Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p17
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 17/30)
Character Range: 178882–181512

registered under Part 3‑2 of the Act; or
 (ii) a device for which an effective application for listing or registration under Part 3‑2 of the Act had been made but not finally determined.
transitional device means:
 (a) a Class 1 in‑house IVD medical device that is in existence before 1 July 2017; or
 (b) a Class 2 in‑house IVD medical device that is in existence before 1 July 2017; or
 (c) a Class 3 in‑house IVD medical device that is in existence before 1 July 2017; or
 (d) a Class 4 in‑house IVD medical device that is in existence before 1 July 2016; or
 (e) a listed or registered transitional device; or
 (f) an approved transitional device; or
 (g) an exempt transitional device.
transitional period means:
 (a) for a transitional device that is not an in‑house IVD medical device—the period starting on 1 July 2014 and ending immediately before the transition day for the device; and
 (b) for a transitional device that is an in‑house IVD medical device—the period starting on the later of:
 (i) 1 July 2014; and
 (ii) the day the device comes into existence;
  and ending immediately before the transition day for the device.
transition day, for a transitional device, means the day on which Schedule 1 to the 2010 Amendment Regulations starts to apply, for all purposes, in relation to the device.

Meaning of finally determined
 (2) For this Division, an application is finally determined at the first time both the following conditions are met:
 (a) a decision has been made not to grant the application;
 (b) there is no longer any possibility of a change in the outcome of the decision.
 (3) For paragraph (2)(b), the possibility of a discretion being exercised after the period has ended, to extend the period for seeking review by a court or tribunal of the decision or for starting other proceedings (including appeals) arising out of the application, decision or review, is not to be considered.

References to including a device in the Register
 (4) In this Division, a reference to including a device in the Register is a reference to including the device in the Register under Chapter 4 of the Act.

11.2  Application of 2010 Amendment Regulations
 (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device as set out in Subdivisions C to F of this Division unless:
 (a) the device was included in the Register before 1 July 2014; or
 (b) an effective application for including the device in the Register was made before 1 July 2014 and the application was finally determined before that date.
 (2) To avoid doubt, the amendments made by Schedule 1