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