Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p25
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 25/30)
Character Range: 198930–201734

included in the Register.

Inclusion application made before 1 July 2017—application withdrawn or finally determined
 (3) If:
 (a) an effective application for including the device in the Register is made before 1 July 2017; and
 (b) the application is withdrawn or is finally determined;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the application is withdrawn or is finally determined (as the case may be).

Inclusion application not made before 1 July 2017
 (4) If an effective application for including the device in the Register is not made before 1 July 2017, the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2017.

Subdivision F—Class 1, 2 and 3 in‑house IVD medical devices

11.20  Application of this Subdivision
  This Subdivision applies in relation to a transitional device that is any of the following:
 (a) a Class 1 in‑house IVD medical device;
 (b) a Class 2 in‑house IVD medical device;
 (c) a Class 3 in‑house IVD medical device.

11.21  Application of 2010 Amendment Regulations for all purposes
  The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2017.
Note: The amendments made by Schedule 1 to the 2010 Amendment Regulations are affected by amendments made by Part 2 of Schedule 1 to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015. Regulation 11.26 deals with the application of those 2015 amendments.

Division 11.2—Transitional provisions relating to joint replacements

11.22A  Purpose of this Division
  This Division includes transitional provisions relating to:
 (a) the Therapeutic Goods (Medical Devices) Amendment Regulation 2012 (No. 1); and
 (b) the Therapeutic Goods (Medical Devices) Amendment (Joint Replacements) Regulation 2015.

11.23  Refund of fees in relation to inclusion of certain devices in the Register as Class III medical devices
 (1) This regulation applies in relation to an implantable medical device if:
 (a) the device is of the kind referred to in subregulation 11.22(1) of the old Regulations; and
 (b) the device is not a joint replacement medical device; and
 (c) an application to include the device in the Register as a Class III medical device was made on or after 1 July 2012 and before the commencement of the amending Regulation.
Note: Subregulation 11.22(1) of the old Regulations referred to an implantable medical device that is intended by the manufacturer to be any of the following:
(a) a total or partial shoulder joint replacement;
(b) a total or partial hip joint replacement;
(c) a total or partial