Therapeutic Goods Act 1989

A requirement that is comparable to a conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied to a medical device by the manufacturer of the device if:

there has been a contravention of the requirement; and

the contravention relates, wholly or partly, to that device or its manufacture.

However, for the purposes of this Chapter (other than Part 4‑11), subsection (1) does not apply if:

the quality management system applied in the manufacture of the medical device complies with one or more conformity assessment standards that apply to it; and

the contravention is only in respect of a part or parts of the requirement to which that conformity assessment standard, or one or more of those conformity assessment standards, relate.