I. How to judgeMedical DevicesDo exports require professional agents?

According to the latest data from the General Administration of Customs in 2025, the following three scenariosIt is mandatory to entrust a professional agent.:

• Enterprises exporting Class II/III medical devices for the first time (Customs special supervision code requirements)
• Involves high-risk products such as implantable/life-sustaining devices (requiring special qualification filing).
• The target market is regions with stringent regulations such as the EU, the US, and Japan (for instance, the EU MDR certification process can take up to 18 months).

2. What are the latest requirements for medical device export certification?

Regulatory Changes in Major Global Markets in 2025:

• The transition period for the EU MDR has ended.: All legacy equipment must complete the Clinical Evaluation Report (CER) update.
• The U.S. FDA adds new AI medical device classifications.: Algorithm validation dataset submission required
• China NMPA implements UDI traceability system：Products for domestic sales after export require dual coding.

III. How to Avoid Product Expiration Due to Customs Clearance Delays?

Analysis of Frequently Asked Questions in the Past Three Years:

• Missing calibration certificate for temperature control equipment(Accounting for 68% of cold chain issues)
• Mixed use of multiple country labels(If the simultaneous appearance of CE and FDA logos raises questions)
• False declaration of HS code(The tax rate difference between medical and non-medical devices reaches 12%.)

IV. What core modules should professional agency services include?

Essential Competency Matrix for High-Quality Service Providers:

• Regulatory Pre-Review System: Real-time updates of regulatory databases for 50+ countries
• Risk management system:
  • Product Liability Insurance (Recommended Coverage ≥ USD 5 Million)
  • Special Transport Insurance (covering clinical trial equipment)
• Emergency response mechanisms: 72-hour Customs Clearance Exception Handling SOP

V. How to Verify the Genuine Capabilities of an Agency?

Recommended adoptionThree-dimensional verification method:

• Check the AEO certification status (dual certification for China/target country)
• Please provide export cases of similar products from the past three years (including sample customs clearance documents).
• Simulate emergency scenarios to test response speed (e.g., FDA inspection contingency plan)

VI. What are the special considerations for emerging market expansion?

According to the latest 2025 survey:

• Southeast Asian countries: It is necessary to register a local authorized representative in advance (such as the Indonesia MD series certification).
• The Middle East Region: Halal certification must be obtained (involving auxiliary materials such as lubricants, etc.).
• African Union: Accept CE certification but requires additional French technical documentation.

7. How to reasonably control agency service fees?

Recommended adoptionTiered pricing model:

• Basic Service Fee (Certification Processing + Basic Customs Clearance)
• Value-added service package (expedited processing/customized documentation, etc.)
• Risk-sharing clause (Delay compensation calculated proportionally based on cargo value)