Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41hb:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41HB (pt 2/2)
Character Range: 766928–769213

(ii) in the case of a decision not to grant the approval—of the reasons for the decision.
 (7) The use by a person for experimental purposes in humans of specified kinds of medical devices that are the subject of an approval granted to someone else under paragraph (1)(e) is subject to the conditions (if any) specified in the regulations relating to one or more of the following:
 (a) the preconditions on the use of devices of those kinds for those purposes;
 (b) the principles to be followed in the use of devices of those kinds for those purposes;
 (c) the monitoring of the use, and the results of the use, of devices of those kinds for those purposes;
 (d) the circumstances in which the person must cease the use of devices of those kinds for those purposes.
Note: Breach of the conditions may be an offence: see subsections 41MN(9), (9A) and (9B).

Varying approval for use solely for experimental purposes in humans
 (8) If:
 (a) the Secretary grants an approval to a person under subsection (1) for use of the kind referred to in paragraph (1)(e); and
 (b) the person requests the Secretary to do either or both of the following:
 (i) vary the medical device or kind of medical device specified in the approval;
 (ii) vary the conditions imposed under subsection (2) on the approval; and
 (c) the request is in a form (if any) approved, in writing, by the Secretary; and
 (d) the request is accompanied by such information relating to the medical device or kind of medical device as is required by the Secretary; and
 (e) the request is accompanied by the fee prescribed by the regulations;
the Secretary must, by notice in writing, vary or refuse to vary the approval. Any variation may be different than the variation requested and may involve imposing new conditions on the approval or varying or removing existing conditions.
 (9) The Secretary must notify the person making the request under subsection (8) of:
 (a) the Secretary's decision on the request; and
 (b) for a decision to vary the approval in a way that is different than the variation requested or a decision to refuse to vary the approval—the reasons for the decision.
 (10) A variation under subsection (8) takes effect at the time the Secretary notifies the person under subsection (9) of the variation.