Cancellations and suspensions

Regulatory action due to Voluntary revocation at the request of the manufacturer., effective 22/06/2018

Regulatory action due to The goods were not eligible for listing as they contained a substance in an amount which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 23/04/2018

Regulatory action due to The goods were not eligible for listing as they did not meet the requirements set out in Schedule 4 of the Therapeutic Goods Regulations.The goods were not eligible for listing as they contained a substance in an amount which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 23/04/2018

Regulatory action due to The goods were not eligible for listing as they contained a substance in an amount which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 23/04/2018

Regulatory action due to The goods were not eligible for listing as they contained a substance in an amount which is not permitted by Schedule 4 of the Therapeutic Goods Regulations., effective 23/04/2018

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 20/04/2018

Regulatory action due to Pursuant to subsection 41GA(1)(b) of the Act, there are likely grounds for cancelling this ARTG entry, in accordance with subsection 41GN(1)(b) of the Act. The suspension from the ARTG was effective on 5 April 2018 for a period of six months., effective 05/04/2018

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 03/04/2018

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 03/04/2018

Regulatory action due to As it appeared to the Secretary that the presentation of the goods was unacceptable, the certification made under s.26A(2)(c) of the Act was incorrect.The goods do not conform to a standard applicable to the goods., effective 06/03/2018

Regulatory action due to The Device has been cancelled as the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked. The sponsor did not provide evidence that the device complies with Essential Principles 1 and 6 prior to the expiry of the suspension period.The grounds for cancellation apply only to SerenoCem Granules BCG050 (the Device) and the cancellation is limited under s41GO to vary ARTG 152441 accordingly., effective 28/02/2018

Regulatory action due to Pursuant to section 41GA(1)(a)(i) of the Act, there is a potential risk of death, serious illness or serious injury if the Device continues to be included in the Register and pursuant to section 41GA(I)(b) of the Act it is likely that Medtronic Australasia Pty Ltd will, within the 6 month period of suspension, be able to take the action necessary to ensure that the Device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register., effective 05/02/2018

Regulatory action due to Pursuant to section 41GA(1)(a)(i) of the Act, there is a potential risk of death, serious illness or serious injury if the Device continues to be included in the Register and pursuant to section 41GA(I)(b) of the Act it is likely that Medtronic Australasia Pty Ltd will, within the 6 month period of suspension, be able to take the action necessary to ensure that the Device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register., effective 05/02/2018

Regulatory action due to Voluntary revocation at the request of the manufacturer., effective 24/01/2018

Regulatory action due to The sponsor failed to comply 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 17/01/2018

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