Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p11
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 11/19)
Character Range: 244826–247418

Register means the day on which the inclusion of that kind of device in the Register commences.
transitional kind of medical device means a kind of medical device included in the Register because of an application that was made before 25 November 2021 (whether the inclusion day for the entry of that kind of medical device occurred before, on or after that day).

11.60  Reports about adverse events or occurrences for medical devices
  Subregulation 5.8A(1), as inserted by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to information of a kind mentioned in subsection 41MP(2) or 41MPA(2) of the Act that is given to the Secretary on or after the commencement of that Part.

11.61  Patient implant cards and patient information leaflets
 (1) The amendments of Part 9 and of item 1.15 of the table in Part 1 of Schedule 5 made by Part 3 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an application for consent that is made on or after the commencement of those amendments.
 (2) The amendments of clauses 13A.1 to 13A.4 of Schedule 1 made by Part 3 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an implantable medical device, or an active implantable medical device, that is imported, supplied or exported on or after the commencement of that Part.
 (3) If:
 (a) on or after 1 January 2021 and before the commencement of this regulation, a person made an application of a kind covered by paragraph (a) or (b) of item 1.15 of the table in Part 1 of Schedule 5 (as that item was in force before that commencement); and
 (b) the application was made solely in relation to the application of either or both of clauses 13A.2 and 13A.3 of Schedule 1 (as those clauses were in force before that commencement); and
 (c) on or after 1 January 2021 and before the commencement of this regulation, the person paid the fee applicable in relation to the application under item 1.15 of the table in Part 1 of Schedule 5 (as that item was in force before that commencement);
the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the application under regulation 9.1AA if the application had been made on the day on which this regulation commences.

11.62  Medical devices assembled or adapted at point of care
  Item 1.3B of the table in Part 1 of Schedule 4, as