Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 1/30)
Character Range: 138790–141424

5                            a medical device of a kind described in subclause 3.2(3A) of Schedule 2  Class IIa or Class IIb

8A.2  Waiver of charges in relation to transitional medical devices
 (1) This subregulation applies in relation to a kind of medical device if, at any time during a charge year:
 (a) the medical device is a transitional medical device; and
 (b) the entry for the kind of medical device in the Register does not include any medical device that is not a transitional medical device; and
 (c) the medical device is included in the Register and classified both as:
 (i) a class of medical device mentioned in column 2 of an item of the table in the definition of transitional medical device in regulation 8A.1; and
 (ii) a class of medical device described in the provision mentioned in column 1 of that item; and
 (d) the same kind of medical device is also listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, made under the Private Health Insurance Act 2007, as in force from time to time.
 (2) The Secretary must, on behalf of the Commonwealth, waive the annual charge payable under the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of transitional medical device in the Register during the charge year if:
 (a) the person liable to pay the charge applies for the charge to be waived for the charge year; and
 (b) the application is made in the form (if any) approved, in writing, by the Secretary for the purposes of this subregulation; and
 (c) the Secretary is reasonably satisfied that subregulation (1) applies in relation to the transitional medical device.

8A.3  Refund of certain charges in relation to transitional medical devices
 (1) This subregulation applies in relation to a kind of medical device if, at any time during a charge year:
 (a) the medical device is a transitional medical device; and
 (b) the entry for the kind of medical device in the Register does not include any medical device that is not a transitional medical device; and
 (c) the medical device is included in the Register and classified both as:
 (i) a class of medical device mentioned in column 2 of an item of the table in the definition of transitional medical device in regulation 8A.1; and
 (ii) a class of medical device described in the provision mentioned in column 1 of that item; and
 (d) the same kind of medical device is also listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, made under the Private Health Insurance Act 2007, as in force from time to time; and
 (e) the annual charge payable under