US FDA Export Certificate

U.S. FDA Export Certificate

Firms exporting food, products from the United States are often asked by foreign customers or foreign governments to supply an export certificate for products regulated by U.S. FDA. An export certificate is a document prepared by U.S. FDA containing information about a product’s regulatory or marketing status.

FDA issues export certificates by industry as follows:

Certificate to Foreign Government (Conventional foods, food additives, food contact substances, infant formula)
Certificate for Cosmetics (Cosmetic products identified under section 201(i) of the FD&C Act (21 U.S.C. 321(i))
Certificate to Foreign Government (Medical devices)
Health Certificates (Collagen and gelatin products intended for export to the European Union (EU))
Certificate of a Pharmaceutical Product (Human drugs)
Certificate of Free Sale (Dietary supplements, medical foods, foods for special dietary use)

Registrar Corp can help you obtain an export certificate. Simply complete the form below:

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GCLID
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International Office Email
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Download Type
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Inquiry Type*
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Industry
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Campaign Content
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Match Type
My company imports*
- Seafood
- Juice
Detention Options
- I need assistance with a U.S. FDA Detention
- I need assistance with a U.S. FDA Import Alert
I would like to export to
I would like assistance with

Food and Beverages

Dietary Supplements

Medical Devices

Drugs

Cosmetics
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I would like assistance with
- Registration
- Agent Located in Region
- Labeling Requirements
- Good Manufacturing Practices
- Safety Plans
- Color Additives
- Adverse Event Reporting
- Master Files
- Other
Specify Other*
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Regulations Summary
What type(s) of Master File do you need assistance with?
What countries do you want to submit your Master File to?
Provide your company information
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Assessment Type
- Label Assessment
- Food Safety Plan Assessment
- Post BTA
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File to assess
- Food Safety Plan
- Product Labels
Is your Food Safety Plan FDA-Compliant?

U.S. FDA requires most types of registered food facilities to implement Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plans. A HARPC plan must follow unique standards mandated by U.S. FDA. Other food safety systems may not completely satisfy FDA requirements.
U.S. FDA requires most types of registered food facilities to implement Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plans. A HARPC plan must follow unique standards mandated by U.S. FDA. Other food safety systems may not completely satisfy FDA requirements.
Deadline Approaching for FDA's New Label Rules

Many food companies have less than 12 months to update their labeling to comply with new FDA labeling rules. The new rules include updates to the nutrition facts chart, serving sizes, mandatory declarations, and more.
Labeling mistakes result in more than 22% of all detentions in the United States.

