VaccineEquipment ImportsSpecial characteristics recognition

After the implementation of the newly revised Biosafety Law in 2025, vaccine production equipmentImport Clearancehas formeda dual regulatory system: In addition to the regular import process for electromechanical products, it also needs to pass the biosecurity approval of the provincial drug regulatory department. According to the data of the General Administration of Customs in January 2025, the average customs clearance time for imported equipment related to the vaccine production line is 18 working days longer than that of ordinary equipment, and 68% of the delays come from the biosecurity certification link.

Decomposition of Key Operation Processes

• Pre - filing stage
  • Apply for a biosecurity license 90 days in advance (the validity period is shortened to 12 months)
  • Prepare a technical white paper on equipment parameters (needs to include proof of the microbial protection level)
• Key Points of On - site Inspection
  • Sealing Detection (using the positive pressure test method)
  • Residue Sampling (pay attention to the medium residue index)

Solutions to Typical Problems

When a certain vaccine enterprise imported a freeze - drying unit produced in Germany in March 2025, due todifferences in the expression of technical parametersthe customs clearance was blocked. Through thetri - party certification comparison table(corresponding items between CE certification and NMPA standards) prepared in advance, we completed the technical review within 48 hours and avoided demurrage charges.

• Top 3 Common Customs Clearance Obstacles:
  • Incomplete biosecurity approval materials (accounting for 42%)
  • Incorrect equipment classification (especially classification disputes for sterilization equipment)
  • The technical verification document has expired (Note the new GMP standard in 2025).

Benchmark for selecting agency services

By comparing the customs clearance data from 2024 to 2025, professional agencies can improve the import timeliness of vaccine equipment by 40%. It is recommended to focus on examining the agentsFour core capabilities:

• Resources for the green channel of biosafety approval
• Operation authority of the localized drug regulatory filing system
• Emergency technical dispute resolution expert group
• Real - time monitoring system for cold chain transportation

Forward - looking risk prevention and control

In response to the newly implemented MDR regulations of the EU in 2025, it is recommended to require suppliers to provideDouble compliance statement. A domestic vaccine enterprise has successfully shortened the customs inspection time to 3 hours by pre - installing equipment traceability chips, and this solution has been included in the bonus items of the 2025 customs AEO certification.