I am looking to find guidance for manufacturers outside of New Zealand on adverse event reporting. Specifically, I need a reference that confirms (or not) that when an adverse event occurs it does not need to be reported unless field corrective actions will be taking place. Similar information is provided in MEDDEV 2.12-1, Rev. 8 5.1, MPR Guidance 10/03/2011 2.3.2 and ARGMD v1.1 p301. I just can't confirm that for New Zealand's Medsafe Legislation or Regulation.