Surgical guides and biomodels post-listing review draft department report

Overview

Surgical guides and biomodels are non-implantable, single-use personalised medical devices used in planning and decision-making before and during surgery. 

We commenced the post-listing review of surgical guides and biomodels in response to: 

  • rapid growth in use of these devices – PL benefits paid by health insurers rose from $1.6 million in 2016–17 to $20.6 million in 2021–22 

  • reports suggesting overuse and inappropriate use 

  • uncertainty about comparative clinical effectiveness and cost-effectiveness 

  • uncertainty about eligibility on the PL – whether the devices are considered essential to implanting another device. 

The surgical guides and biomodels post-listing review process is outlined on our website

We have published a draft surgical guides and biomodels department report. The draft report outlines the review process, findings and proposed outcomes for in scope devices listed in 07.02.02 – Cranium, 07.02.05 – Mandible, Maxilla and Temporomandibular Joint (TMJ), 07.02.07 – Orbit and 07.02.09 – Anatomical biomodels.  

Surgical guides and biomodels DRAFT department report

Why your views matter

The draft report is provided for your feedback. We will collate feedback on the draft report before presenting options to the delegate for a decision.   

Closes 15 Jun 2026

Opened 25 May 2026

Audiences

  • Academics
  • Businesses
  • Commonwealth agencies
  • Community groups
  • General public
  • Health professionals
  • Health staff
  • Health workforce
  • HPRG (TGA) Staff
  • Local governments
  • Medical Devices & IVDs
  • Non-government organisations
  • Other
  • State government agencies

Interests

  • Dental health
  • e-Health
  • Health and Medical Research
  • Health insurance
  • Health technology
  • Hospitals
  • Human health
  • Legislation
  • Medicare
  • Preventative health
  • Regulatory policy
  • Rural health services