Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p3
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 3/19)
Character Range: 225357–227968

regulation ceases to have effect at the end of 24 November 2022.

Subdivision C—Programmed or programmable medical device or software that is a medical device

11.44  Definitions
  In this Subdivision:
inclusion day for an entry of a kind of medical device in the 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 made before 25 February 2021 (whether the inclusion day for the entry of that kind of medical device occurred before, on or after that day).

11.45  Programmed or programmable medical device or software that is a medical device—classification rules

Applications and entries other than a transitional kind of medical device
 (1) Clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, apply 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.

Transitional kind of medical device
 (2) Subject to subregulations (3), (4A) and (5), clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, apply in relation to a transitional kind of medical device on and after 1 November 2024.
 (3) Clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, do 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 November 2024;
  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 11.46 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.
 (4A) Clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the