Malaysia: Transition Phase for Registration Application with Exemption by CAB for Covid-19 Test Kit

On 14 July 2023, MDA announced the Covid-19 test kit evaluation during the emergency/pandemic will be shifted to the registration phase in accordance with Circular No 2/2014.

Starting from 31 July 3023, the acceptance of registration applications for Covid-19 test kits through the existing process as stated in MDA/GL/07 Guideline for Registration of Covid-19 IVD Test Kits will be terminated.

Therefore, all Covid-19 test kit registration applications must undergo assessment from Conformity Assessment Body (CAB) via Verification or Full Assessment. For any manufacturer that chose to undergo the Full Assessment process, the assessment must be done in MDA-authorized laboratories which comply with ISO 15189 or ISO 17025. Besides, MDA will not issue any Evaluation Letter for the laboratories.

Source: Medical Device Authority (MDA)