Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:6:p6
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 6 (pt 6/19)
Character Range: 232519–235234

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 after 1 November 2024.

Subdivision D—Personalised medical devices

11.48  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).

11.49  Personalised medical devices—reports
 (1) Subregulation 10.3A(1), as inserted by Schedule 3 to the amending regulations, applies in relation to a custom‑made medical device that is manufactured on or after 25 February 2021.
 (2) Subregulation 10.3A(2), as inserted by Schedule 3 to the amending regulations, applies in relation to a custom‑made medical device that is imported into Australia on or after 25 February 2021.

11.50  Personalised medical devices—conformity assessment procedures
 (1) The amendments of clause 7.2 of Schedule 3 made by Schedule 3 to the amending regulations apply in relation to a custom‑made medical device that is manufactured on or after 25 February 2021.
 (2) The repeal and substitution of subclause 7.6(2) of Schedule 3 made by Schedule 3 to the amending regulations applies in relation to a medical device that is manufactured on or after 25 February 2021.

11.51  Personalised medical devices—exemptions
 (2) Items 2.12 and 2.13 of the table in Part 2 of Schedule 4, as added by Schedule 3 to the amending regulations, apply in relation to a custom‑made medical device that is manufactured on or after 25 February 2021, where the request from the health professional is made on or after that day.
 (3) Item 2.14 of the table in Part 2 of Schedule 4, as added by Schedule 3 to the amending regulations, applies in relation to a patient‑matched medical device if it is manufactured on or after 25 February 2021 and before 1 July 2029.

11.52  Personalised medical devices—classification rules

Applications and entries other than a transitional kind of medical device
 (1) Clause 5.4 of Schedule 2, as substituted by Schedule 3 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