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

16 March 2018

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.

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Cancellations of certain devices within an entry

Displaying 1 - 12 of 12

2018

Date of effect: 28 Feb 2018

Endotherapeutics Pty Ltd

Product name/ARTG reference: Cement, orthopaedic, bone

ARTG number: 152441

Device name/s: SerenoCem Granules BCG050

Type of regulatory action: Cancelled from the ARTG under s41GK and 41GO

The Device has been cancelled as the period applying to the suspension under subsections 41GA(3) and 41GC(3) has expired before the suspension is revoked. The sponsor did not provide evidence that the device complies with Essential Principles 1 and 6 prior to the expiry of the suspension period.

The grounds for cancellation apply only to SerenoCem Granules BCG050 (the Device) and the cancellation is limited under s41GO to vary ARTG 152441 accordingly.

Date of effect: 4 Jan 2018

Boston Scientific Pty Ltd

Product name/ARTG reference: Mesh, surgical (Solyx SIS System)

ARTG number: 150342

Device name/s: Solyx SIS System

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 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: Solyx SIS System.

Date of effect: 4 Jan 2018

Boston Scientific Pty Ltd

Product name/ARTG reference: Mesh, surgical (Uphold [TM] LITE w/ Capio SLIM)

ARTG number: 150342

Device name/s: Uphold [TM] LITE w/ Capio SLIM

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 some devices included in the entry are unacceptable. However, as another device of the same kind is included under the ARTG entry, the entry has been varied to exclude this device: Uphold [TM] LITE w/ Capio SLIM.

Date of effect: 4 Jan 2018

Coloplast Pty Ltd

Product name/ARTG reference: Mesh, polymeric, non-biodegradable (Restorelle DirectFix Anterior and Restorelle DirectFix Posterior)

ARTG number: 190172

Device name/s: Restorelle DirectFix Anterior and Restorelle DirectFix Posterior

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

Cancelled on the basis that 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: Restorelle DirectFix Anterior and Restorelle DirectFix Posterior.

2017

Date of effect: 11 Aug 2017

Endotherapeutics Pty Ltd

Product name/ARTG reference: Prosthesis, internal incontinence

ARTG number: 118082

Device name/s: Safyre T, Safyre T plus, Safyre VS

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: 25 Jul 2017

Maquet Australia Pty Ltd

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

ARTG number: 144010

Device name/s: HCU 20 and HCU 30

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.

Date of effect: 19 Jul 2017

Philips Electronics Australia Ltd

Product name/ARTG reference: Philips HeartStart MRx

ARTG number: 95661

Device name/s: HeartStart MRx

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.

Date of effect: 19 Jul 2017

Philips Electronics Australia Ltd

Product name/ARTG reference: Philips HeartStart MRx

ARTG number: 261352

Device name/s: HeartStart MRx

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.

Date of effect: 4 Jul 2017

LivaNova Australia Pty Ltd

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

ARTG number: 194514

Device name/s: Flextherm and Stockert Heater-Cooler 1T

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.

2016

Date of effect: 2 Feb 2016

Mundipharma Pty Ltd

Product name/ARTG reference: Dressing, hydrogel

ARTG number: 179506

Device name/s: BurnAid or any other dressing, hydrogel containing tea tree oil

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.

2015

Date of effect: 12 Aug 2015

Medical Specialities Australia Pty Ltd

Product name/ARTG reference: Mesh, surgical

ARTG number: 97288

Device name/s: TiLOOP Tape; TiLOOP Two; TiLOOP Total 4; TiLOOP Total 6; TiLOOP Fix; TiLOOP Mesh; TiLOOP Patch; and TiLOOP Clip

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.

Date of effect: 7 Aug 2015

Mathys Orthopaedics Pty Ltd

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

ARTG number: 122258

Device name/s: Selexys Acetabular Component TPS and TH+

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+.