Conformity Assessment Certificate - Australian Government


You will require this certificate if you intend to manufacture certain kinds of medical devices. Once a certificate has been issued, your device may be entered onto the Australian register of medical devices.

Devices that must be approved under this certificate include:

  • devices that contain animal-originated tissue that has been made non-viable
  • devices that contain tissues, cells, microbial or recombinant substances and are intended for use in or on a human body
  • devices that incorporate (or are intended to incorporate) a substance that may be considered to assist the device
  • Class 4 in-vitro devices.

Please consult the Contact Officer for more information.

Service type


A licence defines the need to obtain recognition / certification and registration to undertake a certain business activity.

Eligibility requirements

Please consult with the Contact Officer for information on any eligibility requirements.


Fees Details for this service in table format.

Task Type Business Structure Description
Apply Application All

Please consult the Contact Officer for information on fees to be submitted.


Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods (Medical Devices) Regulations 2002 Australian Government

Approval time

Maximum of 225 working days.

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.

Please use these contact details for help or more information:


Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Toll Free: 1800 020 653
Website: Therapeutic Goods Administration (Opens in new window)