Global DNAequipment. For example, Indonesia has the SNI certification, Thailand has the TISI certification, and the Philippines has the BPS certification. It is necessary to confirm in advance the equipment voltage (such as 380V/50Hz in Thailand), the compatibility of the CE certification, and the proof of environmentally friendly materials.Market 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 EquipmentSupervision
• 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
• Solutions: 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