Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p7
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 7/19)
Character Range: 235026–237613

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.

Transitional kind of medical device
 (2) Subject to subregulations (3) and (5), clause 5.4 of Schedule 2, as substituted by Schedule 3 to the amending regulations, applies in relation to a transitional kind of medical device on and after 1 July 2029.
 (3) Clause 5.4 of Schedule 2, as substituted by Schedule 3 to the amending regulations, does not apply in relation to a transitional kind of medical device before the day applicable under subregulation (4) if:
 (a) the person applies under the Act:
 (i) on or after the inclusion day for the entry of the transitional kind of medical device; and
 (ii) on or after 25 February 2021; and
 (iii) before 1 July 2029;
  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 11.53 in relation to the transitional kind of medical device; and
 (c) the unique product identifier of the devices 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 whichever of the following events occurs first:
 (a) the person withdraws the application mentioned in paragraph (3)(a);
 (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 11.53 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 clause 5.4 of Schedule 2, as substituted by Schedule 3 to the amending regulations, applies in relation to the transitional kind of medical device on and after the later of those days.

11.53  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 (5) 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