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18 Clinical assessment fee

When a clinical assessment is required (1) A listing application or variation application relating to a medical device requires a clinical assessment if: (a) expert clinical advice from a clinical expert with relevant expertise in the use of the medical device is necessary to determine whether or not the medical device satisfies the listing criteria set out in either of the following subparagraphs: (i) 14(5)(b)(i); (ii) 16(3)(b)(i); or (b) the Minister is satisfied on any other grounds that the application requires a clinical assessment.

Note 1: The listing criteria mentioned in paragraph (a) relate to whether the medical device is no less clinically effective than alternative devices or treatments.

Note 2: Notice must be given of a decision that the Minister is satisfied as mentioned in paragraph (1)(b) of this section (see subsection 26(1)). Such a decision made by a delegate of the Minister is reviewable (see section 27).

Amount of clinical assessment fee (2) The clinical assessment fee is $4,090.