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

28 August 2015

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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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

Grounds for cancellation

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

Grounds for cancellation

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

Grounds for cancellation

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+.