I.Medical DevicesWhat skills are needed for exports?

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

• Qualifications of Production EnterprisesISO 13485 Quality System Certification, Product Registration Certificates (e.g., China NMPA, US FDA 510(k))
• Qualifications of Trade EnterprisesMedical Device Operating License, Import and Export Rights
• Access to target countriesEU CE MDR Certification, US FDA Registration, Japan PMDA Certification, etc.

How to Choose ReliableExport agentThe service provider?

Recommended fromSix dimensionsEvaluation of professional service providers:

• Experience in the industry: at least completed20 medical device export cases above Class II
• Completed qualifications: AEO Customs Advanced Certification, Medical Devices GSP Certification
• Service network: have clearing partners in major markets such as Euro-American Day
• Compliance Capacity: Equipped with Professional Registrar, familiar with the latest changes in MDR/FDA
• Risk Control: Supplementary programs such as product liability insurance and transport insurance
• Case Verification: Requirements for Export Customs Certificates for Similar Products

What are the standard export processes for medical devices?

Professional services should include9-Step Full Process Management:

• Classification of products (Class I/II/III)
• Compliance assessment of target market regulations
• Compilation of technical documentation (including clinical evaluation reports)
• Declaration of registration abroad
• Import and Export License
• Special packaging/cold chain design
• Customs classification and declaration
• Coordination of port purposes
• After-Sales Quality Tracking (UDI Tracking Management)

What are the key differences between national medical device registration requirements?

• The European market:2025 year MDR transition period ends, all products above Class IIa must be audited by the announcement agency
• US Market:510(k)/PMA Applications Average Time Consumption of132 Days/280 Days (FDA 2024 Annual Report)
• Southeast Asian MarketsASEAN Medical Device Directive (AMDD) Requires Local Authorized Representative
• The African MarketPre-certification by WHO is required in 32 out of 54 countries.

How to ensure the quality of medical equipment after-sales service?

Professional agencies should be establishedLevel 3 after-sales management system:

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

How to Control Medical Device Export Risks?

Recommended adoptionRisk Matrix ManagementThe tactic:

• Legal risksContract: Intellectual property assignment, registered subject liability
• Risk of logisticsMandatory full transportation insurance for Class III medical devices (insurance coverage not less than 200% of the cargo value)
• Risk of PaymentRecommended LC payment method with export credit insurance
• Risk of complianceUpdate the target country regulatory database quarterly to analyze the gap