medical Devices
Application Form
Application for the Listing of Local Manufacturers (LM) (via MDIS)
Guidance Notes
[GN-08] Guidance Notes for Listing of Local Manufacturers of Medical Devices
Code of Practice
[COP-03] Code of Practice for Listed Local Manufacturers of Medical Devices
Application for Renewal / Change of Listing
Application Form
Renewal and Change Application Form for Listed Importers/Distributors (MD203) (via MDIS)
Renewal / Change Form for Listed Local Manufacturers (via MDIS)
For other documents related to the Medical Device Administrative Control System, please refer to the Issue Document Page.