Restructuring of Bidding Qualifications Under New Industry Regulations

Announcement No. 47 of the General Administration of Customs in 2025 clearly stipulates that,Class II ImportMedical EquipmentComplete clinical trial data must be provided.In a March 2025 MRI equipment tender at a top-tier hospital, three bidders were directly disqualified for failing to submit clinical evaluation reports certified under the EU MDR. The latest policy changes include:

• The validity period of the registration certificate has been extended from 4 years to 5 years.
• The Chinese label must include traceability information for the device serial number.
• Implantable devices require additional biocompatibility testing.

Five Critical Details in Technical Parameter Matching

In the 2025 CT equipment bidding for a Beijing-based medical group, the winning bidder was unable to install the equipment upon arrival due to an error in the power supply parameter labeling. Special attention must be paid to the bidding documents:

• Voltage specification matching (the difference between 220V±10% and 230V±5%)
• Ambient temperature range (difference between laboratory and clinical environments)
• Software version compatibility (must explicitly support DICOM 3.0 protocol)

Hidden Cost Calculation of Customs Clearance Time Efficiency

According to the 2025 customs clearance data, the average clearance cycle for medical equipment has been reduced to 3.8 working days. However, special circumstances may still cause delays in bidding timelines. It is recommended to adoptThree-stage risk control method:

• Pre-declaration stage
  • Apply for advance ruling on commodity classification.
  • Prepare a duplicate copy of the medical device registration certificate.
• Declaration phase
  • Arrange third-party quality and safety verification
  • Synchronized application for the exemption list from clinical evaluation

Bidirectional Verification Mechanism for Bidding Documents

The bid analysis for the second quarter of 2025 from a provincial procurement center revealed that 42% of bidders were penalized due to missing document elements. It is recommended to establishFour-dimensional verification system:

• Verification of Consistency Between Technical Parameters and Registration Certificate
• After-sales Terms and Warranty Period Correspondence Review
• Payment terms andL/CTerm Matching Degree
• Transportation Plan and Equipment Protection Level Compatibility

Special scenario response strategies

The successful case in a 2025 epidemic prevention supplies bidding in the Southwest region shows:Adopt the pre-clearance + bonded warehousing modelThe supply cycle can be shortened by 30%. Specific operations include:

• Conducting equipment pre-commissioning in the comprehensive bonded zone
• Application for Temporary Admission under ATA Carnet
• Establish an emergency consumables buffer stock