Malaysia: The Implementation of Electronic Medical Device Registration Certificate

Medical Device Authority of Malaysia (MDA) announced the implementation of the electronic medical device registration certificate starting on 2 May 2023. Currently, both physical registration certificates and online registration certificates are still applicable for importing purposes or marketing purposes in the Malaysian market. The transitional period will be ongoing until 31 December 2023.

The establishment parties may collect the physical medical device registration certificate at the MDA’s office after 7 working days from the completed application status. While at the same time, the online medical device registration certificate may be downloaded from MeDC@St2.0+ system once the fee payment is cleared and the application status is completed.

The implementation of the electronic medical device registration certificate will take full effect on 1 January 2024 and MDA will not issue any physical medical device registration certificate.

Source: MDA

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