DR4

For sponsors of 'retained registered disinfectants'

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'.

Appendices that continue to have regulatory relevance

These appendices only apply to the regulation of registered hospital, household and commercial grade disinfectants, for which an effective application was submitted before the 4 October 2007 deadline:

• to include the product in the ARTG, or
• for a TGA Conformity Assessment Certificate.

This is provided for by the Therapeutic Goods Amendment Act 2007 which allows these therapeutic devices 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.

These appendices are not relevant to medical devices regulated under the new regulatory system for those types of product. Any medical devices marketed in Australia since 4 October 2007 must meet the requirements set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical Devices) Regulations 2002.

• Appendix 3: Changes or variations to therapeutic devices in the ARTG (pdf,146kb)
  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,133kb)
  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: TGO 54, TGO54A, TGO54B and Guidelines (Disinfectants)
• Appendix 19: Therapeutic Goods (Single Therapeutic Goods) Order No 1 of 1991 (as amended)