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Medical devices and IVDs: Cancellations from the ARTG

20 May 2021

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:

For cancellations of face masks following post-market review, see: Post-market review of face masks: Cancelled ARTG entries

Medical devices and IVD cancellations

Displaying 476 - 500 of 507

2016

Date of effect: 2 May 2016

Murray International Trading Pty Ltd

Product name/ARTG reference: One Step HCG Urine Pregnancy Test

ARTG number: 260088

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

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).

2015

Date of effect: 1 Oct 2015

Hypo2 Australia Pty Ltd

Product name/ARTG reference: Chamber, patient, hyperbaric

ARTG number: 204982

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: 19 Aug 2015

Melbourne Hyperbaric Oxygen Therapies

Product name/ARTG reference: Chamber, patient, hyperbaric

ARTG number: 225150

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: 14 Aug 2015

Orthotech Pty Ltd

Product name/ARTG reference: Prosthesis, internal, joint, shoulder, total

ARTG number: 173236

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.

Date of effect: 29 May 2015

Atris Pty Ltd

Product name/ARTG reference: Infant sleep positioner

ARTG number: 226334

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

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).

Date of effect: 8 May 2015

Rose and Lily Pty Ltd

Product name/ARTG reference: Infant sleep positioner

ARTG number: 217067

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

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).

Date of effect: 26 Mar 2015

Rose and Lily Pty Ltd

Product name/ARTG reference: Pillow, general-purpose

ARTG number: 175244

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

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).

Date of effect: 3 Feb 2015

Gytech Pty Ltd

Product name/ARTG reference: Mesh, surgical

ARTG number: 180394

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

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).

Date of effect: 3 Feb 2015

Gytech Pty Ltd

Product name/ARTG reference: Prosthesis, incontinence

ARTG number: 180392

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

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).

Date of effect: 3 Feb 2015

Gytech Pty Ltd

Product name/ARTG reference: Mesh, surgical

ARTG number: 189722

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

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).

Date of effect: 3 Feb 2015

Gytech Pty Ltd

Product name/ARTG reference: Mesh kit

ARTG number: 180395

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

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).

2014

Date of effect: 5 Nov 2014

TFS Manufacturing Pty Ltd

Product name/ARTG reference: Prosthesis, incontinence

ARTG number: 132657

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

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).

Internal review confirmed cancellation decision. Application made by sponsor for AAT review of internal decision to confirm cancellation.

The cancellation has been confirmed by the Administrative Appeals Tribunal on 29 November 2018. The full decision is available at: TFS Manufacturing Pty Ltd and Minister for Health [2018] AATA 4456 (29 November 2018).

Date of effect: 5 Nov 2014

Ultimate International Pty Ltd

Product name/ARTG reference: Manual-inflation electronic sphygmomanometer, portable

ARTG number: 204514

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

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) and (3)(c).

Date of effect: 4 Nov 2014

Alpine Pharma Pty Ltd

Product name/ARTG reference: Sphygmomanometer, electronic, automatic-inflation, portable, arm/wrist

ARTG number: 200683

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

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) and (3)(c).

Date of effect: 4 Nov 2014

Machinery Forum (Vic) Pty Ltd

Product name/ARTG reference: Sphygmomanometer, electronic, automatic

ARTG number: 158834

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

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) and (3)(c).

Date of effect: 27 Aug 2014

Endotherapeutics Pty Ltd

Product name/ARTG reference: Urogynaecological surgical mesh (Prosthesis, internal, bladder, urinary, mesh)

ARTG number: 200723

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

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).

Date of effect: 27 Aug 2014

Endotherapeutics Pty Ltd

Product name/ARTG reference: Urogynaecological surgical mesh (Prosthesis, internal, bladder, urinary, mesh)

ARTG number: 158894

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

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).

Date of effect: 19 Jun 2014

Medtel Pty Ltd

Product name/ARTG reference: Pillow

ARTG number: 157514

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: 10 Mar 2014

Born Brands Pty Ltd

Product name/ARTG reference: Pillow

ARTG number: 163606

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

The sponsor failed to comply within the required timeframe with a notice under s.41JA requiring further information about the kind of medical device.

Date of effect: 4 Feb 2014

Hoyland Medical Pty Ltd

Product name/ARTG reference: Light, transilluminator

ARTG number: 206812

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).

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).

Date of effect: 4 Feb 2014

Biosoft Pty Ltd

Product name/ARTG reference: Light, transilluminator

ARTG number: 207079

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).

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).

Date of effect: 3 Feb 2014

Livingstone International Pty Ltd

Product name/ARTG reference: Syringe, hypodermic, metered-delivery

ARTG number: 140670

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).

2013

Date of effect: 1 Oct 2013

Bausch & Lomb (Australia) Pty Ltd

Product name/ARTG reference: Lubricant, eye [44237]

ARTG number: 161568

Type of regulatory action: Cancelled under s.41GN(1)(c)

As the sponsor of the kind of medical device failed to comply with the notice under s.41JA of the Act, requesting the sponsor to give the TGA information relating to the kind of device, within a further 10 working days from the day specified in the notice, the entry was cancelled.

Date of effect: 30 Sep 2013

Hendricks Instruments Service Pty Ltd

Product name/ARTG reference: Endotherapy, forceps

ARTG number: 163380

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

As the kind of medical device included in the Register was not correctly classified, the certification made under s.41FD(c) was incorrect.

As the sponsor was not identified in the product information, the sponsor failed to comply with a condition of inclusion imposed under s. 41FO.

As the information supplied with the device did not comply with the essential principles, the certification made under s.41FD(d) was incorrect.

As the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certification made under s.41FD(f) was incorrect.

Date of effect: 24 Sep 2013

Gelpal (NSW)

Product name/ARTG reference: Compress, hot/cold pack, reusable

ARTG number: 185076

Type of regulatory action: Cancelled under s.41GN(1)(f)

As the device labelling did not comply with the essential principles, the certification made under s.41FD (d) was incorrect.

As the sponsor failed to provide evidence that conformity assessment procedure has been applied to the device, the certifications made under s.41FD(f) and (g) were incorrect.

As the promotional material did not comply with the Therapeutic Goods Advertising Code 2007, the certification made under s.41FD(h) was incorrect.

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