MDA Malaysia Publishes Guideline on Re-registration of Registered Medical Device

The Malaysian Medical Device Authority (MDA) has released the first edition of the guideline on the re-registration process for registered medical devices in June 2022. 

There are two stages for the process. Stage 1 is the application for conformity assessment, which is conducted by the conformity assessment body (CAB). Stage 2 is the application for re-registration via the MeDC@St application system. 

Every medical device is registered for 5 years and will require re-registration before it is allowed to be placed back in the market.  

The guideline covers all medical device classes, and the application fee and registration fee differ for all these classes. 

More details can be found in “MDA/GL/08 Guideline for Re-Registration of Registered Medical Device, 1st edition, June 2022”:  

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