The Medical Device Authority (MDA) has recently started to approve Covid-19 Self-Test Kits, for the general public’s direct use. It hopes that the wide sale of these kits will help in early detection of the infection among the general public and lead to an alleviation of the huge burden on the country’s healthcare system caused by late detection of severe stages among the patients.

Now MDA has issued a directive intended for Establishments intending to import and distribute these registered Covid-19 self-test kits. Firstly, they shall have a significant MDA establishment license. Covid-19 self-test kit brands that have received conditional approval from the MDA must be sold at registered drug stores or pharmacies or and authorized wellbeing offices only. There is also a ceiling cap price imposed on these kits by the Health Ministry.

Only registered pharmacies and authorized health facilities are allowed to sell Covid-19 Self-Test Kits online with conditions they must follow the manufacturer's guidelines for proper storage and delivery techniques to assure the test kits' safety and effectiveness. MDA encourages the public to only purchase the Covid-19 self-test kits granted conditional approval. An updated list of Covid-19 Self-Test Kits that have obtained conditional approval can be availed on MDA’s website here (updated from time to time).

MDA advises the public to use the test kits as per Instruction For Use (IFU) to ensure they are used and disposed of safely and correctly. The report of the test results must comply with the specified instructions for use. Furthermore, all positive results obtained from using the kits must be registered with the government via the local MySejahtera Covid-19 tracking app.


Conditional Approval for Covid19 RTK (Self-Test)