Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) A person may apply to the Secretary for a medical devices (priority applicant) determination in relation to a medical device.
(2) An application under subregulation (1) must:
(a) be in writing; and
(b) be in a form approved, in writing, by the Secretary; and
(c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.
(3) An application under subregulation (1) is taken not to have been made unless:
(a) the application meets the requirements in subregulation (2); and
(b) the fee prescribed in item 1.5A of Part 1 of Schedule 5 for making the application has been paid.