Conformity assessment overview

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.

We have developed guidance material specific to conformity assessment for medical devices. This guidance material reflects updates to regulatory requirements in the Australian Regulatory Guidelines for Medical Devices (ARGMD).

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

• Conformity assessment certificate process and timeframes
  An overview for manufacturers applying for a conformity assessment certificate
• Conformity assessment certificate repository (medical devices)
  The Certificate Repository allows conformity assessment certificates to be automatically generated once a conformity assessment application is complete.
• Australian Conformity Assessment Bodies
  Australian corporations that are an Australian Conformity Assessment Body and issue Australian Conformity Assessment Body certificates for medical devices under Australian law. 

Applications and notifications

• Application for conformity assessment certificates (medical devices)
  Form and instructions for manufacturers to be supplied with the application for a conformity assessment certificate for medical devices.
• Substantial changes affecting a TGA conformity assessment certificate and Transfers of certificates
  Manufacturers must notify the TGA about any plans for 'substantial changes' to particular elements covered by a TGA issued conformity assessment certificate. There are also responsibilities where a TGA issued conformity assessment certificate transfers from one entity to another.
• Application for Australian Conformity Assessment Bodies
  Application form for an Australian Conformity Assessment Body determination.

Related guidance

• Declaration of conformity templates (medical devices)
  Forms for manufacturers to make Declarations of Conformity for a medical device.
• Declaration of conformity templates (IVDs)
  Templates for manufacturers to make Declarations of Conformity for an in vitro diagnostic medical device.
• Essential Principles Checklist (medical devices)
  It is the manufacturer's responsibility to demonstrate compliance with the Essential Principles for their medical device(s).
• Standards orders and medical devices
  Non-mandatory medical device standards orders (MDSO) and conformity assessment standards orders (CASO).
• Determinations for Australian Conformity Assessment Bodies
  This guidance is intended to assist Australian corporations seeking an Australian Conformity Assessment Body determination for medical devices (including IVDs) ay the Therapeutic Goods Administration (TGA).