Many companies do not realize their labels are non-compliant until their products are detained, which may result in delays, re-labeling expenses, or destruction of inventory. Help avoid costly issues in port. Have Registrar Corp's experts assess the FDA compliance of your labels.
Upload your current Food Safety Plan for a free assessment
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Max. file size: 50 MB.
Upload your product labels for a free preliminary assessment
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Max. file size: 50 MB.
Do you have your Registration and PIN?*
- Yes
- No
Do you have your FURLS Username and Password?*
- Yes
- No
NOTE: Registrar Corp cannot verify or recover your registration without:
- Your Registration Number and PIN
- or
- your FURLS Login and Password.
If you do not have either set of information, we encourage you to re-register.
Re-Register Now
Routing Number*
Country*
Company Name*
Contact Name*
Email*
Phone*
Physical Address*
City*
State / Province / Region
Postal Code
Is your company headquartered in the United States?*
Approximate Number of Suppliers
I Need Assistance With:
- Regulatory Updates via Email
- New FDA Food Facility Registration
- Renew FDA Food Facility Registration
- U.S. Agent Service for FDA Communications
- Facility 360
- FDA Prior Notice
- Labeling and Ingredient Review
- FCE-SID Regulations
- Preparing for FDA Inspection
- HACCP or HARPC Food Safety Plan
- Food Defense Plan
- Foreign Supplier Verification Program (FSVP)
- Detention/DWPE Assistance
- FDA Compliance Monitor
- Other
I Need Assistance With:
- Regulatory Updates via Email
- Drug Establishment Registration
- Drug Listings
- New Blanket No-Change Certification
- U.S. Agent and Registrant Contact
- Self-Identification for Generic Drugs
- Drug Labeling and Ingredient Requirements
- Drug Master Files
- eCTD Requirements
- Detention/DWPE Assistance
- FDA Compliance Monitor
- Other
I Need Assistance With:
- Regulatory Updates via Email
- Cosmetic Labeling and Ingredient Requirements
- California Safe Cosmetics Reporting
- Voluntary Cosmetic Registration Program (VCRP)
- Color Additives / Color Batch Certification
- Detention/Import Alert Assistance
- Other
I Need Assistance With:
- Regulatory Updates via Email
- Medical Device Establishment Registration
- U.S. Agent and/or Official Correspondent
- Device Listings
- Unique Device Identifier (UDI) Requirements
- Device Labeling Requirements
- Electronic Medical Device Reporting (eMDR)
- Medical Device Master Files (MAF)
- Detention/Import Alert Assistance
- Other
Specify Other*
Website
Comments
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Registration Status
FDA Registration Number*
(11 Digit Number)
FDA PIN*
(Please indicate capital letters)
FURLS Username*
FURLS Password*
Medical Device Owner / Operator Number
DUNS Number
Facility Establishment Identifier
Labeler Code
Compliance Information
FDA Registration Number
FDA PIN
List Products You Would Like to Ship*
Upload Labels for the Products Listed Above
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Max. file size: 50 MB.
Upload Food Safety Plan*
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Max. file size: 50 MB.
FCE Registration Number*
SID Numbers*
Upload Your Product Label
Max. file size: 15 MB.
Upload Your Food Safety Plan
Max. file size: 15 MB.
Upload Your Product Label
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Max. file size: 15 MB, Max. files: 10.
Upload Your Food Safety Plan
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Max. file size: 15 MB.
Upload Your HACCP Plan
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Max. file size: 15 MB.
Upload The Detention's Notice of Action
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Max. file size: 15 MB.
Upload your MMRs
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Max. file size: 15 MB.
I would like assistance with
- Export Listing Requirements
- Export Certificates
Which Products Would You Like Help With?
- Dairy Exports to Chile, China, or the EU
- Collagen and Gelatin Exports to the EU
- Seafood Exports to the EU or China
- Infant Formula Exports to China
What type of Export Certificate do you need?*
- Certificate to Foreign Government - Food
- Certificate of Free Sale - Dietary Supplements
- Certificate to Foreign Government - Medical Devices
- Certificate of a Pharmaceutical Product
- Certificate of a Cosmetic Product
- Health Certificates - Collagen and Gelatin Exported to the EU
Which best describes your device?*
- The manufacturer holds at least one NIOSHNIOSH uses very high standards to test and approve respirators for occupational uses. NIOSH-approved disposable respirators are marked with the manufacturer’s name, the part number (P/N), the protection provided by the filter (e.g., N-95), and "NIOSH," This information is printed on the facepiece, exhalation valve cover, or head straps. approval for a filtering facepiece respirator that is produced in accordance with applicable standards of authorization in other countries
- The device has a regulatory authorization under a jurisdiction other than China
- The device demonstrates acceptable performance to applicable standards documented by reports from a recognized independent test laboratory
- The device is on the Centers for Disease Control and Prevention (CDC) list of respirator alternatives during the COVID-19 pandemic.
NIOSH Approved Respirators*
Provide the following information for each of your NIOSH approved respirators
Manufacturer Name Model Number NIOSH Approval Number
Please provide the following information about your device
Manufacturer Name*
Manufacturer Address*
City*
State / Province / Region
Postal Code
Country*
Device Model Number*
How many respirators do you plan to send to the U.S.?
Upload your product label
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Max. file size: 50 MB.
Upload a marketing authorization document / certificate
Issued by another regulatory authority or conformity assessment body. Include the authorization number and name of the assessment body (if applicable)
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Max. file size: 50 MB.
Name of Testing Body
Upload Certificate of conformity to applicable standards
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Max. file size: 50 MB.
Upload test report
Report should demonstrate applicable performance standards have been met
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Max. file size: 50 MB.
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