Companies can export or import products to or from the United States as long as the facilities that produce, store, or otherwise handle them are registered with the U.S. Food and Drug Administration (U.S. FDA), and prior notice of incoming shipments is provided to the FDA.
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ITB HOLDINGS LLC assists companies around the world with their FDA Registration needs, including manufacturers of hand sanitizers, N95 masks and other COVID-19 (Coronavirus) personal protective equipment (PPE), as well as ventilators covered by Emergency Use Authorizations (EUA)s .
FDA Biennial Registration Renewal for domestic and foreign Food Facilities was required between October 1 and December 31, 2020. If you failed to renew your registration, you must now obtain a new FDA Registration Number.
- Foreign Food Facility Registration
- Domestic Food Facility Registration
- U.S. Agent Service
U.S. FDA’s Center for Devices and Radiological Health (CDRH) approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high mark set in 2018, in response to the COVID-19 pandemic.
Of the 625 Emergency Use Authorization (EUA) or EUAs the FDA issued for medical devices in 2020, such as tests and sample collection devices, personal protective equipment (PPE), ventilators, and others, several were for novel medical devices, including in vitro diagnostic devices for COVID-19.
The U.S. Food and Drug Administration (FDA) is warning manufacturers, exporters, importers and distributors: Methanol is not an acceptable active ingredient for hand sanitizers and must not be used, due to its adverse events including deaths.
Exporting Hand Sanitizers or PPEs? Contact ITB HOLDINGS LLC, today, to register your company and list your products, with extra savings. Make sure your DUNS Number is current.
Don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, European Union, are the same or similar.