Prepare for a medical device application audit

Application audits are conducted to verify that devices submitted for inclusion in the ARTG meet the relevant legislative requirements.

For some applications, an audit is mandatory under the legislation. Others may be selected for auditing at the discretion of the delegate.

If your application is selected for audit, you may be asked to provide further documentation.

Please read Auditing of medical device, including IVD medical device, applications for more information.