REGISTRATION OF COVID-19 IVD TEST KITS

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 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 registration [AT] mda [DOT] gov [DOT] my/ Contact Number : +603 - 8230 0376. To obtain further guidance in regards to this submission, establishment may make an appointments via consultation [AT] mda [DOT] gov [DOT] my.

 

Updated: 29 March 2022

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb [AT] mda [DOT] gov [DOT] my

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  • Last Modified: 30 November 2022.
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