Personalised medical devices are devices that are either designed and manufactured, or modified after they are supplied, to suit an individual.
This document provides information and examples to help you understand the Australian regulatory framework for personalised medical devices (the Framework) and provides you with information and examples about how these devices are regulated, and what your regulatory obligations are if you are manufacturing or supplying a personalised medical device.
The intention of the examples is not to tell you how every device is regulated, but to provide enough information to help you identify the concepts and boundaries in the Framework so you can apply these concepts to your own circumstances…
