FDA Certification

FDA Certification in UAE

Helping UAE manufacturers and exporters of food, drugs, dietary supplements, cosmetics, and medical devices get FDA-registered to access the United States market.

FDA Certification - what does it mean?

The US Food and Drug Administration (FDA) is the federal agency that protects public health by regulating food, drugs, medical devices, cosmetics, and related products. "FDA certification" is the common term for meeting the FDA's requirements to sell these products in the United States - which, for most products, means registering your facility with the FDA. It's important to understand that the FDA itself does not issue an "FDA certificate" or "approve" your facility; registration records that your establishment is registered, and you cannot label products as "FDA approved."

How to get an FDA registration number?

An FDA registration number confirms that an establishment is registered with the US FDA. It applies to the establishment, not to specific products, it does not prove FDA approval, and it should not be printed on product labels. The FDA does not issue a "registration certificate" itself - IACS can manage the registration on your behalf and issue a confirmation that your registration is complete, that your company is registered, and that your registration number is valid.

Registration, clearance, and approval

• Registration: food, drug, device, and cosmetic facilities register with the FDA (and list products where required).
• Clearance (510(k)): most moderate-risk medical devices are "cleared" before marketing.
• Approval: high-risk devices (PMA) and new drugs (NDA) are "approved" based on safety and effectiveness data.

Who can apply?

• Food facilities: must register with the FDA (and renew biennially) to export food to the US.
• Drug manufacturers: register the establishment and list drugs; new drugs require FDA approval.
• Medical device manufacturers: register and list devices; many require 510(k) clearance, and high-risk devices require PMA approval.
• Dietary supplement manufacturers: register their facility. The FDA does not approve supplements before marketing (new dietary ingredients require notification). 
• Cosmetic manufacturers: under MoCRA, facility registration and product listing are now mandatory (the voluntary VCRP was discontinued in 2023). 

What we do and how we help?

IACS helps UAE manufacturers of food, drugs, dietary supplements, cosmetics, and medical devices get FDA-registered and obtain a valid registration number, at a competitive price. We help you determine what applies to your product, prepare and submit the registration, and meet related requirements such as the US Agent. 

How to apply?

• Identify your product category and the FDA requirement that applies (registration, listing, clearance, or approval)
• Contact IACS with your details to discuss the right route for your product
• Prepare your establishment and product information (and appoint a US Agent as a foreign establishment)
• IACS submits your registration and product listing to the FDA
• Receive your FDA registration number and an IACS confirmation that registration is complete

Contact us to discuss FDA registration for your products.

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