Bidding Qualification Restructuring Under New Industry Regulations

Announcement No. 47 of the General Administration of Customs in 2025 clearly requires thatCategory II importsMedical Equipmentmust provide complete clinical trial data. In a March 2025 MRI equipment tender from a top-tier hospital, three bidders were directly disqualified for failing to submit clinical evaluation reports with EU MDR certification. The latest policy changes include:

• Extension of registration certificate validity from 4 years to 5 years
• Chinese labels must include device serial number traceability information
• Additional biocompatibility testing requirements for implantable devices

Five Critical Details in Technical Parameter Matching

In a 2025 CT equipment tender from a Beijing medical group, the winning bidder faced installation failure due to power parameter labeling errors. Special attention should be paid to:

• Voltage specification matching (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

According to 2025 customs clearance data, the average customs clearance cycle for medical equipment has been reduced to 3.8 working days, but special case handling may still delay bidding timelines. It is recommended to adoptThree-Phase Risk Control Method:

• Pre-declaration stage
  • Advance commodity classification pre-ruling
  • Prepare duplicate copies of medical device registration certificates
• Declaration phase
  • Arrange third-party quality and safety verification
  • Simultaneously apply for clinical evaluation exemption catalog

Bid Document Dual Verification Mechanism

Analysis of tender documents from a provincial procurement center in Q2 2025 showed that 42% of bidders lost points due to missing document elements. It is recommended to establishFour-Dimensional Verification System:

• Consistency verification between technical parameters and registration certificates
• Correspondence review between after-sales terms and warranty periods
• Payment terms andL/CClause matching degree
• Adaptability between transportation solutions and equipment protection levels

Special scenario response strategies

In a 2025 epidemic prevention materials tender in Southwest China, successful cases demonstrated:Adopt pre-clearance + bonded warehousing modelCan shorten the supply cycle by 30%. Specific operations include:

• Utilize comprehensive bonded zones for equipment pre-debugging
• Apply for ATA Carnet temporary admission
• Establish emergency consumables buffer inventory