Global Import Agent
Global compliance services

Medical Devices & Cosmetics

FDA registration, listing, labelling and GMP support for medical devices and cosmetics entering the US.

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Specialist support for your route to market.

510(k)

510(k) Premarket Notification support for medical devices entering the US market.

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GMP

GMP audits, documentation and training for medical device and cosmetic manufacturers.

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Client feedback

Trusted support, in our clients’ own words.

“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 MckayAstute Beverages
Frequently asked questions

Medical Devices & Cosmetics

Requirements vary by product and destination. These answers outline the starting point for the questions we receive most often.

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Do I need to register my medical device or cosmetic facility with the FDA?

Yes. All manufacturers, repackers, and distributors of medical devices must register their facilities annually. Cosmetic facilities are not required to register unless they manufacture OTC (over-the-counter) products or use restricted ingredients.

What is a 510(k) premarket notification, and does my medical device need one?

A 510(k) is a premarket submission required for certain Class II medical devices to demonstrate that the device is substantially equivalent to an already legally marketed device. Not all devices require a 510(k) submission, but we can help determine if yours does.

What are FDA labeling requirements for cosmetics?

Cosmetic labels must include:

  • Identity statement (product name)
  • Net quantity of contents
  • Ingredient list in descending order
  • Name and address of the manufacturer or distributor
  • Required warnings (if applicable)

Additionally, cosmetic products cannot contain drug claims (e.g., “treats acne”) without being classified as an over-the-counter drug.

Can my cosmetic product contain color additives?

Only FDA-approved color additives are allowed in cosmetics. Certain colors require batch certification, and others may only be used in specific types of products (e.g., eye-area products). We review formulations to ensure compliance.

What happens if my medical device or cosmetic product is detained by the FDA?

If your product is detained, we can assist in:

  • Identifying the cause of the detention
  • Communicating with the FDA and Customs
  • Preparing necessary documentation for release
  • Implementing corrective actions to prevent future detentions

What are the main reasons medical devices and cosmetics are refused entry into the U.S.?

Products may be refused entry due to:

  • Missing or incorrect FDA registration
  • Non-compliant labeling or packaging
  • Unauthorized ingredients or restricted substances
  • GMP violations or poor manufacturing practices
Discuss your requirements

Talk through your product and target market with our team.

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Consultation

Tell us what you need to import.

Share your product, target market and compliance question. A member of our team will respond promptly.

Scope your product and target market
Identify the applicable regulatory route
Receive a clear proposal and next steps