The Medical Device Authority MDA will start using electronic medical device registration certificates starting on May 2, 2023. Once the application is complete (complete status) and the registration money is paid, the establishment can get the medical device registration certificate from the MeDC@St2.0+ system.
Medical device importation and placement into the Malaysian market are both permitted with the use of physical and electronic medical device registration certificates. The transition period from physical to electronic medical device registration certificates is until December 31, 2023.During this transition period:
- The organization will get a certificate of registration of physical medical devices, similar to the current method, and the electronic medical device registration certificate may be retrieved from the MeDC@St2.0+ system at the same time.
- To facilitate this transition, establishments must obtain a certificate of registration of physical medical equipment from the MDA office within 7 working days of the application’s completion
MDA will no longer issue physical medical device registration certificates after the electronic medical device registration certificate is completely deployed on January 1, 2024.
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Source: mda.gov.in
