In another twist of events, the Medical Device Authority (MDA) of the Health Ministry clarified in a statement today that it never permitted MyEG to advertise, distribute or sell COVID-19 rapid test kits.
Several days ago, the Ministry of Health (MOH) had declared MyEG’s COVID-19 rapid test kits as “fake news.” MyEG released a statement shortly after that its affordable, one-step test kit for the disease was “not fake news” but pending approval from the ministry. The kit, developed by a “reputable” Chinese biomedical firm, is approved in Europe and China where it is currently widely used. Subsequently, the MOH rescinded the social media post about the fake news. However, it did not elaborate on why it withdrew the post.
Earlier today, MyEG claimed its kit has received approval from the US FDA.
“We would like to announce that checks established that MDA never issued any sort of permission to MyEG to advertise, distribute or sell rapid Covid-19 test kits,” said the MDA’s chief executive in a statement today.
The MDA said MyEG’s advertisement could trigger confusion as people are not trained to interpret the test results accurately or handle the situation correctly once results are obtained.
“Tests to detect Covid-19 must be conducted by qualified medical personnel who are trained at ministry-approved health facilities to ensure the handling and treatment of patients are carried out according to set procedures, and with that, can we contain the outbreak of infection,” read the statement.
MDA explained that companies looking to supply COVID-19 test kits here must first obtain approval and licensing to operate under the Medical Device Act 2012 (Act 737). However, in light of the pandemic, the MDA said that any establishment seeking for approval for these kits can do so via the authority’s special access registration method to gain relevant exemptions.
It stressed that once a test kit obtains approval, advertising of the test kits is not allowed in any shape or form. In addition, the distribution of these kits has to be done through authorised health premises.
Non-compliance can result in a fine not exceeding MYR200,000 or imprisonment of no more than two years, or both, under Section 5(2) Act 737; and/or a fine of no more than MYR300,000 or a jail term of no more than two years, or both, under Section 44(2) of the same act.
MyEG’s COVID-19 rapid test kit is claimed to accurately detect the novel coronavirus within a span of 30 minutes without the need for nose or throat swabs. The government’s e-services provider advertises its kit for MYR99 (~USD23) per unit or MYR990 (~USD230) for a set of 10. It also offers an upgraded kit with testing for additional antibody, retailing at MYR149 (~USD34) per unit and also in a pack of five.
Upon quick checking, MyEG continues to advertise the kit on its website.
VIA Malay Mail