Malaysia: Cancellation of the Regulation Governing the Exemption from the Compliance Assessment Process by the Compliance Assessment Body (CAB) for the Registration of COVID-19 Test Kits

On April 2^nd, 2024, the Medical Device Authority (MDA) of Malaysia announced the cancellation of the Circular of the Authority for Medical Devices (PBPP) Number 1/2022: Exemption from the Compliance Assessment Process by the Compliance Assessment Body (CAB) for The Registration of Covid-19 Test Kits. This requirement applies to manufacturers who want to register their COVID-19 test kits in Malaysia. Concerning the revocation of this circular letter, every application for the registration of COVID-19 test kits must go through the Compliance Assessment Body’s (CAB) verification or full compliance assessment process to comply with the Medical Device Authority requirement.

For test kits that undergo the full compliance evaluation process, an evaluation test in a laboratory certified by ISO 15189—Medical Laboratories, Requirements for Quality and Competence—is required.

This announcement is also in line with the announcement made regarding the Transition Period for Registration Applications with the Exemption of the Compliance Assessment Process by the Compliance Assessment Body (CAB) to Registration Based on Circular Letter Number 2/2014 for the Registration of COVID-19 Test Kits dated 14 July 2023.

The announcement can be obtained from the homepage of Medcast 2.0+ system or you may access this link. 

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