Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p39
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 39/40)
Character Range: 135000–137736

including a written agreement with the manufacturer of the devices, that require the manufacturer to make available information mentioned in paragraph 41FD(e) or (g) of the Act;
 (e) whether the devices contain substances that are prohibited imports under the Customs Act 1901;
 (f) whether the devices are to be used exclusively for one or more of the purposes specified under section 41BEA of the Act;
 (g) the accuracy and completeness of information included in or with the application;
 (h) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of the Therapeutic Goods Regulations 1990 for exempting a person from liability to pay an annual charge for inclusion of the devices in the Register for a financial year, based on low value turnover of the devices;
 (i) matters relating to an application to the Secretary under regulation 43AAH of the Therapeutic Goods Regulations 1990 to waive the annual charge for inclusion of the devices in the Register for a financial year;
 (j) matters relating to:
 (i) any malfunction or deterioration in the characteristics or performance of the devices; or
 (ii) any inadequacy in the design, manufacture, labelling, instructions for use or advertising materials of the devices; or
 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the devices;
  that has led to any complaint or problem in relation to the devices, no matter how minor;
 (k) matters of the kind mentioned in subsection 41MP(2) of the Act;
 (l) whether the devices comply with conditions to which the inclusion of the devices in the Register is subject;
 (m) matters relating to the formulation of ingredients that constitute the devices.

8.1  Notice period (Act s 41JA)
  For paragraph 41JA(2)(a) of the Act, the notice period for a kind of medical device in relation to which a person is required, by written notice given by the Secretary under subsection 41JA(1) of the Act, to give information to the Secretary is:
 (a) if the information relates to manufacturing records—5 years; and
 (b) if the information relates to distribution records:
 (i) in the case of records relating to a Class III medical device, or Class IIb medical device that is an implantable medical device—10 years; and
 (ii) in the case of records relating to any other device—5 years.

Part 8A—Waiver and refund of charges

8A.1  Definitions
  In this Part:
charge year has the same meaning as in the Therapeutic Goods (Charges) Regulations 2018.
transitional medical device means a medical device of a kind mentioned in column 1 of an item in the following table if:
 (a) the medical device was, immediately before 25 November 2021, included in the Register and classified as a