Tga Medical Devices Australia

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, condoms, contact lenses, in vitro diagnostic medical devices, disinfectants, X …

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, …

Australian regulatory guidelines for medical devices …

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

The Australian Regulatory Guidelines for Medical Devices (ARGMD): provides information on the import into, export from and supply of medical devices within …

Medical devices overview | Therapeutic Goods …

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

Therapeutic Goods Administration (TGA) | Australian …

https://www.tga.gov.au/

Therapeutic Goods Administration (TGA) We are Australia's government authority responsible for evaluating, assessing and monitoring products that are defined …

Overview of medical devices and IVD regulation

https://www.tga.gov.au/overview-medical-devices-and-ivd-regulation

For other medical devices, conformity assessment should be demonstrated by providing appropriate certification issued to the manufacturer by an appropriate assessment body …

IVD guidance documents | Therapeutic Goods …

https://www.tga.gov.au/ivd-guidance-documents

The TGA is developing guidance specific for IVDs as part of the Australian Regulatory Guidelines for Medical Devices (ARGMD). The first of these chapters are now available. …

Database of Adverse Event Notifications (DAEN)

https://www.tga.gov.au/database-adverse-event-notifications-daen-medical-devices

The Database of Adverse Event Notifications - medical devices contains information from reports of adverse events that the TGA has received in relation to medical devices used …

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 …