Forms for medical device & IVD sponsors

These forms are for the medical devices and in vitro diagnostic medical devices industry.

Medical devices & in vitro devices forms

• 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
• 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
• 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

Related forms

• Australia-United States Free Trade Agreement
  The Australia-US Free Trade Agreement (the Agreement) came into force on 1 January 2005
• Client details form
  This form should be completed by or for each client involved with the supply of therapeutic goods in Australia for which the TGA requires address details
• Request to transfer the sponsorship of an ARTG entry
  Use by the accepting company and the relinquishing company to request to transfer the sponsorship of an ARTG entry