Regulatory Affairs Update: Malaysia

Malaysia: MDA Announced The Implementation Of Electronic Establishment License Certificates Starting June 5, 2024

The Medical Device Authority (MDA) has announced the implementation of electronic establishment licenses, effective from June 5, 2024.

Once the application is completed (status complete) and the license fee has been paid, establishments may download the establishment license from the MeDC@St2.0+ system. Additionally, MDA will continue to issue physical establishment license certificates for use by establishments.

Establishments must collect the physical establishment license certificate from the MDA office after 7 working days from the date of completed application (status complete).

Further information on this regulation can be accessed here: PENGUMUMAN PELAKSANAAN PENGGUNAAN SIJIL LESEN ESTABLISMEN ELEKTRONIK BERMULA 5 JUN 2024

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