From February 11th 2002, all companies and manufacturers who apply for the FDA registration outside America have to inform the FDA their American authorized representative’s name, address and phone number. Every company must assign a unique American authorized representative no matter how many products of medical device, medicine or biological product it products. It’s main purpose is to make it convenient for FDA to contact or to deal with some regulation fairs with American agent. Besides, the American agent can deal with annual registration and payment, additional product registration. Also, he will help FDA with the import regulation problems and relevant auditing. American medical device agent must be American or enterprise agent in America, not a answering machine or a fax machine or just an email address. As an American agent, it must be contacted in 24 hours.
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Trade Leads Directory -> All Trade Leads -> Health & Beauty -> Medical Supplies -> American Medical Device Authorized Representative
