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Published: 27 January 2021

How to get a medical device approved in Australia

Getting a medical device approved can be complex. However, it is often not what people expect because in most countries, including Australia, the focus in on the manufacturer rather than the product. Furthermore, medical device regulation is usually principles-based and about managing risk and product quality, rather than a checklist of requirements.

Watch our video below to learn the basics of what is needed.

Platypus MedTech Consultants Pty Ltd
+61 2 6198 3242

Level 1, The Realm, 18 National Circuit
Barton, ACT 2600
Platypus MedTech Consulting acknowledges that we live and work on the land of the Ngunnawal, Ngarigo and Whadjuk Nyoongar peoples. We also acknowledge the Traditional Owners of Country throughout Australia where we deliver our services. We recognise their connections to land and waters, the sophistication of First Nations knowledge and their contributions to engineering and science. We pay respect to their Elders, engineers and scientists, both past and present.
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