Australia Authorized Representative

From the Therapeutic Goods Act 1989, Chapter 1—Preliminary, 3 Interpretation sponsor, in relation to therapeutic goods, means:

1.  A person who exports, or arranges the exportation of, the goods from Australia; or
2. A person who imports, or arranges the importation of, the goods into Australia; or
3. A person who, in Australia, manufactures the goods, or arranges for another
4. A person to manufacture the goods, for supply (whether in Australia or elsewhere); but does not include a person who:
5. Exports, imports or manufactures the goods; or
6. Arranges the exportation, importation or manufacture of the goods; on behalf of another person who, at the time of the exportation, importation, manufacture or arrangements, is a resident of, or is carrying on business in, Australia.

Responsibilities of MD Sponsor

• Implement procedures, including a written agreement with the manufacturer, to obtain information from the manufacturer as requested by the TGA

• Ensure that-
  • Sufficient information is available to substantiate compliance with the Essential Principles, or procedures are in place to provide such information from the manufacturer to the TGA within 20 working days.
  • An appropriate conformity assessment procedure is applied to medical devices.
  • The manufacturer has appropriate conformity assessment evidence for the medical device.
  • The conformity assessment evidence remains valid while the device is supplied in Australia.
• For devices other than Class I not supplied sterile or with a measuring function, submit the conformity assessment evidence to the TGA.
• Apply for inclusion of the medical devices in the ARTG, certifying that the provided information is complete and correct.
• Pay the fee for applying to include the medical device in the ARTG, and, where applicable, pay the fees for an application audit.

• Upon request-
  • Provide documentation relating to the medical device to the TGA.
  • Deliver samples of the medical device to the TGA.
  • Allow a person authorized by the TGA to enter and inspect any premises, including those outside Australia, where the devices are manufactured or located.
• Notify the TGA of certain incidents and performance issues.
• Ensure that the information about the device complies with regulatory requirements.
• Pay the annual charges for the ongoing inclusion of the medical device in the ARTG.
• There are criminal and civil penalties for making false statements.