Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41fc
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41FC
Character Range: 62222–63537

41FC  Applications

 (1) An application for a kind of medical device to be included in the Register must:
 (a) be made in accordance with a form approved, in writing, by the Secretary or in such other manner as is approved, in writing, by the Secretary; and
 (b) be delivered to an office of the Department specified by the Secretary.

 (2) An application is not effective if:
 (a) the application is not made in accordance with subsection (1); or
 (b) the prescribed application fee has not been paid; or
 (c) regulations made for the purposes of section 41EA require the manufacturer of the kind of device to have a conformity assessment certificate relating to the kind of medical device before an application under this section can be made, and no such certificate is in force; or
 (d) the application contains information that is false or misleading in a material particular.

Note: A person might also be guilty of an offence if the person makes a statement in an application that is false or misleading in a material particular: see section 41FE.

 (3) An approval of a form may require or permit an application or 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.