Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41MEA

Civil penalty relating to supplying a medical device

             (1)  A person contravenes this subsection if:

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

                     (b)  the person has manufactured the device; and

                     (c)  the conformity assessment procedures have not been applied to the device; 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

             (2)  A person contravenes this subsection if:

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

                     (b)  the person has manufactured the device; and

                     (c)  the conformity assessment procedures have not been applied to the device; 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.