How to get a medical device approved in Australia

Jan 27, 2021

By Platypus Technical

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.