Conformity assessment

29 June 2017

The TGA is developing guidance material specific to conformity assessment for medical devices to update the regulatory requirements in the Australian Regulatory Guidelines for Medical Devices (ARGMD). The first of these are now available, and further guidance is under development.

The ARGMD provides more information on conformity assessment for medical devices. As the ARGMD is currently under review, any guidance listed here (which is also covered in the ARGMD) should be considered the latest version.

General information

Applications and notifications

Note: The new online conformity assessment application form is expected to be launched soon, and new guidance for completing it will be made available.