Cancellations and suspensions

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

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 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 17/10/2016

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 17/10/2016

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 12/10/2016

Regulatory action due to The goods were not eligible for listing as the indication was for the treatment of a condition specified in Part 2 of Appendix 6 to the Therapeutic Goods Advertising Code (see Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations).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.The goods do not conform to a standard applicable to the goods.The goods have changed so they have become separate and distinct from the goods included in the ARTG., effective 12/10/2016

Regulatory action due to As the sponsor did not provide sufficient information to substantiate that the kind of device was correctly classified, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the Register were correct, in a material particular., effective 12/10/2016

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.The goods do not conform to a standard applicable to the goods.The goods have changed so they have become separate and distinct from the goods included in the ARTG.It appeared to the Secretary that the presentation of the goods was unacceptable., effective 19/08/2016

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 18/07/2016

Regulatory action due to The goods were not eligible for listing as they contained a substance which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 11/07/2016

Regulatory action due to The goods have changed so they have become separate and distinct from the goods included in the ARTG.The goods do not conform to a standard applicable to the goods., effective 11/07/2016