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.
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PageThis page compiles all our resources related to face masks and COVID-19.
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PageThe Australian Register of Therapeutic Goods (ARTG) is the central database of therapeutic goods that can be legally supplied in or exported from Australia.
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PageLinks to information on IVD medical devices, including HIV and nutrigenetic tests.
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GuidanceManufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
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PageStandards and guidelines for medical devices marketed in Australia.
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PageThe medical devices reforms aim to enhance the safety, performance, and quality of medical devices in Australia and focus on patient safety.
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PageRegulatory decisions, notices and advice for industry about medical devices and IVDs
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PageAustralian corporations can now apply to become an Australian Conformity Assessment Body (Australian CAB)
Contact us
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 |