(1) The Secretary may give the sponsor of kinds of medical devices exempted under subsection 41HA(1) from Division 3 of Part 4 - 11, a written notice requiring the sponsor to give to the Secretary specified information or documents relating to one or more of the following:
(a) the supply of devices of those kinds;
(b) the handling of devices of those kinds;
(c) the monitoring of the supply of devices of those kinds;
(d) the results of the supply of devices of those kinds;
(e) any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of those kinds.
(2) If a medical device is exempt under subsection 41HA(1) because a medical practitioner has signed a statement in accordance with regulations made for the purposes of this section, the Secretary may give the medical practitioner a written notice requiring the medical practitioner to give to the Secretary specified information or documents relating to one or more of the following:
(a) the condition of the person to whom the medical device is to be given or is given;
(b) the supply of the device;
(c) the handling of the device;
(d) the monitoring of the supply of the device;
(e) the results of the supply of the device;
(f) any other matter prescribed by the regulations for the purposes of this paragraph in relation to medical devices of that kind.
(3) A notice under this section must specify a reasonable period within which the person must comply. The period must be at least 10 working days starting on the day on which the notice is given.
(4) A notice under this section may require information to be given in accordance with specified software requirements:
(a) on a specified kind of data processing device; or
(b) by way of a specified kind of electronic transmission.