Government Gives Conditional Approval for Covid-19 Self-Test Kits

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PETALING JAYA: The government has granted conditional approval for the import and distribution of Covid-19 self-test kits for public use.

In a statement today, the Medical Device Authority (MDA), an agency under the health ministry, said that the conditions included having clear and easy instructions on how to use them and instructions on the proper methods of disposal.

MDA chief executive Ahmad Shariff Hambali said the board members made the decision in a meeting today on conditions imposed on the companies licensed to import and distribute the kits.

“These companies must also carry out safety and performance monitoring including recording the distribution of the self-test kits,” he said.

According to MDA, the conditions are important to ensure the safety and performance of these self-test kits as they will be distributed to the public to facilitate rapid screening for Covid-19.

“The self-test kit does not replace the diagnostic functions of the RT-PCR test, but has the advantage of rapid and convenient screening,” it said.

The MDA added that a list of self-test kits given conditional approval will be published on their website as a guide for those interested in purchasing them. It will be updated from time to time.

MDA said companies who wish to receive this conditional approval must first be licensed under the Medical Device Act 2012 (Act 737).

So far, only two Covid-19 self-test kits have passed the necessary technical evaluation and performance trials. The two will be given approvals for import and distribution soon.

Meanwhile, 15 other kits are currently undergoing laboratory tests before a decision on their conditional approvals can be made.

MDA also advised the public to use the test-kits according to their instructions which are stated on their labels to ensure that the kits are used properly and disposed of safely.

They should also take the necessary follow-up actions, such as reporting their test results.


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