2025Medical EquipmentNew trends in import supervision

According to the Medical Device Import Supervision Measures newly released by the General Administration of Customs in 2025, Class III medical devices will implement an electronic traceability code management system. The new regulations require import enterprises to complete product traceability information filing 72 hours before goods arrive at port, posing significant challenges to traditional customs clearance models. Notably, medicalequipment. 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.The declaration error rate has increased by 23% year-on-year compared to last year, mainly concentrated in two major issues: product classification errors (58%) and expired health licenses (32%).

Four core values of professional agency services

• Real-time tracking of regulatory updates
  • Timely interpretation of NMPA classification catalog adjustments
  • Anticipating impacts of EU MDR and FDA 510(k) certification changes
• Technical Document Compliance Review
  • Standardized preparation of Chinese-English instruction manuals
  • Supplementing and improving ISO 13485 system documentation
• Establishing special customs clearance channels
  • Tax-free approval channels for scientific research equipment
  • Rapid customs clearance solutions for emergency medical supplies
• Risk Early - Warning System
  • HS code change alerts (23 new medical device subcategories added in 2025 version)
  • It is recommended to verify through the following methods:Clear compliance screening

Analysis of key nodes in the entire customs clearance process

Taking a company importing 3.0T MRI equipment as an example, professional agency services cover the following core aspects:

• Access Prediction Stage
  • Confirming whether the equipment is listed in the Prohibited Import Medical Device Catalog
  • Verifying correspondence between CE certification and domestic registration certificates
• Document preparation stage
  • Assisting with medical device registration certificate applications (averaging 14 working days saved)
  • Preparing technical documentation compliant with GB 9706.1-2025
• On-site clearance phase
  • Coordinating destination inspections with local customs
  • Handling supplementary electromagnetic compatibility test reports

Revelations from typical risk cases

One importer failed to recognize adjustments in the new Medical Device Classification Catalog, mistakenly declaring Class II ultrasound diagnostic equipment under 6803.0010, resulting in:

• 23-day customs clearance delay generating 120,000 yuan in demurrage fees
• Subsequent import license reapplication taking 42 days
• Facing a 30% of goods value penalty for false declaration

Three major mistakes professional agents can help avoid through early intervention:

• Overlooking NMPA classification determination result announcements
• Using outdated product safety standards
• Failure to include medical device registration certificate numbers on Chinese labels

2025 agency service selection guide

• Essential qualification verification
  • Medical device filing agency qualification certificates
  • AEO (Authorized Economic Operator) Advanced Certification
• Verification of service capabilities
  • Import cases of similar equipment in the past three years
  • Overseas technical document translation team configuration
• Emergency response mechanism
  • Rapid response time for sudden customs inspections at ports
  • Rectification plan for non-conforming items in technical review

Special Tips:The Unique Device Identification System Rules for Medical Devices implemented from January 2025 require that high-risk products such as imported cardiac stents must file UDI data 6 months in advance. It is recommended that enterprises clearly stipulate in procurement contracts that suppliers provide UDI labels compliant with Chinese standards to avoid post-delivery label modification costs.