FDA Registration for Medical Device Manufacturers
Medical device establishment registration, device listing, and US Agent services. Contact us for a custom quote.
Get a Free QuoteHow medical device registrations are handled
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- ✓ Response target within 24 hours
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- ✓ Covers Class I, II, and III devices
Medical Device Registration Overview
Foreign manufacturers shipping medical devices to the United States must register their establishment and list their devices with the FDA. The process includes obtaining an FEI number, registering the establishment, listing each device, and designating a US Agent.
FDA establishment registration is required before any device can be commercially distributed in the US.
Each device must be listed with FDA under a product code and regulation number.
A US Agent must be designated for all foreign establishments.
Annual registration renewal is required each year between October 1 and December 31.
Questions device manufacturers ask before starting
Common questions from foreign medical device manufacturers before they begin US registration work.
Do foreign medical device manufacturers need FDA establishment registration?+
Yes. Any foreign establishment that manufactures, prepares, propagates, compounds, or processes a medical device for commercial distribution in the US must register with FDA.
What is the difference between establishment registration and device listing?+
Establishment registration identifies your facility with FDA. Device listing identifies the specific devices you manufacture. Both are required.
Do I need a US Agent for medical devices?+
Yes. All foreign medical device establishments must designate a US Agent who serves as FDA’s point of contact.
When must I renew my device establishment registration?+
Annual registration renewal is required each year between October 1 and December 31. Failure to renew can result in your products being refused entry at the US border.