What you should consider when importing PPE
Personal Protective Equipment (PPE)
Under the EUA (Emergency Use Authorization), the FDA accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea, and Mexico who have similar standards to NIOSH (National Institute for Occupational Safety and Health).
FDA issued a new EUA for non-NIOSH-approved N95 respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator meets certain standards.
■ Determine whether the manufacturer is registered with the FDA, and has a DUNS Number.
■ Ask the manufacturer to provide Owner / Operator Number.
■ Request the Listing Number for each product.
■ Make sure you have your company’s Employer Identification Number (EIN) and DUNS Number.
Then, contact ITB HOLDINGS LLC to register your company as Medical Device Establishment.