The Medical Device Authority (MDA) will implement the use of medical device registration certificates electronically from May 2nd, 2023. The establishment can download the medical device registration certificate from the MeDC@St2.0+ system after the application is completed (status complete) and payment of the registration fee has been cleared.
In this transition period, both physical and electronic medical device registration certificates can be used for the purpose of importing or placing medical devices in the Malaysian market. The establishment is given a transition period until December 31st, 2023, during which physical medical device registration certificates will still be issued according to the existing process and at the same time the electronic medical device registration certificate can be downloaded from the MeDC@St2.0+ system. In order to launch this transition process, the establishment is 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).
Beginning January 1st, 2024, MDA will no longer issue physical medical device registration certificates in favor of electronic ones.