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Australia TGA: FAQ Importing & Supplying Medical Devices

Recently on 3rd January, 2023 Australia's Therapeutic Goods Administration (TGA) released a guidance on frequently asked questions related to "Importing & Supplying medical devices".

For example a FAQs on Importing medical devices is "Can health professionals import medical devices for use in their clinical practice?" .

Similarly a FAQ to " What are the responsibilities of health professionals who supplies medical devices?"

If a health professional supplies a medical device to the Australian market, including by using it in their clinical practice, they become the sponsor of the device.

Medical device sponsors are responsible for:

  • applying to the TGA to have each kind of medical device included on the ARTG

  • ensuring the device continues to meet all legislative requirements once on the market

  • record keeping about medical devices supplied

  • reporting any adverse events or problems

  • taking corrective or preventative action, such as recalls, if necessary.

Clcik this LINK to know more about the FAQs related to "Importing & supplying Medical Devices".


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