I.Medical EquipmentThe Triple Firewall of Import Qualification

According to the latest 2025 "Regulations on the Supervision and Administration of Medical Devices," imported medical equipment must obtainMedical Device Registration CertificateandImport licenseDual Certification. Data from the 32 medical enterprises we have served shows that 23% of application delays stem from licensing issues:

• Registration Certificate Category Matching
  • The filing period for Class I equipment is 15 working days.
  • The registration cycle for Class II devices is 6-8 months.
  • The registration cycle for Class III devices is 12-18 months.
• Special requirements for import licensing
• Radiation equipment requires additional environmental approval.
• Implantable devices require marketing authorization proof from the country of origin.

II. Five Key Control Points in the Customs Clearance Process

A case study of imported MRI equipment at a top-tier hospital in 2024 demonstrates that standardized declaration can save 23 days in customs clearance:

• Pre - classification of Goods: Submit technical parameters 30 days in advance.
• The latest tax rebate declaration system in 2025 has achieved full - process electronicization, which is specifically divided into five steps::
  • FDA/CE Certification Bilingual Version (Chinese-English)
  • Verification of Disinfection Certificate Validity Period
• On-Site Inspection Preparation: Arrange for professional technical personnel to accompany.

III. The Precise Calculation Model for Import Duties and Taxes

Comprehensive Tax Rate Calculation Table for Medical Device Imports in 2025:

IV. In-Depth Analysis of Typical Risk Cases

Case 1:A certain enterprise imported a CT machine but failed to complete the required3CThe certification process led to the detention of the equipment at the port, incurring a daily late declaration fee of 0.2%, ultimately resulting in a penalty payment of 870,000 yuan.

Solution:Through the AEO-certified enterprise express channel, emergency certification can be completed within 72 hours.

Case 2:The insurance company refused to compensate for the 2.3 million cargo loss due to the failure of biological activity in orthopedic implants caused by excessive transportation temperature.

Solution:Adopt a dual-temperature recorder + real-time monitoring system to maintain a complete chain of evidence.