REGISTRATION OF COVID-19 IVD TEST KITS
REGISTRATION OF COVID-19 IVD TEST KITS
The Covid-19 assessment Committee Of experts has agreed that all Covid-19 test kit applications pending Conditional Approval and Special Access would be halted and that all future applications will be submitted using the Medcast online system. The deadline for applications pending in CA and SA is set for March 3rd, 2022. As a result, all establishments must submit an application through the Medcast system (online system ) ―Medical Device Centralized Online Application System (MeDC@St 2.0)
Please refer to COVID application MDA guideline and Guidance Document Guideline (MDA/GL/MD-01, MDA/GL/IVD-1, MDA / GL / 07 and MDA/GD/0059 )
Any queries should be submitted via email / Contact Number : +603 - 8230 0376. To obtain further guidance in regards to this submission, establishment may make an appointments via .
Updated: 29 March 2022
