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. If the American agent can not be contact by FDA after registration, that enterprise will be cancel this registration and must be required to register again. And this may leave a bad impression on FDA because of some fake information the enterprise provided. The main responsibility of the American agent is to help FDA to contact with relevant foreign enterprises, to answer questions about imported products and scheduling for foreign factory's examination. If information or documents cannot be sent to foreign enterprises immediately by FDA, they can received by related American medical device agent.
Some enterprises may feel very confused in the process of digital registration because of their limited understanding of foreign language, professional abilities and FDA registration regulations. Therefore, to find an American agent is a fast and convenient way for enterprises and their exported products.
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