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FDA Registration for Medical Device & Cosmetic Facilities

Expert Facility Registration Services for Medical Devices & Cosmetics

Our FDA Registration Services for Medical Device and Cosmetic Facilities provide end-to-end support, ensuring accurate registration, timely renewals, and ongoing compliance with FDA regulations, including 21 CFR Part 807 for medical devices and FD&C Act requirements for cosmetics.

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Why FDA Facility Registration is Essential

The FDA requires registration of all domestic and foreign facilities involved in the production, processing, packing, or distribution of medical devices and cosmetics intended for the U.S. market.

Key compliance reasons:

  • Legal requirement for U.S. market access
  • Prevention of import detentions and shipment delays
  • Compliance with FDA inspection protocols
  • Fulfillment of U.S. Agent designation for foreign facilities

Consequences of non compliance:

  • Refusal of entry at U.S. ports
  • Product recalls and enforcement actions
  • FDA warning letters and potential legal penalties
  • Loss of consumer trust and brand reputation

Our comprehensive FDA registration services ensure seamless compliance, uninterrupted market access, and regulatory peace of mind.

Medical & Cosmetic Registrations

FDA Registration Services for Medical Device & Cosmetics

Initial FDA Medical Device Registration

We manage the entire facility registration process, ensuring compliance with FDA requirements for medical devices (21 CFR Part 807) and cosmetics (FD&C Act).

  • Facility details entry, including activities and product categories
  • Confirmation of registration completion with FDA registration number issuance
  • U.S. Agent designation for foreign facilities

Annual FDA Registration Renewal

FDA registrations for medical devices and cosmetics must be renewed annually between October 1 and December 31. We ensure on-time renewals.

  • Annual renewal submissions to maintain active FDA registration
  • Monitoring of regulatory updates affecting renewal requirements
  • Immediate updates on renewal status and compliance notifications

Medical Device Listing Services

In addition to facility registration, medical device manufacturers must list all devices intended for U.S. distribution. We provide accurate device listing services aligned with FDA requirements.

  • FDA medical device listing submissions via FURLS
  • Support for device modifications and updates in FDA records
  • Annual listing maintenance and re-submissions as required

Cosmetic Product Labeling & Ingredient Compliance Support

Although the FDA does not pre-approve cosmetic products, facilities must ensure compliant labeling and ingredient safety under FD&C Act standards to ensure they meet FDA regulations.

  • Review of cosmetic product labels for FDA compliance
  • Ingredient analysis for restricted or banned substances
  • Country of origin labeling and manufacturer details verification

U.S. Agent Representation for Foreign Facilities

Foreign manufacturers must appoint a U.S. Agent to handle FDA communications and emergency inquiries. We provide reliable U.S. Agent services for medical device and cosmetic facilities.

  • Official U.S. Agent designation for FDA registration purposes
  • Support for regulatory inquiries and compliance notifications
  • Assistance with post-market surveillance requirements

FDA Registration Amendments & Updates

FDA facility information changes, such as ownership transfers, address modifications and updates, or product expansions, must be promptly updated with the FDA. 

  • Device listing modifications to reflect new products or changes
  • Timely updates to avoid registration invalidation
  • Verification of submission acceptance by the FDA

Why Choose Our FDA Registration Services?

FDA Expertise

Specialists in medical device (21 CFR Part 807) and cosmetic facility registration requirements.

End-to-End Support

From initial registration to annual renewals, device listings, and U.S. Agent representation.

Timely Submissions

Error-free registrations submitted on time to avoid compliance interruptions.

Global Reach

Comprehensive support for domestic and foreign facilities, including international regulatory insights.

