WITHDRAWAL OF MEDICAL DEVICE REGISTRATION (NEW AND RE-REGISTER) AND CHANGE OF NOTIFICATION APPLICATION
Please be informed that from 1st April 2023, MDA will withdraw the medical device registration (new and re-register) application and change notification application that has not been completed within 30 working days. However, a transitional period is given to applicant until 1st May 2023 for the full implementation on withdrawal of the medical device registration (new and re-register) application and change notification application.
Submission of medical device registration (new and re-register) and change notification application shall be provided with the information, particulars or document as stated in the Medical Device Act 2012 [Act 737], Medical Device Regulations 2012, guidance documents and guidelines which has been provided on the MDA website (portal.mda.gov.my).
Incomplete application will be returned to establishment in order for the establishment to complete it and provide information or documents as required within 30 working days. MDA will drop the application from the system if:
- Any information, particulars or documents as required was not provided within 30 working days; or
- The establishment return the application without the information, particulars or documents as required. Due to this, establishment has to check and ensure the information or documents submitted are correct and completed before returned to MDA.
However, this will not affect the right of the establishment to make a new application. Application fee will not be refunded.
For more assistance, kindly email your inquiry to registration [AT] mda [DOT] gov [DOT] my.
Updated: 23rd March 2023