Ensure Smooth Global
Trade with US FDA
Export Certificates

When exporting FDA-regulated products from the United States, foreign customers or governments often require an Export Certificate as proof that your product complies with US regulations. These certificates confirm a product’s regulatory or marketing status, helping to streamline customs clearance and facilitate international trade.

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2,000+ Medical Device Manufacturers Trust Registrar Corp

What is an FDA Export Certificate?

Official document issued by the FDA

Confirms product complies with US regulations

Verifies legal marketing status in the US (if applicable)

Confirms manufacturing facility meets FDA standards

Types of US FDA Export Certificates

Medical Devices - Export certificate types

Certificate to Foreign Government (CFG) – Food

Conventional foods, food additives, food contact
substances, infant formula

Certificate for Cosmetics

Cosmetic products under section 201(i) of the FD&C Act

Certificate to Foreign Government (CFG) Medical Devices

Medical devices for export

Health Certificates

Collagen and gelatin products intended for export to
the European Union (EU)

Certificate of a Pharmaceutical Product (CPP)

Human drugs

Certificate of Free Sale

Dietary supplements, medical foods, foods for special
dietary use

How Registrar Corp Helps You Obtain an FDA Export Certificate

Navigating the export certificate process can be complex. Different countries have unique requirements, and FDA’s documentation process can be time-consuming. Registrar Corp simplifies this process by:

Determining Eligibility

Ensuring your product and facility meet FDA’s requirements for certification

Preparing and Submitting Requests

Helping you compile the necessary documentation  and submit a complete request to FDA

Expediting the Process

Avoiding delays by ensuring your application is  accurate and complete

Providing Compliance Guidance

Advising on additional regulatory steps needed
for international trade

Medical Devices - Registrar Corp Helps obtain FDA export certificate

Case Study: Securing an Export Certificate for 
a Medical Device Manufacturer

Challenge:

A US medical device company faced delays in obtaining a CFG due to
missing documents and incomplete compliance checks.

Solution:

Registrar Corp ensured 21 CFR Part 820 compliance, compiled required
FDA documentation, and submitted a complete application.

Results:

CFG approved in record time, enabling market entry in Europe and the
Middle East while avoiding future delays.

Get Your FDA Export Certificate Today

Avoid costly shipment delays and regulatory roadblocks. Registrar Corp makes it easy to obtain the right FDA export certificate for your products.

Step 1: Complete the form

To be able to work with you, we would need certain basic
contact details and the type of export certificate you need.

Step 2: We review your request

Once you fill the form, our regulatory specialists will review your request
and reach out to you to confirm the required documentation and the
timelines, payment details etc.

Step 3: We submit your application

Once we have your details, we will submit your application and guide you through any
additional steps if needed. Our regulatory advisors will keep you updated at every step.

Step 4: You receive the certificate

On successfully fulfilling all requirements, you will receive your FDA
export certificate to be able to expand your global reach.

Why Global Drug Companies Choose Registrar Corp?

20+ Years of FDA
Regulatory Expertise
Trusted by thousands
of global manufacturers

Faster Approval Times
Avoid delays with
expert-guided
applications

Hassle-Free Process
We handle the paperwork
and submissions for you

End-to-End Compliance
Support Beyond export
certificates, we assist
with labeling, facility
registration, and more

Need help? Speak with
an FDA compliance specialist
to start the process

Request a consultation