4Definitions

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.