Considering the significance of public health and safety conditions, MDA acknowledges the necessity for the public to use self-test COVID-19 rapid test kits (RTK), to aid in the detection and control of COVID-19 infections. The self-test kit can help to quickly determine COVID-19 infection status. They can help to curb widespread COVID-19 infections.  However, these COVID-19 RTK do not substitute the real-time diagnostic function of reverse transcription-polymerase chain reaction (RT-PCR) tests.

MDA has explained the requirements that need to be followed by establishments for approval of COVID-19 RTK submitted via the Conditional Approval Route. However, to use the special access route, only applications received by MDA before July 14, 2021, will be entertained. MDA will grant a conditional Approval Letter if the submitted technical documents meet the requirements.

The applicants shall submit required technical documentation, which will be reviewed by MDA. If there are concerns related to the safety and performance of the COVID-19 RTK, MDA may request more documentation and explanation. In addition, an establishment that intends to apply for conditional approval shall have a valid establishment license with an in-vitro diagnostic (IVD) scope on the Good Distribution Practice of Medical Device (GDPMD) certification. Once is granted with the Conditional Approval Letter, the COVID-19 RTK shall only be sold by registered community pharmacies or a licensed health facility. All the applications are to be submitted via email to MDA,

MDA advises the public to use these test kits properly according to the instructions for use, dispose of them safely, and take appropriate further action, including reporting the test results obtained on the MySejahtera mobile app.


Table 1: Conditional Approval for Covid-19 RTK (self-test) Fee


Description of fees for Conditional Approval for Covid-19 RTK (self-test)

Fee Payable (RM)


Application Fee



Conditional Approval Letter Fee





MDA/GL/005: Guideline for Conditional Approval For COVID-10 Rapid Test Kit (Self-Test)