Announcement on Enforcement of Payment for all Subsequent Notification Clinical Research Use in MeDC@St 2.0+.
Greetings from Medical Device Authority Malaysia.
Dear Valued Customer,
On 10th February 2022, MDA have officially launched MeDC@St2.0+ which is another enhancement to the online application system. For notification module, additional features that have been improved in the Clinical Research Use sub-module for the benefit of the users are, includes:
- 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;
- Notification letter now can be downloaded and printed directly from MeDC@St2.0+ account.
Therefore, to ensure that this system can continuously provide best of service and quality improvement to the user, MDA will implement the collection of administrative fees for new application of Subsequent Notification of Clinical Research Use (CRU). The details are as follows:
Administrative fee Amount = RM110/per notification
Effective Date of Collection = 1 April 2022