Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p22
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 22/30)
Character Range: 191419–194318

applies in relation to an approved transitional device.

11.13  Application of 2010 Amendment Regulations—certain purposes
  The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to an approved transitional device, on and after 1 July 2014, for purposes connected with:
 (a) an application for a conformity assessment certificate in respect of the device; or
 (b) issuing a conformity assessment certificate in respect of the device; or
 (c) an application for including the device in the Register; or
 (d) including the device in the Register.

11.14  Application of 2010 Amendment Regulations—all purposes
  The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to an approved transitional device, for all purposes, on and after:
 (a) if the device is covered by subparagraph (c)(i) of the definition of approved transitional device in subregulation 11.1(1)—the day the device ceases to be a device to which item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990 applies; and
 (b) if the device is covered by subparagraph (c)(ii) of the definition of approved transitional device in subregulation 11.1(1)—the day the approval for the device ceases to have effect; and
 (c) if the device is covered by subparagraph (c)(iii) of the definition of approved transitional device in subregulation 11.1(1):
 (i) if approval is given for the device under paragraph 19(1)(b) of the Act—the day the approval ceases to have effect; and
 (ii) in any other case—the day the application for approval is finally determined.

Subdivision E—Class 4 in‑house IVD medical devices

11.15  Application of this Subdivision
  This Subdivision applies in relation to a transitional device that is a Class 4 in‑house IVD medical device.

11.16  Application of 2010 Amendment Regulations—certain purposes
  The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after the later of the following days:
 (a) 1 July 2014;
 (b) the day on which the device comes into existence;
for purposes connected with:
 (c) an application for a conformity assessment certificate in respect of the device; or
 (d) issuing a conformity assessment certificate in respect of the device; or
 (e) an application for including the device in the Register; or
 (f) including the device in the Register.

11.17  Application of 2010 Amendment Regulations—conformity assessment certificate applied for before 1 July 2016
 (1) This regulation applies in relation to the device if an application for a conformity assessment certificate in respect of the device is made before 1 July 2016.

Certificate issued and inclusion application made before 1 July 2017—device included in Register
 (2) If:
 (a) a conformity assessment certificate in respect of the device is issued before 1 June 2017; and
 (b) an effective application for