Document ID: chunk:federal_register_of_legislation:C2024C00632:section:9d:p4
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 9D (pt 4/4)
Character Range: 91242–93370

to the request; and
 (ba) subsection (3CB) does not apply to the request; and
 (c) the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or performance of the kind of medical device for the purposes for which it is to be used;
the Secretary may vary the entry in accordance with the request.
 (4) If:
 (a) particular therapeutic goods cease to be medical devices because of a declaration under subsection 41BD(3); and
 (b) those goods are included in the Register under Chapter 4 as a kind of medical device;
the Secretary must move the entry relating to the goods from the part of the Register for medical devices to whichever other part of the Register is applicable.
Note: Variations to the Register also occur to give effect to limited cancellations of entries of kinds of medical devices from the Register: see subsection 41GO(2).

Form and manner of requests
 (6) The Secretary may, by writing:
 (a) approve a form for particular kinds of requests under this section; and
 (b) approve the manner of making particular kinds of requests under this section.
 (7) If:
 (a) the Secretary has approved a form for, and the manner of making, a kind of request under this section; and
 (b) either:
 (i) the kind of request is one under subsection (3) and which, under the regulations, must be decided within 175 or 255 working days; or
 (ii) the kind of request is one prescribed by the regulations for the purposes of this subparagraph;
then a request of that kind is not effective unless:
 (c) the request is in accordance with that form; and
 (d) the request contains the information required by that form; and
 (e) the request is made in that manner; and
 (f) any prescribed application fee has been paid; and
 (g) the request is accompanied by information that is:
 (i) of a kind determined under subsection (8); and
 (ii) in a form approved, in writing, by the Secretary.
 (8) The Secretary may, by legislative instrument, determine a kind of information for the purposes of subparagraph (7)(g)(i).
Note: See also subsection 33(3A) of the Acts Interpretation Act 1901.