registration of covid 19 ivd test kits

REGISTRATION OF COVID-19 IVD TEST KITS IN MALAYSIA

The MDA Covid-19 assessment Committee Of experts has agreed that all Covid-19 test kit applications pending Conditional Approval and Special Access will be halted. In addition, 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. All establishments must submit an application through the Medcast system (online system ) ―Medical Device Centralized Online Application System (MeDC@St 2.0)

Any queries should be submitted via email registration@mda.gov.my / Contact Number : +603 – 8230 0376. To obtain further guidance in regards to this submission, you may make an appointment via consultation@mda.gov.my .

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