ExperimentEquipment Importss three hidden pitfalls

The global laboratory equipment market size is expected to exceed $68 billion in 2025, with Chinas import share continuously rising to 37%. ButMedical EquipmentPolicy changes such as catalog updates, implementation of the new EU IVDR regulations, and expansion of the US EAR control list have caused unexpected clearance delays for 84% of import companies.

Core value matrix of professional agents

Certification system:

• Medical device registration certificate (CFDA)
  • The average approval cycle for Class II devices has been shortened to 120 days
  • Clinical evaluation requirements have been refined to 7 technical parameters
• Measuring instrument pattern approval (CMA)

Commodity classification technology:

• The 2025 HS code update adds 12 new subheadings
  • Gene sequencers are separately classified under 9018.2015
• Tariff reduction ratio under the ASEAN agreement increased to 92%

Practical operation process breakdown

Case study of a listed pharmaceutical company importing cryo-electron microscope:

• Equipment parameters: -180°C ultra-low temperature system
  • Involves3CSpecial treatment for non-catalog items
• Clearance difficulties:
  • Separate declaration of vacuum pumps causing classification disputes
  • Software system triggering technology export controls
• Solution:
  • Applying for tax exemption qualifications for scientific research equipment
  • Split shipping solution saving 18% logistics costs

2025 industry warning indicators

Technical standard upgrades:

• ISO 17025: 2025 calibration requirements add quantum measurement specifications
• FDA 510(k) review adds AI algorithm verification module

Tariff policy windows:

• Tax policy for importing major technical equipment extended to 2027
• Hainan Free Trade Port zero-tariff list adds 12 types of testing equipment

Agent service selection evaluation form

• Essential capabilities:
  • Single window declaration error rate <0.3%
  • Classification dispute resolution success rate >85%
• Value - added service items:
  • Pre-review of destination country technical regulations
  • Used equipment residual value assessment system