Cancellations and suspensions

Regulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.It appeared to the Secretary that the presentation of the goods was unacceptable.The goods do not conform to a standard applicable to the goods., effective 04/07/2016

Regulatory action due to The sponsor failed to provide information in response to a Notice issued under section 41JA, failed to demonstrate the application of the appropriate conformity assessment procedures for devices of the kind and failed to provide sufficient information to demonstrate compliance with the Essential Principles., effective 29/06/2016

Regulatory action due to The sponsor failed to provide information in response to a Notice issued under section 41JA, failed to demonstrate the application of the appropriate conformity assessment procedures for devices of the kind and failed to provide sufficient information to demonstrate compliance with the Essential Principles., effective 29/06/2016

Regulatory action due to The goods were not eligible for listing as they contained a substance which is not permitted by Schedule 4 of the Therapeutic Goods Regulations.The goods have changed so they have become separate and distinct from the goods included in the ARTG.As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.It appeared to the Secretary that the presentation of the goods was unacceptable.The applicable provisions of the Therapeutic Goods Advertising Code have not been complied with., effective 15/06/2016

Regulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.It appeared to the Secretary that the presentation of the goods was unacceptable.The goods do not conform to a standard applicable to the goods., effective 10/06/2016

Regulatory action due to The manufacturer requested in writing the revocation of their TGA conformity assessment certification., effective 31/05/2016

Regulatory action due to The manufacturer requested in writing the revocation of their TGA conformity assessment certification., effective 31/05/2016

Regulatory action due to The manufacturer requested in writing the revocation of their TGA conformity assessment certification., effective 31/05/2016

Regulatory action due to The manufacturer requested in writing the revocation of their TGA conformity assessment certification., effective 31/05/2016

Regulatory action due to The manufacturer requested in writing the revocation of their TGA conformity assessment certification., effective 31/05/2016

Regulatory action due to The Device is automatically cancelled from the Register, on the basis that the ARTG entry had been suspended from the Register under section 41GA and the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension was revoked., effective 31/05/2016

Regulatory action due to , effective 16/05/2016

Regulatory action due to It appeared to the Secretary that the quality, safety or efficacy of the goods was unacceptable., effective 16/05/2016

Regulatory action due to It appeared to the Secretary that the quality, safety or efficacy of the goods was unacceptable., effective 16/05/2016

Regulatory action due to The sponsor did not provide evidence that the Device is safe or performs 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 s.41FN(3)(a)., effective 02/05/2016

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 28/04/2016

Regulatory action due to It appeared to the Secretary that the quality, safety or efficacy of the goods was unacceptable., effective 18/04/2016

Regulatory action due to It appeared to the Secretary that the quality, safety or efficacy of the goods was unacceptable., effective 18/04/2016

Regulatory action due to It appeared to the Secretary that the quality, safety or efficacy of the goods was unacceptable., effective 04/04/2016

Regulatory action due to It appeared to the Secretary that the quality, safety or efficacy of the goods was unacceptable., effective 04/04/2016

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.It appeared to the Secretary that the presentation of the goods was unacceptable., effective 23/03/2016

Regulatory action due to It appeared to the Secretary that the quality, safety or efficacy of the goods was unacceptable., effective 09/03/2016

Regulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect.The sponsor failed to comply with a condition of listing under s.28(5)(ab) of the Act (that the goods would not be advertised for an indication other than those accepted in the Register)., effective 08/03/2016

Regulatory action due to As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(j) of the Act was incorrect., effective 02/03/2016

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.The goods do not conform to a standard applicable to the goods., effective 26/02/2016