Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41MB

Exceptions

  (1)   Sections   41MA and 41MAA do 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 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.


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