In early July, CMDE assumes a new responsibility — as technical review center. In this new departmental structure, two (2) offices have been established: one for the online submission system (Project Management Department (and another for clinical evaluation (Clinical and Statistics Department).
The Project Management Department is assigned to monitor the new online submission system which started to take effect last June 24. The current submission route shall no longer be effective starting on October 1, 2019.
The Clinical and Statistics Department, on the other hand, is further divided into two (2) sub-departments: the 1st department shall handle the Clinical evaluation reports and Clinical trial reports for General Medical Devices, while the 2nd department shall handle the clinical evaluation report and clinical trial report of the IVD devices and reagents.