Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:2:p2
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 2 (pt 2/12)
Character Range: 29821–32506

9.
C3 (section 23) application has the meaning given by Part 1 of Schedule 9.
C4 (section 9D) application has the meaning given by Part 1 of Schedule 9.
C4 (section 23) application has the meaning given by Part 1 of Schedule 9.
changes table means the table published on the Department's website for the purposes of this definition, as in force from time to time.
Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.
Class 1 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
Class 2 biological means a biological (other than an export only biological):
 (a) that:
 (i) has been subjected to only minimal manipulation; and
 (ii) is only for homologous use; and
 (iii) is not mentioned in Schedule 16 as a Class 1, 3 or 4 biological; or
 (b) that is mentioned in Schedule 16 as a Class 2 biological.
Class 2 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
Class 3 biological means a biological (other than an export only biological):
 (a) that is not a Class 1, 2 or 4 biological; or
 (b) that is mentioned in Schedule 16 as a Class 3 biological.
Class 3 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
Class III medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.
Class 4 IVD medical device has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.
complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.
designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.
designated orphan drug means a medicine in relation to which a designation under regulation 16J is in force.
disinfectant means a substance:
 (a) that is recommended by its manufacturer for application to an inanimate object to kill micro organisms; and
 (b) that is not represented by the manufacturer to be suitable for internal use.
disposable therapeutic vape means a therapeutic good:
 (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and
 (b) that is fully assembled with all the constituent components fixed permanently in place and that is