COVID-19 home test kits

Transition Period for the Registration of COVID-19 Test Kits with Exemption from Compliance Process by the CAB 

On July 14, 2023, the Medical Device Authority of Malaysia (MDA) announced a transition period of registration with exemption from compliance assessment process by the Compliance Assessment Body (CAB) for the registration of COVID-19 test kits based on Circular Letter Number 2/014.

In accordance with Number Circular 2/2014, the evaluation of the COVID-19 test kit during an emergency or pandemic will be moved to the registration application. Effective July 31, 2023, acceptance of applications for the registration of COVID-19 test kits in the existing process as described in MDA/GL/07 Guideline for Registration of COVID 19 IVD Test Kits, will cease. Therefore, all applications for the registration of COVID-19 test kits need to go through an assessment process by a Compliance Assessment Body (CAB) in the form of Verification or Full Assessment. A COVID-19 test kit that is subjected to the Full Assessment evaluation procedure must pass an evaluation test in a testing facility that has received MDA accreditation (ISO 15189 or ISO 17025). MDA will not issue any Evaluation Letter to the testing laboratory.

For further information on the announced registration application Transition Period With Exemption From Compliance Assessment Process By Compliance Assessment Body (CAB) For Registration Of Covid-19 Test Kits based on Circular Letter Number 22/014, please refer to this link.

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