1. Which institutions have FDA-approved products?Export agentThe Qualification?

According to the latest international trade regulations of 2025, legal agencies exporting FDA-certified products must meet the following conditions:

• The basic qualifications:
  • Holding the "Import and Export License" issued by the Ministry of Commerce.
  • Possesses AEO (Authorized Economic Operator) Advanced Certification qualification.
  • Registered with the General Administration of Customs for importExport agentEncoding
• Professional Competency Requirements:
  • FDA regulatory expert team (minimum of 3 certified compliance specialists)
  • In the past three years, there have been 20+ successful cases of FDA product agency exports.
  • FDA inspection guidance with a pass rate of over 95%.

II. What are the core services included in FDA product export agency services?

Professional agencies should provide end-to-end services, including:

• Compliance Audit Services:
  • FDA Registration Status Verification (including special certifications such as 510k/PMA)
  • Compliance Review of Product Labels and Instructions
  • Pre-review of GMP Quality System Documentation
• Customs declaration and clearance services:
  • FDA Prior Notice Pre-Notification Filing
  • U.S. Customs AMS/ISF Filing System Operation
  • FDA Import Alert Evasion Strategies

III. How to Evaluate the Professional Competence of an FDA Agency?

It is recommended to evaluate from five dimensions:

• 22. Industry experience:Medical Devices, pharmaceuticals, food, and other specialized sectors require corresponding experience.
• Compliance Record:Please provide proof of FDA clearance rate for the past 12 months.
• Emergency capability:FDA's Rapid Response Mechanism for Detained Goods (72-Hour Solution)
• Technical Support:Is it equipped with a real-time FDA database query system?
• 26. Service network:Direct partnership with local customs clearance agents in the United States

IV. How to Resolve Common Issues with FDA Product Exports?

• Question 1: What should I do if my FDA registration is rejected?
  • Solution: Request the agency to provide pre-registration review services to identify common issues such as product classification errors in advance.
• Question 2: How to respond when FDA factory inspection is required during customs clearance?
  • Solution: Professional institutions should provide simulated factory audit services, including document preparation and on-site guidance.
• Question 3: What should be done if a product is placed on the Import Alert list?
  • Solution: Compliance agents should have experience in handling DIOP procedures (Detention without Physical Examination).

Special reminder: According to the FDA's latest 2025 policy, all Class II and above medical device exports must undergo electronic submission through the FDA ESG system. When selecting an agency, ensure its system integration capability.