THERAPEUTIC GOODS ACT 1989 - SECT 41EB Applications

THERAPEUTIC GOODS ACT 1989 - SECT 41EB

  (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.