Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:43aage
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 43AAGE
Character Range: 398742–400290

43AAGE  Person may notify Secretary that turnover of IVD device for financial year will not be of low value
 (1) This regulation applies in relation to the following:
 (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;
 (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.
 (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person's turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.
 (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.
Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).