During the life-cycle of a medical device, changes may take place from time to
time. To safeguard public health, the information in the Medical Device Administrative Control System (MDACS), including details of listed medical devices, should be up-to-date. The Local Responsible Person (LRP) has the responsibility to timely inform MDD of any change to the listed medical device. This document aims to assist the LRP in categorising, managing and reporting changes of listed medical devices. It is intended to guide the LRP to differentiate changes to a medical device listed under MDACS and report the changes to Medical Devices Division (MDD) accordingly…
