MedicalEquipment importSpecial characteristics recognition

According to the latest "Medical devicesThe "Classification Catalog" indicates that imported medical devices cover 68 secondary product categories, among which Class III high-risk devices account for 42%. Compared to the import of general goods, medical devices...Product registration, cold chain transportation, usage traceabilityThere are significant differences in aspects such as:

• Registration cycle discrepancy: China NMPA filing/registration takes 90-240 working days.
• Documentation Requirements for Customs Clearance: Must be provided simultaneously.Certificate of OriginDocuments including instructions for use, quality certification, clinical evaluation, and 12 other categories
• Transportation Standards: In vitro diagnostic reagents require temperature control between 2-8°C throughout the entire process, with a deviation not exceeding ±1°C.

Selection criteria for professional agency companies

Based on the 2025 special inspection data on medical devices from the General Administration of Customs, the three core elements for compliant imports are:Document Integrity (35%), Customs Clearance Timeliness (28%), Risk Control Capability (22%)It is recommended to evaluate service providers from five dimensions:

• Qualification certification system
  • Medical Device Business License (including import business license items)
  • Import and exportCustoms Registration Certificate for Consignor/Consignee of Goods
  • ISO13485 Medical Device Quality Management System Certification
• Practical customs clearance operation capability
  • Pre-classification accuracy rate >98%
  • Document review pass rate >95%
  • Emergency response mechanism for sudden issues within 30 minutes
• Supply chain management capabilities
  • Medical Device Dedicated Bonded Warehouse (Class 10,000 Cleanliness)
  • The temperature fluctuation of cold chain transportation equipment is less than ±0.5°C.
  • GPS+RFID Dual-Mode Tracking System
• Industry service experience
  • Successful operation of Class III devices in ≥50 cases.
  • Professional 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
  • The legal advisory team's experience in handling Class A audit cases.
  • Full-process insurance coverage for product liability insurance
  • UDI Implementation Capability for Medical Devices

The four key stages of the import process

Taking the import of cardiac interventional devices as an example, the typical operational cycle in 2025 is projected to be 85-110 working days:

• Preparation Phase (20th-25th)
  • Confirm the product classification (CFDA Class III 04-13).
  • Apply for an import registration certificate (proof of overseas market approval required).
• Customs declaration and clearance phase (7-12 days)
  • Pre-classification declaration (technical parameter sheet required)
  • Destination Quarantine (Biosafety Testing)
• Logistics and distribution phase (3-5 days)
  • Transportation in a Constant Temperature Chamber (Recording Temperature Fluctuation Curve)
  • Hospital terminal sign-off (verify UDI code)
• After-sales service phase (full process)
  • Adverse Event Monitoring Report
  • Guidelines for Clinical Application Technology

Three new trends in industry development

According to the 2025 Medical Device Import White Paper:

• Increasing demand for multinational registrations: On average, companies need to complete registrations in 2.3 countries/regions.
• Cold Chain Standards Upgraded: The New GSP Requires Temperature Recording Frequency During Transportation to Be Increased to Every Minute.
• Localized Service Extension: Establishing Local Technical Service Centers in the RCEP Region as a New Competitive Edge