Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41MA

Offences relating to importing a medical device

             (1)  A person commits an offence 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

                    (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 device does not comply with the essential principles.

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 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

                    (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 device does not comply with the essential principles.

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 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.

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

Offences relating to supplying a medical device

             (5)  A person commits an offence 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

                    (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 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 device does not comply with the essential principles.

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 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

                    (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 device does not comply with the essential principles.

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 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.

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

Offences relating to exporting a medical device

             (9)  A person commits an offence 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

                    (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 device does not comply with the essential principles.

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 (12) instead: see section 53A.

           (10)  A person commits an offence 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

                    (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 device does not comply with the essential principles.

Penalty:  2,000 penalty units.

           (11)  Subsection (10) is an offence of strict liability.

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

           (12)  A person commits an offence 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.

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

Exception

           (13)  Paragraphs (9)(b), (10)(b) and (12)(b) do not apply to the extent that the essential principles in question relate to labelling medical devices for supply in Australia.

Note:          A defendant bears an evidential burden in relation to the matters in this subsection: see subsection 13.3(3) of the Criminal Code .