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) health practitioner;

(b) included in the Register;

(c) medical device;

(d) Register;

(e) sponsor;

(f) supply.

In this instrument:

Act means the Therapeutic Goods Act 1989.

adverse event means an adverse event that occurs in relation to a person in Australia following use of a medical device 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 medical device.

defect, in relation to a medical device, 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;
(b) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the medical device.

Therapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.