Medical devices regulation basics
Related information
- What is a medical device?
Medical devices are used on humans, have therapeutic benefits, have a physical effect on the body - What do I need to do to supply a medical device in Australia?
The TGA requirements vary depending on the classification of the medical device - How to get your medical device onto the ARTG
General information about how to get a medical device onto the Australian Register of Therapeutic Goods - How to ensure medical devices applications are processed swiftly
Providing complete and correct information at the time of lodging your application will assist with the turnaround for processing - How to make an application through TGA eBusiness services
Frequently asked questions about the Australian medical devices legislation and the Device Electronic Application Lodgement system (DEAL) - How to get information about medical devices regulatory changes
There are a number of ways of obtaining or receiving information about changes related to the regulation of medical devices in Australia - Health Technology Assessment (HTA)
The Australian Government Health Technology Assessment (HTA) website provides information about processes used to inform decisions about the registration of health technologies for use in Australia - Medical device industry associations
A list of associations for Australian medical device sponsors and manufacturers - Medical devices: providing feedback to the TGA
There are various feedback mechanisms available