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Australian regulatory guidelines for medical devices (ARGMD)

Related information

18 October 2019

PLEASE NOTE

We are currently in the process of reviewing and updating the Australian Regulatory Guidelines for Medical Devices (ARGMD).

The previous version of the ARGMD can be found on our archived site here.

If you:

  • would like to nominate an area of guidance that has not yet been covered or provide feedback on the guidance that appears here; or
  • you notice erroneous/missing information, broken links, etc please contact us at devices@tga.gov.au with the subject line "ARGMD".

The Australian Regulatory Guidelines for Medical Devices (ARGMD):

  • Provides information on the import into, export from and supply of medical devices within Australia.
  • Explains the legislative requirements that govern medical devices.

ARGMD

Conformity assessment is the systematic and ongoing examination of evidence and procedures to ensure that a medical device (including IVD medical devices) complies with the essential principles. Manufacturers of all medical devices (including IVD medical devices) manufactured and/or supplied in Australia should ensure that they have:

  • appropriate conformity assessment procedures in place for the device; and
  • appropriate documentation demonstrating compliance of the device with the essential principles.

Evidence that a device has undergone an appropriate conformity assessment procedure must be held before a device can be included in the Australian Register of Therapeutic Goods (ARTG). For more information about acceptable documentation and the submission of a valid application for inclusion of a medical device (including IVDs) in the ARTG, please see:

Some medical devices (including IVD medical devices) must have a TGA Conformity Assessment certificate. An application for their inclusion into the ARTG cannot be made with evidence from a comparable overseas regulator. Devices that are required to have a TGA Conformity Assessment certificate are listed in Regulation 4.1 of the Therapeutic Goods (Medical Devices) Regulations 2002. For further information, refer to 'Manufacturing medical devices: where to start'.

The following pages contain information and guidance for manufacturers who intend to submit an application for TGA-issued conformity assessment certificate:

Other information relevant to submitting evidence to support the application for TGA-issued conformity assessment certificate:

Once a medical device has been included in the ARTG the device must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval.

The TGA has mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices. These requirements facilitate the monitoring of device performance and ensure systematic investigation of failures and/or deviations in the way a device performs, in an attempt to prevent an adverse event occurring again.

Information received by the TGA once a device is included in the ARTG informs actions including:

  • Corrective actions including, but not limited to, changes to device design, construction and information accompanying the device;
  • Suspension and/or cancellation of the product;
  • Recall actions including safety alerts; and
  • Educational resources including website notifications.

The following pages contain information relating to ongoing post-market responsibilities and activities for sponsors and manufacturers:

Reporting an adverse event

If you are a consumer or health care provider and you wish to report an adverse event, you can do so at Medical device incident reporting & investigation scheme (IRIS).