Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 1/19)
Character Range: 220518–223193

6                            a medical device of a kind described in subclause 3.2(3A) of Schedule 2  Class IIa or Class IIb

11.40  Transitional medical devices—application of amendments

Applications and entries other than for transitional medical devices
 (1) The amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations, and the amendments made by Part 4 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, apply on and after 25 November 2021 in relation to the following:
 (a) an application for a kind of medical device to be included in the Register that is made on or after 25 November 2021;
 (b) a kind of medical device that is included in the Register as a result of such an application.

Applications and entries for transitional medical devices
 (2) Subject to subregulations (3) and (5), the amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations, and the amendments made by Part 4 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, apply in relation to a transitional medical device on and after:
 (a) for a transitional AIMD device—1 November 2024; and
 (b) for a transitional medical device other than a transitional AIMD device—1 July 2029.
 (3) The amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations, and the amendments made by Part 4 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, do not apply in relation to a transitional medical device before the day applicable under subregulation (4) if:
 (a) a person applies under the Act:
 (i) on or after the inclusion day for the entry of the transitional medical device; and
 (ii) on or after 25 November 2021; and
 (iii) before the day mentioned in paragraph (2)(a) or (b) (as the case may be) for the transitional medical device;
  to have a kind (the new kind) of medical device included in the Register; and
 (b) the person gives to the Secretary a notice under regulation 11.41 in relation to the transitional medical device; and
 (c) the unique product identifier of the device of the new kind is the unique product identifier, or one of the unique product identifiers, stated in the notice.
 (4) For the purposes of subregulation (3), the day is the day after the day on which:
 (a) the person withdraws the application mentioned in paragraph (3)(a); or
 (b) that application lapses under section 41FK of the Act; or
 (c) that application is finally determined.
 (5) If:
 (a) a person is required under regulation 11.41 to give a notice to the Secretary in relation to a transitional medical