The regulatory standards for the approval of medical devices in Australia


The regulatory standards for the approval of medical devices in Australia

22 November 2011

© Commonwealth of Australia 2011
ISBN 978-1-74229-527-5

View the report as a single document - (PDF 688KB)

View the report as separate downloadable parts:

MEMBERSHIP OF THE COMMITTEE (PDF 6KB)
ABBREVIATIONS (PDF 12KB)
RECOMMENDATIONS (PDF 64KB)
Chapter 1 - Introduction (PDF 18KB)

Terms of reference
Conduct of the inquiry
Acknowledgement
Note on references
Structure of the report
Chapter 2 - Regulatory issues (PDF 231KB)

Introduction
The role of the TGA in regulating quality of devices
Safety standards and approval processes for devices that are remanufactured for multiple use
Other matters
Chapter 3 - High revision rates: the consumer experience (PDF 183KB)

Introduction
The DePuy ASR hip system
The consumer experience
Notifying authorities, patients and the general public about faulty devices
Chapter 4 - Subsidised devices (PDF 73KB)

Introduction
Subsidised devices
Issues
Chapter 5 - Conclusion and recommendations (PDF 36KB)
Additional Comments by Independent Senator Nick Xenophon (PDF 32KB)
APPENDIX 1 - Submissions and Additional Information received by the Committee (PDF 8KB)
APPENDIX 2 - Public Hearing (PDF 7KB)
APPENDIX 3 - Review of Health Technology Assessment in Australia December 2009–Recommendations (PDF 19KB)
APPENDIX 4 - Review to improve the transparency of the Therapeutic Goods Administration–Final Report–June 2011 Executive Summary & Recommendations (PDF 18KB)
APPENDIX 5 - ASR timelines (PDF 13KB)

For further information, contact:

Committee Secretary
Senate Standing Committees on Community Affairs
PO Box 6100
Parliament House
Canberra ACT 2600
Australia

Phone: +61 2 6277 3515
Fax: +61 2 6277 5829
Email: community.affairs.sen@aph.gov.au