ARTICLE SUMMARY:
Each month in Global Spotlight we provide market access facts from the country highlighted on the cover of Market Pathways' print issue. The March cover features the Australian Parliament House in Canberra.
Regulation
Authority: Therapeutic Goods Administration (TGA)
Key Leader: Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division, TGA
Points of Interest:
- More than 95% of devices gain TGA registration via an abridged route leveraging overseas approvals, primarily from the EU, US, Canada, and Japan.
- Major device safety reforms take effect in 2026, including mandatory adverse event reporting for hospitals and unique device identification (UDI) rules for implantable devices.
Reimbursement
Authority: Department of Health, Disability and Ageing
Key leader: Mark Butler, Minister for Health and Ageing,
Points of Interest:
- The Prescribed list of Medical Devices and Human Tissue Products sets minimum rates private health insurers must pay for devices. It currently contains about 11,000 billing codes.
- Last year, the government completed a four-year initiative to reduce private-sector device benefits to align with public hospital prices, including final cuts to cardiac implantable electronic devices that took effect in July.
More Resources
- TGA device chief Tracey Duffy spotlighted Aussie device regulatory initiatives during a March 10 presentation at the International Medical Device Regulators Forum’s meeting in Singapore, and her slides, including application trends and pending policies, are online.
- Australia’s health department hosts a page that concisely fleshes out the rationale and procedures for the recently completed roll out of device payment cuts.
