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
- 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