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DR4: archived guidance

Device Requirements version 4 (DR4) was written in 1998 about the regulation of therapeutic devices, which were listed or registered on the ARTG.

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.

The terms 'therapeutic devices' and 'medical devices' refer to distinct product groups in the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002.

Certain types of therapeutic devices are now referred to as 'other therapeutic goods' on our website.

We now consider disinfectants to be therapeutic devices or 'other therapeutic goods'.

DR4

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

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.

The information contained in DR4 is now relevant only for:

  • Hospital, household and commercial grade disinfectants

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.

DR4

DR4 Volume 1

DR4 Volume 2 (Appendices)

Appendices that continue to have regulatory relevance

These appendices only apply to the regulation of registered hospital, household and commercial grade disinfectants registered before 4 October 2007.

See the current DR4 web page for links to:

  • Appendix 3: Changes or variations to therapeutic devices in the ARTG
    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
    This document details standard and specific conditions applying to registered or listed therapeutic goods under Section 28 of the Therapeutic Goods Act 1989.
  • Appendix 18: Guidelines for the evaluation of sterilants and disinfectants
  • Appendix 19: Therapeutic Goods (Single Therapeutic Goods) Order No 1 of 1991 (as amended)