The access code to a billion-dollar market

Chinas rehabilitation medical equipment market size is expected to exceed 120 billion yuan in 2025, with an average annual compound growth rate maintained above 18%. However,Medical EquipmentThe error rate in import HS codes reaches as high as 43%, causing enterprises an average loss of over 68,000 yuan per shipment. Professional agency services have become a key support for enterprises to break through technical barriers and avoid compliance risks.

Three key qualifications for medical device imports

• Basic qualifications
  • Medical device registration certificate from the country of origin (requires consular authentication)
  • Manufacturers quality management system certification
  • Business license for importing entities (covering Class II and III medical devices)
• Special Requirements
  • Electromagnetic Compatibility Test Report (2025 Edition GB 9706.1 Standard)
  • Radiation equipment requires approval from the Ministry of Ecology and Environment
  • Drug-device combination products require additional pharmaceutical approvals

Four-step breakdown of customs clearance strategy

Case study of a German company importing hyperbaric oxygen chambers shows professional agents can reduce clearance time from 28 days to 9 working days:

• Commodity classification: Precise differentiation between HS 9019/9021 category differences
• Pre - review of documents: Advance verification of FDA/CE certification equivalency
• On-site inspection: Application for medical device dedicated inspection channel
• Tax payment: Utilize the tariff reduction and exemption policies of free trade agreements

Practical Handbook for Cost Control

• : The US Customs has a relatively high inspection rate for tool products. Incomplete documents or label errors are likely to cause customs clearance delays.: General tariff rate 8% vs ASEAN agreement rate 0%
• Value - added Tax: Medical devices 13% standard tax rate (non-deductible)
• Hidden costs
  • Late declaration penalty: 0.5‰ of cargo value per day (charged after exceeding 14 days)
  • Container detention fee: $120/day for overdue 40HQ containers

Risk warning and response plan

Year 2025 General Administration of Customs special inspection data shows:

• 28% of return shipment cases originated from expired certification documents
• 15% of administrative penalties involved exceeding the applicable scope of medical devices

Successfully handled by professional agencyPre-inspection databaseandRegulatory warning systemCompliance risks can be reduced by 76%. An agency company utilized an intelligent classification system to increase customer declaration accuracy from 67% to 98%.

The golden rule for selecting an agent

• Verify the permitted scope of the Medical Device Business Filing Certificate,
• Validate similar cases from the past three yearsEquipment ImportsStories
• Confirm overseas factory inspection capabilities (especially for Class II devices)
• Evaluate emergency response speed (e.g., FDA detention emergencies)

When a Shanghai-based company faced German customs detention of magnetic therapy equipment, professional agents completed CE certification updates and provided technical document translations within 72 hours, avoiding RMB 2 million in return shipment losses. This典型案例 reveals: choosing agents withFull - chain service capabilitiescapabilities is the true moat for medical device import risk control.