Medical device conformity assessment application

We accept different kinds of regulatory evidence for medical devices. One option is a TGA issued conformity assessment certificate.

Guidance

Prepare your application by reading Application instructions: Conformity assessment certification.

Forms

Following an application, we will send an acknowledgement email requesting supporting data.

You must submit the 'Supporting data form' with your application supporting data. Forms must be current and complete.

More information

• Supporting documentation for inclusion of a medical device
• Obtain and maintain regulatory evidence
• Evidence from comparable overseas regulators