The access code to a billion-dollar market

China's 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)
  • Manufacturer's 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 TaxMedical 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. 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.Stories
• 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.