How to supply Medical Device in Australian?

The medical device must be included on the Australian Register of Therapeutic Goods (ARTG) before place it into the Australian market.

If this medical device is manufactured in Australian, the manufacturer is responsible for prepare and submit application to include device in ARTG via TGA eBS.

If this medical device is manufactured overseas, the manufacturer must appoint an Australian sponsor, the sponsor is responsible for prepare and submit application to include device in ARTG via TGA eBS.

KINGSMEAD PTY LTD can supply sponsor service for you.

Responsibilities of a medical device sponsor

According to , the medical device sponsor must:

• Have procedures in place, including a written agreement with the manufacturer, to obtain information from the manufacturer when requested by the TGA

• Ensure that

– They have available sufficient information to substantiate compliance with the Essential Principles or have procedures in place to ensure that such information can be provided from the manufacturer to the TGA within 20 working days

– An appropriate conformity assessment procedure has been applied to the 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 to include the medical devices in the ARTG, including certifying that the information provided is complete and correct

• Ray the fee for applying to include the medical device in the ARTG, and where applicable pay the fees for an application audit to be conducted

• Upon request

– Provide documentation relating to the medical device to the TGA

– Deliver samples of the medical device to the TGA

– Allow a person authorised by the TGA to enter and inspect any premises, including outside Australia, where the devices are manufactured or located

• Notify the TGA of certain incidents and performance issues

• Ensure the information about the device complies with the regulatory requirements

• Pay the annual charges for ongoing inclusion of the medical device in the ARTG

There are criminal and civil penalties for making false statements.