Medical devices and IVDs: Cancellations from the ARTG

16 August 2018

Following a review by the TGA, medical device entries (including IVDs) can be cancelled from the Australian Register of Therapeutic Goods. These cancellations are made by the Secretary under section 41GK, 41GL, 41GM and 41GN of the Therapeutic Goods Act 1989.

Where other actions are taken in relation to safety, the TGA will generally publish additional information about the issue on its alerts page.

The reasons for a cancellation are stated in the database below under 'Grounds for cancellation'.

The heading 'Decision status' provides updated information about cancellation decisions, for example information about any decision to revoke a cancellation decision. It will not appear in every entry.

To find out whether a product is currently authorised for supply in Australia, check the ARTG. For cancellations that result in only one or more medical devices of a kind being cancelled and not the entry removed from the ARTG, see:

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Medical devices and IVD cancellations

Displaying 1 - 25 of 86

2018

Date of effect: 6 Aug 2018

Hovans's Group Pty Ltd

Product name/ARTG reference: Stimulator [13762]

ARTG number: 190674

Type of regulatory action: Cancelled from the ARTG under paragraphs 41GN(1)(b) and 41GN(1)(f)

The certifications made by the sponsor under section 41FD in relation to the inclusion of the kind of device in the ARTG are incorrect in a material particular and the sponsor failed to comply with the conditions of inclusion stipulated under paragraph 41FN(3).

Date of effect: 20 Apr 2018

Profile Surgical Pty Ltd

Product name/ARTG reference: Forceps, biopsy

ARTG number: 186551

Type of regulatory action: Cancelled from the ARTG under s41GN(1)(b)

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).

Date of effect: 4 Jan 2018

Coloplast Pty Ltd

Product name/ARTG reference: Mesh, polymeric, non-biodegradable (Altis Single Incision Sling)

ARTG number: 190173

Type of regulatory action: Cancelled from the ARTG under s.41GN(1)(e)

Cancelled on the basis that the Secretary is satisfied that the safety and performance of the kind of device is unacceptable.

2017

Date of effect: 8 Nov 2017

Leading Asia Pacific Pty Ltd

Product name/ARTG reference: Massager, electrical, home use

ARTG number: 215075

Type of regulatory action: Cancelled from the ARTG in accordance with paragraphs 41GN(1)(f) and 41GN(1)(b) of the Act

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.

Date of effect: 31 Aug 2017

Genesis Biotech Pty Ltd

Product name/ARTG reference: PregSure Digital Pregnancy Test' and 'PregSure Pregnancy Test'

ARTG number: 236402

Type of regulatory action: Cancelled from the ARTG under s.41GN (1) (b) and 41GN (1) (e)

As the sponsor did not provide evidence that the devices are safe or perform 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 41FN(3)(a).

Date of effect: 11 Aug 2017

Endotherapeutics Pty Ltd

Product name/ARTG reference: Prosthesis, internal incontinence

ARTG number: 174659

Type of regulatory action: Cancelled from the ARTG under s41GN (1)(b)

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).

Date of effect: 26 May 2017

Town & Country Mattress & Bed

Product name/ARTG reference: HomeCare Hi Lo Hospital Bed

ARTG number: 218592

Type of regulatory action: Cancelled from the ARTG under s.41GN(1)(b)

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).

Date of effect: 21 Mar 2017

Shantex Pty Ltd

Product name/ARTG reference: Vinyl examination/treatment glove, non-powdered

ARTG number: 218314

Type of regulatory action: Cancelled from the ARTG under s.41GN(1)(b)

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).

Date of effect: 7 Mar 2017

International Consolidated Business Pty Ltd

Product name/ARTG reference: Hospital Plus Disinfectant Floor Cleaner

ARTG number: 232453

Type of regulatory action: Cancelled from the ARTG under s.30(2)

As the sponsor did not comply with a product specific condition of registration for the Therapeutic Goods in the ARTG and the failure to provide information required under a s.31 letter.

Date of effect: 7 Mar 2017

International Consolidated Business Pty Ltd

Product name/ARTG reference: Hospital Plus Surface Spray Disinfectant

ARTG number: 232452

Type of regulatory action: Cancelled from the ARTG under s.30(2)

As the sponsor did not comply with a product specific condition of registration for the Therapeutic Goods in the ARTG and the failure to provide information required under a s.31 letter.

Date of effect: 3 Mar 2017

Atris Pty Ltd

Product name/ARTG reference: Positioning aid system

ARTG number: 279055

Type of regulatory action: Cancelled from the ARTG under s.41GN(1)(b)

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).

