Regulatory Updates

The Medical Device Authority (MDA) has announced the implementation of electronic establishment licenses, effective from June 5, 2024. Once the application is completed (status complete) and the license fee has been paid, establishments may download the establishment license from the MeDC@St2.0+ system. Additionally, MDA will continue to issue physical establishment

The Medical Device Authority (MDA) has announced the revocation of Circular Letter No. 1/2022, which exempted the compliance assessment process by Conformity Assessment Bodies (CAB) for the registration of COVID-19 test kits under the Medical Device Act 2012. Effective February 23, 2024, COVID-19 test kit registration must adhere to the

Following the enactment of the One License Per Establishment Role Policy outlined in the “General Directive of the Minister of Health No. 1/2024, in accordance with the provisions of the Medical Device Authority Act 2012 [Act 738]: Implementation of the One License Per Establishment Role Policy,” the Medical Device Authority

On May 23, 2024, the Medical Device Authority (MDA) of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices, designated as MDA/GD/0020. The main highlights from this draft guidance document are as follows:  Establishments are required to identify the appropriate application type,