Therapeutic Goods Act 1989

Sections 41MA and 41MAA do not apply if:

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

the medical device fails to comply with 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.

Medical device standards are determined under Division 2 of Part 4‑2.

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.

In the prosecution for an offence, the defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code).

In proceedings for the contravention of a civil penalty provision, the defendant must prove the matters in this section.