Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41mq
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41MQ
Character Range: 136285–137413

41MQ  Notification of adverse events etc. where application withdrawn or lapses

 (1) If an application for inclusion of a kind of medical device in the Register is withdrawn or lapses, the Secretary may give the applicant written notice requiring the applicant:
 (a) to inform the Secretary in writing whether the applicant is aware of any information of a kind mentioned in subsection 41MP(2) relating to the kind of device; and
 (b) if the applicant is aware of such information, to give the information to the Secretary in writing.

 (2) Notice under subsection (1) may only be given within 10 working days after an application is withdrawn or lapses.

 (3) A person is guilty of an offence if the person fails to comply with the requirements of a notice under subsection (1) within 20 working days after the notice is given to the person.

Maximum penalty: 400 penalty units.

 (4) A person is guilty of an offence if:
 (a) the person gives information in purported compliance with a notice under this section; and
 (b) the information is false or misleading in a material particular.

Maximum penalty: 400 penalty units.