Did you know? If your medical device or drug facility is not registered (or renewed) by December 31, 2013, you may not be able to import products to the United States. The U.S. FDA requires any facility that handles an FDA-regulated good to register. Members of some industries (drugs and medical devices) must also list their products with FDA and – if they’re located outside the U.S. – identify any known importers. This last is the latest in a long chain of updates and modifications to the system and requirements for registration, most of which have only served to increase the burden on registrants.
Any registered facility must renew its registration with FDA by December 31, 2013, or the registration will become inactive and FDA may detain its shipments at the border. The FDA fee for registration and renewal for fiscal year 2014 is $3,313. If you attempt to pay the User Fee before October 1, you will be charged $2,575, which will only apply for the end of fiscal year 2013.
It can take FDA 3-5 business days to process a user fee payment and return confirmation, and it’s not possible to complete the registration or renewal process without their confirmation. All together, the registration process can take two or more weeks – so get started today! Don’t let your registration lapse and your shipments be stopped! Contact FDAImports.com to find out how we can help you with your registration or renewal, starting at $29.
