Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41LE

             (1)  Nothing in section 41LA, 41LB or 41LC requires the applicant to pay more than 3 / 4 of the conformity assessment fee before the making of the decision if:

                     (a)  the application is for the issuing of a conformity assessment certificate under Part 4-4; and

                     (b)  consideration of the application will involve an examination of the design of medical devices; and

                     (c)  a period is prescribed under paragraph 63(2)(dc) for making a decision on the application.

             (2)  If the decision is not made within that period, the conformity assessment fee is 3 / 4 of the fee that, apart from this subsection, would have been the conformity assessment fee.

             (3)  If:

                     (a)  the decision is made within that period; and

                     (b)  part of the conformity assessment fee under section 41LA is, because of subsection (1) of this section, unpaid when the decision is made;

that part becomes due and payable on the making of the decision.

             (4)  For the purposes of this section, a decision is taken to be made on the application when the applicant is notified under subsection 41EE(1) of the Secretary's decision on the application.