Australian regulatory guidelines for medical devices (ARGMD)

Related information

23 October 2018

The ARGMD is currently under review. Some components have been superseded by new guidance or regulatory amendments - the following information is designed to help you identify the most current information available.

This page will be updated periodically to reflect the introduction of new information as it becomes available. If you wish to confirm the currency or accuracy of any aspect of the ARGMD please contact us at devices@health.gov.au or on 1800 141 144.

Updates to sections of the ARGMD

(Previous ARGMD Section 2)

The Annual Charge Exemption (ACE) scheme has replaced the Low Value Turnover (LVT) provisions.

(Previous ARGMD Section 4)

A new tool to assist manufacturers and sponsors with classifying their medical device is available through SME Assist.

  • Conformity assessment overview (Previous ARGMD Section 5)
  • What a manufacturer needs to know about conformity assessment (Previous ARGMD Section 6)
  • What a sponsor needs to know about conformity assessment (Previous ARGMD Section 7)

Guidance relating to conformity assessment is available through our website including:

(Previous ARGMD Section 8)

Guidance about the use of evidence from comparable overseas regulators is now available.

(Previous ARGMD Section 15)

Note: Medical devices that contain materials of non-viable animal, microbial, or recombinant origin are still covered by the ARGMD.

Therapeutic goods derived from biologicals (human cells or tissues, or live animal cells, tissues and organs) are regulated under the Biologicals Regulatory Framework and more information is available from the Australian Regulatory Guidelines for Biologicals (ARGB).

Biologicals combined with a medical device

Biologicals presented as a combination product with a medical device (i.e. integrated with the medical device) will be regulated under the Biologicals Regulatory Framework, and included in the ARTG as a biological. The device component will be assessed according to the medical device regulatory requirements, but will not be included in the ARTG separately.

Transmissible Spongiform Encephalopathies (TSE)

If you are using materials derived from human and other animal species in the manufacture of your goods, you should also review the information on Transmissible Spongiform Excephalopathies (TSE): TGA approach to minimising the risk of exposure.

(Previous ARGMD Section 18)

(Previous ARGMD Section 20)

Information about access to unapproved medical devices in Australia is available from the Accessing unapproved products section of our website:

(referenced throughout the ARGMD)

IVDs are regulated as subset of medical devices, and have specific regulatory requirements:

(referenced throughout the ARGMD but primarily in Section 3)

Clinical evidence is one of the essential principles that must be met under the Therapeutic Goods (Medical Devices) Regulations 2002.

Clinical evidence guidelines for medical devices are now available.

Note: While this guideline refers to IVDs, it is acknowledged that the information provided at this point is incomplete.

(referenced throughout the ARMD – primarily Section 2)

Guidance about the use of evidence from comparable overseas regulators is now available.

Total and partial hip, knee or shoulder joint replacements were reclassified as Class III medical devices on 1 July 2012.

After a three year transition, any total and partial hip, knee or shoulder joint replacements must apply for inclusion on the ARTG as a Class III medical device from 1 July 2015.

More information can be found at: Reclassification of hip, knee and shoulder joint replacements.

Previously, Australian medical device manufacturers needed to obtain a TGA conformity assessment certificate before applying for their product to be supplied in Australia.

From 5 November 2014, Australian medical device manufacturers have had the option of using conformity assessment certification from an alternative conformity assessment body (such as a European Notified Body) when making an application to the TGA. This applies whether the medical device is manufactured in Australia or overseas.

More information can be found at: Conformity assessment requirements for Australian medical device manufacturers - streamlining requirements.

(referenced throughout the ARGMD – but predominantly in Section 13)

The Australian Communications and Media Authority (ACMA) have replaced the 'A-tick' and 'C-tick' compliance marks with the Regulatory Compliance Mark (or RCM).

More information can be found on the ACMA website on their Product labelling page.

(impacts various section os the ARGMD – but predominantly in Section 2)

Guidance about the use of evidence from comparable overseas regulators is now available.

The following pages contain information that supplements content in the ARGMD.

ARGMD

V1.1, May 2011

How to access a pdf or Word document

*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.

Complete ARGMD document

Individual parts of ARGMD
Part Contents
  1. Introduction to the regulatory guidelines
  2. Fees and charges for medical devices
  3. The essential principles
  4. Classification of medical devices
  5. Conformity assessment overview
  6. What a manufacturer needs to know about conformity assessment
  7. What a sponsor needs to know about conformity assessment
  8. Differences between the Australian and European Union medical device regulatory requirements
  9. International agreements
  1. Including medical devices in the ARTG
  2. Application audits of medical device applications
  3. Information about a medical device
  4. Active medical devices
  5. Medical devices incorporating a medicine
  6. Medical devices containing materials of animal, microbial or recombinant origin
  7. Systems and procedure packs
  8. Medical devices for export
  9. Custom-made medical devices
  10. Single-use devices (SUDs) and the reuse of SUDs
  11. Access to unapproved medical devices in Australia
  1. Changes to ARTG Inclusions
  2. Post-market vigilance and monitoring requirements
  3. Recalls, suspensions, cancellations and tampering of medical devices
  1. Bibliography
  2. Contact Details
  3. Glossary
  • Index