Amazon will ask you some documents to prove that the product is registered in the US. And also that you havr a US Agent. If you need help let us know at easymedicaldevice.com
Perhaps my understanding is not right, but it seems that you are talking about resellers (distributors?) Of product that should be MD but are not yet (ex. Not the right classification / lack of technical file) but what if I want to distribute a device made by a major manufacturer that we know as a RA team to have a real MD. Then, as a reseller, which level of paperwork should I build? Would it be enough to ask him is DoC, write down a contract basically saying he keeps all the responsibilities over his product without looking at anything else (ex. Risk management file) ?
Hi, how do I get in touch with Michael Wetherington? Wondering if online sale of compression nebulizers is allowed on Amazon within the United States
Amazon will ask you some documents to prove that the product is registered in the US. And also that you havr a US Agent. If you need help let us know at easymedicaldevice.com
Perhaps my understanding is not right, but it seems that you are talking about resellers (distributors?) Of product that should be MD but are not yet (ex. Not the right classification / lack of technical file) but what if I want to distribute a device made by a major manufacturer that we know as a RA team to have a real MD. Then, as a reseller, which level of paperwork should I build? Would it be enough to ask him is DoC, write down a contract basically saying he keeps all the responsibilities over his product without looking at anything else (ex. Risk management file) ?
Did you find an answer to this?
timecode for FDA please?