Medical Device Registration in Australia & New Zealand

Thinking about selling your medical device or IVD in Australia or New Zealand? If your device already has CE Marking or approvals in other key markets, you are well on your way to TGA compliance. However, the medical device regulatory system in Australia and New Zealand is not identical to the European system and there are important things you need to know.

In this 11-page white paper, we provide an overview of the regulatory process in Australia. You will learn:

• What is the regulatory process for medical devices in Australia and New Zealand?
• How are medical devices and IVDs classified in Australia?
• How can we leverage our CE Marking certificate or approvals in other markets?
• What are ARTG listings?
• How do conformity assessment routes compare to those in Europe?
• What is the role of the Australian TGA Sponsor?

We'll answer all these questions and much more in this white paper.