Medical Equipment?Import Agency?Current Status and Challenges of the Industry

By 2025, China?Medical Devices?The market size is projected to exceed 1.5 trillion yuan, with imported equipment maintaining a stable share of 35%-40%. With the implementation of the revised 2025 edition of the "Regulations on the Supervision and Administration of Medical Devices," import agents will need to simultaneously possessThree core competencies:

• Interpretation of Regulations and Compliance Management Capability
  • Master the latest NMPA registration and submission requirements
  • Be familiar with international certification conversion rules such as CE/FDA.
• Specialized Logistics Support System
• Real-time monitoring of cold chain temperature control equipment
• Shockproof and compression-resistant precision instrument packaging solution
• Comprehensive risk management mechanism
  • The ability to accurately classify HS codes
  • Experience in Utilizing Tariff Reduction Policies

Evaluation Dimensions of High-Quality Proxy Service Providers

Select medical care?Equipment import?When selecting agents, it is recommended to establish an evaluation system based on the following dimensions:

• Qualification verification:
  • Does the category of the Medical Device Business License match?
  • Customs AEO certification level
• Industry experience:
  • Number of similar equipment import cases
  • Emergency incident handling success rate
• Service Network:
  • Overseas inspection site coverage
  • Strategic Layout of Domestic Bonded Warehouses

Key Control Points in Import Operation Process

The typical import process for medical devices can be divided into three main stages:

• Preparatory phase (30 working days)
  • Technical Parameter Compliance Pre-review
  • Application for Exemption from CCC Certification
  • Preparation of Import License Documentation
• Customs clearance logistics phase (7-15 working days)
  • Application for Pre-classification Advice
  • Destination Inspection Application
  • Customs Bond Scheme Design
• After-sales service phase
  • Handover of Equipment Commissioning Technical Documentation
  • Access to the Quality Traceability System

Typical Risks and Countermeasures

According to customs statistics on medical device import violation cases in 2025, the main risks are concentrated in:

• Document management risks (accounting for 42%)
  • Countermeasure: Establish a four-tier document verification mechanism
• Commodity classification risk (accounting for 35%)
  • Countermeasure: Implement HS code pre-ruling application.
• Exchange rate fluctuation risk (accounting for 18%)
  • Countermeasures: Hedging Tools and Payment Cycle Optimization

Practical case analysis

In the case of a tertiary hospital importing a 3.0T MRI equipment, the professional agency company saved costs through the following measures:

• Utilizing the tax exemption policy for educational and scientific supplies to reduce tariffs by 1.2 million yuan.
• Design an air-sea intermodal transportation solution to reduce transit time by 40%.
• Avoiding late declaration fees through classification pre-ruling.

Choosing a professional medical equipment import agency service provider is essentially a procurement process.Risk control abilityandThe ability to convert policy dividendsIt is recommended that enterprises focus on the depth of understanding of industry-specific characteristics and the completeness of the service system when selecting partners, rather than simply comparing service rates.