Cancellations and suspensions

Regulatory action due to The goods have changed so that 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 30/10/2015

Regulatory action due to The goods have changed so they have become separate and distinct from the goods included in the ARTG.As the information included in or with the application was incorrect, the certification made under s.26A(2)(k) of the Act was incorrect., effective 27/10/2015

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 01/10/2015

Regulatory action due to The goods do not conform to a standard applicable to the goods., effective 22/09/2015

Regulatory action due to The sponsor failed to comply within 14 days after the end of the period specified in a notice under section 31 requiring it to provide information or documents relating to the goods., effective 22/09/2015

Regulatory action due to The goods have changed so that they have become separate and distinct from the goods included in the ARTG.As it appeared to the Secretary that the presentation of the goods was unacceptable, the certification made under s.26A(2)(c) was incorrect.As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) was incorrect.The goods do not conform to a standard applicable to the goods., effective 25/08/2015

Regulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) was incorrect.The goods do not conform to a standard applicable to the goods., effective 25/08/2015

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 19/08/2015

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 14/08/2015

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 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

Regulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) was incorrect.The sponsor failed to comply with a condition of listing under s.28(5)(ab) (that the goods would not be advertised for an indication other than those accepted in the Register).The goods do not conform to a standard applicable to the goods.The applicable provisions of the Therapeutic Goods Advertising Code have not been complied with., effective 18/06/2015

Regulatory action due to As the sponsor did not provide sufficient information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition of inclusion to which the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 29/05/2015

Regulatory action due to As the sponsor did not provide sufficient information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition of inclusion to which the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 08/05/2015

Regulatory action due to The goods were not eligible for listing as they contained a substance in an amount that exceeded the maximum daily dose of that substance prescribed for listed medicines in Division 2 of Part 5 of Schedule 4 of the Therapeutic Goods Regulations (see item 3, Part 1 of Schedule 4)., effective 05/05/2015

Regulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) was incorrect., effective 10/04/2015

Regulatory action due to As the sponsor did not provide sufficient information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition of inclusion to which the kind of device in the ARTG was subject under s.41FN(3)(a)., effective 26/03/2015

Regulatory action due to , effective 25/02/2015

Regulatory action due to , effective 25/02/2015

Regulatory action due to , effective 13/02/2015

Regulatory action due to , effective 11/02/2015

Regulatory action due to , effective 11/02/2015

Regulatory action due to , effective 11/02/2015

Regulatory action due to It appeared to the Secretary that the presentation of the goods was unacceptable. As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) was incorrect., effective 09/02/2015

Regulatory action due to The goods do not conform to a standard applicable to the goods., effective 05/02/2015