Commonwealth Consolidated Regulations

THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 4A.9

  (1)   This regulation applies if the Secretary decides under subregulation   4A.6(1) not 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)   The notice must state the reasons for the decision.