Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41ME

Offences relating to supplying a medical device

             (1)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person supplies the device in Australia; and

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

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the conformity assessment procedures have not been applied to the device.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

             (2)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person supplies the device in Australia; and

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

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  the use of the device, if the device were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the conformity assessment procedures have not been applied to the device.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code .

             (4)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person supplies the device in Australia; 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.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.

Offences relating to exporting a medical device

             (5)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person exports the device from Australia; and

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

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  either:

                              (i)  the use of the device has resulted in, or will result in, harm or injury to any person; or

                             (ii)  the use of the device, if the device were used, would result in harm or injury to any person; and

                     (e)  the harm or injury has resulted, will result, or would result, because the conformity assessment procedures have not been applied to the device.

Penalty:  Imprisonment for 5 years or 4,000 penalty units, or both.

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

             (6)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person exports the device from Australia; and

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

                    (ca)  the device is not of a kind covered by an exemption in force under section 41GS; and

                     (d)  the use of the device, if the device were used, would be likely to result in harm or injury to any person; and

                     (e)  the harm or injury would be likely to result because the conformity assessment procedures have not been applied to the device.

Penalty:  2,000 penalty units.

             (7)  Subsection (6) is an offence of strict liability.

Note:          For strict liability, see section 6.1 of the Criminal Code .

             (8)  A person commits an offence if:

                     (a)  the person manufactures a medical device; and

                     (b)  the person exports the device from Australia; 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.

Penalty:  Imprisonment for 12 months or 1,000 penalty units, or both.