Malaysia: Announcement on the Implementation of the Transitional Period for the Use of Electronic Medical Device Registration Certificates

The Medical Device Administration (MDA) has implemented the use of electronic medical device registration certificates since May 2, 2023. After the application is completed (status completed) and the registration fee is paid, enterprises can download the electronic medical device registration certificate from their official website.

Both paper and electronic medical device registration certificates can be used to import or put medical devices into the Malaysian market. The transition period from paper medical device registration certificate to electronic medical device registration certificate ends on December 31, 2023. During the transition period, enterprises can continue to receive paper medical device registration certificates according to the existing process, and can download electronic medical device registration certificates from their system. In order to start this transition process, enterprises need to go to the MDA office to collect the paper medical device registration certificate in 7 working days after the date of completion of the application (status completed).