THERAPEUTIC GOODS ACT 1989 - SECT 41BIA Meaning of non - application of overseas requirements comparable to conformity assessment procedures
THERAPEUTIC GOODS ACT 1989 - SECT 41BIA
Meaning of non - application of overseas requirements comparable to conformity assessment procedures(1) 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:
(a) there has been a contravention of the requirement; 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 requirement to which that conformity assessment standard, or one or more
of those conformity assessment standards, relate.