PCR test with person in full PPE

Malaysia: Announcement On Registration Of COVID-19 Test Kits That Have Been Applied Via Conditional Approval And Special Access

On 16 December 2022, the Medical Device Authority (MDA) of Malaysia has published an announcement to emphasize that all Conditional Approval and Special Access for COVID-19 test kits have been halted.  Any future placement of COVID-19 test kits on the Malaysian 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 MDA Medical Device Centralized Online Application System (MeDC@St) 2.0+, after completing the evaluation at the testing facilities and passing the set performance criteria.

The MDA advised all establishments to refer to the following guidelines, to get further information on the requirements and procedure for the registration of COVID-19 test kits:

  1. MDA/GL/MD-01, Third Edition, March 2019 – How to Apply for Medical Device Registration under Medical Device Act 2012 (Act 737).
  2. MDA/GL/IVD-1, First Edition, May 2014 – How to Apply for In-Vitro Diagnostic (IVD) Medical Device Registration under Medical Device Act 2012 (Act 737).
  3. MDA/GL/07, Second Edition, January 2022 – Guideline for Registration of COVID-19 Test Kits.
  4. MDA/GD/0059, First Edition, November 2021 – Medical Device Guidance Document COVID-19 RTK (Self-Test) – Requirements.

Please refer to this link to read the full announcement on the registration of COVID-19 Test Kits online.

If you have any queries regarding the announcement, please get in touch or click the button below.

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