Jika FCA tersebut melibatkan sebarang pengubahsuaian peranti perubatan termasuk kemas kini label/IFU, apakah yang perlu dilakukan oleh establismen? | If the FCA involves any modification of the medical device, including updating the label/IFU, what does the establishment need to do?
Establismen perlu membuat Change Notification dalam sistem MeDC@St dan notifikasi FCA secara serentak.
The establishment needs to make a Change Notification in the MeDC@St system and an FCA notification simultaneously.