Global Import Agent have successfully worked with me to land product in the U.S and remain compliant for FDA regulations. I'm really happy with their response times, and easy to use tech platform that facilitates the process.
Jane Mckay
Jane MckayAstute Beverages
I had hit a brick wall trying to get my FDA number for export of my rum to the USA. Ryan and James knew all the right contacts to sort this out for me. I could not have done it without Global Import Agent. They even sorted out my prior notification paperwork for me. I can highly recommend them.
James Singlehurst
James SinglehurstRevival Rum
Ryan, Chris and their team were exceptional in getting our food supplement product FSVP compliant. Pretty good experience with Global Import Agent overall.
Kelvin Yeo
Kelvin YeoAdvagen
Great level of service in the 3 months we have been working with Global Import Agent to date. From the first call with Fabrizzio to the comms with Ryan, James & Carlos, all has been good and the progress we are making is fantastic!
Jeff Webster
Jeff WebsterHunter & Gather
I recently had the pleasure of working with Ryan and his team for a label review of a dietary supplement, which was intended for commercialization in the United States. My experience was overwhelmingly positive, as they provided exceptional and professional support throughout the process.
Renato Di Lorenzi
Renato Di LorenziLoli Pharma
We use Global Import Agent as our FSVP agent for importing dietary supplements into the US from the EU. They've provided us with professional high-quality service thus far. Recommend!
Keiu Kadarik
Keiu KadarikEcosh Life
We were a start up working on our first import, and Global Import Agent was superb in taking care of our documentation and import process. Highly recommend.
Hee Joong Kim
Hee Joong KimMuom Life
Ryan is very helpful from the beginning to end. He responds super fast and he is on point to the issue / objectives.
Wonsik Woo
Wonsik WooLifeLab
James, Ryan and Carlos have been really helpful all along our FSVP. Great service.
Anahi Cabrera Herrera
Anahi Cabrera HerreraScience In Sport
Flexible and helpful FSVP agent. After comparing a couple of agents, this one is the one we picked. No regrets!
Andreas Edström
Andreas EdströmSwedish Signature AB
they are fast, efficient, and always open to help. They have been a great support for me and my company
Alba Rodríguez
Alba RodríguezGricha
Great to deal with, cost efficient and professional, highly recommended
Stephen Goument
Stephen GoumentGolden Turmeric
​What our clients say

Client Feedback

Read what our clients have to say about our services and how we have helped them export product.

Q. Who must register their facility with the FDA?

  • Medical Device Facilities: Manufacturers, distributors, repackagers, and relabelers.
  • Cosmetic Facilities: Domestic and foreign manufacturers, packers, and distributors intending to market in the U.S.

Q. How often must FDA registrations be renewed?

  • Annually between October 1 and December 31.
  • Failure to renew on time may result in registration invalidation and import refusals.

Q. Do foreign manufacturers need a U.S. Agent?

  • Yes, all foreign facilities must appoint a U.S.-based Agent for FDA communications.
  • We provide full U.S. Agent services with 24/7 availability.

Q. What happens if my facility isn’t registered?

  • FDA may refuse entry of your products into the U.S.
  • Your business could face regulatory penalties, recalls, and legal action.
  • Registration is also essential for FDA inspections and market surveillance.

Q. What additional requirements apply to medical devices?

  • Device listing for all medical devices intended for U.S. sale.
  • Compliance with Unique Device Identification (UDI) requirements.
  • For certain classes, Premarket Notification (510(k)) or Premarket Approval (PMA) may be required.

Q. What cosmetic products require registration?

While cosmetic facility registration is voluntary, it is highly recommended for:

  • Products with therapeutic claims
  • Color additives requiring FDA certification
  • Products imported into the U.S., as it facilitates customs clearance

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Our team is friendly, responsive and we love to talk to people interested in what we do. Feel free to get in touch and one of our team will always get back to you. Guaranteed!

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Get Expert FDA Facility Registration Support Today

Accurate FDA facility registration is essential for regulatory compliance and uninterrupted market access in the U.S. Our FDA Registration Services for Medical Device and Cosmetic Facilities ensure error-free submissions, timely renewals, and continuous regulatory compliance, allowing you to focus on your business growth without regulatory setbacks.

Our friendly team is always happy to help and will reach out as soon as possible.


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