Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For the purposes of subsection 18 (1) of the Act, the therapeutic goods or classes of therapeutic goods specified in Schedule 5 are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).
(1AA) For the purposes of item 7 in Schedule 5, a device or part of a device:
(a) is powered if the whole or part of the energy applied to it comes from a source other than the application of human energy; and
(b) is non‑powered if paragraph (a) does not apply.
(1A) For the purposes of subsection 18 (1) of the Act, the therapeutic goods or classes of therapeutic goods specified in an item in column 2 of Schedule 5A are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F) subject to compliance with the relevant conditions specified in column 3 of that Schedule.
(2) If:
(a) therapeutic goods that, in relation to a provision of Part 3‑2 of the Act, are exempt goods cease to be exempt goods; and
(b) the sponsor of the goods has applied for registration or listing of the goods before the goods cease to be exempt goods;
the goods are taken to be exempt goods until the application for registration or listing is determined.