MDA grants conditional approval for self-test kits

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KUALA LUMPUR – The Health Ministry’s Medical Device Authority (MDA) today agreed to grant conditional approval for the importation and distribution of COVID-19 self-test kits in the country.

MDA chief executive Ahmad Shariff Hambali said so far, two COVID-19 self-test kits had passed the prescribed technical evaluation and performance testing and would be given import and distribution approval in the near future, while another 15 were undergoing performance testing in laboratories before a decision is made.

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He said the special meeting of the MDA Board today also agreed to finalise conditions to be complied with by any company that obtains permission to import and distribute the test kits.

“Among the important conditions that need to be complied with include clear and easy-to-understand instructions for use and disposal methods, a safety monitoring system and test kit performance, including test kit distribution records,” he said in a statement today.

He said these conditions were important to provide a control mechanism to ensure the safety and performance of the test kit which would be distributed and used by the public as a COVID-19 infection screening test.

Ahmad Shariff said although the test kit can be used as a screening test to get immediate results on their infection status, it does not replace the real-time diagnostic function of reverse-transcription polymerase chain reaction (rRT-PCR).

“MDA advises the public to use the kit according to the instruction for use contained on the labeling to ensure that the kit is used properly and disposed of safely, and also actions to be taken, including reporting the test results,” he said.

He said any company intending to obtain conditional approval must have an establishment license under the Medical Devices Act 2012 (Act 737), adding that a list of test kits that have been granted conditional approval will be posted on the MDA website.