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THERAPEUTIC GOODS ACT 1989 - SECT 41JB

Complying with the Secretary's requirements

             (1)  The person must give the information or documents to the Secretary:

                     (a)  within such reasonable time, being not less than 10 working days from the day on which the notice is given, as is specified in the notice; and

                     (b)  in such form as is specified in the notice.

             (2)  The form may require or permit information to be given in accordance with specified software requirements:

                     (a)  on a specified kind of data processing device; or

                     (b)  by way of a specified kind of electronic transmission.

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

                    (aa)  the person is covered by paragraph 41JA(1)(b), (ba), (d) or (da) or subsection 41JA(1E); and

                     (b)  the person fails to comply with the notice.

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).

          (3A)  Subsection (3) does not apply if the person has a reasonable excuse.

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

          (3B)  A person commits an offence if:

                     (a)  the person is given a notice under section 41JA; and

                     (b)  the person is covered by paragraph 41JA(1)(b), (ba), (d) or (da) or subsection 41JA(1E); and

                     (d)  the person fails to comply with the notice.

Penalty:  100 penalty units.

          (3C)  An offence against subsection (3B) is an offence of strict liability.

          (3D)  Subsection (3B) does not apply if the person has a reasonable excuse.

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

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, will result in, or is likely to 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, or would be likely to result in, harm or injury to any person.

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 (7) instead: see section 53A.

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

             (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.

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

             (8)  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.

Penalty:  100 penalty units.

             (9)  An offence against subsection (8) is an offence of strict liability.



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