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Therapeutic Goods Administration (TGA) 🇦🇺

Description

TGA is an Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. TGA regulates medicines, medical devices and biologicals to help Australians stay healthy and safe.

Official website

https://www.tga.gov.au

Medical device reforms: Consumer Working Group meeting statement, Meeting 14, 2 July 2024

From Therapeutic Goods Administration (TGA) 🇦🇺

Read key points of discussion from the meeting 14 of the Medical Devices Consumer Working Group (MDCWG).

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Updated 3 weeks ago

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EU MDR Transition web publication service

From Therapeutic Goods Administration (TGA) 🇦🇺

The EU MDR Transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition.

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Medical device reforms: improving consumer/patient information

From Therapeutic Goods Administration (TGA) 🇦🇺

The TGA publishes consumer-centred information to increase awareness and understanding of devices of public interest or concern.

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Updated 1 month ago

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Medical device reforms: publicly reporting TGA's assessment timeframes

From Therapeutic Goods Administration (TGA) 🇦🇺

We publish medical device application processing times twice every year.

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Medical device reforms: five questions to ask before you get a medical implant

From Therapeutic Goods Administration (TGA) 🇦🇺

When considering an implant, the guide helps consumers ask the right questions.

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Medical device reforms: establishment of a Unique Device Identification system

From Therapeutic Goods Administration (TGA) 🇦🇺

Strengthened patient safety through the establishment of a UDI database for medical devices.

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Medical devices reforms: IVD companion diagnostics

From Therapeutic Goods Administration (TGA) 🇦🇺

Our goal is to harmonise with other jurisdictions (and international standards where necessary).

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Medical devices reforms: software regulation

From Therapeutic Goods Administration (TGA) 🇦🇺

New classifications clarify regulation of software-based medical devices.

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Medical devices reforms: low-risk products

From Therapeutic Goods Administration (TGA) 🇦🇺

Improve consumer safety, reduce regulatory burden, and improve regulation knowledge with appropriate regulation of low-risk devices.

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Recall coordinators for therapeutic goods

From Therapeutic Goods Administration (TGA) 🇦🇺

Recall coordinators play an important part in the uniform recall procedure for therapeutic goods

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Essential Principles checklist

From Therapeutic Goods Administration (TGA) 🇦🇺

A checklist to help medical device manufacturers prove compliance with the Essential Principles

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Medical device reforms: Medical Devices Consumer Working Group

From Therapeutic Goods Administration (TGA) 🇦🇺

The Medical Devices Consumer Working Group was established in 2019 after the release of TGA’s Action Plan for Medical Devices and a consumer workshop.