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When should I register as an establishment for medical device exports?
Domestic establishments must register within 30 days of the establishment entering into any activity requiring registration, including processing devices for exportation outside of the U.S. If you are required to list your devices, you must submit device listing information at the time of initial registration. Foreign establishments must register, notify us of their United States agent, as well as list their devices prior to exporting to the U.S. Your registration must be renewd annually each year. The registration period extends from October 1st through September 30th. How to Register In September, 2007, Section 207 of the Medical Device User Fee Modernization Act of 2002 (MDUFMA) amended section 510 of the Federal Food, Drug and Cosmetic Act (the Act) to require electronic submission of device registration and listing information unless FDA grants a waiver request. MDUFMA also authorizes FDA to collect a user fee for annual registration of certain types of establishments. Effective October 1, 2007, all establishment registrations are to be submitted electronically using FDA
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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