Malaysia MDA released an update on the use of Electronic Medical Device Registration Certificate starting 2 May 2023. Establishment can download the Medical Device Registration Certificate from MeDC@St2.0+ system once the application is complete (status complete) and paid the registration fee.
Both physical and electronic Medical Device Registration Certificates can be used for the purpose of importing or placing the medical device in Malaysia market. The transition period for the use of physical Medical Device Registration Certificate to electronic Medical Device Registration Certificate will last until 31 December 2023. Establishment can obtain the physical Medical Device Registration Certificate from MDA officer as per current practice and can download the electronic Medical Device Registration Certificate from MeDC@St2.0+ system during the transition period.
Starting from 1 January 2024, the electronic Medical Device Registration Certificate will be fully effective and MDA will no longer issue physical Medical Device Registration Certificate.
For further details on the Transition Period for the use of Electronic Medical Device Registration Certificate, please refer to the following weblink:
https://www.mda.gov.my/announcement/1193-pengumuman-tempoh-peralihan-pelaksanaan-penggunaan-sijil-pendaftaran-peranti-perubatan-secara-elektronik.html