Conditional approval granted for import, distribution of Covid self-test kits

The health ministry’s Medical Device Authority (MDA) today agreed to grant conditional approval for the import 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.

He said a special meeting of the MDA board today also agreed to finalise conditions for compliance 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.

Shariff said although the test kit can be used as a screening test for immediate results on 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 instructions for use on the label to ensure that the kit is used properly and disposed of safely, and also for actions to be taken, including reporting the test results,” he said.

He said any company intending to obtain conditional approval must have an establishment licence 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.