Tga Medical Devices

Medical devices & IVDs | Therapeutic Goods …

https://www.tga.gov.au/medical-devices-ivds

Medical devices include a wide range of products such as medical gloves, bandages, syringes, ...

Medical devices | Therapeutic Goods Administration (TGA)

https://www.tga.gov.au/products/medical-devices

Medical devices mainly work in a physical or mechanical way on the human body, or they’re used to measure or monitor it. Listen. Medical devices include a wide range of products, …

Medical devices overview | Therapeutic Goods …

https://www.tga.gov.au/products/medical-devices/medical-devices-overview

Australian regulatory guidelines for medical devices …

https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd

The TGA has mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices. These requirements facilitate the …

Medical device inclusion process | Therapeutic Goods …

https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good-0/supply-medical-device/medical-device-inclusion-process

Medical devices, including IVD medical devices, are included in the Australian Register of Therapeutic Goods (ARTG) as a 'kind of medical device'. Page Find out the …

Database of Adverse Event Notifications - medical devices

https://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx

The Database of Adverse Event Notifications (DAEN) – medical devices allows you to search adverse event reports for medical devices received by the TGA since 1 July …

Is my product a medical device? | Therapeutic Goods …

https://www.tga.gov.au/resources/my-product-medical-device

The Australian Regulatory Guidelines for Medical Devices (ARGMD) provides information on the regulation of medical devices in Australia. You may wish to seek the services of a …

Real world evidence and patient reported outcomes – …

https://www.tga.gov.au/real-world-evidence-and-patient-reported-outcomes-medical-devices

The TGA is implementing a Unique Device Identification system for Australian medical devices. When fully implemented, the label of most devices will include a UDI in both a …

Australian TGA knocks back Hydrix’ (ASX:HYD) Guardian device

https://themarketherald.com.au/australian-tga-knocks-back-hydrix-asxhyd-guardian-device-2023-02-15/

The Australian Therapeutic Goods Administration (TGA) has rejected Hydrix’ (HYD) application for its implanted heart monitoring system to be distributed in Australia. …