Recently on 3rd January, 2023 Australia's Therapeutic Goods Administration (TGA) released a guidance on frequently asked questions related to "Importing & Supplying medical devices".
The FAQ's were related to important topics such as Regulation | Importing medical devices | Health professionals as sponsors | Trade exhibitions | Penalties | Suspect 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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