Obligations of Foreign Distributors of US Medical Devices

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ehoqa

#1
We are a manufacturer of a Class II implantable device (not subject to medical device tracking of Part 821) in the US. We are working with a distributor in Australia to sell our devices there. We do have CE Marking and will go through Australia's TGA process. We are trying to come up with a contract that lists requirements that the Australian distributor needs to agree to in order to sell our devices, such as record keeping for X years, relaying complaints to us, etc.

My questions are: What are the US FDA's requirements for foreign distributors of medical devices, if any? Must they keep specific type of records for X amount of years, or have a postmarket surveillance program, etc.? What information must we as the manufacturer be able to collect from the foreign distributor if they were to sell our medical devices in Australia (or anywhere else besides the US) if an incident were to occur from one of their non-US sales?

All I can seem to find are requirements for what I believe are domestic (US) distributors, that they must maintain complaint records for 2 years or the expected life of the device, whichever is greater, from section 803.18(d)(1)-(3)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=803.18

I'm thinking that the US isn't supposed to control foreign distributors' activities to such extents. I want to find out what needs to be spelled out in the contract to meet US regulatory requirements.

Any insight or a hint to where to look would be much appreciated. Thank you in advance!
 
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