Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) A conformity assessment procedure is taken, for the purposes of this Chapter, not to have been applied to a medical device if:
(a) there has been a contravention of the conformity assessment procedures; and
(b) the contravention relates, wholly or partly, to that device or its manufacture.
(2) However, for the purposes of this Chapter (other than Part 4 - 11), subsection (1) does not apply if:
(a) 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
(b) the contravention is only in respect of a part or parts of the conformity assessment procedures to which that conformity assessment standard, or one or more of those conformity assessment standards, relate.
(3) For the purposes of this section, a conformity assessment standard relates to a part or parts of the conformity assessment procedures only if the standard specifies that part or parts.