Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41jd
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41JD
Character Range: 104346–106037

41JD  Secretary may require information etc. about devices exempted under section 41HA from inclusion in the Register

 (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.