Malaysia: Implementation of the use of Electronic Medical Device Registration Certificate in Malaysia

On 26^th October 2023, the Medical Device Authority of Malaysia (MDA) published an announcement on the implementation of the use of electronic medical device registration certificate beginning November 1, 2023.

With this move for applications approved after 1 November 2023, only electronic medical device registration certificates will be issued by MDA.

Instead, the establishment can download the medical device registration certificate from the MeDC@St2.0+ system once the application status is marked as complete and the registration fee payment has been cleared. For applications approved before 1 November 2023, the establishment will receive a physical medical device registration certificate as per the existing process and at the same time the electronic medical device registration certificate can be downloaded from the MeDC@St2.0+ system. Establishments are required to collect the physical medical device registration certificate at the MDA office after 7 working days from the date the application is completed (status complete).

The announcement of this new implementation of an electronic medical device certificate can be found here (in Malaysian language).

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