What certifications are required for the export of medical equipment?

According to the latest international trade regulations in 2025, the export of medical equipment must comply withVIII. How to handle the environmental protection requirements of special countries?:

• Domestic mandatory certifications:
  • Medical DevicesRegistration Certificate/Record Filing Certificate (NMPA)
  • Medical Device Production License
  • Import and Export Rights
• Certification of target market access:
  • EU CE Certification (Note: Transition Period for the 2025 MDR New Regulations Deadline)
  • U.S. FDA 510(k) or PMA
  • Japan PMDA certification
  • Medical Device Registration Certificate for Southeast Asian Countries (e.g., Malaysia MDA)

II. How to Design an Efficient Customs Clearance Plan?

In 2025, the General Administration of Customs will implement regulations on medical devices.Hierarchical clearance management, it is recommended to adopt the following strategies:

• Accurate Product Classification:
  • Differences in Classification Between Medical Consumables (HS 9018) and Diagnostic Equipment (HS 9019)
  • Implantable devices must be declared separately.
• Triple verification of customs clearance documents:
  • Quality System Documentation (ISO 13485)
  • Certificate of Free Sale
  • Biocompatibility Report (New Requirement for 2025)
• Leveraging the customs clearance facilitation for AEO-certified enterprises

Third,International logisticsWhat are special requirements?

The transportation of medical devices must comply withGDP Cold Chain Standards:

• Transportation method options:
  • Air freight: Suitable for high-value consumables (time sensitivity > temperature control requirements)
  • Sea freight: Suitable for large equipment (requires shockproof and moisture-proof packaging)
  • Cross-border Railway: China-Europe Freight Trains Utilize Constant Temperature Containers at 10-25°C.
• Special packaging requirements:
  • Sterile instruments must be double-barrier packaged in a sterile system.
  • Diagnostic reagents must be transported with dry ice (2025 IATA new regulations limit the usage amount).

IV. How to Address Registration Challenges in Overseas Markets?

2025 Key Market Registration Strategy:

• The European market:
  • Under the MDR regulation, an EU Authorized Representative (EC REP) must be designated.
  • Full implementation of the UDI system
• The American Market:
  • FDA adds AIMedical DevicesClassification Guidelines
  • The 510(k) review cycle has been extended to 132 days.
• Southeast Asian markets:
  • Enjoy tariff preferences by utilizing the RCEP agreement
  • Accelerating Mutual Recognition of the ASEAN Medical Device Directive (AMDD)

V. How to Prevent and Control International Trade Risks?

Special attention is required in 2025.Three major risk points:

• Technical Barriers to Trade:
  • New EU regulations require the submission of clinical evaluation reports.
  • The U.S. FDA intensifies on-site inspections of Chinese factories.
• Exchange rate fluctuations:
  • It is recommended to use forward exchange settlement to lock in the exchange rate.
  • The proportion of cross-border RMB settlements has increased to 42%.
• Intellectual property protection:
  • Register patents in the target market in advance.
  • Customs Record Protection (Special Record for Medical Devices Added in 2025)

VI. Frequently Asked Questions

Q: Is it possible to export without going through an agent?
A: Theoretically feasible, but it involves the preparation of 22 professional documents and coordination with 15 regulatory departments. Professional agency services can reduce time costs by 30%.

Q: How long does the export certification process take?
A: EU CE certification takes approximately 8-12 months (under the new MDR regulations), while the U.S. FDA 510(k) averages 9 months. It is recommended to initiate the certification process 18 months in advance.

Q: How to handle the risk of certification failure?
A: It is recommended to adoptPhased Verification Strategy, Conduct a preliminary technical document review first, then formally submit the application, which can save 40% of the re-review costs.