Australia Therapeutic Goods Act 1989 s41FN-1-2: Automatic ARTG conditions: let authorised persons enter, inspect, test, sample and record at any premises (including overseas) where the devices are dealt with, produce and allow copying of device documents, and deliver a reasonable number of samples within at least 10 working days of request

What does s41FN-1-2 require?

Every ARTG inclusion of a kind of medical device is conditional on the sponsor allowing an authorised person to enter at a reasonable time any premises, in Australia or overseas, where it or anyone else deals with devices of that kind; to inspect the premises and devices; to examine, measure, test, require testing of and sample devices or related things; and to make still or moving images or recordings. On request the sponsor must produce documents about the included devices and allow them to be copied, and must deliver a reasonable number of samples within the period requested (at least 10 working days) and in line with any other stated requirements.