Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) Sections 41MA and 41MAA do not apply if:
(a) the medical device complies with one or more medical device standards that apply to it; and
(b) 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.
Note: Medical device standards are determined under Division 2 of Part 4 - 2.
(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.
Note 1: 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 ).
Note 2: In proceedings for the contravention of a civil penalty provision, the defendant must prove the matters in this section.