Comprehensive Analysis of All-inclusive Medical Equipment Import Agency Services

Medical EquipmentImport RepresentationThe all-inclusive fee model will undergo new changes in 2025. According toMedical Equipmentindustry association statistics, companies using all-inclusive services have achieved 40% faster customs clearance and 27% lower hidden costs. This article provides an in-depth analysis of the core value and operational points of the agency fee all-inclusive model.

I. Core Advantages of All-inclusive Agency Services

• Cost visualization: Includes all-process fees such as customs declaration, logistics, and documentation
• Risk transfer mechanism:
  • Tariff calculation error compensation
  • Port demurrage cost guarantee clause
• Compliance guarantee system: Latest medical device registration certificate filing services

II. Five Key Indicators for Service Provider Selection

2025 Customs AEO certification adds new intelligent document review requirements. Key considerations include:

• 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.Case database scale (recommended >200 cases)
• Localized service network covering key ports
• Pre-classification accuracy rate (industry benchmark 92%)
• Emergency response time (written feedback within 30 minutes)
• Insurance coverage (recommended including product liability insurance)

III. Fee Structure and Cost Control

Comparison of all-inclusive fee structures for 3 typical medical equipment types (unit: USD):

• Ultrasonic diagnostic equipment
  • Basic service fee: 1200-1500
  • Special documentation fee: 300-500
• Endoscope system
  • Cold chain transportation surcharge: 800-1200
  • Biosafety certification fee: 600-900

IV. Key points for operational process optimization

• Pre-declaration stage: HS code pre-confirmation + tariff guarantee
• Logistics control: Real-time data interface for temperature control equipment
• Expedited Clearance: Synchronous processing of medical device operation license

V. Response to 2025 industry new regulations

According to the latest draft amendment of Medical Device Import Management Measures:

• Import filing validity period shortened to 12 months
• Clinical evaluation reports must include localized data
• Mandatory implementation of Unique Device Identification (UDI)

Professional advice:Select service providers with pre-classification databases and regulatory alert systems, focusing on their implementation cases for the 2025 EU MDR new regulations. It is recommended to specify the interface standards for digital declaration systems in contracts, reserving 10-15% of service fees as performance bonds.