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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.
- Conformity assessment Certificate Repository (medical devices)
The new Certificate Repository allows conformity assessment certificates to be automatically generated once a conformity assessment application is complete
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.
- 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.
- 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).