Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41BE

Kinds of medical devices

General

             (1)  For the purposes of this Chapter, a medical device is taken to be of the same kind as another medical device if they:

                     (a)  have the same sponsor; and

                     (b)  have the same manufacturer; and

                     (c)  have the same device nomenclature system code (see subsection (3)); and

                     (d)  have the same medical device classification; and

                     (e)  are the same in relation to such other characteristics as the regulations prescribe, either generally or in relation to medical devices of the kind in question.

Unique medical devices

             (2)  If a medical device is not of the same kind as any other medical device:

                     (a)  this Chapter applies in relation to the device as if it were a kind of medical device; and

                     (b)  references in this Chapter to delivering a reasonable number of samples of the kind of device are taken to be references to delivering the device.

Device nomenclature codes

             (3)  The Minister may, by legislative instrument, determine device nomenclature codes for medical devices.



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