Global DNAEquipment importMarket New Landscape

According to BCC Researchs prediction, the global gene testing equipment market size will exceed $28 billion in 2025. As the second - largest import market, China accounts for 23%. Currently, the main source countries of equipment show obvious differentiation:

• High - end sequencing equipment: American - funded brands account for 78% of the market share (Illumina, Thermo Fisher)
• Nucleic acid extraction equipment: German and Japanese companies have a technological advantage (QIAGEN, Shimadzu)
• Portable detector: South Korean manufacturers have an average annual growth rate of 31% (Seegene, BioSewoom)

Three customs clearance barriers for the import of professional equipment

In recent agency cases, we have summarized the unique customs clearance risk points of biological equipment:

• Disputes over commodity classification
  • There is a 30% tariff difference between HS Codes 9027 and 8471 for sequencers
  • The supporting reagent kit may triggerMedical devicesSupervision
• Biosafety approval
  • Order No. 178 of the General Administration of Customs requires the provision of the filing certificate of a P3 laboratory
  • Equipment of US origin requires additional special item approval
• Stringent transportation conditions
  • Optical components require shock - proof packaging (amplitude ≤ 0.3g)
  • Enzyme preparations need to maintain a - 20℃ cold chain with full - process monitoring

Key points for the design of customized customs clearance solutions

We recommend adopting a three - stage risk control model:

• Pre - classification stage
  • Provide a description of the equipment principle and a functional module decomposition diagram
  • Apply for a pre - ruling on classification (on average, it shortens 7 working days)
• Document preparation stage
  • The processing cycle of biosecurity approval documents is compressed to 12 working days
  • Equivalence certificate of the US FDA 510(k) certification
• Logistics execution stage
  • Configure dual - temperature - zone transportation (-20℃/+4℃ synchronous control)
  • Implement three - level earthquake - proof acceptance at the installation site

Analysis of typical customs clearance cases

In 2023, represented an IVD enterprise to import the third - generation sequencing system:

• Problem diagnosis: The equipment contains bio - chip components and was misclassified into HS Code 9022
• Solution: Provide a technical white paper to demonstrate the nature of data collection
• Achievement Data:
• The tariff cost is reduced by 9.7%
• The port detention time is shortened to 3 days
• The transportation loss rate is controlled within 0.2%

Three compliance key points that importers must master

• Supplier qualification review: Check the validity period of the FDA registration number and CE certification
• Integrity of temperature records: Keep at least the temperature curve of the whole transportation process for 72 hours
• Emergency plan formulation: Prepare a backup power supply to cope with the risk of temporary power outages at the port