We have a request from an individual who would like to purchase one of our medical devices in Australia, despite the device not being ARTG registered.
Under the regulations (TG(MD)), there is allowance for exemptions of devices "to be used solely for experimental purposes in humans", and it appears that it is the trial sponsor's responsibility to apply for such an exemption.
Questions:
- What is our responsibility as a foreign manufacturer in such a scenario (unapproved device, experimental use exemption, direct-to-user shipping)? Is it sufficient to just request from the individual proof they received exemption approval, and we're good to ship?
- Are we exposing ourselves to any liabilities? From my (cursory) reading of regulations, penalties appear to be directed at sponsors/importers, but if there is anything non-conforming about the exemption, is there still a possibility that we may be liable for attempting to ship an unapproved device?
NOTE: While the subject of this thread deals specifically with Australia, for the sake of discussion it'd also be informative to know how such a scenario might be dealt with in other markets as well. Who is responsible for exemptions? What liabilities does the foreign-manufacturer expose themselves to?
Any input/discussion appreciated as always...
MM
Under the regulations (TG(MD)), there is allowance for exemptions of devices "to be used solely for experimental purposes in humans", and it appears that it is the trial sponsor's responsibility to apply for such an exemption.
Questions:
- What is our responsibility as a foreign manufacturer in such a scenario (unapproved device, experimental use exemption, direct-to-user shipping)? Is it sufficient to just request from the individual proof they received exemption approval, and we're good to ship?
- Are we exposing ourselves to any liabilities? From my (cursory) reading of regulations, penalties appear to be directed at sponsors/importers, but if there is anything non-conforming about the exemption, is there still a possibility that we may be liable for attempting to ship an unapproved device?
NOTE: While the subject of this thread deals specifically with Australia, for the sake of discussion it'd also be informative to know how such a scenario might be dealt with in other markets as well. Who is responsible for exemptions? What liabilities does the foreign-manufacturer expose themselves to?
Any input/discussion appreciated as always...
MM