In this free white paper, learn how to register your medical device in Australia or 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:
We'll answer all these questions and much more in this white paper.
About the authors:
Evangeline Loh, PhD, RAC (US/EU) is Global Regulatory Manager for Emergo by UL.
Lori White is a Senior Global Regulatory Specialist for Emergo by UL.
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