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THERAPEUTIC GOODS ACT 1989 - SECT 41BG

Manufacturers of medical devices

             (1)  The manufacturer of a medical device is the person who is responsible for the design, production, packaging and labelling of the device before it is supplied under the person's name, whether or not it is the person, or another person acting on the person's behalf, who carries out those operations.

             (2)  If subsection (1) does not apply to a medical device, the manufacturer of the device is the person who, with a view to supplying the device under the person's name, does one or more of the following using ready-made products:

                     (a)  assembles the device;

                     (b)  packages the device;

                     (c)  processes the device;

                     (d)  fully refurbishes the device;

                     (e)  labels the device;

                      (f)  assigns to the device its purpose by means of information supplied, by the person, on or in any one or more of the following:

                              (i)  the labelling on the device;

                             (ii)  the instructions for using the device;

                            (iii)  any advertising material relating to the device;

                            (iv)  technical documentation describing the mechanism of action of the device.

             (3)  However, a person is not the manufacturer of a medical device if:

                     (a)  the person assembles or adapts the device for an individual patient; and

                     (b)  the device has already been supplied by another person; and

                     (c)  the assembly or adaptation does not change the purpose intended for the device by means of information supplied by that other person, on or in any one or more of the following:

                              (i)  the labelling on the device;

                             (ii)  the instructions for using the device;

                            (iii)  any advertising material relating to the device;

                            (iv)  technical documentation describing the mechanism of action of the device.

             (4)  A person is not the manufacturer of a medical device if the person is included in a class of persons prescribed by the regulations for the purposes of this subsection.



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