Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic medical devices, disinfectants, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, baby incubators, heart valves.
- Face masks and COVID-19
Compilation of resources related to face masks and COVID-19 - COVID-19 tests
General information about rapid antigen testing in Australia - COVID-19 rapid antigen point-of-care tests
General information about rapid antigen point-of-care testing in Australia - Medical devices regulation basics
General information about how medical devices are regulated in Australia - IVD medical devices regulation basics
General information about how in vitro diagnostic medical devices (IVDs) are regulated in Australia - Manufacture of medical devices: Quality management
Manufacturers are responsible for demonstrating that their medical devices comply with the Essential Principles - Standards, guidelines & publications (medical devices & IVDs)
Standards, guidelines and publications about the regulation of medical devices and in vitro diagnostic medical devices - Forms for medical device & IVD sponsors
Links to forms for sponsors of medical devices and in vitro diagnostic medical devices - Medical devices reforms
The reforms aim to enhance the safety, performance and quality of medical devices in Australia by improving the process of allowing devices into the market, the monitoring of devices that are on the market, and the information that is given to patients - Regulatory decisions & notices (medical devices & IVDs)
Links to regulatory decisions about medical devices and in vitro diagnostic medical devices, e.g. advertising exemptions - Australian conformity assessment bodies
Australian corporations that are an Australian conformity assessment body and issue Australian conformity assessment body certificates for medical devices under Australian law
Contact details for enquiries about medical devices or IVDs
If your enquiry is not about medical devices or IVDs, see: Contact the TGA
In this section: Premarket enquiries | Postmarket enquiries
Premarket enquiries
| Email: | devices@health.gov.au for general medical device enquiries COVIDtests@tga.gov.au for enquiries about COVID test kits |
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| Phone: |
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| Post: | Medical Devices Authorisation Branch Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia |
| Street address (for deliveries) |
Therapeutic Goods Administration |
Postmarket enquiries
If you are a sponsor and wish to recall a product, contact TGA recalls.
| Email: |
For general postmarket medical device enquiries and adverse event reporting: iris@health.gov.au For medical device annual reports and product reviews: postmarketdevices@health.gov.au |
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| Phone (adverse event reports only): |
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| Fax (adverse event reports only): | For adverse event reports related to medical devices, you may fax: +61 2 6203 1713 |
| Post: | Devices Post Market Monitoring Medical Devices Surveillance Branch Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia |
| Street address (for deliveries) |
Therapeutic Goods Administration 27 Scherger Drive Fairbairn ACT 2609 Australia |