(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 commit an offence, or contravene a civil penalty provision, if the person makes a statement in an application that is false or misleading in a material particular: see sections 41EI and 41EIA.
(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.