PHI 89/20 Removal of Urogynaecological Mesh Devices

In accordance with Therapeutic Goods (Medical Devices) Regulations 2002, urogynaecological mesh devices have been reclassified to Class III. Further information on the reclassification and the urogynaecological mesh devices approved under the new regulatory requirements is available on the Therapeutic Goods Administration (TGA) website.

Sponsors of some urogynaecological meshes did not reclassify their devices by the required date of 1 December 2020, and requested cancellation of their respective entries from the Australian Register of Therapeutic Goods (ARTG).

One of the criteria for listing the product on the Prostheses List is that the product must be entered and current on the ARTG. The billing codes where the entry is suspended or cancelled from the ARTG will be removed from the Prostheses List. 

The removal of the billing code may be achieved through an amendment to Schedule of the Private Health Insurance (Prostheses) Rules under section 333-20 of the Private Health Insurance Act 2007.

The urogynaecological meshes that are no longer on the ARTG, and respectively will be removed from the Prostheses List are listed in the table on page 2.

The Rules take effect on the day they are registered on the Federal Register of Legislation. It is anticipated the Amendment Rules will be made and registered in early January 2021.

Further information – future listings

Any sponsor with a Class III ARTG inclusion for their urogynaecological mesh devices will be able to submit a new Prostheses List application for their device(s).

Any queries in relation to the Prostheses List should be sent to prostheses@health.gov.au.