Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p24
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 24/30)
Character Range: 196487–199192

June 2017; and
 (b) an effective application for including the device in the Register is made no later than 30 days after the day the certificate is issued; and
 (c) the application for including the device in the Register is finally determined;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on the day the application for including the device in the Register is finally determined.

Certificate issued on or after 1 June 2017 and inclusion application not made within 30 days
 (7) If:
 (a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2017; and
 (b) an effective application for including the device in the Register is not made within 30 days after the day the certificate is issued;
the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, 30 days after the day the certificate is issued.
 (8) If the amendments made by Schedule 1 to the 2010 Amendment Regulations do not apply in relation to the device, for all purposes, under any of subregulations (2) to (7) of this regulation, then the amendments apply in relation to the device under regulation 11.18.

11.18  Application of 2010 Amendment Regulations—devices not covered by regulation 11.17
 (1) This regulation applies in relation to the device if the amendments made by Schedule 1 to the 2010 Amendment Regulations do not apply in relation to the device, for all purposes, under any of subregulations 11.17(2) to (7).
Note 1: This regulation will apply, for example, in relation to a device if an application for a conformity assessment certificate is not made in respect of the device before 1 July 2016.
Note 2: The amendments made by Schedule 1 to the 2010 Amendment Regulations are affected by amendments made by Part 1 of Schedule 1 to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015. Regulation 11.25 deals with the application of those 2015 amendments.

Inclusion application made before 1 July 2017—device included in Register
 (2) If:
 (a) an effective application for including the device in the Register is made before 1 July 2017; and
 (b) the device is included in the Register;
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 device is 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