Overview of the medical device regulatory process
Information document no. 41
March 2006
This document is a flow chart showing the Australian medical device regulatory process.
This document is provided for guidance only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 for legislative requirements.
Overview of the medical device regulatory process (pdf,28kb)