Malaysia: Self-Test Covid-19 Test Kit for Conditional Approval (Approved)

ARQon
Sep 20, 2021
1 min read

Medical Device Authority (Malaysia) has published a Conditional Approval for Covid-19 Rapid Test Kit (Self-test) guideline in July 2021 to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.

This Covid-19 RTK (self-test) is available at pharmacy counters and can be used by the public according to the instructions supplied. This is seen to aid individuals in determining the status of an infection before seeking medical guidance for further action. This also alleviates the pressure on healthcare professionals.

The normal registration process appears to take a lengthy time, involving the process of evaluating technical document conformity as well as a full clinical research on a medical device. Furthermore, there is currently no technical code that can be used to describe such medical devices for the purposes of conformity assessment by CABs, and no registered CAB can undertake conformance assessments for Covid-19 test kits.

The Covid-19 RTK (self-test) products have received temporary or conditional approval in some countries, including Emergency Use Authorization (EUA) in the United States and Provisional/Interim Authorization in the United Kingdom and Singapore.

Sources:

Conditional Approval for Covid-19 Rapid Test Kit (Self-Test) Guideline