Certificate of Exportability Legalization for UAE

For companies exporting pharmaceuticals, biologics, or medical devices from the United States to the United Arab Emirates (UAE), the legalization of a Certificate of Exportability is often a critical requirement. Whether for product registration, customs clearance, or compliance with UAE health regulations, this certificate must be authenticated and legalized before it can be officially accepted by UAE authorities.

The Arab American Chamber of Commerce provides specialized services for Certificate of Exportability legalization, ensuring that your documents meet UAE standards and are processed with precision and efficiency.

Understanding Certificate of Exportability Legalization

A Certificate of Exportability is an official document issued by the U.S. Food and Drug Administration (FDA). It allows the export of products that are not authorized for marketing in the United States but can be legally exported under Section 801(e) of the Federal Food, Drug, and Cosmetic Act. This certificate verifies that such products comply with U.S. export regulations and can be shipped to foreign markets.

While issued by the FDA, the document cannot be used directly in the UAE without proper legalization.

Since the UAE is not a member of the Hague Apostille Convention, apostille certification alone is not sufficient. Instead, a Certificate of Exportability must undergo a full legalization chain to be officially recognized by UAE authorities.

Why the UAE Requires Legalization of Certificate of Exportability

The UAE government enforces strict documentation standards to safeguard public health and ensure that imported products are genuine and compliant. Certificate of Exportability Legalization gives UAE officials assurance that products exported from the U.S. meet regulatory requirements and are eligible for export under FDA oversight.

Common purposes for which a legalized Certificate of Exportability may be required in the UAE include:

• Product Registration: To register pharmaceuticals, biologics, or devices with UAE health authorities.

• Customs Clearance: Required to release shipments of FDA-regulated goods at UAE entry ports.

• Regulatory Compliance: Demonstrates that products comply with U.S. export laws and UAE import regulations.

• Import Licensing: Often needed when applying for licenses to distribute U.S.-made products in the UAE.

• Market Entry Support: Facilitates approval for products that are not sold in the U.S. but are authorized for export.

The Role of the Arab American Chamber of Commerce

Working through the legalization process independently can be time-consuming and complicated, with strict requirements that must be followed carefully. The Arab American Chamber of Commerce offers a streamlined solution for individuals and organizations requiring Certificate of Exportability legalization for the UAE.

Key Benefits:

• Professional Expertise: Skilled specialists handle each step of the process.

• Time Efficiency: The Chamber minimizes delays by coordinating directly with the relevant authorities.

• Regulatory Compliance: Every document is processed in accordance with UAE standards.

• Reliable Recognition: Documents legalized through the Chamber are trusted and accepted by UAE agencies.

By using professional legalization services, individuals avoid errors that could result in rejections or additional costs.

Ensuring Compliance with Confidence

Legalizing a Certificate of Exportability is a vital step for U.S. exporters seeking to enter the UAE market with FDA-regulated products. Given the detailed procedures and strict standards involved, professional assistance ensures peace of mind, compliance, and efficiency.

The Arab American Chamber of Commerce is a trusted partner for Certificate of Exportability legalization, offering reliable, accurate, and compliant services tailored to UAE requirements. With their expertise, U.S. exporters can confidently expand into the UAE, knowing their documentation will be officially recognized and accepted.