Australia Therapeutic Goods (Medical Devices) Regulations 2002 r5.11: Automatic condition: for Class III, implantable Class IIb and Class 4 IVD devices, give the Secretary an annual report before 1 October for the first three reporting periods after inclusion

What does r5.11 require?

For Class III devices, implantable Class IIb devices and Class 4 IVDs, the sponsor owes the Secretary a report by 30 September following each of three reporting periods: the broken year from the inclusion date to the following 30 June and the two full financial years after it. Each report either states there were no supplies anywhere in the world during the period, or gives the regulation 5.8 complaint and adverse event information that came to light in the period, or confirms there was none. Devices up-classified on 25 November 2021 keep their original inclusion date for the count.