Starting May 2, 2023, the Medical Device Authority of Malaysia (MDA) will implement the use of ‘Electronic Medical Device Registration Certificate’. This electronic medical device registration certificate can be downloaded from the MeDC@St2.0+ system once the application status is deemed as complete.
A transition period up until December 31, 2023, is given to the establishment, in which physical medical device registration certificates will still be given to the establishments. At the same time, the establishments could also retrieve their electronic medical device registration certificate from the MeDC@St2.0+ system. In this transition period, both physical and electronic medical device registration certificate could be used for the purpose of importing or placing medical devices in the Malaysian market. The establishments must pick up the physical medical device registration certificate from the MDA office within 21 working days after the application’s completion (status complete) date in order to begin this transition procedure.
Beginning on January 1, 2024, all physical medical device registration certificates will no longer be issued by MDA in preference for the use of electronic ones.
For further information on the transition period for the implementation of the use of electronic medical device registration certificate, please refer to this link.
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