Tga Medical Device

Medical devices & IVDs | Therapeutic Goods …

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

[email protected] for general medical device enquiries [email protected] for enquiries about COVID test kits. TTY or computer with modem users phone 1800 555 677 then ask for 1800 141 144. Speak and listen (speech to speech relay) users phone 1800 …

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. Medical devices include a wide range of products, such as …

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

Steps to include a medical device (including IVD medical devices) in the Australian Register of Therapeutic Goods (ARTG). If you intend to supply a medical device in Australia, you …

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 - medical devices

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

The TGA uses adverse event reports to monitor the safety of medical devices. This is part of the ongoing monitoring and compliance activities undertaken by the TGA. An adverse …

Database of Adverse Event Notifications (DAEN)

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

A look at TGA's medical device event report process. TGA safety monitoring of medical devices Find out how the TGA monitors medical devices and detects potential safety …

TGA Guidance on Classification of Active Medical …

https://www.regdesk.co/tga-guidance-on-classification-of-active-medical-devices-basics/

Oct 26, 2021. The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance …