Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) If an application is made under section 41FC for a kind of medical device to be included in the Register in relation to a person, the Secretary must carry out an assessment of whether the requirements set out in subsection (2) have been met in relation to the application.
(2) The requirements are as follows:
(a) the application must be made:
(i) in accordance with the form approved, in writing, by the Secretary for that classification of medical device; or
(ii) in such other manner as is approved, in writing, by the Secretary for that classification of medical device;
(b) the prescribed application fee for that classification of medical device must be paid;
(c) the application must be delivered to an office of the Department specified by the Secretary;
(d) the application must be accompanied by information that is:
(i) of a kind determined under subsection (7) for that classification of medical device; and
(ii) in a form determined under subsection (8) for that classification of medical device;
(e) if 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 section 41FC can be made--such a certificate is in force;
(f) the applicant has certified the matters in section 41FD.
Passing preliminary assessment
(3) An application passes preliminary assessment if the Secretary:
(a) has carried out an assessment, under subsection (1), in relation to the application; and
(b) is satisfied that the requirements set out in subsection (2) have been met in relation to the application.
(4) If the application has not passed preliminary assessment, the Secretary must refuse the application.
Note: The Secretary is required to give notice of the refusal: see section 41FG.
Approval of forms etc.
(5) For the purposes of paragraph (2)(a), the Secretary may approve different forms and different manners for making applications for different medical device classifications.
(6) 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.
Determination of kinds and forms of information
(7) The Secretary may, by legislative instrument, determine a kind of information for the purposes of the application of subparagraph (2)(d)(i) to medical devices of a particular classification.
(8) The Secretary may, by legislative instrument, determine a form of information for the purposes of the application of subparagraph (2)(d)(ii) to medical devices of a particular classification.