1. Authorities

Medical Devices Class I & II
Australia

This section provides an overview of the Authorities involved in setting regulations and managing compliance with the medical devices in scope.

The Australian government designates specific authorities as responsible for the administration, evaluation, and assessment, and ongoing monitoring of products that are defined as therapeutic goods – in this report specific to medical devices. 

Department of Health and Aged Care (DoH/AC)

The Department of Health and Aged Care (DoH/AC )is responsible and accountable for the regulatory environment in the health and aged care sector in Australia and is the government department charged with top-level administration and policy making. The Australian Government, through this Department and its portfolio entities, has significant responsibility for regulating the wide range of health and aged care systems, which include therapeutic goods and products such as medicines, vaccines, cell tissue, and blood production and medical devices which can include levels of control of medical device deployment in:

• Aging and aged care services
• Controlled drugs
• Gene technology
• Private health insurance
• Radiation protection and nuclear safety
• Embryo research
• Security-sensitive biological agents
• Health provider compliance
• Hearing services

The DoH/AC executes its appointed duties through the nominated regulators for the respective product or service e.g., the Therapeutic Goods Administration for regulatory oversight of therapeutic goods including medical devices (all classes).

Therapeutic Goods Administration (TGA)

The Therapeutic Goods Administration (TGA) regulates the supply of medical devices in Australia.

TGA is Australia's designated government authority responsible, with overarching legislative power and control, for evaluating and assessing, licensing and approving, monitoring, and when required, pursuing legislated penalty actions against corporate entities and individual persons, for products that are defined as therapeutic goods.
TGA, in conjunction with other co-related and applicable government agencies with interest in the therapeutic good type and classification, completely regulates medical devices, medicines, and biological therapeutic goods and combinations thereof, in whatever form or combination those take in Australia if not otherwise exempted from applicable therapeutic goods legislative instruments.

Though not involved in the same capacity as the TGA, local state and territory governments have a legislated role in administering medical devices, if identified as necessary in the respective states and territories.

State and Territory Health Authorities

• The New South Wales Ministry of Health (NSW Health)
• Australian Capital Territory Department of Health
• Northern Territory Department of Health
• Western Australian Department of Health
• South Australian Department of Health
• Queensland Department of Health
• Tasmanian Department of Health
• Victorian Department of Health

All these agencies are charged by the Federal Government with administering those parts of applicable legislation e.g., the Therapeutic Goods Act 1989, as those instruments might apply to the respective states and territories.

These agencies apply regulation activities which might encompass working on behalf of the TGA at the State level to:

• accredit individuals and organizations in the supply, control, storage, and installation of medical devices (e.g., into hospitals and government facilities such as aged care facilities) via contracts and supply arrangements;
• monitor, review, receive, and investigate complaints;
• conduct regular audits, reviews, investigations, and risk monitoring.

1.1 References

1. The Department of Health and Aged Care

https://www.health.gov.au/about-us/what-we-do/legislation-we-administer

2. Therapeutic Goods Act 1980

https://www.legislation.gov.au/Details/C2023C00102

3. Therapeutic Goods (Medical Devices) Regulations 2002

https://www.legislation.gov.au/Details/F2023C00565