Decision tree
Heading
Medical devices
Body
In line with the intended purpose of a product, the term ‘medical device’ is defined by Section 41BD of the Therapeutic Goods Act 1989 as:
- to diagnose, prevent, monitor, treat or alleviate a disease
- to diagnose, prevent, monitor, treat or alleviate or compensate for an injury or disability
- to investigate, replace or modify the anatomy or a physiological process
- for controlling conception
- an accessory to a device that performs any of the above functions
Question
Does your product have an intended use as a medical device?