Document ID: chunk:federal_register_of_legislation:F2025L00198:reg:17
Version: federal_register_of_legislation:F2025L00198
Segment Type: reg
Provision Reference: reg 17
Character Range: 25556–27441

17  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 any of the following subsections:
 (i) 12(5); or
 (ii) 14(3); or
                     (iii)  15(4); or
 (b) the Minister is satisfied on any other grounds that the application requires a clinical assessment.
Note 1: The listing application is to identify that a clinical assessment is required for the purposes of paragraph (a).
Note 2: The listing criteria for Part A and Part C of Schedule 1 mentioned in paragraph (a) relate to whether the medical device was compared to medical devices listed in Schedule 1 or alternative treatments, and whether the comparison demonstrated that the medical device is no less clinically effective than alternative devices or treatments, and the benefit amount is proportionate to the clinical-effectiveness of the device.
Note 3: The listing criteria for Part D of Schedule 1 mentioned in paragraph (a) relate to whether the medical device was compared to medical devices listed in Schedule 1, and whether the comparison demonstrated that the device is no less clinically effective than alternative devices, and the benefit amount is proportionate to the clinical-effectiveness of the device.
Note 4: Notice must be given of a decision that the Minister is satisfied as mentioned in paragraph (1)(b) of this section that an application requires a clinical assessment (see subsection 25(1)). Such a decision made by a delegate of the Minister is reviewable (see section 26).

Amount of clinical assessment fee
 (2) The clinical assessment fee is $3,970.