Over the years we’ve worked with hundreds of companies to get their facilities registered and their products listed so they can meet their obligations, during which, we’ve come across a lot of misconceptions about registration. Here are some of the primary issues we see each year.
Only the importer or exporter must register: FICTION.
The requirements for which types of facility in the supply chain must register vary by commodity, and which specific facility must register may depend on your business structure or supply chain. However, as a rule of thumb, the manufacturer for any FDA-regulated commodity must be registered with the FDA, and in some cases must submit a listing of each of its products.
Registration is quick and easy: FICTION.
Depending on your commodity, there may be several prerequisites to set up before you can register. For instance, drug companies must have a current DUNS number, and device facilities have to create an account on a separate government website to pay the fee before registration.
Not registering (or renewing) is no big deal: FICTION.
Between June 2015 and October 2016, there were more than 7,000 products subject to import detain because it appeared the registration/listings were not done properly. You may not get caught right away, but the new Automated Customs Environment system for brokers makes it much more likely.
Registrations must be renewed or updated frequently: FACT.
The renewal period varies by commodity (drug, medical device, and tobacco facilities renew annually; food facilities renew every even-numbered year). However, if any of the registration information changes before the renewal period, you should update your registration.
My importer can be my U.S. Agent: BOTH
Acting as the U.S. Agent is a responsibility and a risk; the U.S. Agent’s purpose is to facilitate communications with the foreign facility, but the U.S. Agent can be held responsible for some fees. FDA is now moving toward a process where it asks the designated U.S. Agent to confirm their willingness to serve before FDA will finalize the registration. Make sure your importer is willing before you designate them!
Registration and listing is basically just filling out forms: FICTION.
Though it’s true that previously registration and listing did involve simply filling out and submitting paper forms, FDA has increasingly moved into online systems for these submissions. These systems involve huge amounts of technical validation, and often require specific information or formats in order to accept submissions. For example, a drug listing can only include ingredients whose names are included in the Unique Ingredient Identifier database – and only by those exact names.
Registration and listing can be a complex, tedious process, involving some legal analysis and requiring you to create accounts on multiple government websites and match data in obscure databases. FDAImports.com has extensive experience in this work, and we stand ready to assist companies of all sizes. Contact us today for further information or assistance with FDA registration and listing.
