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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