Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 1/2)
Character Range: 214575–217638

2                                                           1 December 2019                a pre‑commencement entry

Division 11.6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017

11.32  Definitions
  In this Division:
Amendment Regulations means the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017.
commencement day means the day on which Part 3 of Schedule 4 to the Amendment Regulations commences.

11.33  Application—statements in relation to exempt devices
  The amendments of regulations 7.2 and 8.2 of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to the use of a medical device in or on a person on or after the commencement day.

Division 11.7—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018

11.34  Application of amendments
  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a medical device imported into Australia:
 (a) on or after the commencement of this regulation; or
 (b) during the 12 months ending immediately before that commencement, if the device was held under the direct control of the sponsor immediately before that commencement.

Division 11.8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018

11.35  Application—regulation 4.3G (conditions applying automatically to conformity assessment certificates)
  Regulation 4.3G applies to a conformity assessment certificate issued before, on or after 1 July 2018.

11.36  Application—regulation 5.13 (conditions applying automatically to medical devices included in the Register)
  Regulation 5.13 applies to a kind of medical device included in the Register before, on or after 1 July 2018.

Division 11.9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018

11.37  Application of table item 1.5 in Part 1 of Schedule 5
 (1) Table item 1.5 in Part 1 of Schedule 5, as amended by the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018, applies in relation to applications made on or after 1 July 2018.
 (2) If, on or after 1 July 2018 and before the commencement of Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018, a person:
 (a) applied for the inclusion in the Register of a Class I medical device intended by the manufacturer to be for export only; and
 (b) paid the fee prescribed in relation to that application by table item 1.5 in Part 1 of Schedule 5 to these Regulations as in 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