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Medical devices reforms: Low risk products
Project status: in progress
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.
|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.