Like Medicines, Therapeutic Devices are categorised as either Listable or Registrable Products which contain animal or human origin. Those materials or products which significantly affect body functions must be registered whereas most devices only need listing.

Registered devices must have full toxicology and efficacy data in the submission. Listed devices must merely provide product details, GMP, and labelling for submission. Most devices need to be manufactured in a GMP approved facility.

From the second quarter 2002 submissions are in computer format and submitted on line to Canberra by the Consultancy. The Consultancy maintains an up to date set of regulatory requirements, computer programs and application forms.

The Consultancy can prepare, submit and monitor the progress of Listings and Registrations of Therapeutic Devices.