Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p26
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 26/30)
Character Range: 201496–204329

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 knee joint replacement.
 (2) The Secretary may refund any fee paid in relation to the application.
 (3) If any annual charge has been paid in respect of the inclusion of the device in the Register as a Class III medical device, the Secretary may refund the difference between the annual charge paid and the annual charge that would have been payable in respect of the inclusion of the device in the Register as a Class IIb medical device.
 (4) In this regulation:
amending Regulation means the Therapeutic Goods (Medical Devices) Amendment (Joint Replacements) Regulation 2015.
old Regulations means these Regulations as in force immediately before the commencement of the amending Regulation.

Division 11.3—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015

11.24  Definitions
  In this Division:
2010 Amendment Regulations has the meaning given by regulation 11.1.
2015 Amendment Regulations means the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015.
commencement day means the day this Division commences.
transitional device has the meaning given by regulation 11.1.
transition day has the meaning given by regulation 11.1.

11.25  Application of 2015 Amendment Regulations—transitional Class 4 in‑house IVD medical devices
 (1) This regulation applies in relation to a transitional device that is a Class 4 in‑house IVD medical device.
 (2) The amendments made by Part 1 of Schedule 1 to the 2015 Amendment Regulations apply in relation to the device, for a purpose connected with a matter mentioned in any of paragraphs 11.16(c) to (f), on and after the later of the following days:
 (a) the commencement day;
 (b) the day on which the device comes into existence.
 (3) The amendments made by Part 1 of Schedule 1 to the 2015 Amendment Regulations apply in relation to the device, for all purposes, on and after the later of the following days:
 (a) the commencement day;
 (b) the transition day for the device.

11.26  Application of 2015 Amendment Regulations etc.—transitional Class 1, 2 and 3 in‑house IVD medical devices
 (1) This regulation applies in relation to a transitional device that is a Class 1 in‑house IVD medical device, Class 2 in‑house IVD medical device or Class 3 in‑house IVD medical device.
 (2) Subject to subregulations (3) and (4), the amendments made by Part 2 of Schedule 1 to the 2015 Amendment Regulations apply in relation to the device for all purposes, on and after 1 July 2017.
 (3) If, before the commencement