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Medical devices reforms: Low risk products

Project status: in progress

2 December 2020

Project overview

Appropriate regulation of low risk devices to improve consumer safety, reduce regulatory burden and improve knowledge of regulations.

In response to the 2015 Expert Review of Medicines and Medical Devices Regulation, the TGA reformed the regulation of a number of low risk products

Reform to the regulation of low-risk products is occurring two streams:

Further reforms to low risk devices are under consideration.


Consultation Status

Options for the future regulation of 'low risk' products

The future regulation of low risk products

Consultations closed 12 May 2017
Targeted consultation on TGO 103 on tampons (Explanatory Statement) Consultation concluded March 2019
Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance Consultation closed on 12 February 2019
Consultation: Products used for and by people with disabilities Consultation closed 25 October 2019

For more information see Consultations and reviews.

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For more information about other reforms visit Medical devices reforms.