Australia Therapeutic Goods (Medical Devices) Regulations 2002 r5.10: Automatic condition: record complaint and adverse event information and each distribution of the device as soon as practicable and keep the records 10 years for Class III, implantable Class IIb and Class 4 IVD devices and 5 years for others

What does r5.10 require?

Promptly on learning of it, the sponsor must write up any regulation 5.8 information (complaints, problems and adverse events), and promptly after each shipment it must record the distribution of every device it sends out. Records for Class III devices, implantable Class IIb devices and Class 4 IVDs must be kept for 10 years; all others for 5 years. Distribution records are what make recalls under the Uniform Recall Procedure for Therapeutic Goods possible, and they match the 5-year and 10-year notice periods in regulation 8.1.