Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p18
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 18/30)
Character Range: 181282–184100

1 July 2014; or
 (b) an effective application for including the device in the Register was made before 1 July 2014 and the application was finally determined before that date.
 (2) To avoid doubt, the amendments made by Schedule 1 to the 2010 Amendment Regulations apply, for all purposes, on and after 1 July 2014 in relation to:
 (a) a transitional device covered by paragraph (1)(a); and
 (b) a transitional device covered by paragraph (1)(b); and
 (c) an IVD medical device that is not a transitional device.

Subdivision B—General provisions relating to transitional devices

11.3  Application of this Subdivision
  This Subdivision applies in relation to a transitional device unless:
 (a) the device was included in the Register before 1 July 2014; or
 (b) an effective application for including the device in the Register was made before 1 July 2014 and the application was finally determined before that date.

11.4  Transitional devices exempted from requirement to be included in the Register
 (1) For paragraph 41HA(1)(b) of the Act, a transitional device is exempt from the operation of Division 3 of Part 4‑11 of the Act during the transitional period for the device.
 (2) Subregulation 7.1(3) does not apply in relation to a transitional device during the transitional period for the device.
 (3) Regulation 3.10 does not apply in relation to a transitional device, during the transitional period for the device, for a purpose 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.

11.5  Essential principles for transitional devices
 (1) For section 41CA of the Act, the essential principles set out in clauses 3 and 6 of Schedule 1 to these Regulations, as in force immediately before 1 July 2010, are prescribed for a transitional device during the transitional period for the device, for a purpose other than a purpose mentioned in subregulation (2).
 (2) Regulation 2.1 and Schedule 1 to these Regulations as in force on and after 1 July 2010 apply in relation to a transitional device for a purpose 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;
and not for any other purpose, during the transitional period for the device.

Subdivision C—Listed or registered transitional devices and exempt transitional devices

11.6  Application of this Subdivision
  This Subdivision applies in relation to the following devices: