Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41eb
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41EB
Character Range: 41126–42640

41EB  Applications

 (1) An application for a conformity assessment certificate 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.

Note: A conformity assessment fee is payable under section 41LA for consideration of the application.

 (2) An application is not effective if:
 (a) the prescribed application fee has not been paid; or
 (b) 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 41EI.

 (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.

 (4) The Secretary may, by written notice given to an applicant for a conformity assessment certificate, require the applicant to allow an authorised person, at any reasonable time specified in the notice, to inspect:
 (a) the premises (including premises outside Australia) and equipment, processes and facilities that are being or will be used to manufacture medical devices of the kind in question; and
 (b) any other kinds of medical devices on those premises.