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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

Cyberjaya

16 Dec 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: 27 January 2023.
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