Therapeutic Goods Act 1989

A medical device complies, for the purposes of this Chapter (including Part 4‑11), with the essential principles if and only if it does not contravene any of the essential principles.

However, a medical device is also taken, for the purposes of this Chapter (other than Part 4‑11), to comply with the essential principles if:

the medical device complies with one or more medical device standards that apply to it; and

the medical device contravenes the essential principles only in respect of a part or parts of the essential principles to which that medical device standard, or one or more of those medical device standards, relate.

For the purposes of this section, a medical device standard relates to a part or parts of the essential principles only if the standard specifies that part or parts.