(1)

For section 41LC of the Act, the Secretary may, subject to subregulation (7), approve, in relation to a kind of medical device, the payment of an assessment fee by instalments if:

(a)

the person who is liable to pay the fee (the applicant ) has applied in writing to pay the amount by instalments; and

(b)

the amount payable exceeds $10 000; and

(c)

the Secretary is reasonably satisfied that the applicant will experience financial hardship if the amount is paid before the commencement of the consideration or audit of the application to which the fee relates (the relevant application ); and

(d)

any information or material required under subregulation (3) has been given to the Secretary.

(2)

An application under subregulation (1) must:

(a)

state the reasons why paying the full amount of the fee before the consideration or audit of the relevant application commences would cause financial hardship to the applicant; and

(b)

have with it documents or other material in support of the application.

(3)

The Secretary may reasonably require information or material in addition to the documents or material mentioned in paragraph (2) (b).

(4)

If the Secretary approves an application for payment by instalments:

(a)

half of the fee is due for payment before the commencement of the consideration or audit of the relevant application; and

(b)

one-quarter of the fee is due for payment at the end of one month after the last day when the amount referred to in paragraph (a) may be paid; and

(c)

the remaining one-quarter of the fee is due for payment:

(i)

if the relevant application is withdrawn — when the application is withdrawn; and

(ii)

in any other case — when the applicant is notified of the Secretary's decision in respect of the relevant application under section 41EE or 41FJ of the Act.

(5)

If the Secretary receives an application for payment by instalments, the Secretary must:

(a)

within 30 days of receiving the application and any information or material required under subregulation (3), give notice, in writing, to the applicant stating whether the application has been approved; and

(b)

if the application is approved, include with the notice information about the amount of each instalment and when it is due for payment.

(6)

If:

(a)

the Secretary approves an application for payment by instalments; and

(b)

any amount of the instalment payable by the applicant is not paid when it becomes due for payment;

the balance of the fee becomes due for payment.

(7)

This regulation does not apply if another assessment fee, or an evaluation fee under section 24 of the Act, (or part of either of those kinds of fee) that is due for payment by the applicant is unpaid.