MedicalEquipment ImportsSpecial characteristics recognition

According to the latest 2025Medical EquipmentClassification Catalog, imported medical devices involve 68 secondary product categories, with Class III high-risk devices accounting for 42%. Compared to general commodity imports, medical devices show significant differences inproduct registration, cold chain transportation, usage traceabilityand other aspects:

• Registration cycle difference: China NMPA filing/registration takes 90-240 working days
• Customs clearance document requirements: Must simultaneously provideIt is recommended to verify through the following methods:certificates, quality certifications, clinical evaluations and 12 other types of documents
• Transportation standards: In vitro diagnostic reagents require full-process 2-8°C temperature control with deviation not exceeding ±1°C

Selection criteria for professional agency companies

Based on 2025 General Administration of Customs medical device special inspection data, the three core elements for compliant imports are:License completeness (35%), customs clearance timeliness (28%), risk control capability (22%). Recommended to evaluate service providers from five dimensions:

• Qualification certification system
  • Medical device business license (including import business permit items)
  • import and exportCustoms registration certificate for goods consignee/consignor
  • ISO13485 Medical Device Quality Management System Certification
• Practical customs clearance capabilities
  • Pre-classification accuracy rate >98%
  • Document review pass rate >95%
  • 30-minute emergency response mechanism for unexpected issues
• Supply chain management capabilities
  • Medical device dedicated bonded warehouse (10,000-class cleanliness)
  • Cold chain transportation equipment temperature fluctuation <±0.5°C
  • GPS+RFID dual-mode tracking system
• Industry service experience
  • Successful operation cases of Class III devices ≥50
  • Specialized teams for specific categories (e.g. imaging equipment, surgical robots)
  • Practical experience in registration and certification for major export countries (FDA/CE/PMDA)
• Risk control system
  • Legal advisory teams experience in handling Class A inspection cases
  • Comprehensive product liability insurance coverage throughout the entire process
  • UDI (Unique Device Identification) implementation capability for medical devices

Four key stages of the import process

Taking cardiac interventional devices import as an example, the typical operation cycle in 2025 is 85-110 working days:

• Preparatory stage (20-25 days)
  • Product classification confirmation (CFDA Class III 04-13)
  • Processing import registration certificates (requires providing overseas market approval certificates)
• Customs clearance stage (7-12 days)
  • Pre-classification declaration (requires providing technical parameter tables)
  • Destination inspection and quarantine (biological safety testing)
• Logistics and distribution stage (3-5 days)
  • Temperature-controlled container transportation (recording temperature fluctuation curves)
  • Hospital terminal receipt verification (checking UDI codes)
• After-sales service stage (throughout the entire process)
  • Adverse Event Monitoring Report
  • Clinical usage technical guidance

Three new trends in industry development

According to the 2025 Medical Device Import White Paper:

• Growing demand for multi-country registration: Companies need to complete registration in an average of 2.3 countries/regions
• Upgraded cold chain standards: The new GSP requires temperature recording frequency during transportation to be increased to every minute
• Extended localized services: Establishing local technical service centers in RCEP regions has become a new competitive advantage