Here's our situation:
- We are a US-based LLC that sells a custom-branded, 501(k) exempt, Class I medical device for the skincare/beauty industry.
- Our Chinese manufacturer applies our branding & labeling to the device & packaging. They ship the final packaged product directly to a third-party logistics provider's (3PL) warehouse in the US that fulfills orders from our online store.
- Our Chinese manufacturer is probably private label manufacturing for other companies as well.
- Our Chinese manufacturer is registered as a Foreign Exporter establishment with the FDA. The device is also listed and associated to their establishment.
- Do we need to register ourselves with the FDA? If so, as what? An initial importer?
- Who should be responsible for the UDI registration/labeling requirements—we or the manufacturer? Especially if the manufacturer does private label manufacturing for other companies/brands.