REGISTRATION OF COVID-19 TEST KITS THAT HAVE BEEN APPLIED VIA CONDITIONAL APPROVAL AND SPECIAL ACCESS
MDA would like to inform that all Conditional Approval and Special Access for COVID-19 test kits have been halted and future placement of COVID-19 test kits on the market shall be subjected to their registration under section 5 of the Medical Device Act 2012 (Act 737). Application to register the test shall be made online via our Medical Device Centralized Online Application System (MeDC@St).
With this arrangement, all COVID-19 test kits that have completed evaluation at the testing facilities and passed the set performance criteria shall proceed for registration via MeDC@St. Please refer to the relevant reference documents, namely MDA/GL/MD-01, MDA/GL/IVD-1, MDA/GL/07 and MDA/GD/0059 to get further information on the requirements and procedure for the registration of COVID-19 test kits.
Any queries should be forwarded via email to registration [AT] mda [DOT] gov [DOT] my or call 603-82300376. Further guidance and consultation may be obtained by making appointment at consultation [AT] mda [DOT] gov [DOT] my
Medical Device Authority
16 Dec 2022