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Devices Business Support

This section is for manufacturers of medical devices and IVDs
21 November 2018
New guidance for menstrual cups published
5 April 2019

Therapeutic Goods order for Tampons renewed

19 November 2021

Sterilants & disinfectants are regulated in a variety of ways in Australia, depending on the intended purpose of the product as discerned from the claims made in the instructions for use, labelling and promotional material. The following table provides an overview of the manner in which...

In response to the public consultation on the Options for the future regulation of 'low risk' products , the Government has endorsed a range of reform activities following analysis of the consultation responses. These include changes to how tampons and menstrual cups are regulated.

Prior...

13 April 2022
The Medical Devices Reforms aim to enhance the safety, performance and quality of medical devices in Australia and focus on patient safety
Regulation Impact Statement: Unique Device Identification System for medical devices 27 October 2020: As part of the 2020-2021 Budget, the Australian Government announced it will establish a Unique Device Identification (UDI) database for medical devices Regulatory impact statement: Proposed...
16 January 2019
Disclaimer

This document is intended as a guide only. It should not be relied upon to address every aspect of...

1 August 2013

The TGA Blueprint included a commitment to consult with stakeholders on changing the way medical devices are included in the Australian Register of Therapeutic Goods (ARTG) .

What was decided?

The product name proposal as outlined in the TGA Blueprint will not proceed at this time. The...

4 July 2014

Over recent years concerns have arisen with:

premarket scrutiny of higher risk medical devices, particularly those which are implanted; transparency of TGA decision making on medical device; and use of third party assessment bodies to assess conformity of medical devices to Australian...

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