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Clinical evidence requirements for inclusion of medical devices in the Australian Register of Therapeutic Goods

Australian medical devices guidelines

Guidance document number 4, Version 1.6

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.

This document is intended as a guide to the requirements for clinical evidence needed to support an application for the inclusion of a medical device on the Australian Register of Therapeutic Goods.

Australian medical devices guidelines: 4. Clinical evidence requirements for inclusion of medical devices in the Australian Register of Therapeutic Goods (pdf,51kb)

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Contents

  • Introduction
  • The essential principles and the role of clinical evidence
  • Identification of what clinical data is needed
  • What is clinical data and how can it be generated?
  • What is required of a clinical evaluation?
  • What about devices entered in the ARTG prior to 4 October 2002?