Equipment Attribute Identification:Radiofrequency and laser devices are uniformly classified as Class II medical devices, while those with energy exceeding 50W are upgraded to Class III.
Enhanced Customs Inspection:The inspection ratio for beauty devices has been increased to 15% (only 8% in 2023).
New Logistics Regulations:Equipment containing lithium batteries must provide UN38.3 certification, and cold chain transportation requires real-time temperature monitoring data.
II. Eight-Step Operational Process for Agency Import
Professionalforeign tradeStandard service process of an agency company:
Phase 1: Qualification Review
The importer is required to provide: Medical Device Business License (Class III requires a filing certificate).
The manufacturer must provide: CE/FDA certification (starting from 2025, verification by a CNAS-accredited laboratory is required).
Phase 2: Contract Signing
Clarify the division of responsibilities under DDP/DAP terms
Agreement on the Payment Method for the 3% Quality Bond
Phase 3: International Shipping
It is recommended to use air cushion vehicles + constant temperature containers for precision instruments.
It is recommended to purchase transportation insurance covering 0.3% of the cargo value.
III. Three Key Points for Customs Declaration
In accordance with the requirements of Announcement No. 47 of the General Administration of Customs in 2025:
Medical Device Attribute Confirmation
Please submit the "Product Intended Use Statement" and the "Technical Parameter Comparison Table" simultaneously to avoid classification disputes.
The latest tax rebate declaration system in 2025 has achieved full - process electronicization, which is specifically divided into five steps:
The submission must include notarized translations of FDA/CE certifications, samples of Chinese warning labels, and electromagnetic compatibility test reports.
IV. Four Practical Strategies for Cost Optimization
Tariff Planning:By utilizing the RCEP agreement tariff rates, the tax on Japanese-made equipment can be reduced to 5.8%.
Logistics solutions:LCL shipping can save 35% on freight costs (when cargo value is <$100,000).
Exchange rate lock:It is recommended to adopt a forward approach.FX Settlement AgencyHedging exchange rate risk
Compliance management:Completed ahead of schedule.3CCertification can avoid an average of 23 days of customs clearance delays.
V. Analysis of Typical Risk Cases
Case 1:A Korean beauty device was mistakenly classified under small household appliances, resulting in a 200,000 yuan administrative penalty. Solution: Apply for a Customs Classification Advance Ruling.
Case 2:The German imported equipment was returned due to lack of radiation safety certification. Recommendation: Request the exporter to provide an IEC 60601-1 test report.
Professional foreign trade agency services can help importers reduce customs clearance time by 40% and lower overall costs by 15-20%. It is recommended to choose an agency company with medical device import qualifications and establish a long-term customs compliance cooperation mechanism.