Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41mg
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41MG
Character Range: 840147–841329

41MG  Exceptions
 (1) Sections 41ME, 41MEA 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.
 (3) Sections 41ME, 41MEA and 41MF do not apply if an overseas regulator conformity assessment document is in force in relation to the medical device.
Note 1: In the prosecution for an offence, the defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code).
Note 2: In proceedings for the contravention of a civil penalty provision, the defendant must prove the matters in this section.