Medical devices and IVDs: Cancellations from the ARTG

30 June 2016

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:

Cancellations

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Super Cheap CPAP

Product name/ARTG reference: Air filter

ARTG No: 211620
Type of cancellation OR Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)(c) and (f)
Date of effect:

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.

Super Cheap CPAP

Product name/ARTG reference: Mask, air/oxygen

ARTG No: 210899
Type of cancellation OR Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)(c) and (f)
Date of effect:

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.

Biodental Technologies Pty Limited

Product name/ARTG reference: Dental bonding agent, polymer based

ARTG No: 148216
Type of cancellation OR Type of regulatory action:
Cancelled from the ARTG under s41GK
Date of effect:

The manufacturer requested in writing the revocation of their TGA conformity assessment certification.

Biodental Technologies Pty Limited

Product name/ARTG reference: Dental material, pit/fissure sealing

ARTG No: 148217
Type of cancellation OR Type of regulatory action:
Cancelled from the ARTG under s41GK
Date of effect:

The manufacturer requested in writing the revocation of their TGA conformity assessment certification.

Biodental Technologies Pty Limited

Product name/ARTG reference: Dental material, reinforcing fibre

ARTG No: 148197
Type of cancellation OR Type of regulatory action:
Cancelled from the ARTG under s41GK
Date of effect:

The manufacturer requested in writing the revocation of their TGA conformity assessment certification.

Biodental Technologies Pty Limited

Product name/ARTG reference: Dental material, filling/restorative, polymer based

ARTG No: 149310
Type of cancellation OR Type of regulatory action:
Cancelled from the ARTG under s41GK
Date of effect:

The manufacturer requested in writing the revocation of their TGA conformity assessment certification.

Biodental Technologies Pty Limited

Product name/ARTG reference: Dental etching composite

ARTG No: 148302
Type of cancellation OR Type of regulatory action:
Cancelled from the ARTG under s41GK
Date of effect:

The manufacturer requested in writing the revocation of their TGA conformity assessment certification.

Murray International Trading Pty Ltd

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

ARTG No: 260088
Type of cancellation OR Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b) and s.41GN(1)(e)
Date of effect:

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).

Hypo2 Australia Pty Ltd

Product name/ARTG reference: Chamber, patient, hyperbaric

ARTG No: 204982
Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)
Date of effect:

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).

Melbourne Hyperbaric Oxygen Therapies

Product name/ARTG reference: Chamber, patient, hyperbaric

ARTG No: 225150
Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)
Date of effect:

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).

Orthotech Pty Ltd

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

ARTG No: 173236
Type of cancellation OR Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(e)
Date of effect:

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

Atris Pty Ltd

Product name/ARTG reference: Infant sleep positioner

ARTG No: 226334
Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)
Date of effect:

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).

Rose and Lily Pty Ltd

Product name/ARTG reference: Infant sleep positioner

ARTG No: 217067
Type of cancellation:
Cancelled from the ARTG under s.41GN(1)(b)
Date of effect:

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).

Rose and Lily Pty Ltd

Product name/ARTG reference: Pillow, general-purpose

ARTG No: 175244
Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)
Date of effect:
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).

Gytech Pty Ltd

Product name/ARTG reference: Prosthesis, incontinence

ARTG No: 180392
Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)
Date of effect:
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).

Gytech Pty Ltd

Product name/ARTG reference: Mesh, surgical

ARTG No: 180394
Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)
Date of effect:
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).

Gytech Pty Ltd

Product name/ARTG reference: Mesh kit

ARTG No: 180395
Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)
Date of effect:
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).

Gytech Pty Ltd

Product name/ARTG reference: Mesh, surgical

ARTG No: 189722
Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)
Date of effect:
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).

Ultimate International Pty Ltd

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

ARTG No: 204514
Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)
Date of effect:
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).

TFS Manufacturing Pty Ltd

Product name/ARTG reference: Prosthesis, incontinence

ARTG No: 132657
Type of regulatory action:
Cancelled from the ARTG under s.41GN(1)(b)
Date of effect:
Decision status: Internal review confirmed cancellation decision. Application made by sponsor for AAT review of internal decision to confirm cancellation.
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).

Machinery Forum (Vic) Pty Ltd

Product name/ARTG reference: Sphygmomanometer, electronic, automatic

ARTG No: 158834
Type of regulatory action:
Cancelled from the ARTG under s. 41GN(1)(b)
Date of effect:
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).

Alpine Pharma Pty Ltd

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

ARTG No: 200683
Type of regulatory action:
Cancelled from the ARTG under s. 41GN(1)(b)
Date of effect:
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).

Endotherapeutics Pty Ltd

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

ARTG No: 158894
Type of regulatory action:
Cancelled from the ARTG under s. 41GN(1)(b)
Date of effect:
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).

Endotherapeutics Pty Ltd

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

ARTG No: 200723
Type of regulatory action:
Cancelled from the ARTG under s. 41GN(1)(b)
Date of effect:
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).

Medtel Pty Ltd

Product name/ARTG reference: Pillow

ARTG No: 157514
Type of regulatory action:
Cancelled from the ARTG under s. 41GN(1)(b)
Date of effect:
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).

Born Brands Pty Ltd

Product name/ARTG reference: Pillow

ARTG No: 163606
Type of regulatory action:
Cancelled from the ARTG under s. 41GN(1)(c)
Date of effect:
The sponsor failed to comply within the required timeframe with a notice under s.41JA requiring further information about the kind of medical device.

Biosoft Pty Ltd

Product name/ARTG reference: Light, transilluminator

ARTG No: 207079
Type of regulatory action:
Cancelled from the ARTG under s. 41GN(1)(b)
Date of effect:

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).

Hoyland Medical Pty Ltd

Product name/ARTG reference: Light, transilluminator

ARTG No: 206812
Type of regulatory action:
Cancelled from the ARTG under s. 41GN(1)(b)
Date of effect:

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).

Livingstone International Pty Ltd

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

ARTG No: 140670
Type of regulatory action:
Cancelled from the ARTG under s. 41GN(1)(b)
Date of effect:
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).