Industry status: 2025Medical EquipmentImports will face structural adjustments

According to the latest data from the General Administration of Customs, precision instrument imports reached $28.7 billion in the first half of 2024, with medical testing equipment accounting for 41%. Notably, the revised Medical Device Supervision and Administration Regulations to be implemented in 2025 explicitly require:Class III medical device importers must hold provincial-level drug regulatory department filing certificates, which imposes higher compliance requirements on agency service providers.

Five core competencies of high-quality agencies

• Special equipment filing qualifications
  • Medical device operation filing certificates (new CT equipment filing category added in 2025)
  • Import measuring instrument type approval certificates
• Customs clearance time guarantee system
  • Pre-classification accuracy rate >98%
  • Local inspection emergency response mechanism
• Tax planning capability
  • Free trade agreement tariff application rate >85%
  • Success rate of tax exemption policy applications for R&D equipment

Pre-operation review, process monitoring, post-event traceability

A genetic testingEquipment Importscase shows that an agencys negligence in updating technical regulations caused $1.2 million worth of equipment to be detained at port for 37 days. It is recommended to establish:

• Technical regulation dynamic monitoring: FDA 510(k), CE certification annual updates
• Supply chain traceability mechanism: Key componentsIt is recommended to verify through the following methods:Explicit verification
• Legal relief contingency plans: Intellectual Property Infringement Rapid Response Channel

Supplier Evaluation Quantitative Model

• Basic Capabilities (40%): Customs Clearance Efficiency, Error Rate, Filing Qualifications
• Value-added Services (35%): Laboratory Equipment Calibration, Technical Document Translation
• Emergency Response Capabilities (25%): 48-hour Anomaly Response, Deposit System

New Requirements for Medical Device Agency in 2025

According to upcoming regulatory policies, Class III medical device agency service providers must additionally possess:

• Real-time Monitoring System for Cold Chain Transportation (2-8°C Equipment)
• Electronic Declaration System with Direct Data Connection to Drug Regulatory Authorities
• Special Customs Clearance Solutions for Biosafety Laboratory Equipment

Four Misconceptions in Selection Decisions

• Blind Pursuit of Low Prices Leading to Compliance Risks (When Price Difference <5%, Priority Should Be Given to Service)
• Neglecting Localized Service Capabilities (Key Ports Should Have Dedicated Operation Teams)
• Confusionforeign tradeAgency and Freight Forwarding Functions
• Failure to Verify Historical Operation Records (Require Provision of Customs Clearance Files for Similar Equipment)