Dear Liyan,
1.The FDA, Request more document that is ISO 13485.
2.Along with the certificate, The FDA officials inform us " if we do not stated the brand name and not clear about the packing detail we cannot release our goods from the customs. Since this government An examination of more strictly. If the documents or goods that are not clear. They refused to release it. So, The authorities can not guarantee document to be imported to us.
Anyhow, we needed your help.