Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p16
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 16/30)
Character Range: 176404–179110

or (7) in relation to a decision does not affect the validity of the decision.
 (9) Application may be made to the Administrative Review Tribunal for review of a reviewable decision.
Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.

Part 11—Transitional provisions

Division 11.1—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1)

Subdivision A—Preliminary

11.1  Interpretation
 (1) In this Division:
2010 Amendment Regulations means the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1) as in force immediately before 1 July 2014.
approved transitional device means an IVD medical device (other than an in‑house IVD medical device) that, immediately before 1 July 2010:
 (a) was a diagnostic good for in vitro use; and
 (b) was declared not to be a medical device under subsection 41BD(3) of the Act; and
 (c) was:
 (i) exempt from listing or registration under Part 3‑2 of the Act because item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990 applied to the device; or
 (ii) covered by an approval under paragraph 19(1)(b) of the Act; or
 (iii) a device for which an application for approval under paragraph 19(1)(b) of the Act had been made but not finally determined.
diagnostic good for in vitro use has the same meaning as in the Therapeutic Goods Regulations 1990 as in force on 30 June 2010.
exempt transitional device means an IVD medical device (other than an in‑house IVD medical device) that, immediately before 1 July 2010:
 (a) was a diagnostic good for in vitro use; and
 (b) was declared not to be a medical device under subsection 41BD(3) of the Act; and
 (c) was exempt from listing or registration under Part 3‑2 of the Act; and
 (d) was not a device to which item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990 applied.
listed or registered transitional device means an IVD medical device (other than an in‑house IVD medical device) that, immediately before 1 July 2010:
 (a) was a diagnostic good for in vitro use; and
 (b) was declared not to be a medical device under subsection 41BD(3) of the Act; and
 (c) was:
 (i) listed or 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