Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41MAA

Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles

Civil penalty relating to importing a medical device

             (1)  A person contravenes this subsection if:

                     (a)  the person imports a medical device into Australia; and

                     (b)  the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and

                     (c)  the Secretary has not consented to the importation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.

Civil penalty relating to supplying a medical device

             (2)  A person contravenes this subsection if:

                     (a)  the person supplies a medical device for use in Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the supply; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.

Civil penalty relating to exporting a medical device

             (3)  A person contravenes this subsection if:

                     (a)  the person exports a medical device from Australia; and

                     (b)  the medical device does not comply with the essential principles; and

                     (c)  the Secretary has not consented to the exportation; and

                     (d)  the device is not of a kind covered by an exemption in force under section 41GS.

Maximum civil penalty:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.



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