Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This regulation applies if the Secretary decides under subregulation 4A.6(1) to make a conformity assessment body determination in respect of an Australian corporation.
(2) The Secretary must notify the Australian corporation within 20 working days.
(3) When all conformity assessment body determination assessment fees that are due and payable for the application have been paid, the Secretary must:
(a) make the determination, including specifying:
(i) the scope of the determination in accordance with subregulation (4); and
(ii) the commencement and duration of the determination in accordance with regulation 4A.8; and
(b) give it to the corporation.
(4) The conformity assessment body determination must specify whether it:
(a) is of general application; or
(b) is limited to either or both of the following:
(i) one or more specified medical devices;
(ii) one or more specified conformity assessment procedures.
(5) The conformity assessment body determination may specify conditions to which it is subject.
Note: See regulation 4A.19.