These forms are for the medical devices and in vitro diagnostic medical devices industry. For a complete list of forms, see: Forms

For general privacy information, see: Privacy.

A C D E N R T V

A

• Application for certificate of free sale or export certificate for a medical device
  Use to apply for a certificate of free sale or an export certificate for a medical device
• 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
• Application for priority review designation - medical devices
  Form to apply for designation for Priority Review of either conformity assessment or inclusion in the ARTG of a medical device
• Australia-United States Free Trade Agreement
  The Australia-US Free Trade Agreement (the Agreement) came into force on 1 January 2005

C

• Custom-made medical devices
  Notification form for Australian manufacturers or sponsors to advise TGA of specific details about a custom-made medical device

D

• Declaration of conformity templates (IVDs)
  Templates for manufacturers to make Declarations of Conformity for an in vitro diagnostic medical device
• Declaration of conformity templates (medical devices)
  Forms for manufacturers to make Declarations of Conformity for a medical device

E

• Essential principles - consent for noncompliance
  Form for sponsors to request consent to import, supply or export medical devices which do not meet an Essential Principle
• Essential principles checklist (medical devices)
  It is the manufacturer's responsibility to demonstrate compliance with the essential principles for their medical devices
• European Medical Device Directive - Essential requirements checklist
  Checklist for exporting medical devices from Australia to Europe showing Essential Requirements – Annex I, 93/42/EEC as amended by Directive 2007/47/EC

N

• Notification of a change in sponsorship
  Use to notify of a change in sponsorship of an ARTG entry

R

• Request for pre-submission meeting
  For medical devices and IVD applications
• Request to cancel an entry/entries from the Australian Register of Therapeutic Goods (ARTG)
  Use to cancel an entry from the ARTG

T

• TGA Business Services forms
  Forms for sponsors, agents and manufacturers to apply for access to TGA Business Services
• Transfers of conformity assessment certificates
  This form, along with sufficient documentary evidence for the relevant event, is to be provided as part of a change application

V

• Varying entries in the ARTG - medical devices and IVDs
  New guidance available