In light of the ongoing pandemic situation, MDA has granted conditional approval to establishments intending to supply COVID-19 self-test kits in Malaysia. A detailed guidance document is published on this, intending to provide establishments with information about the requirements for distributing Covid-19 RTK (self-test) in the market. This guidance document does not apply to Covid-19 test kits for professional use only.
In this new guidance, there are a few requirements that need to be addressed. The establishment should provide QR code on COVID-19 RTK (self-test) label which will redirect to the kit’s instructions for use, disposal method and reporting mechanism together with medical device information. Establishments must collect data on the medical device's safety and performance and submit a report to the Authority on a regular basis or when the Authority requests it. Other than complying with the labelling requirements as set out in the Sixth Schedule of the Medical Devices Regulations 2012, manufacturer also need to provide the labelling information as follows:
- i. methods of reporting (for the users) to medical practitioners/ relevant authority (if positive/ negative/ invalid)
- ii. detailed disposal methods
As necessary, establishments should also provide a video tutorial to help users understand how to safely use a self-test kit, disposal procedures, and what to do if test results are positive, negative, or invalid. The Covid-19 RTK (self-test) kits can ONLY be sold by registered establishment.