HEADLINE: PETALING JAYA, Malaysia- MMA: Get only MDA-approved Covid-19 self-test kits or there can be health risks
MALAYSIA
PETALING JAYA: The public has been advised to only purchase Covid-19 saliva self-test kits that are approved by the Medical Device Authority (MDA) or there can be health risks if the kits are fake, of compromised quality or even recycled.
It is important that the public check the approved list of self test kits on MDA’s website at www.portal.mda.gov.my before making a purchase and only purchase the kits from authorised sellers, the Malaysian Medical Association (MMA) said today.
“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,” its president Professor Dato’ Dr. Subramaniam Muniandy said in a statement.
“It is also important that the public strictly follow the instructions on saliva testing for Covid-19 to obtain an accurate result. It must also be ensured that the test kits are properly disposed of after use to prevent spread of infection. Once used, the kits become healthcare biological waste.”
MMA also agreed with the Malaysian Pharmacists Society (MPS) that stricter regulations on the sale of Covid-19 self test kits are needed.
“Unauthorised sellers have been advertising and selling self test kits direct to consumers online on social media platforms,” Subramaniam said.
“Some of these sellers are even claiming their self test kits have an accuracy of 99% 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.”
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He said stricter regulation is needed as certain quarters may be taking advantage of the pandemic and the fear among the public.
MMA urged the Domestic Trade and Consumer Affairs Ministry to work closely with 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.
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.
