Commonwealth Consolidated Regulations

THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 9.6

    The Secretary may reduce by 70% the amount of an assessment fee specified in Schedule   5 in relation to a medical device if the supply of the medical device:

  (a)   is in the interest of public health; and

  (b)   would not be commercially viable for the manufacturer or sponsor of the medical device if the full amount of the fee were paid.