KUCHING (Aug 25): The public must only purchase Covid-19 saliva self-test kits that are approved by Medical Device Authority (MDA), said Malaysian Medical Association (MMA) president Professor Dato Dr Subramaniam Muniandy.
Dr Subramaniam said it is important to ensure only test kits that have been approved by the authority are on sale to avoid unnecessary health risk.
“The Ministry of Health had announced that only healthcare facilities and pharmacies are allowed to sell the Covid-19 saliva self-test kits. Currently, only 12 Covid-19 saliva self-test kits have been approved by the MDA,” he said in a statement.
Thus, Dr Subramaniam said it is important for the public to check the approved list of self-test kits on MDA’s website at www.portal.mda.gov.my before making a purchase.
“It is also important that the public follow strictly the instructions on saliva testing for Covid-19 to obtain an accurate result.”
Dr Subramaniam stressed the test kits must be properly disposed of after use to prevent spread of infection because once used, the kits become healthcare biological waste.
“MMA also agrees with the Malaysian Pharmacists Society (MPS) that stricter regulation on the sale of Covid-19 self-test kits are needed.”
He said unauthorised sellers had been advertising and selling self-test kits direct to consumers online on social media platforms.
“Some of these sellers are even claiming their self-test kits have an accuracy of 99 per cent without disclosing the brand of their product.
“It is indeed worrying as the public can be easily duped into purchasing self-test kits that are fake or kits with compromised quality.”
In this respect, Dr Subramaniam said stricter regulation is needed as certain quarters may be taking advantage of the pandemic and the fear among the public.
“We urge the Domestic Trade and Consumer Affairs Ministry to work closely with the MDA and the police to monitor the sale of Covid-19 self-test kits and investigate claims of unapproved or fake self-test kits in the market to safeguard and protect the health of consumers.”
He said all importers of approved Covid-19 self-test kits must also conform with the Good Distribution Practice for Medical Devices (GDPMD) as stated in the Medical Devices Act 2012 (Act 737).
“The certification ensures an establishment’s ability to maintain the quality, safety and performance of medical devices in its custody,” said Dr Subramaniam.