Date of effect: 3 Mar 2017

Atris Pty Ltd

Product name/ARTG reference: Pillow

ARTG number: 278775

Type of regulatory action: Cancelled from the ARTG under s.41GN(1)(b)

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).

Date of effect: 11 Jan 2017

SleepSorted

Product name/ARTG reference: Mask air/oxygen

ARTG number: 262927

Type of regulatory action: Cancelled from the ARTG under s.41GN(1)(b)(c) and (f)

The sponsor failed to provide information in response to a Notice issued under section 41JA. Further as the sponsor did not provide sufficient information to substantiate compliance of the kind of device with the essential principles and the application of the appropriate conformity assessment procedures to the device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the ARTG were correct, in a material particular, and that the sponsor complies with the conditions of inclusion of the kind of device in the ARTG.

Date of effect: 11 Jan 2017

SleepSorted

Product name/ARTG reference: Home CPAP Unit

ARTG number: 262926

Type of regulatory action: Cancelled from the ARTG under s.41GN(1)(b)(c) and (f)

The sponsor failed to provide information in response to a Notice issued under section 41JA. Further as the sponsor did not provide sufficient information to substantiate compliance of the kind of device with the essential principles and the application of the appropriate conformity assessment procedures to the device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the ARTG were correct, in a material particular, and that the sponsor complies with the conditions of inclusion of the kind of device in the ARTG.

Date of effect: 11 Jan 2017

Con Dekavalas

Product name/ARTG reference: Mask, air/oxygen

ARTG number: 278812

Type of regulatory action: Cancelled from the ARTG under s.41GN(1)(b)(c) and (f)

The sponsor failed to provide information in response to a Notice issued under section 41JA. Further as the sponsor did not provide sufficient information to substantiate compliance of the kind of device with the essential principles and the application of the appropriate conformity assessment procedures to the device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the ARTG were correct, in a material particular, and that the sponsor complies with the conditions of inclusion of the kind of device in the ARTG.

2016

Date of effect: 19 Dec 2016

Kogan Australia Pty Ltd

Product name/ARTG reference: Thermometer, infrared, ear

ARTG number: 254993

Type of regulatory action: Cancelled from the ARTG under s.41GN(1)(e)

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).

Date of effect: 7 Dec 2016

Emagin Pty Ltd

Product name/ARTG reference: Ophthalmic ultraviolet phototherapy system

ARTG number: 259932

Type of regulatory action: Cancelled from the ARTG under s.41GN(1)(b)(c) and (f)

The sponsor failed to provide information in response to a Notice issued under section 41JA. Further as the sponsor did not provide sufficient information to substantiate compliance of the kind of device with the essential principles and the application of the appropriate conformity assessment procedures to the device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the ARTG were correct, in a material particular, and that the sponsor complies with the conditions of inclusion of the kind of device in the ARTG.

Date of effect: 18 Nov 2016

Optimed Pty Ltd

Product name/ARTG reference: Ophthalmic ultraviolet phototherapy solution

ARTG number: 262531

Type of regulatory action: Cancelled from the ARTG under s.41GN1(b) and (f)

As the sponsor did not provide sufficient information to substantiate that the appropriate conformity assessment procedures have been applied to the kind of device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the inclusion of the device in the ARTG were correct, in a material particular.

Date of effect: 5 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Prosthesis, internal, tendon sheath

ARTG number: 147759

Type of regulatory action: Cancelled from the ARTG under s.41GK

The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have 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 is revoked.

Date of effect: 5 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Prosthesis, internal, band, gastroplasty

ARTG number: 143181

Type of regulatory action: Cancelled from the ARTG under s.41GK

The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have 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 is revoked.

Date of effect: 5 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Prosthesis, internal, joint, digit

ARTG number: 147758

Type of regulatory action: Cancelled from the ARTG under s.41GK

The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have 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 is revoked.

Date of effect: 5 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Tissue reconstructive material, synthetic, silicone, block

ARTG number: 143152

Type of regulatory action: Cancelled from the ARTG under s.41GK

The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have 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 is revoked.

Date of effect: 5 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Dressing, occlusive, silicone

ARTG number: 145286

Type of regulatory action: Cancelled from the ARTG under s.41GK

The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have 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 is revoked.

Date of effect: 5 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Tissue reconstructive material, synthetic, silicone, sheet

ARTG number: 143151

Type of regulatory action: Cancelled from the ARTG under s.41GK

The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have 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 is revoked.

Date of effect: 5 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Prosthesis, internal, stent, vaginal

ARTG number: 144436

Type of regulatory action: Cancelled from the ARTG under s.41GK

The Devices are automatically cancelled from the Register, on the basis that the ARTG entries have 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 is revoked.

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