The Medical Device Authority (MDA) of the Health Ministry has clarified that it never gave permission to local online administrative service providers MyEG to advertise, distribute or sell Covid-19 test kits.
MDA’s chief executive in a statement today said the advertisements by MyEG had resulted in many calling the ministry, wanting to know the legitimacy of the tests.
“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,” read the statement.
MDA said the advertisements by MyEG could trigger confusion, encouraging people to purchase the tests, with subsequent danger arising from possible false positives by those not trained to interpret the test results accurately.
“This can increase the risk of infections because we fear the public does not have the sufficient knowledge to interpret the test results obtained or handle the situation once the results are known.
“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.
Checks by Malay Mail showed the test kits are still being advertised on the MyEG website, with a ‘basic’ test kit priced at RM99 a piece, and the ‘advanced’ kit at RM149 per set.
Both test kits are advertised as being able to provide results within 15 minutes through a blood sample and are marketed as products developed by a leading diagnostics company approved by the Chinese health authorities without mentioning local accreditations.
MDA’s statement today pointed out 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), with the test kits also requiring approval under the same Act.
However, in light of the current situation, the MDA said that any establishment looking to gain approval to market these test kits can do so through the authority’s special access registration method to gain relevant exemptions.
“Once a particular type of Covid-19 test kit obtains approval, advertising of the test kits is not allowed in any shape or form and their distribution must be carried out directly to only permitted health premises,” read the statement.
Malaysia today recorded an additional 106 Covid-19 infections, bringing the cumulative number of infections to 1,624.
One more death was recorded over the last 24 hours, bringing the local tally to 15 dead from the virus.
Health director-general Datuk Dr Noor Hisham Abdullah today said Malaysia currently conducts around 7,000 Covid-19 tests and that he expects the healthcare system to achieve around 16,500 tests per day by month’s end. – MMO