Medical DevicesWhat qualifications are required for exports?

As a medical device category, wheelchair exports require special attention to:

• National Qualifications:
  • Business Record Certificate for Class II Medical Devices (domestic products)
  • Import and export rights and customs record
  • In 2025, new cross - border medical device traceability system record
• Target country certification:
  • EU CE certification (MDD 93/42/EEC or new MDR regulations)
  • US FDA 510(k) registration
  • Japan PMDA certification (needs to be passed through a local agent)

How to choose a compliant logistics transportation solution?

It is recommended to adopt a three - level transportation plan design:

• The Maritime: The full - container load transportation cost can be reduced by 30%, and moisture - proof treatment should be noted
• air transport: Suitable for urgent orders, it is recommended to choose IATA - certified temperature - controlled shipping space
• Special scenes1. The transportation of electric wheelchair batteries requires UN38.3 certification. In 2025, the EU will add a lithium - battery transportation filing system.

What are the tariff policies of the main export markets?

2. According to the latest data in 2025:

• USA3. The tariff for medical auxiliary equipment is 3.7% (HTSCODE: 8713.10)
• The European Union4. Ordinary wheelchairs are duty - free, and a 4.5% tariff is levied on electric wheelchairs.
• Southeast Asia5. Under the ASEAN Free Trade Agreement, most countries have tariff reductions and exemptions.

How to choose an international trade payment method?

6. Recommended combined payment plan:

• 7. 30% T/T advance payment + 70% Letter of Credit (It is recommended to be insured by Sinosure).
• 8. Long - term cooperative customers can adopt O/A 90 days (export credit insurance needs to be purchased).
• 9. In 2025, new cross - border settlement pilot projects for the digital yuan will be added.

How to establish an overseas after - sales service system?

10. A three - level service system is recommended:

• Basic Services11. Establish a multilingual maintenance manual database.
• Localization Services12. Set up a bonded maintenance warehouse in the target country.
• Value Added Services13. Provide a five - year parts supply commitment.

How to choose a reliable overseas partner?

14. Focus on three dimensions:

• Qualification review15. Local medical device distribution license
• 16. Channel capabilities17. Coverage rate of hospitals, pharmacies, and e - commerce platforms
• 18. Financial health19. Require the provision of audit reports for the past three years.

What are the common problems in customs inspections and countermeasures?

20. High - frequency problems in the past three years include:

• 21. Disputes over the classification of medical devices (It is recommended to apply for pre - classification in advance).
• 22. Incomplete certification documents (Multilingual certification copies need to be prepared).
• 23. Missing lithium - battery transportation documents (Both UN38.3 report and MSDS are indispensable).