Global Rehabilitationequipment. 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 Q1 2025, Chinas rehabilitation medical equipment import scale exceeded $8.2 billion, with a compound annual growth rate of 9.3%. Among them, neurological rehabilitation robots and intelligent rehabilitation training systems (Class II) accounted for 47%, while the approval rate for Class III active treatment equipment imports decreased by 12 percentage points compared to 2022. The market shows three significant characteristics:Medical EquipmentRegulatory hierarchy refinement:

• Customs added 7 new functional parameter testing standards for rehabilitation equipmentTrade model transformation:
• Bonded maintenance business volume increased by 210% year-on-yearService demand upgrade:
• 81% of importers require agents to have clinical verification support capabilitiesCore process analysis of the complete import procedure

Taking the import of lower limb rehabilitation robots from Germany as an example, professional agency services need to control the following key nodes:

Confirm HS code (200) and medical device registration classification

• Pre - classification stage
  • Verify the matching degree between EU MDR certification and domestic type inspection reports
  • Logistics planning phase
• Precision instruments require constant temperature and humidity containers (temperature error ±2℃)
  • Configure packaging solutions with anti-vibration levels reaching ISTA 3A
  • Prepare the Imported Medical Device Registration Certificate and clinical evaluation report
• Customs declaration phase
  • The equipment software version number (V2.3.5 or above) must be specified during declaration
  • Four-dimensional risk prevention management model

Professional agency service providers should establish the following prevention mechanisms:

Intervene in product design improvements 6 months in advance

• Used equipment needs to provide the Maintenance Record from the Japanese original factory
  • Establish a traceability database for key components
  • Establish key component traceability database
• Compliance risk control
  • Dynamic monitoring of regulatory updates in 28 countries/regions
  • Establish a label management system (supports 11 language conversions)
• Financial risk control
  • Use NDF tools to hedge against exchange rate fluctuations
  • Design tiered payment solutions
• Operational risk control
  • Configure dual verification mechanism (system + manual)
  • Establish emergency response team (30-minute response standard)

Comparative analysis of typical service cases

• Class A agency services
  • Import time for German spinal rehabilitation systems: 127 days
  • Cost structure: 9.7% tariff + 13% VAT + $8500 service fee
• Class B value-added services
  • Reduce market access cycle to 89 days through bonded testing
  • Utilize free trade agreements to reduce tariffs to 6.2%
  • Additional clinical efficacy evaluation report preparation services

Six key tips for selecting agency service providers

Based on 2025 industry research data, quality agencies should possess:

• ≥120 cases of medical device imports
• Familiarity with special customs clearance requirements at 8 major ports
• Capability for overseas factory inspections (covering EU/North America/Asia-Pacific)
• Own bonded warehouses (area ≥3000㎡)
• Professional legal team (handled ≥15 quality disputes)
• Provide equipment calibration services (compliant with JJF 1478-2024 standard)

Under the current trend of stricter import regulations, selecting full-chain service agency partners can improve customs clearance efficiency by 40% and reduce overall costs by 18%-22%. Importers are advised to focus on three core capabilities: technical document processing, quality system integration experience, and post-sales dispute resolution mechanisms.