Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41mg
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41MG
Character Range: 127256–128117

41MG  Exceptions

 (1) Sections 41ME and 41MF do not apply to the extent that:
 (a) the quality management systems applied to the medical device comply with one or more conformity assessment standards that apply to them; and
 (b) the conformity assessment procedures have not been applied to the device only in respect of a part or parts of the conformity assessment procedures to which one or more of those conformity assessment standards relate.

Note: Conformity assessment standards are determined under Division 2 of Part 4‑3.

 (2) 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.

Note: A defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code).