Document ID: chunk:federal_register_of_legislation:C2018A00007:clause:5_41bia
Version: federal_register_of_legislation:C2018A00007
Segment Type: clause
Provision Reference: sch 5 cl 41BIA
Character Range: 80511–81425

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.