Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41MAA

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 relating to matters other than the labelling of the device for supply in Australia; 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.