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. 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 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 plansIntellectual 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)