Device-medicine boundary products

Australian medical devices guidelines

30 November 2005

Guidance document number 35, Version 2.0

TGA advises this document is currently under review. This November 2005 version will remain available for information purposes until a revised document is published.

This guidance document is one of a series that has been produced to help explain the new regulatory system for medical devices in Australia that commenced on 4 October 2002. The new system has been established by the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002.

These guidelines are to assist sponsors in determining the status of therapeutic goods that are not readily identified as medicines or devices. In developing the list, the status of each product as determined by the USA FDA and European Union was considered with the desire that 'internationally' recognised distinctions be adopted as far as possible.

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Contents

  • Disclaimer
  • Further information
  • Amendment schedule
  • Introduction
  • Device and medicine distinctions
  • Definitions
  • Therapeutic goods - status for ARTG purposes