Cancellations and suspensions

Cancellation of the entry due to the sponsor not providing sufficient information to substantiate compliance with the Essential Principles.

Cancellation of the entry due to the sponsor not providing sufficient information to substantiate compliance with the Essential Principles.

Cancellation from the ARTG under subsection 41GN(1) of the Act. Cancellation is limited to some medical devices of the kind and the ARTG is varied accordingly under section 41GO of the Act.

Cancellation from the ARTG under subsection 41GN(1) of the Act. Cancellation is limited to some medical devices of the kind and the ARTG is varied accordingly under section 41GO of the Act.

Cancellation from the ARTG under subsection 41GN(1) of the Act. Cancellation is limited to some medical devices of the kind and the ARTG is varied accordingly under section 41GO of the Act.

Cancellation from the ARTG under subsection 41GN(1) of the Act. Cancellation is limited to some medical devices of the kind and the ARTG is varied accordingly under section 41GO of the Act.

Cancellation from the ARTG under subsection 41GN(1) of the Act. Cancellation is limited to some medical devices of the kind and the ARTG is varied accordingly under section 41GO of the Act

Cancellation from the ARTG under subsection 41GN(1) of the Act. Cancellation is limited to some medical devices of the kind and the ARTG is varied accordingly under section 41GO of the Act.

The sponsor did not provide sufficient 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, and the certifications made are incorrect, or are no longer correct, in a material particular.

Regulatory action due to Failure to respond to s41GN(2) Proposal to cancel, effective 30/06/2021

Regulatory action due to The response from a Section 41JA notification has informed that the device type is not supplied or imported in Australia, or exported from Australia.The grounds for cancellation apply only to T34L variants of infusion pumps (including T34L, T34L NeoFeed and T34L KID models) and the cancellation is limited under s41GO to vary ARTG 131232 accordingly., effective 08/09/2020

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 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 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 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 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 The sponsor requested in writing the cancellation of these devices from the ARTG entry., effective 02/02/2016

Regulatory action due to 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: TiLOOP Tape; TiLOOP Two; TiLOOP Total 4; TiLOOP Total 6; TiLOOP Fix; TiLOOP Mesh; TiLOOP Patch; and TiLOOP Clip., effective 12/08/2015

Regulatory action due to 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: Selexys Acetabular Component TPS and TH+., effective 07/08/2015