Medical in 2025Equipment ImportsNew Regulatory Trends

According to General Administration of Customs Announcement No. 58, Implementation Starts from January, 2025New VersionMedical EquipmentClassification Catalogue, Involving Regulatory Tier Adjustments for 23 Product Categories. Among Them, 7 Types Including High-Frequency Surgical Electrodes Are Upgraded from Class II to Class III Regulation, and 5 New High-Risk Subcategories Are Added for In Vitro Diagnostic Reagents. Enterprises Should Pay Special Attention to:

• HS Code Changes Correspond to Tariff Rate Differences Up to 8%
• Class III Equipment Declarations Require Simultaneous Submission ofBiocompatibility report
• Diagnostic Reagents ImplementCold Chain Transportation Electronic Traceabilitycertificate of tax residence

Breakdown of Medical Equipment Customs Clearance Process

Typical Import Process Takes 40% Longer Than Regular Goods, Key Stages Include:

• Preparation Phase (15-30 Days)
  • Obtaining Medical Device Registration Certificate/Filing Certificate
  • Control of trade term risksImport RepresentationBusiness Filing
• Customs Declaration Phase (3-7 Days)
  • Declaration Elements Must IncludeIntended UseAnd Other Professional Parameters
  • Providing International Certification Documents Such as CE, FDA
• Post-Clearance Management (Continuous Tracking)
  • Adverse Event Monitoring Data Reporting
  • Early Warning Mechanism for Equipment Approaching Expiry

Dual Verification System for Qualification Certification

2025 Customs Inspection Priorities Shift toAuthenticity Verification of Qualification Documents, special attention should be paid to:

• International Certification Requirements
  • EU CE Certification (MDR Regulation)
  • U.S. FDA 510(k) clearance
• Domestic market access qualifications
  • Medical device import registration certificate (valid for 5 years)
  • Filing certificate (Class I equipment)

Typical risk prevention strategies

Medical equipment import dispute cases in the past three years show that main risks are concentrated in:

• Commodity classification errors (accounting for 37%)
  • Solution: Pre-classification application + third-party verification
• Incomplete documentation (accounting for 29%)
• EstablishQuadruple verification mechanism: Manufacturer → Overseas warehouse → Carrier → Customs broker
• Missing Chinese labels (accounting for 18%)
• implementationPre-clearance label review before arrival(1) Port of Departure and Port of Destination:

Analysis of practical cases

A company importing high-frequency electrosurgical system encountered port detention:

• Root cause: Failure to identify classification upgrade in new catalog
• Loss composition: Port detention fee 86,000 + Storage fee 23,000/day
• Solution path:
  • Emergency processing ofMedical device registration certificate modification
  • SupplementElectromagnetic compatibility test report
  • Applicationbond releaseShorten handling cycle

Recommended for enterprises to establishThree-level risk control system: Product pre-classification diagnosis → Qualification document completeness review → Customs clearance contingency plan reserve. SelectingMedical device import specialized qualificationagent service providers can reduce declaration error rate by 42% and shorten average customs clearance time by 5.8 working days.