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16 Cost‑recovery fees that may be charged

(1) For the purposes of section 72‑15 of the Act, this section specifies the fees that may be charged in relation to activities carried out by, or on behalf of, the Commonwealth in connection with the Minister’s consideration of: (a) a listing application relating to a medical device; or (b) a variation application relating to a medical device.

Note: Fees are not charged for listing applications, or variation applications, relating to human tissue products.

(2) The fees are: (a) a standard application fee of $1,370; and (b) if a clinical assessment is required (see section 17)—the clinical assessment fee; and (c) if an economic assessment is required (see section 18)—the economic assessment fee; and (d) if a full health technology assessment is required (see section 19)—the full health technology assessment pathway fee.