Home?Medical Equipment? Why Do Imported Precision Instruments Always Get Stuck in the Customs Clearance Process?
Three Core Pain Points in the Customs Clearance of Imported Instruments
According to the data of the General Administration of Customs in 2025年第一季度, the declaration error rate of precision instrument products is 42% higher than that of ordinary products, and the average port congestion time is 11.7 working days. By analyzing 278 enterprise cases, we found that the main problems are concentrated in:
Classification dispute: Multifunctional testing equipment often involves more than 3 HS code options
Missing documents:Medical EquipmentIt is required to submit both FDA certification and NMPA filing certificates simultaneously
Valuation differences: Equipment with software systems often generates disputes due to the pricing method
Six Core Service Capabilities of Professional Agents
High - quality customs declaration agents should possess compound service capabilities. By comparing the service agreements of 12 leading enterprises, we have refined the key capability model:
Pre - classification diagnosis system
Establish a mapping database of instrument parameters and tariff notes
Configure a dedicated classification verification algorithm
Dynamic compliance monitoring
Automatically capture the update of the medical device classification catalog of the Food and Drug Administration
Synchronize the classification decisions of the General Administration of Customs in real - time
Price declaration strategy library
Declaration plan for separating hardware and embedded software
Royalties declaration template
Analysis of Key Points in Customs Clearance Operations in 2025
For the newly released Measures for the Administration of the Import of Medical Devices (2025 Edition), special attention should be paid to the following during declaration:
The filing time limit for Class II medical devices is shortened to 3 working days.
Laser - type equipment needs to submit an additional radiation safety permit.
The validity period of the calibration certificate is adjusted from 12 months to 9 months.
Typical case: Resolution of an import dispute over a mass spectrometer.
The Orbitrap mass spectrometer imported by a certain biotech company was detained at the port for 28 days due to classification disputes. After our intervention, we took three steps to resolve it:
Extract the technical parameters of the ion - trap mass analysis module of the equipment.
Compare with the Classification Ruling No. 17 of the General Administration of Customs in 2025.
Issue a functional verification report from a third - party testing institution.
Finally, the tariff rate was successfully reduced from 8% to 5%, saving 470,000 yuan in tax and recovering 128,000 yuan in port detention fees.
5 verification dimensions for choosing an agent
Check the number of successful medical device filing cases in the past two years.
Require the provision of pre - confirmation records for the classification of specific commodities.
Verify the AEO certification status and the customs credit rating.
Confirm whether professional testing equipment (such as a spectral analyzer) is equipped.
Test the docking efficiency of its electronic declaration system with the single window.