Medical devices and IVDs: Cancellations of certain devices within an entry

8 September 2017

Following a review by the TGA, medical device entries (including IVDs) can be cancelled from the Australian Register of Therapeutic Goods (ARTG) by the Secretary of the Department of Health under section 41GK, 41GL, 41GM or 41GN of the Therapeutic Goods Act 1989 (the Act).

The Act requires the TGA to publish information about any such cancellation.

With the exception of Class III and Active Implantable Medical Devices (AIMDs), an entry in the ARTG is for a kind of medical device, meaning more than one device can be authorised for marketing by that entry.

Under section 41GO of the Act, a cancellation can be limited by the Secretary if satisfied that the grounds for cancellation apply to only one device, or only some of the devices, covered by the entry. In such a case, rather than the entry being cancelled, it is varied by the Secretary under that section to make it clear that marketing authorisation does not extend to the cancelled device.

The records below include information on the types of cancellation decisions described above and any subsequent decisions to revoke such cancellations. To find out whether a product is currently authorised for supply in Australia, check the ARTG entry. For cancellations at the request of the sponsor that result in only one or more medical devices being cancelled and not the entry being removed from the ARTG, see Medical devices and IVDs: Cancellations requested by the sponsor of certain devices within an entry.

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

Cancellations

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Philips Electronics Australia Ltd

Product name/ARTG reference: Philips HeartStart MRx

ARTG No:
95661 and 261352
Device name/s:
HeartStart MRx
Date of effect:

Type of regulatory action: Cancelled from ARTG under subsection 41GM(2) of the Act

The sponsor has provided information or documents in response to a notice under section 41JA to the effect that medical devices of that kind are not being supplied in Australia, imported into Australia or exported from Australia.

Endotherapeutics Pty Ltd

Product name/ARTG reference: Prosthesis, internal incontinence

ARTG No:
118082
Device name/s:
Safyre T, Safyre T plus, Safyre VS
Date of effect:

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).

Maquet Australia Pty Ltd

Product name/ARTG reference: Heat exchanger, heart-lung bypass

ARTG No:
144010
Device name/s:
HCU 20 and HCU 30
Date of effect:

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

As the sponsor did not provide information under section 41JA of the Act, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under section 41FN(3)(c) of the Act. As the sponsor did not provided a sample, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under section 41FN(2) of the Act. As the sponsor did not provide evidence to demonstrate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under section 41FN(3)(a) of the Act. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices. Other devices under the entry remain.

LivaNova Australia Pty Ltd

Product name/ARTG reference: Heating unit, pad, water, system

ARTG No:
194514
Device name/s:
Flextherm and Stockert Heater-Cooler 1T
Date of effect:

Type of regulatory action: Cancelled from ARTG under S41GN(1)(b)

As the sponsor did not provide information under 41JA, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN (3)(C). As the sponsor did not provided a sample, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN(2). As the sponsor did not provide evidence to demonstrate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of medical device in the ARTG was subject under 41FN(3)(a). However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices: Flextherm and Stockert Heater-Cooler 1T.

Mundipharma Pty Ltd

Product name/ARTG reference: Dressing, hydrogel

ARTG No:
179506
Device name/s:
BurnAid or any other dressing, hydrogel containing tea tree oil
Date of effect:

Type of regulatory action: Cancelled from the ARTG under s. 41GL(d) and the ARTG entry varied under s.41GO

The sponsor requested in writing the cancellation of these devices from the ARTG entry

Medical Specialities Australia Pty Ltd

Product name/ARTG reference: Mesh, surgical

ARTG No:
97288
Device name/s:
TiLOOP Tape; TiLOOP Two; TiLOOP Total 4; TiLOOP Total 6; TiLOOP Fix; TiLOOP Mesh; TiLOOP Patch; and TiLOOP Clip
Date of effect:

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

The Secretary is satisfied that the safety and performance of some devices included in the entry are unacceptable. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude these devices: TiLOOP Tape; TiLOOP Two; TiLOOP Total 4; TiLOOP Total 6; TiLOOP Fix; TiLOOP Mesh; TiLOOP Patch; and TiLOOP Clip.

Mathys Orthopaedics Pty Ltd

Product name/ARTG reference: Prosthesis, internal, joint, hip, acetabular component

ARTG No:
122258
Device name/s:
Selexys Acetabular Component TPS and TH+
Date of effect:

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

The Secretary is satisfied that the safety and performance of some devices included in the entry are unacceptable. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude this device: Selexys Acetabular Component TPS and TH+.