ECGequipment. For example, Indonesia has the SNI certification, Thailand has the TISI certification, and the Philippines has the BPS certification. It is necessary to confirm in advance the equipment voltage (such as 380V/50Hz in Thailand), the compatibility of the CE certification, and the proof of environmentally friendly materials.Three Major Compliance Traps

The agent changes the transportation terms without authorization and adds unauthorized transshipment terms.Medical EquipmentAfter the implementation of the Classification Catalog, ECG equipment importers face a new regulatory environment. According to General Administration of Customs statistics, the medical equipment import declaration error rate in the first half of 2025 increased by 18.7% year-on-year, with 60% of declaration issues concentrated in equipment classification and technical standard recognition.

Value Breakdown of Full-process Agency Import

Professionalforeign tradeThe value created by agents in medical device imports follows a tiered distribution pattern:

• Pre - classification stage
  • Utilize HS code databases to match the latest regulatory requirements
  • Analyze the correspondence between EU CE, US FDA, and CFDA certifications
• Customs declaration phase
  • Select optimal tariff solutions based on equipment technical parameters
  • Handle conversion of Electromagnetic Compatibility (EMC) test reports
• Follow-up management phase
  • Establish complete lifecycle traceability archives for equipment
  • Process annual quality system review documents

Practical cases of cost optimization

A case study of a tertiary hospital importing a dynamic ECG system in 2025 shows:

• Tariff differences: Self-declaration classification errors resulted in 15% tax rate application, while professional agent reclassification reduced it to 8.4% medical device rate
• Logistics costs: Optimized packaging solutions reduced transport damage rate from 3% to 0.5%
• Time Cost: Customs inspection detention time shortened by 72 hours, equipment installation and commissioning cycle advanced by 10 working days

Technical standard compliance pathway selection

For certification conversion of equipment from different origins, differentiated management strategies are recommended:

• EU equipment: CE certification + clinical evaluation report
• US equipment: FDA 510(k) + Chinese manual filing
• Japanese equipment: PMDA certification + supplementary EMC testing

2025 new policy response strategies

Regarding the revised "Imported Medical Device Quality and Safety Management Measures", importers should focus on:

• Establishing traceable software version management systems
• Improving adverse event monitoring and reporting mechanisms
• Preparing equipment cybersecurity compliance statements

Agent Service Selection Evaluation System

Core competency matrix for premium agency service providers:

• Regulatory proficiency: Real-time updates to 42 regulatory agency databases
• Technical analysis capability: Deployment of biomedical engineering professional teams
• Emergency response capability: Establishment of port rapid response channels
• Cost control capability: Development of intelligent tariff matching systems