Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 2/2)
Character Range: 217376–219910

force before that commencement;
the Secretary must refund to the person the difference between the fee paid and the fee prescribed in relation to the application by that table item as in force after that commencement.

Division 11.10—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019

Subdivision A—Definitions

11.38  Definitions
  In this Division:
amending regulations means the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019.
finally determined: an application is finally determined at the first time both the following conditions are met:
 (a) a decision has been made whether or not to grant the application;
 (b) there is no longer any possibility of a change in the outcome of the decision.
unique product identifier, in relation to a medical device, means the unique product identifier given to the device by its manufacturer to identify the device and any variants.

Subdivision B—Reclassification of medical devices

11.39  Definitions
  In this Subdivision:
inclusion day for an entry of a kind of transitional medical device in the Register means the day on which the inclusion of that kind of device in the Register commences.
pre‑commencement entry: an entry of a kind of transitional medical device in the Register is a pre‑commencement entry if that kind of medical device is included in the Register because of an application made before 25 November 2021 (whether the inclusion day for the entry occurred before, on or after 25 November 2021).
transitional AIMD device means a transitional medical device of a kind mentioned in column 1 of item 2 of the table in the definition of transitional medical device.
transitional medical device means a medical device of a kind mentioned in column 1 of an item in the following table if:
 (a) the medical device is, immediately before 25 November 2021, included in the Register and classified as a class of medical device mentioned in column 2 of the item; or
 (b) on 25 November 2021:
 (i) the medical device was the subject of a class of application mentioned in column 2 of the item for inclusion in the Register; and
 (ii) the application had not been finally determined.

Transitional medical device
                             Column 1                                                                 Column 2
Item                         Kind of medical device                                                   Class of medical device or application