From February 11th 2002, all companies and manufacturers who apply for the FDA registration outside Americah***e 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 le***e a bad impression on FDA because of some fake information the enterprise provided. The main resp***ibility of the American agent is to help FDA to contact with relevant foreign enterprises, to answer questi*** 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 regulati***. Therefore, to find an American agent is a fast and convenient way for enterprises and their exported products.
O***unda medical device c***ulting organization is the only c***ulting organization which focuses on the field of medical device. We are able to provide medical devices regulati*** c***ulting, medical devices registration c***ulting, medical devices good manufacturing practice(GMP) c***ulting, ISO13485 registration c***ulting, FDA510K registration, FDA medical devices agent service, European CE registration c***ulting and medical devices clinical trail and other services.