Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p5
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 5/19)
Character Range: 230127–232741

kind of medical device included in the Register—the day applicable under subregulation (4C).
 (4C) For the purposes of subparagraph (4B)(d)(ii), the applicable day is the day after the day on whichever of the following events occurs first:
 (a) the person withdraws the application mentioned in that subparagraph;
 (b) that application lapses under section 41FK of the Act;
 (c) that application is finally determined.
 (5) If:
 (a) a person is required under regulation 11.46 to give a notice to the Secretary in relation to a transitional kind of medical device; and
 (b) the person fails to give the notice in accordance with that regulation before the later of:
 (i) 25 August 2021; and
 (ii) the day occurring 2 months after the inclusion day for the entry of the transitional kind of medical device;
then clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, apply in relation to the transitional kind of medical device on and after the later of those days.

11.46  Secretary must be notified in relation to a transitional kind of medical device
 (1) For the purposes of subsection 41FN(5A) of the Act, a person must give to the Secretary a notice in accordance with subregulation (2) if:
 (a) a kind of medical device is included in the Register in relation to the person; and
 (b) the kind of medical device so included is a transitional kind of medical device; and
 (c) medical devices of that kind are programmed or programmable medical devices or software.
 (2) The notice must:
 (a) be in writing; and
 (b) state:
 (i) the unique device number assigned to that kind of device under section 41FL of the Act; and
 (ii) the unique product identifier given to each medical device (if any) of that kind that the person supplies in Australia; and
 (c) be given to the Secretary before the later of:
 (i) 25 August 2021; and
 (ii) the day occurring 2 months after the inclusion day for the entry of the transitional kind of medical device.

11.47  Programmed or programmable medical device or software that is a medical device—essential principles
 (1) Clause 13B of Schedule 1, as inserted by Schedule 2 to the amending regulations, applies on and after 25 February 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 February 2021;
 (b) a kind of medical device that is included in the Register as a result of such an application.
 (2) Clause 13B of Schedule 1, as inserted by Schedule 2 to the amending regulations, applies in relation to a transitional kind of medical device on and