Registration in Australia
Access to the Australian market
To register a medical device in Australia, a Sponsor (the Local Agent in Australia) must submit an application to the Therapeutic Goods Administration (TGA) to include the device in the Australian Register of Therapeutic Goods (ARTG).
The main steps include device classification, appointment of an Australian Sponsor for foreign manufacturers, preparation of conformity evidence, and submission of the application.
The process and type of technical documentation required follow a risk-based approach to ensure compliance with Australian regulations. Availability of third-country certification, such as CE marking, may simplify the registration process for certain product categories.
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