Forms for sponsors of medical devices

Medical devices forms

• Australian device name (ADN) nomination form
  Use to propose a name for a new ingredient used in a formulated medical device
• Application for certificate of free sale or export certificate for a therapeutic device/medical device
  <http://www.tga.gov.au/devices/cfs-expc.htm>
  Use to apply for a certificate of free sale or an export certificate for a therapeutic device/medical device
• *Therapeutic Devices Application Form and Supplement
  *This form is no longer available on this website. Sponsors are now required to use the Device Electronic Application Lodgement (DEAL) system <http://www.tga.gov.au/online/deal.htm> to apply for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG).

Related (general) forms

• Client details form
  <http://www.tga.gov.au/docs/html/forms/clientdt.htm>
  To be completed by or for each client involved with the supply of the therapeutic goods in Australia for which the TGA requires address details
• Authorisation to cancel a product from the Australian Register of Therapeutic Goods
  <http://www.tga.gov.au/docs/html/forms/artg-cancel.htm>
  Use to request cancellation of the registration/listing/inclusion of medicines and/or devices on the ARTG
• Request to transfer the sponsorship of an ARTG entry - relinquishing company
  <http://www.tga.gov.au/meds/tsfrelinqco.htm>
  Used by the relinquishing company to request to transfer the sponsorship of an ARTG entry
• Request to transfer the sponsorship of an ARTG entry - accepting company
  <http://www.tga.gov.au/meds/tsfacceptco.htm>
  Used by the accepting company to request to transfer the sponsorship of an ARTG entry