Export Certification Process and Requirements for FDA-Regulated Products
This guidance provides a general description of FDA export certification processes for industry and foreign governments. It covers various types of export certificates issued by FDA for different product categories including biologics, drugs, medical devices, food, cosmetics, and veterinary products.
What You Need to Know? 👇
What is FDA export certification and why do I need it for my medical device?
FDA export certification provides official documentation about your medical device’s regulatory status and manufacturing compliance. Foreign governments often require this certification to register or import medical devices into their countries, serving as assurance that products meet U.S. regulatory standards.
How long does it take to get an FDA export certificate for medical devices?
FDA may charge a fee if they issue certification within 20 government working days of receiving a complete request. Processing times can vary based on product complexity, establishment compliance status, and completeness of your application submission.
Can FDA issue export certificates for unapproved medical devices?
Yes, FDA can issue Certificates of Exportability for unapproved devices that cannot be legally marketed in the U.S. but meet requirements under sections 801(e) or 802 of the FD&C Act for legal export.
What prevents FDA from issuing export certification for my medical device?
FDA may deny certification if your manufacturing establishment isn’t compliant with applicable regulations, lacks required FDA registration/listing, or if FDA has initiated enforcement actions. Ongoing inspections or reviews may also delay certification issuance.
How much does FDA charge for medical device export certification?
FDA charges fees for export certifications issued under section 801(e)(4) of the FD&C Act when issued within 20 government working days. Fees vary by product type but won’t exceed statutory maximums established by law.
What does “CGMP compliance” mean on my FDA export certificate?
When FDA states an establishment is CGMP compliant, it’s based on the most recent inspection and available information. This certification confirms your facility meets current Good Manufacturing Practice regulations applicable to medical device manufacturing at the time of certification.
What You Need to Do 👇
Recommended Actions
- Verify product and establishment eligibility for desired certificate type
- Ensure current registration and listing with FDA is maintained
- Confirm compliance with applicable CGMP regulations
- Submit complete certification request with required documentation
- Pay applicable fees for certificates under section 801(e)(4)
- Allow 20 government working days for processing
- Ensure export compliance with other U.S. regulations
- Maintain truthful and accurate information in certification requests
- Monitor establishment and product compliance status
- Contact appropriate FDA center for product-specific guidance
Key Considerations
Non-clinical testing
- Non-Clinical Research Use Only Certificate available for products intended for non-clinical research use only
- Products must be labeled according to 21 CFR 312.160 or 809.10(c)(2)
Labelling
- Products must be properly labeled as authorized in the United States
- For unapproved products, specific labeling requirements apply under sections 801(e) and 802 of the FD&C Act
Safety
- Manufacturing establishments must be in compliance with applicable CGMP regulations
- FDA bases compliance certification on most recent inspection and available information
- FDA will not issue certificates if enforcement actions are ongoing
Other considerations
- Establishments must have required FDA registration and listing
- Fees apply for certificates issued under section 801(e)(4) of the FD&C Act
- 20 government working days processing time
- False or misleading information may result in civil/criminal liability
- Export must comply with other U.S. regulations (Commerce, Treasury departments)
Relevant Guidances đź”—
- Export Requirements for Products Not Approved for Sale in the United States
- Review Process for Denied Export Certificates for Medical Devices
Related references and norms đź“‚
- 21 CFR 312.160: Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
- 21 CFR 809.10(c)(2): Labeling Requirements for In Vitro Diagnostic Products
Original guidance
- Export Certification Process and Requirements for FDA-Regulated Products
- HTML / PDF
- Issue date: 2021-08-20
- Last changed date: 2024-10-01
- Status: FINAL
- Official FDA topics: Export, Medical Devices, Food & Beverages, Drugs, Animal & Veterinary, Biologics, Import
- ReguVirta ID: bc0355e1558c9d81d41a013ebcd1903d