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
IDVs in Australia: how they're regulated - Demonstrating compliance with the Essential Principles
Medical device manufacturers have to demonstrate their devices comply with the Essential Principles - Standards, guidelines and publications (medical devices and IVDs)
Medical devices and in vitro diagnostic medical devices standards, guidelines, and publications - Medical devices reforms
The Medical Devices Reforms aim to enhance the safety, performance, and quality of medical devices in Australia and focus on patient safety. - Regulatory decisions and notices (medical devices and IVDs)
Medical device and in vitro diagnostic regulatory decisions, like advertising exemptions - Australian Conformity Assessment bodies
Australian corporations can apply to become an Australian Conformity Assessment Body.
Contact
Premarket enquiries
| Email: | Email us for general medical device enquiries IVDs@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 27 Scherger Drive Fairbairn ACT 2609 Australia |
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): | +61 2 6203 1713 |
Post: | Devices Post Market Monitoring |
Street address | Therapeutic Goods Administration |