Experimentequipment. 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.s 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