Commonwealth Consolidated Acts Commonwealth Consolidated ActsApproval under subsection 41HB(1)
(1) The Secretary may give to a person granted an approval under subsection 41HB(1) (special and experimental uses), 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:
(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.
Approval under subsection 41HB(1)--use by another person
(2) The Secretary may give to a person using specified kinds of medical devices, that are the subject of an approval granted to someone else under paragraph 41HB(1)(e) (use solely for experimental purposes in humans), a written notice requiring the person to give to the Secretary specified information or documents relating to either of both of the following:
(a) the use of devices of those kinds;
(b) any other matter prescribed by the regulations for the purposes of this paragraph in relation to devices of those kinds.
Compliance period
(3) A notice under this section 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.
Information may need to be given in accordance with specified software requirements
(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.