Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41BH

Meaning of compliance with essential principles

  (1)   A medical device complies, for the purposes of this Chapter (including Part   4 - 11), with the essential principles if and only if it does not contravene any of the essential principles.

  (2)   However, a medical device is also taken, for the purposes of this Chapter (other than Part   4 - 11), to comply with the essential principles if:

  (a)   the medical device complies with one or more medical device standards that apply to it; and

  (b)   the medical device contravenes 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.

  (3)   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.


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