Owners or operators of companies that produce and distribute medical devices intended for commercial distribution in the U.S., including products that are imported for export only, must register annually with the FDA. Foreign and domestic medical device facilities that do not renew their registrations with the FDA by December 31, 2021, could be restricted from the U.S. market. Failure to submit, renew, update, or cancel a registration could also result in civil or criminal penalties.

If you need assistance with registration or have questions regarding this process, reach out to Mohawk Global Trade Advisors.

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