Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:43aac:p4
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 43AAC (pt 4/5)
Character Range: 376195–378760

subregulation are met if:
 (a) the therapeutic goods are a joint replacement medical device; and
 (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and
 (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and
 (d) the person's turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and
 (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person's turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and
 (f) the person's turnover of the medical device for the 2015‑16 financial year was of low value; and
 (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person's turnover of the medical device for the 2015‑16 financial year was of low value.

Biologicals
 (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:
 (a) the inclusion of the biological in the Register commenced in the 2015‑16 financial year; and
 (b) the person's turnover of the goods for the 2015‑16 financial year is of low value; and
 (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person's turnover of the goods for the 2015‑16 financial year was of low value.
Note 1: See regulation 43AAA for the meaning of turnover and when turnover is of low value.
Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).
Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.
Note 4: If a person becomes aware during the 2015‑16 financial year that the person's turnover of the goods for that year will not be of low