The Medical Device Authority (MDA) has begun to provide conditional approval for COVID-19 self-test kits. While they are not meant to replace RT-PCR tests, the regulatory agency under the Ministry of Health says that the kits can help individuals who need a quick result on their infection status before they get further help.
According to the MDA, any companies that want to obtain conditional approvals for their self-test kits must have an establishment license under the Medical Device Act 2012. The agency has planned to put up a list of approved test kits on its website soon.
At this moment, two COVID-19 self-test kits had passed the agency’s technical evaluation and performance testing and will receive conditional approval very soon.
While MDA didn’t specifically mention this but we believe that they are the two saliva-based COVID-19 RTK-Ag self-test kits that have been found to be 90% accurate by the Institute for Medical Research (IMR).
In a nutshell, MDA has also confirmed that another 15 kits are currently undergoing performance testing. Once approved, all these self-test kits can be bought at pharmacies and authorised health facilities.