Therapeutic Goods Act 1989

The Secretary may give to a person who is granted an authority under subsection 41HC(1) (exemptions for medical practitioners), in relation to specified kinds of medical devices, a written notice requiring the person to give to the Secretary specified information or documents relating to one or more of the following:

the supply of devices of those kinds;

the handling of devices of those kinds;

the monitoring of the supply of devices of those kinds;

the results of the supply of devices of those kinds;

any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of those kinds.

If a person is authorised, by subsection 41HC(6) rules, to supply a specified kind of medical device, the Secretary may give the person a written notice requiring the person to give the Secretary specified information or documents relating to one or more of the following:

the supply of devices of that kind;

the handling of devices of that kind;

the monitoring of the supply of devices of that kind;

the results of the supply of devices of that kind;

any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of that kind.

A notice under subsection (1) or (1A) must specify a reasonable period within which the person to whom the notice is given must comply. The period must be at least 10 working days starting on the day on which the notice is given.

A notice under subsection (1) or (1A) may require information to be given in accordance with specified software requirements:

on a specified kind of data processing device; or

by way of a specified kind of electronic transmission.