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THERAPEUTIC GOODS ACT 1989 - SECT 41ME

Criminal offences for failing to apply conformity assessment procedures--manufacturers

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, will result in, or is likely to result in, harm or injury to any person; or

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

                     (e)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to 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 1:       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.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (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.

          (4A)  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:  100 penalty units.

          (4B)  An offence against subsection (4A) is an offence of strict liability.

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, will result in, or is likely to result in, harm or injury to any person; or

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

                     (e)  the harm or injury has resulted, will result, is likely to result, would result, or would be likely to 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 1:       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.

Note 2:       For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

             (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.

             (9)  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:  100 penalty units.

           (10)  An offence against subsection (9) is an offence of strict liability.



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