2025Medical devicesNew Trends in Import Supervision

According to the latest "Medical Device Import Supervision Measures" issued by the General Administration of Customs in 2025, Class III medical devices will implement an electronic traceability code management system for declaration. The new regulations require import enterprises to complete the filing of product traceability information 72 hours before the goods arrive at the port, which poses a significant challenge to traditional customs clearance models. Notably, medicalEquipment importThe error rate in declarations has increased by 23% year-on-year compared to last year, primarily concentrated in two major issues: incorrect product classification (58%) and expired health permits (32%).

Four core values of professional agency services

• Real-time Tracking of Regulatory Updates
  • Timely Interpretation of NMPA Classification Catalog Adjustments
  • Anticipate the impact of changes in EU MDR and FDA 510(k) certification.
• Technical Document Compliance Review
  • Standardized Production of Chinese-English Instruction Manuals
  • Supplement and improve the ISO 13485 system documentation.
• Special customs clearance channel established
  • Tax-free approval channel for scientific research equipment
  • Emergency Medical Supplies Rapid Customs Clearance Plan
• Risk Early - Warning System
  • HS Code Change Alert (23 New Medical Device Subheadings Added in the 2025 Edition)
  • Certificate of OriginConduct compliance screening.

Analysis of Key Nodes in the Entire Customs Clearance Process

Taking the import of a 3.0T MRI device by a certain enterprise as an example, professional agency services cover the following key steps:

• Access Prediction Stage
  • Confirm whether the equipment is listed in the "Prohibited Import Medical Device Catalog."
  • Verify the correspondence between CE certification and domestic registration certificate
• Document preparation stage
  • Assist in obtaining medical device registration certificates (saving an average of 14 working days)
  • Prepare technical documentation compliant with GB 9706.1-2025.
• On-site clearance phase
  • Coordinate with local customs to conduct destination inspections.
  • Handling supplementary materials for EMC test reports

Chronicles of Typical Risk Cases: Lessons Learned

An importer failed to recognize the adjustments in the new edition of the "Medical Device Classification Catalog," mistakenly declaring a Class II ultrasound diagnostic device under code 6803.0010, resulting in:

• The customs clearance delay of 23 days resulted in demurrage charges of 120,000 yuan.
• Subsequent processing of the import license took 42 days.
• Facing a penalty for 30% misdeclaration of the cargo value.

Three Major Avoidable Mistakes That Professional Early Intervention Agents Can Prevent:

• Neglecting the Announcement of Classification and Definition Results by the Drug Administration
• Using outdated product safety standards
• The Chinese label does not indicate the medical device registration certificate number.

2025 agency service selection guide

• Essential qualification verification
  • Medical Device Filing Agency Qualification Certificate
  • AEO (Authorized Economic Operator) Advanced Certification
• Verification of service capabilities
  • Import cases of similar equipment in the past three years.
  • Overseas Technical Documentation Translation Team Configuration
• Emergency response mechanism
  • Port emergency inspection rapid response time
  • Technical Review Nonconformity Rectification Plan

Special Tips:The "Unique Device Identification System Regulation," effective from January 2025, stipulates that high-risk imported products such as cardiac stents must submit UDI data for record six 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 relabeling costs.