Three checkpoints for pre-import qualification preparation

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.須通過(guò)三重資質(zhì)驗(yàn)證體系：進(jìn)口方需持有《Medical Equipment經(jīng)營(yíng)許可證》，經(jīng)營(yíng)范圍須包含對(duì)應(yīng)設(shè)備類別；進(jìn)口產(chǎn)品須在藥監(jiān)局完成Import medical device filing(Filing number valid until 2025年1 February); Overseas manufacturers must possessISO 13485 quality management system certification.

Special requirements for product certification

Unlike ordinary commodity imports, medical devices must complete:

• CFDA registration certification(New AI diagnostic equipment classification added from 2025)
• For Class III medical devicesClinical trial reports
  • Must include data from no fewer than 3 Grade A tertiary hospitals
  • Trial duration must be no less than 6 months
• Radiation equipment requires additionalEnvironmental approval documents

The golden section point of customs clearance strategy

Select the optimal customs clearance solution based on equipment usage scenarios:

• General trade mode(For end-hospital use)
  • Advantage: Can be immediately put into clinical use
  • Disadvantage: Requires full payment of 13% VAT
• Bonded zone model(For display/R&D purposes)
  • Advantage: Deferred payment of import taxes
  • Disadvantage: Equipment must remain within supervised areas

Precision control of logistics solutions

Medical equipment transportation requires establishment ofDual protection mechanism:

• Adoption of precision instrumentsAir cushion shock-absorbing containers
• Full-process temperature control equipment maintaining 22±2℃
• Warehousing selection must haveMedical device storage qualificationswarehouses
  • Independent storage area ≥200㎡
  • Equipped with dual-circuit power supply system

Closed-loop system for after-sales management

EstablishFull lifecycle traceability system:

• Completion within 7 working days after equipment installationFirst-operation documentation filing
• Maintenance records must include:
  • Temperature and humidity data for each maintenance
  • Traceable documentation for component replacements
• Adverse event reports must beWithin 72 hourssubmitted to drug regulatory authorities

Analysis of practical cases

When a Class III hospital imported 3.0T MRI equipment, due tomissing power adaptation certificateresulting in 13-day port detention. Solution:

• Emergency processing oftemporary power compatibility testing
• Coordinating with customs forbond release
• Subsequent submission of the EMC report for EU CE certification

This case demonstrates that a professional agency team can reduce the problem-solving cycle by more than 50% and decrease port demurrage losses by approximately 230,000 yuan.