Cancellations and suspensions

Regulatory action due to Cancelled on the basis that the Secretary is satisfied that the safety and performance of the kind of device is unacceptable., effective 04/01/2018

Regulatory action due to Cancelled on the basis that the Secretary is satisfied that the safety and performance of some devices included in the entry are unacceptable. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices: Restorelle DirectFix Anterior and Restorelle DirectFix Posterior., effective 04/01/2018

Regulatory action due to Cancelled on the basis that the Secretary is satisfied that the safety and performance of some devices included in the entry are unacceptable. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude this device: Solyx SIS System., effective 04/01/2018

Regulatory action due to Cancelled on the basis that the Secretary is satisfied that the safety and performance of some devices included in the entry are unacceptable. However, as another device of the same kind is included under the ARTG entry, the entry has been varied to exclude this device: Uphold [TM] LITE w/ Capio SLIM., effective 04/01/2018

Regulatory action due to ARTG 284239 was suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure., effective 20/12/2017

Regulatory action due to Pursuant to subsection 41GA(1)(b) of the Act, there are likely grounds for cancelling the ARTG entry, in accordance with paragraphs 41GN(1)(f) and 41GN(1)(b) of the Act., effective 08/11/2017

Regulatory action due to The certifications the sponsor made under section 41FD of the Act in relation to the inclusion of the Device in the ARTG are incorrect in a material particular and the sponsor failed to comply with the conditions to which the inclusion of the Device is subject to., effective 08/11/2017

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 01/11/2017

Regulatory action due to Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b)., effective 03/10/2017

Regulatory action due to Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b)., effective 03/10/2017

Regulatory action due to The certification under paragraph 26A(2)(j) of the Act, is incorrect (paragraph 30(2)(ba) of the Act) The presentation of the goods in the case of listed goods is unacceptable (paragraph 30(2)(aa) of the Act) The goods have changed so that they have become separate and distinct from the goods in the ARTG (paragraph 30(2)(b) of the Act) The goods do not conform to a standard applicable to the goods (paragraph 30(2)(e) of the Act) The goods do not comply with an applicable provision of the Therapeutic Goods Advertising Code, and/or any other requirement relating to advertising applicable under Part 5-1 or the regulations (paragraph 30(2)(ea) of the Act), effective 22/09/2017

Regulatory action due to 6 monthly suspension of the device under paragraph 41GA(1)(a)(i) of the Act due to the potential risk of death, serious injury or illness if the kind of device continues to be included in the ARTG., effective 14/09/2017

Regulatory action due to As the sponsor did not provide evidence that the devices are safe or perform as intended, nor did the sponsor provide information to substantiate compliance with the Essential Principles; the sponsor failed to comply with conditions to which inclusion of the kind of device in the ARTG was subject under 41FN(3)(a)., effective 31/08/2017

Regulatory action due to Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this device from the ARTG under subsection GN(1)(b)., effective 31/08/2017

Regulatory action due to Voluntary revocation at the request of the manufacturer., effective 11/08/2017

Regulatory action due to Cancelled by Secretary - 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 s41FN(3)(a)., effective 11/08/2017

Regulatory action due to Cancelled by Secretary - 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 s41FN(3)(a)., effective 11/08/2017

Regulatory action due to Voluntary revocation at the request of the manufacturer., effective 06/08/2017

Regulatory action due to As the sponsor did not provide information under section 41JA of the Act, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under section 41FN(3)(c) of the Act. As the sponsor did not provided a sample, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under section 41FN(2) of the Act. As the sponsor did not provide evidence to demonstrate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under section 41FN(3)(a) of the Act. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices. Other devices under the entry remain., effective 25/07/2017

Regulatory action due to The sponsor has provided information or documents in response to a notice under section 41JA to the effect that medical devices of that kind are not being supplied in Australia, imported into Australia or exported from Australia., effective 19/07/2017

Regulatory action due to The sponsor has provided information or documents in response to a notice under section 41JA to the effect that medical devices of that kind are not being supplied in Australia, imported into Australia or exported from Australia., effective 19/07/2017

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 14/07/2017

Regulatory action due to As the sponsor did not provide information under 41JA, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN (3)(C). As the sponsor did not provided a sample, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN(2). As the sponsor did not provide evidence to demonstrate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN(3)(a). However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices: Flextherm and Stockert Heater-Cooler 1T., effective 04/07/2017

Regulatory action due to I am satisfied that the requirements of section 41GA of the Act have been met and that there are grounds for cancelling the entry under section 41GN(1)(b), due to the non-compliance with Essential Principles 3, 6, and 15., effective 09/06/2017

Regulatory action due to I am satisfied that the requirements of section 41GA of the Act have been met and that there are grounds for cancelling the entry under section 41GN(1)(b), due to the non-compliance with Essential Principles 3, 6, and 15., effective 09/06/2017