Regulatory Update: Malaysia

In response to the ongoing global health crisis, Malaysia has taken a significant step forward in the evaluation process for COVID-19 test kits. This move aligns with Number Circular 2/2014 and marks a crucial transition towards the registration phase. As of July 31, 2023, the acceptance of applications under the MDA/GL/07 Guideline for Registration of COVID-19 IVD Test Kits has come to a close.

Moving forward, all registrations for COVID-19 test kits will undergo assessment by a Compliance Assessment Body (CAB) through either Verification or Full Assessment. For those opting for Full Assessment, a pivotal requirement involves an evaluation test conducted at an MDA-recognized testing laboratory, compliant with ISO 15189 or ISO17025 standards.

It's important to note that the Medical Device Authority of Malaysia will no longer be issuing Evaluation Letters to testing laboratories. This signifies a streamlined approach, ensuring that all evaluations are conducted in accordance with the highest industry standards.

This transition represents a stride towards ensuring the efficacy and reliability of COVID-19 test kits in Malaysia. By aligning evaluation processes with established global standards, the country is fortifying its commitment to safeguarding public health in the face of the ongoing pandemic.