Home About Qualtech NEWS MALAYSIA: Renewal of Establishment License Application and Change of Ownership for Medical Device Registration Application - February 2019
MALAYSIA: Renewal of Establishment License Application and Change of Ownership for Medical Device Registration Application - February 2019

February 18, 2019

With the implementation of the all-new MeDC@St 2.0 system, MDA has enforced a new pathway for all new and renewal applications made by stakeholders. Starting from 2nd January 2019, all Renewal of Establishment License Applications and Change of Ownership for Medical Device Registration Applications shall be made via MeDC@St 2.0. Henceforth, MDA has digitised all application systems for medical devices, including new device registrations, device change notification applications, and new and renewal applications of establishment licenses. Any hard copy or email submissions are no longer not be accepted by MDA, to ensure a harmonised and well-organised submission structure. This system also smoothens out all applications processes, clearly listing out all the required documents to be uploaded.

 

Reference:

Announcement Renewal of Establishment Licence & Change of Ownership for Medical Devices Registration

 

 

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Home About Qualtech NEWS MALAYSIA: Renewal of Establishment License Application and Change of Ownership for Medical Device Registration Application - February 2019