Must medical equipment imports require an agent? Professional analysis of complete process pitfalls avoidance guide

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.New market trends

As of Q2 2025, ChinasMedical Equipmentmarket size has exceeded 1.2 trillion yuan, with imported high-end equipment maintaining a share of over 35%. After the implementation of the new Medical Device Supervision and Administration Regulations, the average registration and filing cycle has extended by 45 working days, and customs special inspections found that 32% of enterprises had incorrect declaration classifications. These data reveal: professional agency services have become a necessary choice to avoid compliance risks and improve customs clearance efficiency.

Five core values of agency services

• Regulatory dynamic monitoring: Real-time tracking of FDA, CE certification changes and customs classification adjustments
• Access qualification preparation:
  • Medical device registration certificate (CFDA)
  • Import RepresentationCommercial filing certificate
  • Special equipment safety certification
• Cost optimization combination: Save 10-15% tariff costs through HS code pre-classification
• Risk Early - Warning System: Early identification of technical trade measures (TBT) barriers
• Emergency response mechanism: Standardized process for resolving customs inspection disputes within 72 hours

Key nodes of full-process operation

Taking Siemens 3.0T MRI equipment import as an example, professional agency services can reduce operation time by 40%:

• Pre - preparation Stage(15 working days):
  • Verify whether the equipment complies with GB 9706.1-2025 new standards
  • Apply for an automatic import license (O license)
• Logistics execution stage:
  • Select air-cushion shockproof special containers
  • Configure constant temperature and humidity transport environment
• Customs clearance and delivery phase:
  • Utilize AEO-certified enterprise fast clearance channel
  • Complete equipment installation and commissioning supervision

Agency selection four-dimensional evaluation

A procurement case from a top-tier hospital shows that quality agencies can reduce overall import costs by 18%:

• Qualification review: Verify Medical Device Business License and customs AEO certification
• Case database comparison: Request import clearance records of similar equipment
• Service network: Confirm presence of in-house clearance teams at major ports
• Risk bearing: Review performance bond terms and compensation plans

Typical risk prevention strategies

Among the ten typical cases reported by the General Administration of Customs in 2025, main risk points for medical equipment imports include:

• Software system version not completing localization adaptation
• Equipment accessories not declared separately causing classification disputes
• After-sales maintenance terms not complying with three-guarantee regulations

Professional agencies establishFour-in-one risk control system(Pre-review + process monitoring + emergency response + traceability improvement), which can reduce trade dispute occurrence to below 2%.