Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 43AAGF

IVD device entered in Register at any time in 2017 - 18 financial year

  (1)   If:

  (a)   an IVD device is included in the Register at any time in the financial year commencing on 1   July 2017 (the 2017 - 18 financial year ); and

  (b)   the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation   43AAGB or 43AAGD, a declaration stating that the person's turnover of the device for the 2017 - 18 financial year, or for a previous financial year, was of low value; and

  (c)   the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017 - 18 financial year; and

  (d)   the Secretary becomes aware that the person's turnover of the device for the 2017 - 18 financial year, or for a previous financial year for which a declaration was given, was not of low value;

the Secretary must give the person a written notice in accordance with subregulation   (2).

  (2)   A notice given to a person under subregulation   (1) must:

  (a)   state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:

  (i)   for the 2017 - 18 financial year; or

  (ii)   for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation   43AAH); and

  (b)   specify the date on which the relevant charge, or charges, become payable.

IVD device entered in Register at any time in financial year commencing on or after 1   July 2018

  (3)   If:

  (a)   an IVD device is included in the Register at any time in a financial year commencing on or after 1   July 2018 (the relevant financial year ); and

  (b)   the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation   43AAGC or 43AAGD, a declaration stating that the person's turnover of the device for the relevant financial year was of low value; and

  (c)   the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and

  (d)   the Secretary becomes aware that the person's turnover of the device for the relevant financial year was not of low value;

the Secretary must give the person a written notice in accordance with subregulation   (4).

  (4)   A notice given to a person under subregulation   (3) must:

  (a)   state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:

  (i)   for the relevant financial year; or

  (ii)   for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation   43AAH); and

  (b)   specify the date on which the relevant charge, or charges, become payable.