Cancellations and suspensions

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 22/10/2014

Regulatory action due to The goods do not conform to a standard applicable to the goods., effective 26/09/2014

Regulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s26A(2)(j) was incorrect., effective 26/09/2014

Regulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 requiring it to provided information about whether the product should have been listed., effective 15/09/2014

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 to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a)(i)., effective 27/08/2014

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 to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a)(i)., effective 27/08/2014

Regulatory action due to The goods have changed so they have become separate and distinct from the goods included in the ARTG.As the presentation of the product was unacceptable, the certification made under s.26A(2)(c) 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., effective 11/07/2014

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 19/06/2014

Regulatory action due to As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months., effective 23/05/2014

Regulatory action due to As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months., effective 23/05/2014

Regulatory action due to As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months., effective 23/05/2014

Regulatory action due to As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months., effective 23/05/2014

Regulatory action due to As there was insufficient evidence to support the indications for the product, the certification made by the applicant under s26A(2)(j) was incorrect., effective 16/05/2014

Regulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 30/04/2014

Regulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 30/04/2014

Regulatory action due to The sponsor failed to comply within the required timeframe with a notice under s.41JA requiring further information about the kind of medical device., effective 10/03/2014

Regulatory action due to The goods did not conform to a standard applicable to the goods as the label did not comply with the Therapeutic Goods Order No. 69 (TGO 69)., effective 06/03/2014

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).As the advertising material used for the promotion of the device was not consistent with the intended purposed as certified by the sponsor under section 41FD, the sponsor failed to comply with a condition to which the inclusion of the kind of device was subject under s.41FN(5)., effective 04/02/2014

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).As the advertising material used for the promotion of the device was not consistent with the intended purposed as certified by the sponsor under section 41FD, the sponsor failed to comply with a condition to which the inclusion of the kind of device was subject under s.41FN(5)., effective 04/02/2014

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 03/02/2014

Regulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 31/01/2014

Regulatory action due to The sponsor failed to comply within the required timeframe with a notice under section 31 of the Act requiring it to provide information about whether the product should have been listed., effective 31/01/2014

Regulatory action due to The manufactured medicine is separate and distinct from the medicine included in the ARTG. As the presentation of the product was unacceptable, the certification made under s26A(2)(c) was incorrect. The goods also did not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act and did not conform to a standard applicable to the goods., effective 23/12/2013

Regulatory action due to As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s26A(2)(c) and (j) were incorrect. The goods also did not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act., effective 18/11/2013

Regulatory action due to As there was insufficient evidence to support the indications for the product and the presentation of the product was unacceptable, the certifications made by the applicant under s26A(2)(c) and (j) were incorrect. The goods also did not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act., effective 18/11/2013