Traders' Corner: Application for Listing of Rapid Antigen Test under MDACS
Traders' Corner: Application for Listing of Rapid Antigen Test under MDACS
Medical device traders who are interested in participating in the MDACS and applying for listing their rapid antigen test kits may refer to the following websites for more information:
Leaflet - Listing of Rapid Antigen Test for COVID-19 under Medical Device Administrative Control System (MDACS)
Quick Guide - Submitting COVID-19 Rapid Antigen Test (RAT) Applications
Video - Application for Listing Rapid Antigen Tests for COVID-19 under Medical Device Administrative Control System (Chinese Version Only)
Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD) (MD102) (via MDIS)
[GN-01] Overview of the Medical Device Administrative Control System
[GN-03] Guidance Notes for Adverse Event Reporting by Local Responsible Persons
For more information on application for listing of in-vitro diagnostic medical device, please refer to the Medical Device Listing Application page.