Cancellations and suspensions

Regulatory action due to As the sponsor did not comply with a product specific condition of registration for the Therapeutic Goods in the ARTG and the failure to provide information required under a s.31 letter., effective 07/03/2017

Regulatory action due to As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 03/03/2017

Regulatory action due to As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 03/03/2017

Regulatory action due to The sponsor failed to comply within 20 working days after a notice was given under section 31 requiring it to provide information or documents about the certifications made in relation to the goods., effective 06/02/2017

Regulatory action due to The sponsor failed to comply with a condition of listing imposed by the Secretary under s.28(2B) of the Act., effective 01/02/2017

Regulatory action due to The sponsor failed to comply with a condition of listing imposed by the Secretary under s.28(2B) of the Act., effective 01/02/2017

Regulatory action due to The sponsor failed to comply with a condition of listing imposed by the Secretary under s.28(2B) of the Act., effective 01/02/2017

Regulatory action due to The sponsor failed to provide information in response to a Notice issued under section 41JA. Further as the sponsor did not provide sufficient information to substantiate compliance of the kind of device with the essential principles and the application of the appropriate conformity assessment procedures to the device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the ARTG were correct, in a material particular, and that the sponsor complies with the conditions of inclusion of the kind of device in the ARTG., effective 11/01/2017

Regulatory action due to The sponsor failed to provide information in response to a Notice issued under section 41JA. Further as the sponsor did not provide sufficient information to substantiate compliance of the kind of device with the essential principles and the application of the appropriate conformity assessment procedures to the device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the ARTG were correct, in a material particular, and that the sponsor complies with the conditions of inclusion of the kind of device in the ARTG., effective 11/01/2017

Regulatory action due to The sponsor failed to provide information in response to a Notice issued under section 41JA. Further as the sponsor did not provide sufficient information to substantiate compliance of the kind of device with the essential principles and the application of the appropriate conformity assessment procedures to the device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the ARTG were correct, in a material particular, and that the sponsor complies with the conditions of inclusion of the kind of device in the ARTG., effective 11/01/2017

Regulatory action due to As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 19/12/2016

Regulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.It appeared to the Secretary that the presentation of the goods was unacceptable., effective 07/12/2016

Regulatory action due to The sponsor failed to provide information in response to a Notice issued under section 41JA. Further as the sponsor did not provide sufficient information to substantiate compliance of the kind of device with the essential principles and the application of the appropriate conformity assessment procedures to the device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the ARTG were correct, in a material particular, and that the sponsor complies with the conditions of inclusion of the kind of device in the ARTG., effective 07/12/2016

Regulatory action due to As the sponsor did not provide sufficient information to substantiate that the appropriate conformity assessment procedures have been applied to the kind of device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the inclusion of the device in the ARTG were correct, in a material particular., effective 18/11/2016

Regulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.It appeared to the Secretary that the presentation of the goods was unacceptable., effective 15/11/2016

Regulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016

Regulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016

Regulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016

Regulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016

Regulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016

Regulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016

Regulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016

Regulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016

Regulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016

Regulatory action due to The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked., effective 05/11/2016