"DR4"

Australian medical device requirements under the Therapeutic Goods Act 1989 (version 4)

The document DR4 is a guidance document that now applies only to the regulation of therapeutic devices that are regulated under the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990.

A new regulatory framework for medical devices was introduced on 4 October 2002, and the transition period for moving product from the 'old' regulatory framework, for which DR4 was the relevant guidance document, ended on 4 October 2007.

DR4 is not relevant to medical devices regulated under the new regulatory system. Any medical devices marketed in Australia must meet the requirements which are set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical Devices) Regulations 2002. See: New Australian medical device regulatory system implemented 4 October 2002 <http://www.tga.gov.au/docs/html/meddevreg.htm>, and other guidance documents available on the TGA website.

The information contained in DR4 is now relevant only for:

• Diagnostic goods for in vitro use
• Devices incorporating human materials
• Hospital, household and commercial grade disinfectants
• Menstrual tampons

All information contained in DR 4 for other medical devices is of historical interest only.

NOTE: Sponsors should note that, for a period of time beyond 4 October 2007, a limited number of listings and registrations will remain on the ARTG.

In mid August 2007 the Therapeutic Goods Amendment Act 2007 (Amendment Act) was passed. This amendment provides for any registered or listed device in the ARTG that was the subject of an effective application for either inclusion in the ARTG or TGA Conformity Assessment Certificate submitted by the 4 October 2007 deadline, to be treated as a transitioning device and continue to be supplied under the terms and conditions of Chapter 3 of the Therapeutic Goods Act 1989 (the Act) until such time as the application is finally determined.

The DR 4 is therefore still applicable to those listings and registrations where applications for inclusion on the ARTG under the new regulatory system are still to be determined.

Hardcopies of DR4

If you require this document in hardcopy please complete a publications order form <http://www.tga.gov.au/pubs/puborder.htm>. Payment must accompany the order. Please note: this document is only available in hardcopy as a double-sided black & white print on plain A4 paper. It does not come with a folder and is not bound in any way.

• Australian price (GST inclusive): $50.00
• Overseas price (+ Airmail): $45.45 (+$25.00)

Electronic copies of DR4

How to access a pdf document

• Cover, Foreword, "How to Use" and Structure (pdf,83kb)
• Table of contents (pdf,37kb)

DR4 Volume 1

• Block (Section) 1 (pdf,152kb)
• Block (Section) 2 (pdf,424kb)
• Block (Section) 3 (pdf,252kb)

DR4 Volume 2 (Appendices)

• Appendix 1: Therapeutic goods advertising code <http://www.tga.gov.au/advert/tgac.htm>
• Appendix 2:
  • Enterprise ID Form (replaced by Client details form <http://www.tga.gov.au/docs/html/forms/clientdt.htm>)
  • The Therapeutic Devices Application Form and Supplement are no longer available on this website. Sponsors are now required to use the Device Electronic Application Lodgement (DEAL) system to apply for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG). DEAL may be accessed at http://www.tgasime.health.gov.au <http://www.tgasime.health.gov.au>. For further information on the DEAL system, please phone 1800 010 624 or email tga.sime@tga.gov.au.
• Appendix 3: Changes or variations to therapeutic devices in the ARTG (pdf,74kb)
  This document summarises the requirements for sponsors to notify or seek approval of changes to registered and listed therapeutic devices or groups of devices.
• Appendix 4: Conditions - standard and specific (pdf,52kb)
  This document details standard and specific conditions applying to registered or listed therapeutic goods under Section 28 of the Therapeutic Goods Act 1989.
• Appendix 5: Device and drug distinctions (superseded by Australian medical devices Guidance document number 35: Device - medicine boundary products <http://www.tga.gov.au/docs/html/devguid35.htm>)
• Appendix 6: ECRI codes
  ECRI Universal Medical Device Nomenclature System cross referenced to Australian Device Groups (ADG)
  • If you require this DR4 appendix in hardcopy please complete a publications order form <http://www.tga.gov.au/pubs/puborder.htm>. Payment must accompany the order. Please note: this document is only available in hardcopy as a double-sided black & white print on plain A4 paper. It does not come with a folder and is not bound in any way.
    • Australian price (GST inclusive): $30.00
    • Overseas price (+ Airmail): $27.25 (+$10.00)
• Appendix 7: Therapeutic goods (excluded goods) orders extracts (pdf,50kb)
  Extracts from Therapeutic Goods (Excluded Goods) Order No. 1 of 1998, Therapeutic Goods (Excluded Goods) Order No. 2 of 1998 and draft Therapeutic Goods (Excluded Goods) Order No. 1 of 1997.
  • Note: Therapeutic Goods (Excluded Goods) Order No. 1 of 1998 was revoked on 4 October 2004 by Therapeutic Goods (Excluded Goods) Order No. 1 of 2004 which was then revoked on 9 November 2005 by Therapeutic Goods (Excluded Goods) Order No. 1 of 2005 <http://www.tga.gov.au/legis/tgeg0501.htm>
• Appendix 8: Exempt goods (pdf,47kb)
  Therapeutic goods regulations, Schedule 5 - Subregulation 12(1) and Schedule 5A - Subregulation 12(1A)
• Appendix 9: Devices fees and charges <http://www.tga.gov.au/docs/html/feesach.htm>
• Appendix 10: GMP Guidelines on standard of overseas manufacturers (Note: This guideline is currently under revision. In the meantime, all enquiries should be emailed to gmpclearance@tga.gov.au)
• Appendix 11: Human or animal origin therapeutic devices (pdf,63kb)
  This document provides a background to and sets out guidelines on the safety issues associated with therapeutic goods of animal/human origin.
• Appendix 12: TGA publications list (no longer available)
• Appendix 13: Therapeutic goods orders and standards applicable to medical devices (as at May 1998) (pdf,57kb)
• Appendix 14: TGA Organisational Chart (no longer available)
• Appendix 15: TGO 11 (revoked by TGO 63 <http://www.tga.gov.au/docs/html/tgo/tgo63.htm>)
• Appendix 16: TGO 37 (General requirements for labels for therapeutic devices) <http://www.tga.gov.au/docs/html/tgo/tgo37.htm>
• Appendix 17: TGO 50 (General standard for pyrogen and endotoxin content of therapeutic goods) <http://www.tga.gov.au/docs/html/tgo/tgo50.htm>
• Appendix 18: TGO 54 <http://www.tga.gov.au/docs/html/tgo/tgo54.htm>, TGO54A <http://www.tga.gov.au/docs/html/tgo/tgo54a.htm>, TGO54B <http://www.tga.gov.au/docs/html/tgo/tgo54b.htm> & Guidelines (Disinfectants) <http://www.tga.gov.au/devices/disinfectants.htm>
• Appendix 19: Therapeutic Goods (Single Therapeutic Goods) Order No 1 of 1991 (as amended) <http://www.tga.gov.au/docs/html/dr4app19.htm>

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