Australian Regulatory Guidelines for Medical Devices (ARGMD)

Development of ARGMD

The TGA is developing a consolidated reference document detailing the Australian regulatory requirements for medical devices.

This document will provide guidance on all the regulatory requirements for medical devices in Australia and will be made available on the TGA Internet site. It will replace the existing guidance documents and information sheets for medical devices. We intend that the project will be complete by the end of this calendar year (2008).

As each section is prepared, it will be released for comment, with a four week deadline. We welcome comments from you on the technical aspects of the document. We are keen to have stakeholder involvement in the development of the ARGMD as we want to ensure that the language is easy to understand.

As each section is completed you will be able to access it here. However the existing guidance material will remain until it can be fully replaced by the ARGMD.

Sharon Woods is the Project Manager and she can be contacted by email at sharon.woods@tga.gov.au or by telephone on 02 6232 8194.

Comments may be sent by email or by mail, and should include your full contact details. The mailing address for comments is:

Ms Sharon Woods
MDP 122
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Australia

Draft table of contents

Here is a draft Table of Contents so that you can see the structure that is planned for the ARGMD, however please be aware that it is updated as the need for new information is identified.

How to access a pdf document

ARGMD table of contents (draft at 30 June 2008) (pdf,60kb)

Some of the key principles that have been used in drafting the documents are:

where possible, direct quotes from the legislation will be used to inform stakeholders of their obligations.
information will only be provided once wherever possible, and there will be links from any related areas. This avoids duplication of information.
forms and checklists will not be part of the ARGMD. They will be available from this website as stand-alone documents to allow people to easily locate them. There will be links from the ARGMD to the relevant forms and checklists wherever appropriate.
although plain english will be used wherever possible, there are times where the information must be technical to inform stakeholders of technical requirements.
the ARGMD will not describe how medical devices are regulated in other countries, as the TGA is not responsible for overseas regulatory frameworks and may not be aware of changes.