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Malaysia: MDA Announced Enforcement of Payment for all Subsequent Notification Clinical Research Use in MeDC@St 2.0+

The Medical Device Authority of Malaysia (MDA) announced that enhancements have been made to the MeDC@St 2.0+. For notification module, an improved features have been added to the Clinical Research Use sub-module as follows:

  • The online form has a new look and allows batch uploads on medical device listings.
  • Print Application that allows printing of online forms that have been submitted.
  • More structured of subsequent notification process that allows notification to be made repeatedly.
  • Establishment can download and printed Notification letters directly from MeDC@St2.0+ account.

To ensure that enhancements are maintained, and quality of the service is always improved, the MDA has implemented the collection of administrative fees effective since 01 April 2022 with amount of RM 110 / per notification.

Further information on “Announcement on Enforcement of Payment for all Subsequent Notification Clinical Research Use in MeDC@St 2.0+.”, please refer to this link.

If you have any queries regarding the Announcement on Enforcement of Payment for all Subsequent Notification Clinical Research Use in MeDC@St 2.0+, please contact us or click the button below.

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