Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41mb
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41MB
Character Range: 123926–124695

41MB  Exceptions

 (1) Section 41MA does 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: A defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code).