一、醫(yī)療機器What essential qualifications are required for export?

According to the latest 2025 international trade regulations, medical device exports must comply withTriple certification system：

• Manufacturer Qualification: ISO 13485 quality system certification, product registration certificates (e.g., China NMPA, U.S. FDA 510(k))
• Qualifications for Trading Enterprises: Medical Device Business License, Import and Export Rights Registration
• Market Access in the Target Country: EU CE MDR certification, US FDA registration, Japan PMDA certification, etc.

II. How to Choose a Reliable輸出代理店Service provider?

It is recommended to start fromsix dimensionsAssessing the service provider's level of professionalism:

• Industry Experience: Has completed at least 20 export cases for Class II or higher medical devices.
• Fully Qualified: Holds AEO Advanced Customs Certification and Medical Device GSP Certification
• Service Network: Has customs clearance partners in key markets such as Europe, the United States, and Japan
• Compliance Capability: Equipped with dedicated regulatory specialists who are well-versed in the latest MDR/FDA updates.
• Risk Management: Provides supporting solutions such as product liability insurance and transportation insurance
• Case Verification: Provide export customs clearance certificates for products of the same category

3. What are the stages included in the standard process for exporting medical devices?

Professional agency services should include9-Step Full-Process Management：

• Product Classification Determination (Class I/II/III)
• Regulatory Compliance Assessment for the Target Market
• Technical Documentation Compilation (including Clinical Evaluation Report)
• Overseas Registration Filing
• Import and Export License Application
• Special Packaging / Cold-Chain Solution Design
• Customs Classification and Declaration
• Destination port customs clearance coordination
• After-sales Quality Tracking (UDI Traceability Management)

4. What are the key differences in medical device registration requirements across countries?

• EU market: The MDR transition period ends in 2025, and all Class IIa and higher devices must undergo Notified Body review.
• アメリカ市場: The average review times for 510(k)/PMA submissions are 132 days and 280 days, respectively (FDA 2024 Annual Report)
• Southeast Asian market: The ASEAN Medical Device Directive (AMDD) requires a local authorized representative
• African market: 32 out of 54 countries require WHO prequalification

V. How is the quality of after-sales service for medical devices ensured?

Professional agents should establishThree-tier after-sales service management system：

• Quality Traceability: Achieve tracking of the smallest sales unit through the UDI system
• Adverse Event Report: Complete the on-site safety report required by MDR regulations within 72 hours
• Regular Maintenance: Provide preventive maintenance records as required by PMDA/FDA
• Recall Management: Establish a 48-hour emergency response mechanism

VI. How to Control the Risks of Medical Device Exports?

It is recommended to adoptRisk Matrix ManagementStrategy:

• Legal risk: The contract clearly defines the ownership of intellectual property and the primary responsibility for registration.
• Logistics risk: Mandatory full-journey cargo insurance for Class III devices (coverage no less than 200% of the goods' value)
• Payment risk: We recommend using the LC payment method in conjunction with export credit insurance.
• Compliance risk: Update the target-country regulatory database quarterly and conduct gap analyses.