Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_76
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 76
Character Range: 72920–75274

76  Subsections 41JB(3) and (4)
Repeal the subsections, substitute:

Offence for failing to comply with a notice

 (3) A person commits an offence if:
 (a) the person is given a notice under section 41JA; and
 (b) the person fails to comply with the notice.

Maximum penalty: 500 penalty units.

Note: Failure to comply with the notice might also lead to suspension or revocation of a conformity assessment certificate (see Divisions 3 and 4 of Part 4‑4) or suspension or cancellation of the entry of a kind of medical device in the Register (see Part 4‑6).

Offences for giving false or misleading information in purported compliance with a notice

 (4) A person commits an offence if:
 (a) the person is given a notice under section 41JA in relation to a kind of medical device; and
 (b) the person gives information in purported compliance with the notice; and
 (c) the information 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.

Maximum 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 (7) instead: see section 53A.

 (5) A person commits an offence if:
 (a) the person is given a notice under section 41JA in relation to a kind of medical device; and
 (b) the person gives information in purported compliance with the notice; and
 (c) the information 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.

Maximum penalty: 2,000 penalty units.

 (6) Subsection (5) is an offence of strict liability.

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

 (7) A person commits an offence if:
 (a) the person is given a notice under section 41JA; and
 (b) the person gives information in purported compliance with the notice; and
 (c) the information is false or misleading in a material particular.

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