Medical devices and IVDs: Cancellations requested by the sponsor of certain devices within an entry

19 May 2017

Sponsors can submit requests to cancel entries in the Australian Register of Therapeutic Goods (ARTG). The Therapeutic Goods Act 1989 (the Act) requires the TGA to publish information on the Secretary of the Department of Health's decision to action these cancellations.

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, the entry 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 other than 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 of certain devices within an entry.

Where other action is taken in relation to safety, the TGA will generally publish additional information about the issue on its alerts webpage.

Cancellations requested by the sponsor of certain devices within an entry

Displaying 1 - 8 of 8

2017

Date action takes effect: 18 May 2017

Alcon Laboratories Australia Pty Ltd

Product name: Alcon Laboratories Australia Pty Ltd, Lubricant, eye

ARTG number: 287219

Device name/s: Systane Hydration Unit Dose (5 x 0.7ml and 30 x 0.7ml)

2016

Date action takes effect: 16 May 2016

Alcon Laboratories Australia Pty Ltd

Product name: Alcon Laboratories Australia Pty Ltd - Lubricant, eye

ARTG number: 204484

Device name/s: Systane Hydration (multidose) 10ml

2015

Date action takes effect: 25 Feb 2015

RQSolutions Medical Devices Distribution Support

Product name: Prosthesis, internal, joint, hip, acetabular component

ARTG number: 191843

Device name/s: Orthodynamics Deltalox Co/Cr (Ti/Nb Coated) Acetabular Shell

Date action takes effect: 25 Feb 2015

RQSolutions Medical Devices Distribution Support

Product name: Acetabular shell

ARTG number: 191888

Device name/s: Orthodynamics Deltalox Co/Cr (Ti/Nb Coated) Acetabular Shell

Date action takes effect: 13 Feb 2015

Signature Orthopaedics Pty Ltd

Product name: Prosthesis, internal, joint, hip, total

ARTG number: 175346

Device name/s: MSA (also known as TSI) Fixed Neck Femoral Stem; MSA (also known as TSI) Exchangeable Neck Femoral Stem; MSA (also known as TSI) Exchangeable Neck Component

Date action takes effect: 11 Feb 2015

Biomet Australia Pty Ltd

Product name: Prosthesis, internal, joint, hip, acetabular component

ARTG number: 98098

Device name/s: Biomet M2A 38 Metal on Metal Acetabular Cup

Date action takes effect: 11 Feb 2015

Biomet Australia Pty Ltd

Product name: Prosthesis, internal, joint, hip, femoral component

ARTG number: 98097

Device name/s: Biomet M2A Magnum CoCr Metal on Metal Modular Femoral Head

Date action takes effect: 11 Feb 2015

Biomet Australia Pty Ltd

Product name: Biomet Australia Pty Ltd - Prosthesis, hip, internal, femoral head component

ARTG number: 117715

Device name/s: Biomet M2A 38 CoCr Metal on Metal Femoral Heads