Therapeutic Goods Act 1989

notify the applicant in writing of his or her decision within 20 working days after the decision is made; and

if the decision is not to include the kind of device to which the application relates in the Register—state in the notice the reasons for the decision; and

if the decision is to include the kind of device in the Register and all assessment fees for the application that are due and payable have been paid:

include the kind of device in the Register, in relation to the person in relation to whom the application was made; and

give the applicant a certificate of the inclusion of the kind of device in the Register.