Document ID: chunk:federal_register_of_legislation:F2023L01291:clause:2_4:p1
Version: federal_register_of_legislation:F2023L01291
Segment Type: clause
Provision Reference: sch 2 cl 4 (pt 1/2)
Character Range: 1921–4804

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) biological;
(b) manufacturer;
(c) medical device;
(d) medicine;
(e) Register;
(f) Secretary;
(g) sponsor;
(h) therapeutic goods.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
adverse event means the following:
 (a) in relation to a medicine or biological—an adverse event that occurs in relation to a person in Australia following the administration of a medicine or a biological;
 (b) in relation to a medical device or other therapeutic good—an adverse event that occurs in relation to a person in Australia following use of a medical device or other therapeutic good that led, or might have led, to the death of, a serious injury to, or serious deterioration in the health of, that person.
Note: An adverse event may not necessarily have a causal relationship with the administration or use of the therapeutic good.
DAEN – Medical Devices means the Database of Adverse Event Notifications for medical devices and other therapeutic goods, maintained by the Therapeutic Goods Administration.
DAEN – Medicines means the Database of Adverse Event Notifications for medicines and biologicals, maintained by the Therapeutic Goods Administration.
defect, in relation to a medical device or other therapeutic good, means any of the following that might lead, or might have led, to the death of, a serious injury to, or serious deterioration in the health of, a person:
 (a) any malfunction or deterioration in the characteristics or performance of the medical device or other therapeutic good;
 (b) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the medical device or other therapeutic good.
event outcome, in relation to a medical device or other therapeutic good, means one of the following outcomes reported to the TGA in relation to an adverse event:
 (a) death;
 (b) injury;
 (c) no injury;
 (d) unknown.
event type, in relation to a medical device or other therapeutic good, means the event type described in the IMDRF Terminology Document that is applicable to the adverse event.
IMDRF Terminology Document means the Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes, published by the International Medical Device Regulators Forum, as in force or existing from time to time.
MedDRA means the Medical Dictionary for Regulatory Activities published by the MedDRA Maintenance and Support Services Organization, as in force or existing from time to time.
other therapeutic good means a therapeutic good that is not a medicine, biological or medical device.
report source category, in relation to a medical device or other therapeutic good, means one of the following categories describing the person who reported the adverse event: