US importer and distributor requirements.
A medical device manufacturer who exports products to the United States (US) may risk success in this activity by not being aware of US importer and distributor requirements. This article discusses the requirements and actions that nonUS manufacturers should take to ensure these requirements are met.
Donawa
Maria
M
Donawa Consulting. medonawa@donawa.com
D003132:Commerce / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000592:standards; D004864:Equipment and Supplies; D005060:Europe; D005568:Forms and Records Control / Q000592:standards; D006801:Humans; D007391:International Cooperation; D011358:Product Surveillance, Postmarketing / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*