Therapeutic Goods Regulations 1990

therapeutic goods that are the subject of an approval or authority under section 19 of the Act;

a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;

medicines covered by an exemption under subregulation 12A(1);

therapeutic goods specified in item 1 or 6 of Schedule 5;

therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A;

a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;

a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);

a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;

therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act.