MedTech Sector Insights

Sample Briefing

Federal Policy & Regulation

Health PHI Circulars ↗

Published 11 June 2026

Spinal fusion cages post-listing review scope and research questions updated

PHI 42/26 announced updates to the scope and research questions for the spinal fusion cages post-listing review on 8 June 2026. Why it matters: Changes review parameters that could affect private health insurance coverage and reimbursement for spinal fusion cage devices.

TGA Articles RSS ↗

Published 11 June 2026, 12:00 am AEST

TGA publishes Therapeutic Goods Six Monthly Report Form Sponsor Approval 2026

The TGA released the Therapeutic Goods (Six Monthly Report Form - Sponsor) Approval 2026 for supply of unapproved therapeutic goods. Why it matters: Device sponsors must comply with new six-monthly reporting requirements for unapproved therapeutic goods supply arrangements.

TGA Resources RSS ↗

Published 11 June 2026, 12:00 am AEST

TGA releases UDI consent dashboard user guide for non-compliant devices

TGA published guidance on using the Consent for Non-compliance Dashboard for UDI-related applications. Why it matters: Provides clarity for sponsors seeking consent to supply devices not meeting UDI requirements.

Health PHI Circulars ↗

Published 11 June 2026

Department releases 2026-27 post-listing review work plan for medical devices

The Department of Health published PHI 41/26 announcing the 2026-27 Annual Work Plan for post-listing reviews on 4 June 2026. Why it matters: Indicates which medical devices on the Prescribed List will face regulatory review affecting private health insurance coverage.

Health PHI Circulars ↗

Published 11 June 2026

Hospital and second-tier benefit updates published in PHI 43/26

The Department issued PHI 43/26 containing hospital and second-tier updates on 11 June 2026. Why it matters: Updates may include changes to medical device coverage or reimbursement rates under private health insurance policies.