Medical devices regulation basics
- What is a medical device?
Medical devices are used on humans, have therapeutic benefits, have a physical effect on the body
- Alcohol wipes (regulation)
The TGA regulates alcohol swabs according to the claims made by the manufacturer
- Custom made medical devices
Manufacturing of custom made devices must, at a minimum, meet conformity assessment procedures regulated by the TGA.
- Electronic cigarettes
The Australian Government is concerned about the use of electronic cigarettes in Australia, and the retail sale of electronic cigarettes containing nicotine is illegal.
- Medical device/medicine 'boundary' products
How antiseptic wipes, irrigation solutions, haemodialysis solutions and IVF media are regulated
- Regulation of medical software and mobile medical 'apps'
Software is becoming increasingly important in medical devices; however, its rapid evolution, particularly in relation to mobile technology, presents new and complex challenges for the TGA and regulatory agencies internationally.
- 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
- Regulatory affairs consultants
Regulatory affairs consultants offer services, including advice and assistance, in relation to regulatory requirements
- Medical devices: providing feedback to the TGA
There are various feedback mechanisms available