Commonwealth Consolidated Acts

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             (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.

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