Australian regulatory guidelines for medical devices (ARGMD)
V1.1, May 2011
The TGA in collaboration with the medical devices industry sector has developed a consolidated reference document detailing the Australian regulatory requirements for medical devices.
This document has been developed as a guide to assist sponsors and manufacturers understand the regulatory requirements for medical devices in Australia. The information in this document replaces many of the existing guidance documents and information sheets for medical devices that were on the TGA website.
It should be noted that this document is for guidance. All regulatory decisions are made using legislation as set out in the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.
This document will continue to evolve over time. Updates/clarifications will be included from time to time. Users should check that they have the most up to date version when referring to this Guidance. Comments and suggestions for future versions are welcomed and should be sent to ODAConsult@tga.gov.au.
*Please note: You will notice that some sections of the document are yet to be added. These sections are currently being drafted and the document will be updated once those sections are finalised.
*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
- Australian Regulatory Guidelines for Medical Devices (ARGMD) (pdf,2.51Mb)
- Australian Regulatory Guidelines for Medical Devices (ARGMD) (Microsoft Word,2.32Mb)
Contents of ARGMD Part 1
- Introduction to the regulatory guidelines
- Fees and charges for medical devices
- The essential principles
- Classification of medical devices
- Conformity assessment overview
- What a manufacturer needs to know about conformity assessment
- What a sponsor needs to know about conformity assessment
- Differences between the Australian and European Union medical device regulatory requirements
- International agreements
Contents of ARGMD Part 2
- Including medical devices in the ARTG
- Application audits of medical device applications
- Information about a medical device
- Active medical devices
- Medical devices incorporating a medicine
- Medical devices containing materials of animal, microbial or recombinant origin
- Systems and procedure packs
- Medical devices for export
- Custom-made medical devices
- Single-use devices (SUDs) and the reuse of SUDs
- Access to unapproved medical devices in Australia
Contents of ARGMD Part 3
- Changes to ARTG Inclusions
- Post-market vigilance and monitoring requirements
- Recalls, suspensions, cancellations and tampering of medical devices
- ARGMD Part 4 - Navigation and Reference (pdf,252kb)
- ARGMD Part 4 - Navigation and Reference (Microsoft Word,3.77Mb)
Contents of ARGMD Part 4
- Contact Details