What is a Medical Device?
Plain English explanation of how medical devices are defined under Australian law, based on Section 41BD of the Therapeutic Goods Act 1989.
What is Not a Medical Device?
Products commonly mistaken for medical devices in Australia, including starting materials, manufacturing equipment, and excluded software.
Regulatory Framework Overview
How the Australian medical device regulatory system works — from the Therapeutic Goods Act down to guidance documents — and how the pieces fit together.
Who Needs to Comply?
Overview of the key roles in Australian medical device regulation — manufacturers, sponsors, importers, and others — and what each role means legally.
Manufacturers
The regulatory obligations of medical device manufacturers under Australian law, including conformity assessment, technical documentation, and post-market responsibilities.
Sponsors
The role and obligations of Australian medical device sponsors — the legally responsible entity for devices imported, supplied or exported in Australia.
Importers and Distributors
How importers and distributors fit into the Australian medical device regulatory framework, and when they may take on sponsor obligations.
Consultants & Auditors
How regulatory affairs consultants, auditors, and other advisers interact with the Australian medical device regulatory framework.
Lifecycle of a Medical Device
A plain English overview of the full regulatory lifecycle of a medical device in Australia — from classification through to post-market obligations.
Glossary of Key Terms
Plain English definitions of the key regulatory terms used in Australian medical device regulation, with references to their legislative source.