Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41EI

             (1)  A person commits an offence if:

                     (a)  the person makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is made in or in connection with an application for a conformity assessment certificate; and

                     (c)  the person knows that the statement is false or misleading in a material particular; and

                     (d)  either:

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

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

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 makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is in or in connection with an application for a conformity assessment certificate; and

                     (c)  the statement is false or misleading in a material particular; and

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

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 makes a statement (whether orally, in a document or in any other way); and

                     (b)  the statement is in or in connection with an application for a conformity assessment certificate; and

                     (c)  the person knows that the statement is false or misleading in a material particular.

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