Industry Status: 2025Medical EquipmentImports will face structural adjustments.

According to the latest data from the General Administration of Customs, the import value of precision instruments in the first half of 2024 reached $28.7 billion, with medical testing equipment accounting for an increased share of 41%. Notably, the revised Medical Device Supervision and Administration Regulations, set to take effect in 2025, explicitly require:Class III medical device importers must hold a filing certificate issued by the provincial drug regulatory authority.This places higher demands on the compliance capabilities of agency service providers.

Five Core Competencies of High-Quality Agents

• Special Equipment Filing Qualification
  • Medical Device Business Filing Certificate (New CT Equipment Filing Category Added in 2025)
  • Import Measuring Instrument Pattern Approval Certificate
• Customs clearance efficiency guarantee system
  • Pre-classification accuracy rate >98%
  • Local Inspection Emergency Response Mechanism
• Tax planning capability
  • The applicable rate of free trade agreement tariffs exceeds 85%.
  • Success rate of tax exemption policy applications for R&D equipment

The three lines of defense for risk prevention and control.

A certain genetic testEquipment ImportsThe case reveals that due to the agency's negligence in updating technical regulations, equipment worth $1.2 million was detained at the port for 37 days. It is recommended to establish:

• Dynamic Monitoring of Technical Regulations: FDA 510(k), CE Certification Annual Renewal
• Supply chain traceability mechanism: Key componentsIt is recommended to verify through the following methods:Please verify.
• Legal Remedy Plan: Intellectual Property Infringement Rapid Response Channel

Supplier Evaluation Quantitative Model

• Basic Competencies (40%): Customs clearance time, error rate, and filing qualifications
• Value-added services (35%): Laboratory equipment calibration, technical document translation
• Emergency response capability (25%): 48-hour anomaly response, margin system

New Requirements for Medical Device Agency in 2025

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

• Real-time Monitoring System for Cold Chain Transportation (2-8°C Equipment)
• The electronic filing system is directly connected to the drug regulatory department's data.
• Special customs clearance plan for biosafety laboratory equipment

Four Misconceptions in Decision-Making

• Blind pursuit of low prices leads to compliance risks (when the price difference is <5%, prioritize service).
• Neglecting localized service capabilities (key ports should be equipped with dedicated operational teams).
• Confusionforeign tradeAgency and Freight Forwarding Functions
• Unverified historical operation records (request for customs clearance archives of similar equipment)