Malaysia: MDA Announced Withdrawal of Incomplete Medical Device Registration (New and Re-Register) and Change Notification Application
On March 23rd 2023, the MDA announced that they will withdraw the medical device registration (new and re-register) application and change notification application that has not been completed within 30 working days, starting from 1st April 2023. A transitional period will be given to the applicant until May 1st for the full implementation on withdrawal of incomplete medical device registration (new and re-register) application and change notification application.
MDA will drop the application from the system for the following reasons applied:
- Any information, particulars or documents as required are not provided within 30 working days; or;
- The establishment return the application without the information, particulars or documents as required. Due to this, establishments need to check and ensure the information or documents submitted are correct and completed before returned to MDA.
This policy, however will not affect the right of the establishment to make a new application, and the application fee will not be refunded.
For further information on the announcement, please refer to this link.
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