Hello,
Based on my understanding and experience with the Australian medical device regulations, only a sponsor can supply your medical device (including R&D devices) in Australia.
Whoever is supplying your device in Australia becomes the sponsor provided, their information is lodged in the ARTG along with the device information. A sponsor could be your company representative within Australia, Distributor or healthcare professional. It makes sense that TGA mandates only sponsors to import and supply devices because they are responsible and legally obligated for
a. Ensuring that the device meets all Australian Regulations and Conformity Assessment procedures.
b. Reporting serious problems and adverse events.
c. Record keeping of supplied devices which enables the tracking of devices during recalls and corrections/ removals etc.
Oh! and TGA also requires that the product being supplied to Australia bears sponsor information ("Distributed by" label etc.,) in addition to manufacturer's information. (as required by 10.2 of the ARGMD).
Hope this helps!
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Phani Puppala
Quality Regulatory Specialist
Franklin MA
United States
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Original Message:
Sent: 26-Sep-2018 10:02
From: Anonymous Member
Subject: Importing Medical Device into Australia (without involving distributor)
This message was posted by a user wishing to remain anonymous
Hello there!
Our company is looking into importing devices to Australia for research purpose only ( to be used in patients). Normally, this should not be an issue since our devices are registered in the ARTG database and both are considered "approved" devices.
The intent is not to involve our current distributor in this process. My understanding based on the agreement with our Australian <g class="gr_ gr_54 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-del replaceWithoutSep" id="54" data-gr-id="54">Sponsor,</g> is that devices are to be only shipped directly to distributors and that they are authorized to import and clear devices from customs.
How can we import devices for research purpose only without involving our current distributor? Will labeling the devices for "Research purpose only. Not for Sale" suffice and will not cause any issues with customs?
Any input is greatly appreciated.
Thank you.